INVOS™
0123
Patient Monitor
Operator's Manual
Medtronic and Medtronic logo are trademarks of Medtronic. ™* brands are trademarks of their respective owner. Other brands are
trademarks of a Medtronic company.
Symbols
kPa
kPa
°F
°C
°F
°C
0123
20
Reference code (part number)
Serial number
Lot number
European Community (EC) authorized representative
Prescription only. US federal law restricts this device to sale by or on the order of a physician.
Protection against fluid ingress: Protected against vertically falling water drops when tilted to 15º
Manufacturer
Date of manufacture
Fragile
Keep dry
Must consult instructions for use
Consult instructions for use
Atmospheric pressure limits (see Environmental Conditions, page 112)
Temperature limits (see Environmental Conditions, page 112)
Humidity limits (see Environmental Conditions, page 112)
Proper waste disposal for electrical and electronic equipment
MR unsafe - Do not use during magnetic resonance imaging
Defibrillation-proof type BF applied part
CSA – Canadian Standards Association certification mark
CE – Conformité Européene authorization mark. 0123 – TÜV SÜD Product Service GmbH (notified body).
Not made with natural rubber latex
Electromagnetic interference may occur in the vicinity of equipment marked with this symbol
Quantity included in package (example: 20)
i
Do not immerse
ii
Table of Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Unpacking and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Power Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Operational Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Monitoring System Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Set Up for Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Optional Set-Up Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Baselines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Trend View Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Event Marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Area Under the Curve (AUC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Finish Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Case Histories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5 Data Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Displaying Monitoring System Screens on an External Monitor . . . . . . . . . . . . . . . . . . . . . . 77
Downloading Case Histories to a USB Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Transmitting Monitoring System Data to External Devices via the Serial Port . . . . . . . . . 78
Data Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
6 Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Patient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Sensor Use Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Operator's Manual English 1
EMI (Electromagnetic Interference) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
7 Product Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Cleaning the Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Service and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Software and Firmware Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Recycling and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
8 Alarms and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Error Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Product Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
9 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Safety Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Accessories/Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
10 Theory of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
11 Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Alarm Audio and Visual Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Sensor Operating Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Equipment Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Biocompatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Appendix A. Clinical Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Hypoxia Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Interventional Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Validation Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Figure 1. Start-up Screen Showing Code Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure 2. INVOS™ Patient Monitor Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure 3. Monitor - Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2 Operator's Manual English
Figures
Figure 4. Monitor - Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Figure 5. Monitor - Right Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Figure 6. Monitor - Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Figure 7. Docking Station - Bottom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Figure 8. Docking Station - Connector for Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Figure 9. Sample Monitoring Screen Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Figure 10. Power Input Connection at Bottom of Docking Station . . . . . . . . . . . . . . . . . . . 24
Figure 11. Docking Station Power Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Figure 12. Battery Location at Back of Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Figure 13. Battery Slot and Latch at Back of Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Figure 14. Battery Installed in Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Figure 15. Monitor Mounted in Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Figure 16. Connecting the Preamplifier Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Figure 17. Connecting the RSC to the Preamplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Figure 18. Power Input Connection at Bottom of Docking Station . . . . . . . . . . . . . . . . . . . 32
Figure 19. Power Button on Top of Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Figure 20. Set-Up Screen - Preamplifier(s) Connected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Figure 21. Set-Up Screen - No Preamplifier(s) Connected . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Figure 22. Monitoring System on Stand with Preamplifier Hung on Rail . . . . . . . . . . . . . 35
Figure 23. Set-Up Screen - Prompt for Sensor Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Figure 24. Monitoring Screen - New Case - No Baselines Set . . . . . . . . . . . . . . . . . . . . . . . . . 45
Figure 26. Default Sensor Placement Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Figure 27. Optional Sensor Placement Sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Figure 28. Highlighting an On-Screen Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Figure 29. Sensor Icons Next to CURRENT Values (Press to Locate Sensor on Patient) . 48
Figure 30. Patient Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Figure 31. Entering a Patient ID Before Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Figure 32. Patient Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Figure 33. Entering a Patient ID During Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Figure 34. Sensor Label Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Figure 35. SETTINGS - GENERAL - SCREEN BRIGHTNESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Figure 36. Monitoring Screen - New Data Set - No Baselines Set . . . . . . . . . . . . . . . . . . . . . 53
Figure 37. SET BASELINES - No Baselines Previously Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Figure 38. SET BASELINES - Baselines Previously Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Figure 39. Monitoring Screen with Baselines Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Figure 40. Trend View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Figure 41. Trend View - One Graph (Top, Default) and Two Graphs (Bottom) . . . . . . . . . 56
Figure 43. SETTINGS - TRENDS - TWO AXIS VIEW vs. ONE AXIS VIEW . . . . . . . . . . . . . . . . . 57
Figure 44. Trend Line Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Figure 45. SETTINGS - TRENDS - TREND LINE AVERAGING . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Figure 46. Trend View Review Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Figure 47. Trend Graph Pop-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Figure 48. Monitoring Screen - Trend Graph Pop-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Figure 49. Visual Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Figure 50. SET ALARM LIMITS - Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Figure 51. SET ALARM LIMITS - Upper Limits On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Figure 52. SETTINGS - ALARMS - ALARM VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Figure 56. Dismissible Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Operator's Manual English 3
Figure 58. Events Marked in Trend View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Figure 59. ADD EVENT Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Figure 60. Event Mark Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Figure 61. EDIT EVENT Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Figure 62. SETTINGS - EVENTS (Screen 1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Figure 63. AUC SUMMARY Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Figure 64. CASE HISTORY List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Figure 65. Case History Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Figure 66. VGA Port on Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Figure 67. Serial Port on Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Figure 68. Serial Port Pin-Outs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Figure 69. Null Modem Cable Diagram for Connection to Serial Port (Two Options) . . 81
Figure 70. Accuracy rSO2 and fSO2, 20 Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Figure 71. Trend rSO2 and fSO2, 20 Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Tables
Table 1. Monitoring System - Standard Shipped Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Table 2. AC Power Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Table 3. Battery Status Indicators - Monitoring System Operating on Battery Power . . 26
Table 4. Institutional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Table 5. Quick Start Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Table 6. Operational Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Table 7. Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Table 8. System Memory - Common Situations and Recommended Actions . . . . . . . . . 42
Table 9. Alarm Audio Button States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Table 10. Audible and Visual Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Table 11. Alarm Limits Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Table 12. Serial Port Pin-Out Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Table 13. Hardware Requirements for Philips VueLink™* and IntelliBridge™*
Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Table 14. Case History Downloads - Data Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Table 15. Case Data Downloads (PC LINK 1 and PC LINK 2) - Data Fields . . . . . . . . . . . . . . 85
Table 16. Data Downloads - Event Codes 1 to 40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Table 17. Data Downloads - Event Codes 41 to 80 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Table 18. Data Downloads - Event Codes 81 to 120 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Table 19. Data Downloads - Event Codes 121 to 254 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Table 20. Data Downloads - Status Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Table 21. Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Table 22. Alarm Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Table 23. Error Conditions and Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Table 24. Monitoring System Accessory Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Table 25. Transport, Storage, and Operating Condition Ranges . . . . . . . . . . . . . . . . . . . . . 113
Table 26. Alarm Audio Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Table 27. Average Alarm Sound Pressure Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Table 28. Alarm Visual Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Table 29. POST Pass Tone Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
4 Operator's Manual English
Table 30. INVOS™ Adult rSO2 Sensor Operating Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Table 31. Electromagnetic Emissions Guidelines and Compliance . . . . . . . . . . . . . . . . . . 116
Table 32. Electromagnetic Immunity Guidelines and Compliance . . . . . . . . . . . . . . . . . . 116
Table 33. Recommended Separation Distance Calculations . . . . . . . . . . . . . . . . . . . . . . . . 117
Table 34. Test Specifications for Enclosure Port Immunity to RF Wireless
Communications Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Table 35. Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Table 36. Performance Characteristics: Accuracy Bias, Error (SD), RMSD, and
Correlation (R2) for rSO2 and fSO2, 20 Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Table 37. Trend Bias, Error (SD), and Correlation (R2) for ΔrSO2 and ΔfSO2, 20 subjects 123
Operator's Manual English 5
6 Operator's Manual English
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 7
•
Safety Information, page 7
•
Obtaining Technical Assistance, page 10
•
Warranty Information, page 11
1.2. Intended Audience
This manual provides information to health-care professionals in a hospital setting for
operation and maintenance of the monitoring system. Refer to the institution for any
additional training or skill requirements beyond those identified here for operation and
maintenance of the monitoring system.
Before operating the monitoring system, carefully read this manual, the Instructions for Use
for the accessories, and all precautionary information and specifications.
1.3. Safety Information
1
This section contains important safety information for use of the monitoring system.
•
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.
•
Cautions alert users to exercise appropriate care for safe and effective use of the
product.
•
Notes provide additional guidelines or information.
1.3.1. 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 107.
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-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
Operator's Manual English 7
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.
1.3.2. 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.
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 multiparameter 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.
1.3.3. 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 91.
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 107.
8 Operator's Manual English
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
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.
1.3.4. 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.
1.3.5. 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.
1
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: 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.
Operator's Manual English 9
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.
1.3.6. 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 on the back of
the monitor and the preamplifiers. The software version for the monitoring system is
displayed on the start-up screen at power-on.
Figure 1. Start-up Screen Showing Code Version
10 Operator's Manual English
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
technicians for use when servicing the monitoring system.
1.5. Warranty Information
To obtain product warranty information, contact Medtronic or a local Medtronic
representative. See Technical Services, page 10.
The information contained in this document is subject to change without notice. Medtronic
makes no warranty of any kind with regard to this material, including, but not limited to,
the implied warranties or merchantability and fitness for a particular purpose. Medtronic
shall not be liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this material.
1
Operator's Manual English 11
12 Operator's Manual English
2. Product Overview
2.1. Overview
This chapter contains basic information about the INVOS™ patient monitor (the
“monitoring system”).
•
Product Description, page 13
•
Indications for Use, page 14
•
Product Views, page 14
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 Chapter 9, Accessories, page 107
Monitoring system features include:
•
User configurable rSO2 baselines (page 52), alarm limits (page 62), and AUC
thresholds (page 70)
•
Physiological and technical alarm reporting (page 99)
2
•
User configurable data display (rSO2, change from baseline, sensor labels, and trend
data) (Figure 9, page 20)
•
Alarm silencing (page 64)
•
Event marking (page 66)
•
Visual representations of sensor locations (page 47)
•
Sensor functional state (page 99):
○
Sensor off
○
Sensor disconnect
○
Sensor fault
•
Case history storage and export (page 73)
Operator's Manual English 13
•
Real-time data output to external devices such as a Philips multi-parameter system or
PC (page 78)
•
VGA, Serial (RS-232), and USB interfaces (Figure 4, page 16 and Figure 7, page 19)
2.3. Indications for Use
The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry
system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation
of blood in the brain or in other tissue beneath the sensor. It is intended for use on
individuals greater than 40 kg at risk for reduced-flow or no-flow ischemic states.
2.4. Product Views
2.4.1. Full System
2.4.1.1. System Component Overview
Figure 2. INVOS™ Patient Monitor Components
1. Sensors
2. Preamplifier
3. Docking station
14 Operator's Manual English
4. Monitor
5. Reusable sensor cable (RSC)
2.4.2. Monitor Components
2.4.2.1. Monitor - Front
Figure 3. Monitor - Front
2
1. VESA™*-compliant stand accessory
2. Power cord (connected to bottom of
docking station)
3. Docking station
4. Monitor indicators (power/battery,
hard disk activity, wireless)
5. Monitor
6. Docking station power indicator
(illuminates blue when the docking
station is receiving AC power)
Operator's Manual English 15
2.4.2.2. Monitor - Left Side
Figure 4. Monitor - Left Side
1. Lever for adjusting monitor angle
2. I/O port cover with latch (slide to
access ports inside)
3. USB 3.0 port
16 Operator's Manual English
4. USB 2.0 port
5. Docking station
2.4.2.3. Monitor - Right Side
Figure 5. Monitor - Right Side
2
1. Docking station
2. Connector for preamplifier (x2)
3. Lever for adjusting monitor angle
Operator's Manual English 17
2.4.2.4. Monitor - Back
Figure 6. Monitor - Back
1. Docking station
2. Connectors for preamplifiers
3. Power button
18 Operator's Manual English
4. Programmable buttons (not used)
5. Lever for adjusting monitor angle
6. Speaker
2.4.2.5. Docking Station
Figure 7. Docking Station - Bottom View
1. Power input connection (DC in jack)
2. LAN port (not used, disabled)
3. VGA port
Figure 8. Docking Station - Connector for Monitor
4. Serial port (RS-232)
5. USB 2.0 port (x2)
2
1. Docking station 2. Connector for monitor
Operator's Manual English 19
2.4.2.6. Monitoring Screen
Figure 9. Sample Monitoring Screen Elements
1 Message area Provides information about alarm conditions. The background indi‐
cates 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 60. If a “?” appears next to the alarm message,
press the “?” for additional information.
N/A Dismiss button
(not shown)
2 Sensor icons Each sensor icon has a label indicating its location on the patient.
3 Date and time Current date in MM/DD/YYYY format (by default) and current time in
4 Battery status indi‐
cator
5 Battery charging
indicator
Available in the message area when an alarm is dismissible. See Dis‐
missing an Alarm, page 65.
See Changing the On-Screen Sensor Labels, page 50.
12- hour HH:MM:SS format (by default). The date and time format can
be changed by an authorized technician.
Indicates the remaining battery capacity:
Charged battery — The level in the icon decreases as battery power is
used.
Low battery — A medium-priority alarm occurs when the monitoring
system is operating on battery power and the battery has a charge of
<33% remaining. The alarm message BATTERY LOW appears.
Critically low battery — A medium-priority alarm occurs when the
monitoring system is operating on battery power and the battery has a
charge of <5% remaining. The alarm message BATTERY CRITICALLY
LOW appears. When no charge remains, the monitoring system auto‐
matically shuts down.
Indicates that the monitoring system is connected to AC power and the
battery is charging.
20 Operator's Manual English
(continued)
AC power indica‐
tor
6 CURRENT The most recent rSO2 reading from each sensor.
7 CHANGE The percent change between the current rSO2 reading and the estab‐
8 Sensor/readings in
alarm state
9 Alarm limits The current alarm limits for each sensor, color-coded to the corre‐
10 Event mark Event marks indicate significant occurrences during monitoring. Event
11 Baseline values The current rSO2 baseline established for each tissue region being
12 Alarm Audio but‐
ton
13 MARK EVENT but‐
ton
14 Patient button While monitoring, press to return to the Set-up screen, reposition on-
15 Trend view The trend view shows the progression of rSO2 values over the course of
16 MENU button Press to access a variety of settings and functions depending on
When the battery is fully charged and the monitoring system remains
connected to AC power, the AC power indicator replaces the battery
charging indicator.
lished baseline for each sensor, color-coded to the corresponding sen‐
sor icon.
If a sensor alarm or loss of readings occurs, the corresponding sensor is
highlighted on the screen. If readings are lost, the CURRENT and
CHANGE values are replaced by dashes. Check the message area for
information about the condition.
sponding sensor icon. A horizontal red line indicates each alarm limit in
the trend view graph. See Setting Alarm Limits, page 62.
marks can be added to the trend graph at any time during monitoring
and are displayed as vertical lines with flags. See Event Marks,
page 66.
monitored, color-coded to the corresponding sensor icon. Dotted lines
in the trend view graph also indicate the baseline values, color-coded
to the corresponding sensor icon. See Baselines, page 52.
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 60
and Silencing or Pausing Alarms, page 64.
Press to add an event mark to the trend graph to indicate a significant
occurrence during monitoring. Choose from a customizable list of
events. See Event Marks, page 66.
screen sensors, or assign or modify a patient ID. See Set Up for Patient
Monitoring, page 42, Repositioning On-Screen Sensors, page 47,
and Assigning or Modifying the Patient ID, page 49.
a case. Data is color-coded to the corresponding sensor icon. rSO2 val‐
ues are presented on the vertical (y) axis. Time is presented on the hori‐
zontal (x) axis. See Trend View Management, page 55.
whether or not sensors are connected and monitoring has begun.
See Menu Structure, page 41.
2
Operator's Manual English 21
22 Operator's Manual English
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 23
•
Unpacking and Inspection, page 23
•
Power Options, page 24
•
Setup, page 27
3.2. Safety Reminders
Warning: Inspect the monitoring system and all accessories before use to ensure there are
no signs of physical damage or improper function. Do not use if damaged.
Warning: Shock hazard — Ensure the monitoring system is properly grounded when
operating on AC power.
Warning: If you do not hear a tone at system start-up, discontinue use of the monitoring
system and contact Medtronic or a local Medtronic representative.
3
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.
Caution: Make sure all connectors are fully engaged and free from moisture. Moisture
intrusion may cause poor performance or no readings at all.
3.3. Unpacking and Inspection
The monitoring system ships in multiple cartons. Upon receipt of the monitoring system,
examine the cartons for evidence of damage. Contact Medtronic Technical Services
immediately if a carton appears damaged. See Technical Services, page 10.
Standard items shipped are listed in Table 1. Quantities of some items may vary based on
customer requirements. Check all items for any sign of damage.
If you need to return the monitoring system for any reason, contact Medtronic Technical
Services. See Technical Services, page 10.
Note: Save the cartons and packing material for any future transport.
Table 1. Monitoring System - Standard Shipped Items
Item Quantity
Patient monitor 1
Lithium-ion battery 1
Patient monitor stand 1
VESA™* docking station 1
Operator's Manual English 23
Table 1. Monitoring System - Standard Shipped Items (continued)
Item Quantity
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)
a
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 10.
a
1
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: Shock hazard — Ensure the monitoring system is properly grounded when
operating on AC power.
The power input connection for the monitoring system is at the bottom of the docking
station. Always use the provided AC power cord and power supply.
Figure 10. Power Input Connection at Bottom of Docking Station
When the power supply is connected to the AC outlet and the docking station, the power
indicator on the docking station illuminates blue (Figure 11).
24 Operator's Manual English
Figure 11. Docking Station Power Indicator
AC power to the monitoring system is indicated as follows:
Table 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, page 26.
3
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.
Operator's Manual English 25
Figure 12. 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.
3.4.2.1. Battery Status Indicators
If using the monitoring system on battery power, be sure to frequently check the battery
status (Table 3).
Table 3. Battery Status Indicators - Monitoring System Operating on Battery Power
Battery status Screen icon Audible alarm Message
Charged
(33% - 100% remaining)
Low
(<33% remaining)
Critically Low
(<5% remaining)
Malfunctioning Low priority - no audible
N/A N/A
Medium priority BATTERY LOW
Medium priority BATTERY CRITICALLY LOW
BATTERY FAILURE
alarm
3.4.2.2. Battery Life
Caution: Dispose of the battery in accordance with local guidelines and regulations.
For maximum battery reliability, replace the battery on a regular basis. Medtronic
recommends replacing the battery once every 2 years. If the battery will not sustain
monitoring for more than approximately 1 hour when fully charged, replace the battery
immediately.
Contact Medtronic or a local Medtronic representative for information about obtaining
replacement batteries. See Technical Services, page 10.
26 Operator's Manual English
3.5. Setup
Use the following instructions to prepare the monitoring system for first use. See Chapter 4,
Operation, page 37 for additional steps to be performed by the clinician when monitoring
a patient.
•
Install the Battery, page 27
•
Insert the Monitor into the Docking Station, page 28
•
Connect the Preamplifier(s), page 29
•
Connect the Reusable Sensor Cables (RSCs), page 30
•
Apply Power, page 31
•
Set Institutional Defaults, page 33
•
Power Off the Monitoring System, page 34
•
Position the Monitoring System in the Clinical Setting, page 34
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 31 for
charging information).
3
To install the battery:
1. Remove the battery from its packaging.
2. At the back of the monitor, make sure that the battery latch, located above the
battery slot, is to the right (Figure 13).
Operator's Manual English 27
Figure 13. 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 14).
Figure 14. 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 monitoring
system. You can mount the docking station on the provided stand or on other VESA™*-
28 Operator's Manual English
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 15).
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
engages.
Figure 15. Monitor Mounted in Docking Station
3.5.3. Connect the Preamplifier(s)
Caution: Make sure all connectors are fully engaged and free from moisture. Moisture
intrusion may cause poor performance or no readings at all.
3
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 16).
Operator's Manual English 29
Figure 16. 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.
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
connector 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.
30 Operator's Manual English
Figure 17. Connecting the RSC to the Preamplifier
3. Repeat these steps for each RSC to be used.
4. Coil and secure the RSC cabling to avoid tangling.
3.5.5. Apply Power
Warning: If you do not hear a tone at system start-up, discontinue use of the monitoring
system and contact Medtronic or a local Medtronic representative.
Before applying power, refer to Power Options, page 24 to understand the requirements
for using AC power and battery power.
To power on the monitoring system:
1. Ensure that the AC outlet is properly grounded and supplies the specified voltage
and frequency. See Electrical, page 112 for voltage and frequency specifications.
2. Connect the power supply to the power input connection on the bottom of the
docking station.
3
Operator's Manual English 31
Figure 18. 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 11, page 25).
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.
Figure 19. 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 114 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 20).
32 Operator's Manual English
Figure 20. Set-Up Screen - Preamplifier(s) Connected
Note: If no preamplifiers are connected to the monitoring system, the screen
prompts you to connect them (Figure 21). See Connect the Preamplifier(s), page 29.
Figure 21. Set-Up Screen - No Preamplifier(s) Connected
Note: Make sure that the battery is fully charged prior to clinical use. Table 2,
page 25 describes the charging status indicators.
3.5.6. Set Institutional Defaults
Table 4 describes the institutional settings available for the monitoring system. Institutional
defaults must be set by an authorized technician. Refer to the monitoring system's service
manual. Refer to Table 6, page 40 for information about additional options that can be set
or changed by the clinician.
3
Operator's Manual English 33
Table 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 dura‐
tion
Alarm reminder signal ON, OFF OFF
Line frequency 50 Hz, 60 Hz 60 Hz
POST during sensor off ON, OFF OFF
Date (Select from calendar) Coordinated Universal Time (UTC)
Date format DD MM YYYY, YYYY MM DD, MM DD YYYY MM DD YYYY
Time (Select hh:mm) N/A
Time format 24 hr, 12 hr 12 hr
Language DANISH, DUTCH, ENGLISH, FRENCH, GER‐
Serial port OFF, PC LINK 1, PC LINK 2, CLINICAL TEST
INDEFINITE, 2 MINS INDEFINITE - When silenced by the user,
alarms remain silent until the user unsilen‐
ces them
For system diagnostics only. Do not set to
ON when used in a clinical setting.
ENGLISH
MAN, GREEK, HUNGARIAN, ITALIAN, NOR‐
WEGIAN, POLISH, PORTUGUESE, ROMA‐
NIAN, RUSSIAN, SLOVAK, SPANISH, SWED‐
ISH
OFF
SETUP, VUE LINK
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 connected.
3.5.8. Position the Monitoring System in the Clinical Setting
Warning: As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
Users may choose from a variety of mounting configurations, including the provided
monitor stand or other VESA™*-compatible mounting options capable of supporting at
least 5.1 lb (2.3 kg) (VESA™* FDMI MIS-D, 75). In addition, the preamplifiers have a fold-away
swivel hook for attachment to rails or poles (Figure 22).
34 Operator's Manual English
Figure 22. Monitoring System on Stand with Preamplifier Hung on Rail
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
Station, page 28.
•
Monitor stand use — When using the monitor stand, place the stand on a sturdy flat
surface. Use the lever on the back of the stand to adjust the angle of the monitor for
best visibility.
•
Power outlet access and power cord position — Ensure that the power outlet used for
the monitoring system is easily accessible.
•
Cable routing — Position the monitoring system for ease of access to all cabling. You
can use the fold-away hooks on the preamplifiers to hang them from rails or poles.
Ensure that cables are routed so that there is no risk of patient entanglement or
strangulation.
•
Monitor access and visibility — Ensure that the operator can easily access and view the
monitor while monitoring. Choose a location that allows visual communication of rSO
values and alarms. See Physical Characteristics, page 111 for visibility specifications.
3
2
Operator's Manual English 35
36 Operator's Manual English
4. Operation
4.1. Overview
This chapter explains how to use the INVOS™ patient monitor (the “monitoring system”) to
view and collect patient regional oxygen saturation (rSO2) data.
This chapter assumes that the monitoring system has been installed at the location of use
and tested by the institution. See Installation, Chapter 3, Installation, page 23 for full
installation instructions.
•
Safety Reminders, page 37
•
Quick Start, page 39
•
Operational Defaults, page 40
•
Menu Structure, page 41
•
Monitoring System Memory, page 42
•
Set Up for Patient Monitoring, page 42
•
Optional Set-Up Tasks, page 46
•
Baselines, page 52
•
Trend View Management, page 55
•
Alarm Management, page 60
•
Event Marks, page 66
•
Area Under the Curve (AUC), page 70
•
Finish Monitoring, page 72
•
Case Histories, page 73
4.2. Safety Reminders
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: Inspect the monitoring system and all accessories before use to ensure there are
no signs of physical damage or improper function. Do not use if damaged.
Warning: Explosion hazard — Do not use the monitoring system in the presence of
flammable anesthetics.
Warning: 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.
4
Warning: As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
Operator's Manual English 37
Warning: Do not set alarm limits to extreme values that render the monitoring system
ineffective. Ensure alarm limits are appropriate for each patient.
Warning: Do not silence, pause, or decrease the volume of audible alarms if patient safety
could be compromised.
Warning: If you do not hear a tone at system start-up, discontinue use of the monitoring
system and contact Medtronic or a local Medtronic representative.
Warning: Monitoring system readings can be affected by certain patient conditions. Refer
to Patient Conditions, page 91.
Warning: Failure to cover the sensor site with opaque material when operating under high
ambient light conditions may result in poor performance.
Warning: Electromagnetic emissions from the monitoring system may interfere with other
critical devices.
Warning: 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: 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: 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: If two sensors are placed in close proximity to each other on a patient, the same
preamplifier should be connected to both sensors to avoid poor performance.
Caution: Make sure all connectors are fully engaged and free from moisture. Moisture
intrusion may cause poor performance or no readings at all.
Caution: The 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.
38 Operator's Manual English
Refer to Safety Information, page 7 for additional warnings and cautions regarding use of
the monitoring system.
4.3. Quick Start
If you are familiar with operating the monitoring system, follow the steps in Table 5 to set
up the device and monitor a patient. Be sure you have reviewed the information in Safety
Reminders, page 37 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 42.
Table 5. Quick Start Steps
1 Make sure all components of the monitoring system are
present:
Monitor, docking station, power supply, power cord, pream‐
plifier(s), reusable sensor cables (RSCs), INVOS™ rSO2 sensors
2 Attach up to four INVOS™ rSO2 sensors to the patient See the Instructions for Use provided with the
3 Power on the monitoring system See Set Up for Patient Monitoring, page 42
4 Optionally, change the sensor placement sequence See Changing the Sensor Placement Sequence,
5 Connect the sensors to the RSCs, following the onscreen
prompts, and verify the sensor locations
6 Secure all cables to avoid patient skin injury or entanglement See Set Up for Patient Monitoring, page 42
7 Optionally, enter a patient ID See Assigning or Modifying the Patient ID,
8 Begin monitoring:
•
For a new case, press NEW DATA SET
•
To continue a case, press APPEND OLD DATA
9 Set baselines
Press MENU, SET BASELINES
10 Set or change alarm limits, as desired
Press MENU, ALARM LIMITS
11 Optionally, change the trend view:
•
Number of graphs
•
Trend-line averaging
•
Time scale
12 Optionally, change the on-screen sensor labels See Changing the On-Screen Sensor Labels,
13 Optionally, check and modify the list of event markers See Changing the Event List, page 69
14 Optionally, change Area Under the Curve (AUC) thresholds See Changing the AUC Threshold, page 71
15 Optionally, adjust the screen brightness See Changing the Screen Brightness, page 51
16 Optionally, adjust the alarm volume See Changing the Alarm Volume, page 63
See Set Up for Patient Monitoring, page 42
sensors
page 46
See Set Up for Patient Monitoring, page 42
page 49
See Set Up for Patient Monitoring, page 42
See Baselines, page 52
See Setting Alarm Limits, page 62
See Trend View Management, page 55
page 50
4
Operator's Manual English 39
Table 5. Quick Start Steps (continued)
17 Respond to alarms, as necessary:
•
Alarm indicators
•
Alarm message lookup
•
Silence or pause alarms
•
Dismiss alarms
18 Mark events, as desired See Event Marks, page 66
19 Finish monitoring See Finish Monitoring, page 72
See:
•
Alarm Indicators, page 60
•
Alarm Messages, page 99
•
Silencing or Pausing Alarms, page 64
•
Dismissing an Alarm, page 65
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 indicated.
Table 6. Operational Defaults
Item Available settings Default
Upper alarm limits OFF, ON OFF
See Setting Alarm Limits, page 62
Lower alarm limits MANUAL, AUTO MANUAL
See Setting Alarm Limits, page 62
Upper rSO2 limit 20 - 95 If ON, default is 90
See Setting Alarm Limits, page 62
Lower rSO2 limit MANUAL: 15 - 90
AUTO: 5 - 30
Silence alarms at startup YES, NO NO - Alarm audio is on by default, but alarm audio may
Alarm audio off/ pause
duration
Alarm reminder signal ON, OFF OFF - No reminder when alarms are silenced
Line frequency 50 Hz, 60 Hz 60 Hz
Alarm volume 1 - 10 5
Screen brightness 1 - 10 7
Time format 24 hr, 12 hr 12 hr
INDEFINITE, 2 MINS INDEFINITE - When silenced, alarms remain silent until
MANUAL: 40
AUTO: 20
See Setting Alarm Limits, page 62
be silenced or paused by the user. See Silencing or
Pausing Alarms, page 64.
This setting may be changed by an authorized techni‐
cian.
the user unsilences them. See Alarm Silence Duration,
page 65.
This setting may be changed by an authorized techni‐
cian.
This setting may be changed by an authorized techni‐
cian.
This setting may be changed by an authorized techni‐
cian.
See Changing the Alarm Volume, page 63
See Changing the Screen Brightness, page 51
This setting may be changed by an authorized techni‐
cian.
40 Operator's Manual English
Table 6. Operational Defaults (continued)
Item Available settings Default
Date format DD MM YYYY, YYYY MM DD, MM
DD YYY
Language Danish, Dutch, English, French,
German, Greek, Hungarian, Italian,
Norwegian, Polish, Portuguese,
Romanian, Russian, Slovak, Span‐
ish, Swedish
Trend line averaging ON, OFF OFF
Trend axis view TWO AXIS VIEW, ONE AXIS VIEW ONE AXIS VIEW
Trend time scale (x-axis) 1, 2, 4, 8, 12, 24 hours 1 hour
Sensor placement
sequence
AUC threshold type FIXED, % BELOW BASELINE FIXED
AUC threshold FIXED: 30 - 60
Serial port OFF, PC LINK 1, PC LINK 2, CLINI‐
4, 3, or 2 sensors 4 sensors
% BELOW BASELINE: 0 - 30%
CAL TEST SETUP, VUE LINK
MM DD YYYY
This setting may be changed by an authorized techni‐
cian.
English
This setting may be changed by an authorized techni‐
cian.
See Turning Trend Line Averaging On/Off, page 57
See Changing the Trend View - Two Graphs or One
Graph, page 56
See Zooming the Trend View, page 58
See Changing the Sensor Placement Sequence,
page 46
See Changing the AUC Threshold, page 71
FIXED: 50
% BELOW BASELINE: 25%
See Changing the AUC Threshold, page 71
OFF
This setting may be changed by an authorized techni‐
cian.
4.5. Menu Structure
Table 7. Menu Structure
MENU ALARM LIMITS UPPER LIMITS
SETTINGS GENERAL SCREEN BRIGHTNESS
CASE HISTORIES
SET BASELINES
AREA UNDER CURVE
a
Available only when no sensors are connected to the monitoring system.
b
Available only when monitoring has begun.
a
b
2
4
LOWER LIMITS
SENSOR PLACEMENT SEQUENCE
ALARMS ALARM VOLUME
TRENDS TREND LINE AVERAGING
TWO AXIS VIEW/ONE AXIS VIEW
EVENTS
RESET AUC
THRESHOLD
Operator's Manual English 41
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
locations 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).
○
The previously used sensor location overrides the last RSC/preamplifier port
assignment. 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 8 describes some common situations, the actions you should perform, and how the
system reacts.
Table 8. System Memory - Common Situations and Recommended Actions
When this situation occurs... Perform this action...
You have started monitoring a patient
but notice that you have the sensor
locations swapped.
Sensors need to be disconnected from
the monitoring system during a case
(for example, to reroute the cables).
The monitoring system is powered off
and back on during a case.
A case has ended. Unplug and discard all sensors that were used during the case. Dismiss the
Navigate to the sensor Set-up screen (see Repositioning On-Screen Sensors,
page 47), drag and drop the sensors to the correct locations on the screen,
confirm the new locations, then press APPEND OLD DATA to resume monitor‐
ing.
Disconnect and reconnect the affected sensors. The monitoring system auto‐
matically assigns the sensors back to the proper locations.
No action is necessary. The monitoring system automatically assigns sensors to
the proper location and resumes monitoring.
“Sensor Not Connected” alarm. The monitoring system returns to the Set-up
screen.
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 37 before monitoring a patient.
42 Operator's Manual English
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
monitoring. 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 29 for
instructions.
•
Reusable sensor cables (RSCs) - Use one RSC per sensor, up to two per
preamplifier. If no RSCs are connected, see Connect the Reusable Sensor Cables
(RSCs), page 30, 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 instructions.
3. Power on the monitoring system:
a. Make sure that the monitoring system’s power supply is plugged into the
docking station and a properly grounded hospital mains outlet (see AC Power,
page 24). You may operate the monitoring system briefly on battery power if
necessary, but AC power is recommended for extended monitoring. See Power
Options, page 24 for additional information about powering the monitoring
system.
b. Press the Power button on top of the monitor (see Apply Power, page 31). If
operating on battery power, check the battery status indicator on the screen to
determine whether the battery needs charging (see Table 3, page 26).
c. Ensure that the POST pass tone sounds when POST completes. See POST Pass
Tone, page 114 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 23).
4
Operator's Manual English 43
Figure 23. Set-Up Screen - Prompt for Sensor Connection
4. Optionally, you can set the sensor sequence for the number of sensors you are
using. If you are using fewer than four sensors, you can set the number to three or
two for onscreen representations. See Changing the Sensor Placement Sequence,
page 46.
5. Connect the RSCs to the sensors that have been applied to the patient:
Caution: If two sensors are placed in close proximity to each other on a patient, the
same preamplifier should be connected to both sensors to avoid poor
performance.
a. Note the highlighted sensor location on screen (Figure 23). Locate the
corresponding sensor applied to the patient.
b. Look for the flashing blue light on the preamplifier and at the end of the
corresponding RSC.
c. Align the sensor’s male connector with the connection slot on the RSC. The
connector 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 location. 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
location and noting the blue flashing light on the RSC cable. Make sure that the
onscreen location matches the sensor location on the patient. If the location
does not match, you can reposition the on-screen sensors rather than
disconnecting the RSCs. See Repositioning On-Screen Sensors, page 47.
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 prolonged contact with patient skin, you can secure the RSCs with the strain-
44 Operator's Manual English
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 49.
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.
Note: You can only append to the most recent case. If the append button is
greyed out, the append feature is disabled.
The monitoring screen appears (Figure 24).
Figure 24. 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 52.
10. Set or change alarm limits, as desired. See Setting Alarm Limits, page 62.
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 55.
12. Optionally, change the on-screen sensor labels. See Changing the On-Screen
Sensor Labels, page 50.
13. Optionally, check the list of available event markers and change it if necessary.
See Changing the Event List, page 69.
14. Optionally, change the Area Under the Curve (AUC) threshold. See Changing the
AUC Threshold, page 71.
15. Optionally, adjust the screen brightness. See Changing the Screen Brightness,
page 51.
4
16. Optionally, adjust the alarm volume. See Changing the Alarm Volume, page 63.
Operator's Manual English 45
17. As you monitor the patient, you may need to perform the following tasks:
•
Respond to alarms - See Alarm Indicators, page 60, Alarm Messages,
page 99, Silencing or Pausing Alarms, page 64, and Dismissing an Alarm,
page 65.
•
Mark clinically significant events - See Event Marks, page 66.
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 72.
4.8. Optional Set-Up Tasks
•
Changing the Sensor Placement Sequence, page 46
•
Repositioning On-Screen Sensors, page 47
•
Assigning or Modifying the Patient ID, page 49
•
Changing the On-Screen Sensor Labels, page 50
•
Changing the Screen Brightness, page 51
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 26. Default Sensor Placement Sequence
If you monitor a different combination of sites, you can change the prompts to one of the
following sequences:
46 Operator's Manual English
Figure 27. 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
corresponding 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.
Figure 28. Highlighting an On-Screen Sensor
4
Operator's Manual English 47
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 29. Sensor Icons Next to CURRENT Values (Press to Locate Sensor on Patient)
2. Press the Patient button.
The patient icon appears.
Figure 30. 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.
48 Operator's Manual English
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,
page 42, but do not begin monitoring.
2. Press PATIENT ID. A keyboard appears.
Figure 31. 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.
4
Operator's Manual English 49
Figure 32. Patient Icon
2. Press the patient icon. A keyboard appears.
Figure 33. 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:
50 Operator's Manual English
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.
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 34. 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.
Operator's Manual English 51
4
2. Press SETTINGS.
3. Press GENERAL.
Figure 35. SETTINGS - GENERAL - SCREEN BRIGHTNESS
4. Press an arrow key to increase or decrease the screen brightness.
5. Press CLOSE.
4.9. Baselines
The monitoring system requires an rSO2 baseline for each tissue region being monitored so
that changes from the baseline can be reported. Changes in rSO2 values of >20% from
baseline are considered clinically significant and cause for concern and possible
interventions.
When measured 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 62.
It is recommended that you obtain baselines while the patient is stable and awake (for
example, prior to surgical induction). You can set baselines for all sensors at once or for
individual sensors. If necessary, you can retake baselines at any time during monitoring.
Automatic Baselines: If you do not actively set baselines, the monitoring system
automatically sets them approximately five minutes after monitoring begins. You can use
these automatic baselines, or retake the baselines. Be aware that sudden large changes in a
patient’s saturation values during the initiation of monitoring can result in
unrepresentative automatically calculated baseline values. If you use automatic baselines,
be sure to check the values to make sure they are appropriate. Manually retake the
baselines, if necessary.
Note: If you reposition or replace a sensor during monitoring, be sure to retake the baseline
for that sensor to ensure a valid representation of rSO2 at that location.
52 Operator's Manual English
To set or retake baselines:
1. Set up the monitoring system and begin monitoring as described in Set Up for
Patient Monitoring, page 42. While baselines have not yet been set, the monitoring
system displays rotating arrows for the CHANGE values next to the CURRENT rSO
readings.
Figure 36. Monitoring Screen - New Data Set - No Baselines Set
2
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 37), or, if automatic baselines have
taken effect, indicates the values and times they were taken (Figure 38).
Figure 37. SET BASELINES - No Baselines Previously Set
4
Operator's Manual English 53
Figure 38. 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 displayed 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.
Figure 39. 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
54 Operator's Manual English
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, page 55
•
Changing the Trend View - Two Graphs or One Graph, page 56
•
Turning Trend Line Averaging On/Off, page 57
•
Zooming the Trend View, page 58
•
Reviewing Data that has Scrolled Off the Trend View, page 58
•
Viewing Previous rSO2 Values on the Trend Graph, page 59
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 provides 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 73.
Figure 40. Trend View
1. rSO
2. Current baselines (color-coded to
3. Trend line (color-coded to sensor
4. Alarm limits (color-coded to sensor
scale (y-axis)
2
sensor labels)
labels)
labels)
5. Alarm limit line
6. Time scale (x-axis)
7. Event mark
4
Operator's Manual English 55
4.10.2. Changing the Trend View - Two Graphs or One Graph
By default, the monitoring system displays all trends on one graph (Figure 41, top). If
desired, you can display trends on two graphs - one for cerebral sensors, one for somatic
sensors (Figure 41, bottom).
Figure 41. Trend View - One Graph (Top, Default) and Two Graphs (Bottom)
To change the trend view (two graphs vs. one graph):
1. Press MENU.
2. Press SETTINGS.
3. Press TRENDS.
56 Operator's Manual English
Figure 43. 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 variability in rSO
values. The averaged data is displayed as a bold line superimposed over the real-time rSO
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 44. Trend Line Averaging
2
2
4
By default, trend line averaging is off.
To turn trend line averaging on/off:
1. Press MENU.
Operator's Manual English 57
2. Press SETTINGS.
3. Press TRENDS.
Figure 45. SETTINGS - TRENDS - TREND LINE AVERAGING
4. Press ON or OFF next to TREND LINE AVERAGING, as desired.
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 indication that current
trends are not shown, “REVIEW MODE” appears on the trend view.
58 Operator's Manual English
Figure 46. 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 47).
Figure 47. Trend Graph Pop-Up
4
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.
Operator's Manual English 59
Figure 48. 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.
4.11. Alarm Management
•
Alarm Indicators, page 60
•
Setting Alarm Limits, page 62
•
Changing the Alarm Volume, page 63
•
Silencing or Pausing Alarms, page 64
•
Dismissing an Alarm, page 65
Note: Refer to Table 22, page 99 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 49). 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 rSO
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 9).
2
60 Operator's Manual English
Figure 49. Visual Alarm Indicators
1. Alarm Audio button
3. rSO2 reading in alarm state
2. Message area
Table 9. Alarm Audio Button States
Alarm Audio button Alarm audio on, silenced, or paused Alarm status
On Alarm of any status or no alarms
Silenced No alarms
Low- or medium-priority alarm
Paused (2 minutes) No alarms
4
Low- or medium-priority alarm
Table 10 summarizes the monitoring system’s alarm indicators.
Operator's Manual English 61
Table 10. Audible and Visual Alarm Indicators
Priority Audible
Medium 3 pulse burst Message area: Flashing yellow bar with text message
Low 2 pulse burst Message area: Yellow bar with text message (not flashing)
a
By default, alarm audio is on, but may be silenced or paused by the user. See Silencing or Pausing Alarms, page 64. See Table 26, page 113 for alarm
tone specifications.
b
See Table 28, page 114 for alarm visual specifications.
c
See Table 22, page 99 for a complete list of alarm messages.
tone
a
Battery icon: For battery alarm, flashing yellow; otherwise,
no change
rSO2 readings area: Yellow flashing background on affec‐
ted reading for sensor alarms (dashes appear if readings
are lost)
Alarm Audio button: Yellow if alarms silenced or paused
Battery icon: No change
rSO2 readings area: No change
Alarm Audio button: Yellow if alarms silenced or paused
Visual indication
b
Example messages
BATTERY LOW
LOW RSO2
TREND DATA LOST
4.11.2. Setting Alarm Limits
Warning: Do not set alarm limits to extreme values that render the monitoring system
ineffective. Ensure alarm limits are appropriate for each patient.
The monitoring system provides default alarm limit settings, as listed in Table 11.
c
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 11. Alarm Limits Settings
Alarm limits item Available settings Default
UPPER LIMITS OFF - No alarm sounds for high rSO2 values
ON - Specify a high rSO2 value that will generate an alarm
Upper limit range (when
ON)
LOWER LIMITS MANUAL - Specify a low rSO2 value that will generate an alarm
Lower limit range when
set to MANUAL
Lower limit range when
set to AUTO
20 to 95 90
AUTO - Specify a percentage below baseline that will generate an alarm
15 to 90 40
-30% to -5% -20%
OFF
MANUAL
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).
62 Operator's Manual English
Figure 50. 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 51. 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.
4. To set lower alarm limits:
a. Press MANUAL or AUTO for LOWER LIMITS, as desired.
b. Next to a sensor, press and hold the slider for the LOWER limit, drag it to the
desired value, and release. You can set different values for each sensor.
5. Press CLOSE. The new alarm limits take effect immediately.
Note: Alarm limit settings remain in effect across power cycles.
4.11.3. Changing the Alarm Volume
Warning: Do not silence, pause, or decrease the volume of audible alarms if patient safety
could be compromised.
Operator's Manual English 63
4
When alarm audio is on, the default alarm volume is set to 5 with a range of 1 to 10.
See Table 26, page 113 for alarm tone specifications.
To change the alarm volume:
1. Press MENU.
2. Press SETTINGS.
3. Press ALARMS.
Figure 52. 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: Do not silence, pause, or decrease the volume of audible alarms if patient safety
could be compromised.
Depending on your institutional default, alarm audio may be on or off when you start a
case. When alarm audio is on, you can silence or pause the audio.
A white Alarm Audio button indicates alarm audio is on.
You can silence or pause alarms by pressing the button. The button changes to indicate
whether alarms are silenced or paused (see Table 9, page 61). Whether an alarm is silenced
or paused depends on institutional default settings (see Alarm Silence Duration, page 65).
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 (see Table 9,
page 61).
64 Operator's Manual English
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.
4.11.4.1. 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.
4.11.4.2. 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 113 for alarm reminder signal specifications.
4
4.11.5. Dismissing an Alarm
Some alarms, such as BATTERY LOW and SENSOR NOT CONNECTED, can be dismissed
without resolving the situation. Others, such as LOW RSO2 and CHECK SENSOR, clear only
when the condition is resolved. Table 22, page 99 indicates which alarms are dismissible
and which are not.
Operator's Manual English 65
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 56. Dismissible Alarm
2. If there are multiple alarms, press the down arrow to view all current alarms and
determine which are appropriate to be dismissed.
3. Press DISMISS next to the appropriate alarm. Dismissible alarms can only be
dismissed individually.
4.12. Event Marks
•
About Event Marks, page 66
•
Marking Events, page 67
•
Viewing an Event Mark Label, page 67
•
Renaming an Event, page 68
•
Changing the Event List, page 69
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.
66 Operator's Manual English
Figure 58. Events Marked in Trend View
4.12.2. Marking Events
To mark an event:
1. While monitoring, press MARK EVENT.
The ADD EVENT menu lists the available events.
Figure 59. 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 69.)
3. Press OK. The event mark appears on the trend graph.
4
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.
Operator's Manual English 67
To view an event mark label:
At the trend graph, press the flag below an event mark line.
The event name and time appear for approximately 5 seconds.
Figure 60. Event Mark Label
4.12.4. Renaming an Event
If an event is mis-named, you can change it at any time while monitoring or reviewing a
case history.
To rename an event:
1. At the trend graph, press the flag below an event mark line.
2. When the event mark label appears, release the flag and press the label or the flag
again. The EDIT EVENT menu appears.
68 Operator's Manual English
Figure 61. 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 69.)
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.
4
Operator's Manual English 69
Figure 62. SETTINGS - EVENTS (Screen 1)
4. Press NEXT or BACK to view all of the available events in alphabetical order.
5. To select or de-select an individual event, press the checkbox next to the event or
the event itself. If necessary, you can restore the list to its default values by pressing
RESTORE.
6. Press CLOSE.
4.13. Area Under the Curve (AUC)
•
About Area Under the Curve (AUC), page 71
•
Changing the AUC Threshold, page 71
•
Resetting AUC Collection, page 72
70 Operator's Manual English
4.13.1. About Area Under the Curve (AUC)
Figure 63. AUC SUMMARY Screen
1. Current AUC totals
2. Current baselines
3. AUC start time
AUC (Area Under the Curve), also referred to as cumulative saturation below threshold,
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 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 72.
4. RESET AUC (press to restart collection)
5. Current AUC threshold type (press to
change)
6. Current AUC threshold (press arrow
keys to change)
4
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.
Operator's Manual English 71
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 63, page 71):
•
FIXED, or
•
% BELOW BASELINE
Press to toggle between the two choices.
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 63, page 71).
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
institution procedures for single-use devices.
72 Operator's Manual English
4. Clean the monitoring system as required by your institution. See Cleaning the
Monitoring System, page 95.
4.15. Case Histories
•
About Case Histories, page 73
•
Viewing Case Histories, page 73
•
Exporting Case Histories, page 75
•
Deleting Case Histories, page 76
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 capacity 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
connected.
2. Press MENU.
3. Press CASE HISTORIES. The CASE HISTORY list appears.
Figure 64. CASE HISTORY List
4
Operator's Manual English 73
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
displayed.
Figure 65. Case History Example
6. View items in the case history as follows:
•
Zoom the trend graph. See Zooming the Trend View, page 58.
•
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 67.
•
Change an event mark label, if necessary, as described in Renaming an Event,
page 68.
•
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 67.
74 Operator's Manual English
•
Export the case history, if desired. See Exporting Case Histories, page 75.
7. Press CLOSE to exit the case history view.
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 78 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
connected.
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 4, page 16 and Figure 7, page 19.
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 you are viewing:
1. Follow the steps in Viewing Case Histories, page 73, 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 4, page 16 and Figure 7, page 19.
4
3. Press the Export button.
A progress bar appears. Do not remove the USB drive while the export is taking
place.
4. When the export is complete, press FINISH or remove the USB drive to return to the
case history list.
Operator's Manual English 75
5. Press CLOSE to exit the case history list.
6. If you have not already done so, remove the USB drive.
4.15.4. Deleting Case Histories
Note: Exporting case histories, as described in the previous section, does not delete them
from the monitoring system. This section explains how to delete case histories.
To delete one or more case histories from the case history list:
1. Make sure that the monitoring system is powered on and that no sensors are
connected.
2. Press MENU.
3. Press CASE HISTORIES. The case history list appears.
4. Press the checkbox next to one or more cases to be deleted.
5. Press the Delete button.
The message “Delete the selected cases?” appears. Press OK to delete.
6. When complete, the following message appears: “Successfully deleted (n) cases.”
7. Press FINISH.
8. Confirm the cases have been removed from the case history list.
Note: If you delete the most recent case, the append feature (continuing a case) is disabled.
76 Operator's Manual English
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 realtime data to external devices such as a Philips multi-parameter system.
•
Safety Reminders, page 77
•
Displaying Monitoring System Screens on an External Monitor, page 77
•
Downloading Case Histories to a USB Drive, page 78
•
Transmitting Monitoring System Data to External Devices via the Serial Port, page 78
•
Data Formats, page 82
5.2. Safety Reminders
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 dataprocessing
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: 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 multiparameter system operator should not rely on the multi-parameter system for generating
alarms.
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 66). Using a VGA cable no longer than 50 feet (15.24 m), connect
the cable between the VGA port and the external monitor.
Operator's Manual English 77
5
Figure 66. 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 75 for
instructions. Downloaded case history data can be graphed using a commercial
spreadsheet program. See Case Histories Downloaded via USB, page 82 for case history
data format and file name information.
Use any of the USB ports on the monitor or docking station to download case histories. The
monitor has one USB 2.0 and one USB 3.0 port (see Figure 4, page 16). The docking station
has two USB 2.0 ports (see Figure 7, page 19). Do not connect any device other than a USB
flash drive to the monitoring system's USB ports.
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 67). 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 79. Contact Medtronic
Technical Services for information about compatibility with other commercial devices.
See Technical Services, page 10.
78 Operator's Manual English
Figure 67. 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
•
8 data bits
•
1 stop bit
•
Flow control: hardware
Pin-outs for the serial port are shown in Figure 68 and described in Table 12.
Figure 68. Serial Port Pin-Outs
Table 12. 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
5.5.2. Transmitting Real-Time Data to a Philips IntelliBridge™* and VueLink™* Open Interface (IVOI) Module
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-
Operator's Manual English 79
parameter system operator should not rely on the multi-parameter system for generating
alarms.
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 13.
Table 13. Hardware Requirements for Philips VueLink™* and IntelliBridge™* Communication
System Hardware requirements
Philips VueLink™* System •
Philips IntelliBridge™* 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™* 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 67, page 79).
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.
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 42.
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 67, page 79).
5. Tighten all screw locks at each connector junction.
6. Ensure that the Philips monitor and IntelliBridge™* module are properly configured
per Philips instructions.
80 Operator's Manual English
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.
8. Begin a case as described in Set Up for Patient Monitoring, page 42.
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 HyperTerminal™*
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 83 for descriptions of the formats.
5.5.3.1. Null Modem Cable Requirements
A 9-pin to 9-pin null modem cable is required for transmitting case data to a computer via
the serial port.
The null modem cable must be no longer than 50 feet (15.24 m).
Refer to Figure 69 for acceptable 9-pin to 9-pin wiring configurations.
Figure 69. Null Modem Cable Diagram for Connection to Serial Port (Two Options)
5
1. Monitoring System Serial Port (Option
1)
2. Computer (PC) COM Port (Option 1)
3. Monitoring System Serial Port (Option
2)
4. Computer (PC) COM Port (Option 2)
Operator's Manual English 81
5.5.3.2. Using a Terminal Emulation Program to Transmit Case Data to a Computer
The following procedure presents general steps for transmitting case data to a computer
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.
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 67, page 79) 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
4. Begin a case as described in Set Up for Patient Monitoring, page 42.
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.
5.6.1.1. 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
CaseID
example, 20171023_0841.
An example file name is:
82 Operator's Manual English
is the date and time the case started (YYYYMMDD_HHMM in 24-hour format). For
.H3
20171023_0841__GBA12P3023.H3
5.6.1.2. 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 14, page 83 for field descriptions.
Column: A B C D E F G
Description: Version Date Time Ch 1 rSO
Column (continued): H I J K
Description (continued): Ch 2 rSO
Column (continued): L M N O
Description (continued): Ch 3 rSO
Column (continued): P Q R S
Description (continued): Ch 4 rSO
Column (continued): Terminating character
Description (continued): 0x0A
Table 14. Case History Downloads - Data Fields
Event Status Rsvd
2
Event Status Rsvd
2
Event Status Rsvd
2
Event Status Rsvd
2
Field Description
Version
Date Date of the reading
Time Time of the reading
Ch n rSO
Event Current event. (Integer)
Status Current status. (Integer)
Rsvd
(Reserved)
<major>.<minor>.<patch>.<build>/[event list version]/[output format version]
Example: 1.2.34.56/1/1
(For Medtronic use only)
Format: MM/DD/YY
Format: HH:MM:SS (24-hour format)
rSO2 reading for channel n. (Integer)
2
Range: 15 to 95
0 = Channel not active
Range: 0 to 160, 252 to 254
See Event Codes for Data Downloads, page 85 for descriptions.
0 = No event
Range: 0 to 19
See Status Codes for Data Downloads, page 88 for descriptions.
0 = No status
Note: Status 21 is not stored in the export file.
Zero, to maintain backwards compatibility.
Format: 0
5
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.
Operator's Manual English 83
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 15, page 85 for field descriptions.
Case data can be accessed and graphed on a computer using a commercial spreadsheet
program.
5.6.2.1. Data Format 1 - PC LINK 1
Column: A B C D E F G H I J K L M N
Description: Ver‐
Description (continued): Ch
Description (continued): Ch
Description (continued): Ch
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
Date Time Ch
sion
Column (continued): O P Q R S T U V W X Y
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
rSO2Event Sta‐
label
rSO2Event Sta‐
label
rSO2Event Sta‐
label
rSO2Event Sta‐
label
tus
tus
tus
tus
Base‐
line
Base‐
line
Base‐
line
Base‐
line
AUC UAL LAL A B Rsvd
AUC UAL LAL A B Rsvd
AUC UAL LAL A B Rsvd
AUC UAL LAL A B Rsvd
5.6.2.2. Data Format 2 - PC LINK 2
Column:
Description: Date Time rSO
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
A B C D E F G H I
Column (continued): J K L M N O P
Description (continued): rSO
Column (continued): Q R S T U V W
Description (continued): rSO
Column (continued): X Y Z AA AB AC AD
Description (continued): rSO
Event Status A B C Rsvd
2
Event Status A B C Rsvd
2
Event Status A B C Rsvd
2
Event Status A B C Rsvd
2
84 Operator's Manual English
Table 15. Case Data Downloads (PC LINK 1 and PC LINK 2) - Data Fields
Field Included in PC
LINK 1 format
Version ✓ <major>.<minor>.<patch>.<build>/[event list version]/ [output for‐
Date ✓ ✓ Date of the reading
Time ✓ ✓ Time of the reading
Ch label ✓ Range: A to Z, S1 to S4
rSO
2
Event ✓ ✓ An event that was marked between the last transmission and this
Status ✓ ✓ Current active status. (Integer)
Baseline ✓ Current baseline value. (Integer)
AUC ✓ Area Under the Curve. (Integer)
UAL ✓ Upper Alarm Limit. (Integer)
LAL ✓ Lower Alarm Limit. (Integer)
A ✓ ✓ Zero, to maintain backwards compatibility.
B ✓ ✓ Zero, to maintain backwards compatibility.
C ✓ Zero, to maintain backwards compatibility.
Rsvd
(Reserved)
Channel n sen‐
sor ID
✓ ✓ Current rSO2 reading for channel. (Integer)
✓ ✓ Zero, to maintain backwards compatibility.
✓ ✓ String (14 characters) - if a sensor is connected.
Included in PC
LINK 2 format
Description
mat version]
Example: 1.2.34.56/1/1
(For Medtronic use only)
Format: MM/DD/YY
Format: HH:MM:SS (24-hour format)
0 = Channel not active
Range: 15 to 95
0 = Channel not active
transmission. (Integer)
Range: 0 to 160, 252 to 254
See Event Codes for Data Downloads, page 85 for descriptions.
0 = No event
Range: 0 to 21
See Status Codes for Data Downloads, page 88 for descriptions.
0 = No status
Range: 15 to 95
Range: 0 to 9999
Range: 20 to 95
Range: 15 to 90
Format: 0.0000
Format: 0.0000
Format: 0
Format: 0
0 = No sensor connected
5
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.
Operator's Manual English 85
Table 16. Data Downloads - Event Codes 1 to 40
Event
code
Description Event
code
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
12 Off CPB 32 Increase CO
13 Skin Closure 33 Increase FiO
2
2
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
Description
Table 17. Data Downloads - Event Codes 41 to 80
Event
code
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
Description Event
code
Description
86 Operator's Manual English
Table 17. Data Downloads - Event Codes 41 to 80 (continued)
Event
code
57 Afterload Reduction 77 Prostaglandin
58 Anti-Arrhythmic 78 Sedation
59 Anti-Epileptic 79 Vasopressor
60 Anti-Pyretic 80 Ventilator Change
Description Event
code
Table 18. Data Downloads - Event Codes 81 to 120
Event
code
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 etCO
92 Arrhythmia 112 Increase FiO
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
Description Event
code
2
2
Description
Description
Table 19. Data Downloads - Event Codes 121 to 254
Event
code
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
Description Event
code
Description
5
Operator's Manual English 87
Table 19. Data Downloads - Event Codes 121 to 254 (continued)
Event
code
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
Description Event
code
252 Begin Post Op
253 First Alert
254 Somatic First Alert
5.6.4. Status Codes for Data Downloads
Description
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 20. 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
88 Operator's Manual English
•
TREND DATA LOST
Operator's Manual English 89
5
90 Operator's Manual English
6. Performance Considerations
6.1. Overview
This chapter contains information about optimizing the performance of the INVOS™
patient monitor (the “monitoring system”).
•
Safety Reminders, page 91
•
Patient Conditions, page 91
•
Sensor Use Considerations, page 91
•
EMI (Electromagnetic Interference), page 92
6.2. Safety Reminders
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: Monitoring system readings can be affected by certain patient conditions. Refer
to Patient Conditions, page 91.
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 warnings
and cautions in the Instructions for Use accompanying the sensor.
A variety of sensor use situations can cause poor measurement performance, including
incorrect site selection, patient preparation, and sensor placement. Refer to the sensor
Instructions for Use for detailed information.
Operator's Manual English 91
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6.5. EMI (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: 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: 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.
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.
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-definition television), it is
possible that high levels of such interference due to close proximity or strength of a source
may result in disruption of monitoring system performance. See Manufacturer’s
Declaration, page 114.
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Disruption may be evidenced by cessation of operation or other incorrect functioning. 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
system's service manual.
The monitoring system generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with these instructions, may cause harmful interference
with other susceptible devices in the vicinity. Contact Technical Services for assistance.
See Obtaining Technical Assistance, page 10.
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94 Operator's Manual English
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.
•
Safety Reminders, page 95
•
Cleaning the Monitoring System, page 95
•
Maintenance Schedule, page 96
•
Service and Calibration, page 97
•
Service Life, page 97
•
Software and Firmware Updates, page 97
•
Recycling and Disposal, page 97
7.2. Safety Reminders
Warning: Inspect the monitoring system and all accessories before use to ensure there are
no signs of physical damage or improper function. Do not use if damaged.
Warning: Explosion hazard — When replacing the battery, do not use the incorrect type.
Use only the battery available from Medtronic. See Accessories/Parts List, page 107.
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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
to rain. Do not immerse in water, solvents, or cleaning solutions, since the monitoring
system and connectors are not waterproof.
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.
Caution: Dispose of the battery in accordance with local guidelines and regulations.
7.3. Cleaning the Monitoring System
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
to rain. Do not immerse in water, solvents, or cleaning solutions, since the monitoring
system and connectors are not waterproof.
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.
Operator's Manual English 95
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™*)
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 10.
Medtronic recommends the following checks at the indicated intervals.
Table 21. 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 31.
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 mon‐
itor.
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 rep‐
resentative, if labels are damaged or illegible.
Annually Replace the reusable sensor cables (RSCs). See Accessories/Parts List, page 107 for part
number and ordering information.
Every 2 years Replace the monitor’s battery. See Accessories/Parts List, page 107 for part number and
ordering information.
After approximately 25,000
hours of operation
Replace the monitor. See Service Life, page 97 for more information.
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