Medtronic PM7100 Service Manual

INVOS™

0123

Patient Monitor

Service Manual

Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.

INVOS™

Symbols

Not made with natural rubber latex

Prescription only. US federal law restricts this device to sale by or on the order of a physician.

Consult instructions for use

Product is a medical device

MR unsafe - Do not use during magnetic resonance imaging

Atmospheric pressure limits (see Environmental Conditions in the operator’s manual)

Humidity limits (see Environmental Conditions in the operator’s manual)

Temperature limits (see Environmental Conditions in the operator’s manual)

Keep dry

Fragile

Proper waste disposal for electrical and electronic equipment

Debrillation-proof type BF applied part

Protection against uid ingress: Protected against vertically falling water drops when tilted to 15°

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

Do not immerse

CSA – Canadian Standards Association certication mark

CE – Conformité Européenne authorization mark. 0123 – TÜV SÜD Product Service GmbH (notied body).

European Community (EC) authorized representative

Reference code (part number)

Importer

Manufacturer

Lot number

Serial number

Date of manufacture

Quantity included in package (example: 20)

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.2 Accessories/Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.3 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.4 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.5 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

1.6 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.3 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2.4 Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

3 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.3 Service Mode Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.4 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

4 Performance Considerations - EMI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

4.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

4.3 EMI (Electromagnetic Interference) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

4.4 Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

5 Product Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.3 Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.4 Annual Inspection Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

5.5 Service and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

5.6 Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

5.7 Software and Firmware Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

5.8 Recycling and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

6 Exporting Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

6.2 Exporting Logs from the Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

7 Basic Safety Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

7.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

7.3 Safety Tests - PM7100 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

7.4 Safety Test - PMPAMP71 Preamplier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

8 INVOS PM7100 Field Test Device (PM71IFTD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

8.2 PM71IFTD Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

8.3 Functional Testing with the INVOS PM7100 Field Test Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

8.4 Maintenance for the INVOS PM7100 Field Test Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Figures

Figure 1. Start-up Screen Showing Code Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Figure 2. INVOS Patient Monitor Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Figure 3. Monitor - Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Figure 4. Monitor - Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Figure 5. Monitor - Right Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Figure 6. Monitor - Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Figure 7. Docking Station - Bottom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Figure 8. Docking Station - Connector for Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Figure 9. Sample Monitoring Screen Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Figure 10. Battery Slot and Latch at Back of Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Figure 11. Battery Installed in Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Figure 12. Accessing Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Figure 13. Enter Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Figure 14. Incorrect Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Figure 15. Change Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Figure 16. Change Password Error Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Figure 17. Contact Service Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Figure 18. Password Reset Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Figure 19. Insert USB Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Figure 20. Key File Error Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Figure 21. Service Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Figure 22. Password Cleared . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Figure 23. Set Password Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Figure 24. Password Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Figure 25. Password Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Figure 26. Service Mode Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Figure 27. Service Mode - SETTINGS - SILENCE ALARMS AT STARTUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Figure 28. Service Mode - SETTINGS - ALARM REMINDER SIGNAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Figure 29. Service Mode - SETTINGS - ALARM AUDIO OFF/PAUSE DURATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Figure 30. Service Mode - SETTINGS - LINE FREQUENCY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Figure 31. Service Mode - DATE/TIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Figure 32. Service Mode - DISPLAY - LANGUAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Figure 33. Service Mode - COMMUNICATION - SERIAL PORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Figure 34. Service Mode - UTILITIES - EXPORT SETTINGS TO USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Figure 35. Exporting Settings to USB - Export Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Figure 36. Service Mode - UTILITIES - IMPORT SETTINGS FROM USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Figure 37. Importing Settings from USB - Import Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Figure 38. Service Mode - UTILITIES - RESTORE FACTORY DEFAULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Figure 39. Service Mode - UTILITIES - UPDATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figure 40. Service Mode - DISPLAY - ABOUT THIS MONITOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 41. ABOUT THIS MONITOR - System Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 42. Service Mode - UTILITIES - EXPORT LOGS TO USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Figure 43. Exporting Logs to USB - Export Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Figure 44. PM7100 Monitor Safety Test Conguration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Figure 45. PMPAMP71 Preamplier Safety Test Conguration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Figure 46. Battery Compartment Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Tables

Table 1. Monitoring System Accessory Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Table 2. Service Mode Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Table 3. Institutional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Table 4. Operational Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Table 5. Electromagnetic Emissions Guidelines and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Table 6. Electromagnetic Immunity Guidelines and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Table 7. Recommended Separation Distance Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Table 8. Test Specications for Enclosure Port Immunity to RF Wireless Communications Equipment . . . . . 51

Table 9. Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Table 10. Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Table 11. Annual Maintenance - Electrical Inspection Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Table 12. AC Dielectric Withstand Voltage Test Parameters - PM7100 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Table 13. Insulation Resistance Test Parameters - PM7100 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Table 14. Line Leakage Current Test Parameters - PM7100 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Table 15. AC Dielectric Withstand Voltage Test Parameters - PMPAMP71 Preamplier . . . . . . . . . . . . . . . . . . . . . 64

1 Introduction

1.1 Overview

This manual contains information for installing, servicing, and maintaining the INVOS patient monitor (the “monitoring system”).

This manual applies to the following products: PM7100, PMPAMP71

Section 1.3, Intended Audience, page 9

•

Section 1.4, Safety Information, page 9

•

Section 1.5, Obtaining Technical Assistance, page 12

•

Section 1.6, Warranty Information, page 13

•

1.2 Accessories/Parts List

Contact Medtronic or a local Medtronic representative to order accessories. See Section 1.5.1, Technical Services, page 12.

Table 1. Monitoring System Accessory Part Numbers

Part number Item

PMSENS71-A INVOS adult rSO2 sensor PMSENS71-P INVOS pediatric rSO2 sensor PMAC71DOC INVOS docking station PMAC71STAND INVOS patient monitor stand PMAC71RSC INVOS reusable sensor cable for PM7100 PMAC71RIC INVOS reusable infant sensor adapter cable for PM7100 PMAC71BAT INVOS PM7100 battery PMAC71PS INVOS PM7100 power supply IS INVOS infant rSO2 sensor CNN/SNN INVOS infant rSO2 sensor VLI INVOS rSO2 interface cable (VueLink™* adapter cable, DB25F to DB9F)

1.3 Intended Audience

This manual provides information to authorized technicians for installation, service, and maintenance of the monitoring system. Refer to the monitoring system’s operator’s manual for operating instructions, specications, and troubleshooting information.

Before performing installation, service, or maintenance tasks, carefully read this manual and all precautionary information.

1.4 Safety Information

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 eective use of the product.

• Notes provide additional guidelines or information.

1.4.1 Explosion, Shock, and Toxicity Hazards Warning: Explosion hazard — Do not use the monitoring system in the presence of ammable anesthetics.

Warning: Explosion hazard — When replacing the battery, do not use the incorrect type. Use only the battery

available from Medtronic. See the Accessories/Parts list in the monitoring system’s operator’s manual.

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

Warning: Shock hazard — Device must only be connected to a supply main with protective earth.

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 certied according to the latest IEC/EN 60950-1 standard for data-processing equipment, the latest IEC/EN 60601-1 or ANSI/AAMI ES60601-1 (US) standard for electromedical equipment, or the latest IEC/EN or ANSI/AAMI (US) 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 or ANSI/AAMI ES60601-1 (US). Anyone who connects equipment to the data interface is conguring a medical system and, therefore, is responsible for ensuring the system complies with the Requirements for Medical Electrical Systems IEC/EN Standard 60601-1 or ANSI/AAMI ES60601-1 (US) 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.

1.4.2 Patient Monitoring and Safety 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 aect the MRI image or the monitoring system’s performance.

Warning: Do not set alarm limits to extreme values that render the monitoring system ineective. 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 multi-parameter system operator should not rely on the multi-parameter system for generating alarms.

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

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

Note: The components of the PM7100 monitor that are connected to protective earth are contained within the external power supply and are not accessible to the user. Exposed metal parts on the monitor are double-insulated from live parts. A ground continuity test should not be performed; doing so may damage

the equipment and void the warranty.

1.4.3 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: Explosion hazard — When replacing the battery, do not use the incorrect type. Use only the battery available from Medtronic. See the Accessories/Parts list in the monitoring system’s operator’s manual.

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.

1.4.4 Sensors, Cables, and Other Accessories Warning: The use of accessories, sensors, and cables other than those specied may result in poor performance

of the monitoring system and increased electromagnetic emissions or decreased electromagnetic immunity of the monitoring system.

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

1.4.5 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 in) to any part of the monitoring system, including cables. Otherwise, degradation of monitoring system performance may result.

Warning:

of the monitoring system and increased electromagnetic emissions or decreased electromagnetic immunity of the monitoring system.

Warning:

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:

disruption of the monitoring system.

Warning:

electromagnetic interference. During such interference, measurements may seem inappropriate or the monitoring system may not seem to operate correctly.

Warning:

or stacked use is necessary, observe the monitoring system to verify normal operation in the desired conguration. Technical alarms may indicate that the conguration 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.

The use of accessories, sensors, and cables other than those specied may result in poor performance

The monitoring system is intended for use by healthcare professionals only. It may cause radio

Any radio frequency transmitting equipment or other nearby sources of electrical noise may result in

The monitoring system is designed for use in environments in which the signal can be obscured by

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

The monitoring system should not be used adjacent to or stacked with other equipment. If adjacent

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.

1.4.6 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.

1.5 Obtaining Technical Assistance

1.5.1 Technical Services

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

Technical Service Call Center

6165 Gunbarrel Ave RGI Bldg 4

Gunbarrel, CO 80301 USA

+1 800 255 6774 option 1

or contact a local Medtronic representative

www.medtronic.com

For international contact information, go to:

www.medtronic.com/covidien/en-us/support.html

Select CONTACT CUSTOMER SERVICE, then select your region.

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 preampliers. 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

Note: In addition, you can view serial numbers and software versions through the monitoring system’s service mode. See Section 5.7.2, Checking Software and Firmware Versions, page 57.

1.5.2 Removing the INVOS Patient Monitor from the Clinical Space

Any time the monitoring system is removed from the clinical space, patient data must be removed from the system.

Note: To retain case history les from the monitoring system, refer to the operator’s manual for information about exporting case histories to external storage.

To remove patient data:

1. Power on the monitoring system and ensure no sensors are connected.

2. Press MENU.

3. Press CASE HISTORIES. The case history list appears.

4. Press the checkbox next to all 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. Conrm the cases have been removed from the case history list.

1.5.3 Related Documents

•

INVOS Patient Monitor Operator’s Manual

monitoring system.

•

INVOS Adult rSO2 Sensor Instructions for Use

and use.

•

INVOS Reusable Sensor Cable Instructions for Use

adult/pediatric sensor to the monitoring system.

•

INVOS Preamplier Instructions for Use

preampliers.

•

INVOS Pediatric rSO2 Sensor Instructions for Use

selection and use.

•

INVOS Infant Sensor Instructions for Use

use.

•

INVOS Reusable Infant Sensor Adapter Cable for PM7100 Instructions for Use

for connecting the infant sensor to the system.

— Provides instructions for installing and operating the

— Provides important information about sensor selection

— Provides instructions for connecting the

— Provides instructions for connecting the monitoring system’s

— Provides important information about sensor

— Provides important information about sensor selection and

— Provides instructions

1.6 Warranty Information

To obtain product warranty information, contact Medtronic or a local Medtronic representative. See Section 1.5.1, Technical Services, page 12.

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

2 Product Overview

2.1 Overview

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

Section 2.2, Product Description, page 15

•

Section 2.3, Product Views, page 16

•

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 preampliers to accommodate up to four sensors (two per preamplier)

• Up to four reusable sensor cables (RSCs) to attach adult or pediatric sensors to the preampliers

• Up to four reusable infant sensor adapter cables (RICs) to attach neonatal sensors to preampliers

• Additional accessories as described in the monitoring system’s operator’s manual

Monitoring system features include:

• User congurable rSO2 baselines, alarm limits, and AUC thresholds

• Physiological and technical alarm reporting

• User congurable data display (rSO2, change from baseline, sensor labels, and trend data)

• Alarm silencing

• Event marking

• Visual representations of sensor locations

• Sensor functional state: – Sensor o – Sensor disconnect – Sensor fault

• Case history storage and export

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

• VGA, Serial (RS-232), and USB interfaces

• Congurable Auto Baseline Period

• Signal Strength Indicator (SSI)

2.3 Product Views

2.3.1 Full System

2.3.1.1 System Component Overview

Figure 2. INVOS Patient Monitor Components

1 Sensors

2 Preamplier

3 Docking station

4 Monitor

5 Reusable sensor cable (RSC)

6 Reusable infant sensor adapter cable (RIC)

2.3.2 Monitor Components

2.3.2.1 Monitor - Front

Figure 3. Monitor - Front

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)

2.3.2.2 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

4 USB 2.0 port

5 Docking station

2.3.2.3 Monitor - Right Side

Figure 5. Monitor - Right Side

1 Docking station

2 Connector for preamplier (x2)

3 Lever for adjusting monitor angle

2.3.2.4 Monitor - Back

Figure 6. Monitor - Back

1 Docking station

2 Connectors for preampliers

3 Power button

2.3.2.5 Docking Station

Figure 7.

1 Power input connection (DC in jack)

2 LAN port (not used, disabled)

3 VGA port

Docking Station - Bottom View

4 Programmable buttons (not used)

5 Lever for adjusting monitor angle

6 Speaker

4 Serial port (RS-232)

5 USB 2.0 port (x2)

Figure 8. Docking Station - Connector for Monitor

1 Docking station

2 Connector for monitor

2.3.2.6 Monitoring Screen

Figure 9. Sample Monitoring Screen Elements

1 Message area Provides information about alarm conditions. The back‐

ground indicates the severity of the condition. If alarm audio is silenced, an alarm audio silenced symbol appears next to the alarm message. See Alarm Management in the operator’s manual. 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

3 Sensor Designator Provides information on the sensor type that is connected.

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

5 Battery status indica‐

tor

Available in the message area when an alarm is dismissible. See Dismissing an Alarm in the operator’s manual.

patient. See Changing the On-Screen Sensor Labels in the operator’s manual.

Pink=Neonatal, Green=Pediatric, Blue=Adult.

time in 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 automatically shuts down.

Battery charging in‐ dicator

6 AC power indicator When the battery is fully charged and the monitoring system

7 CURRENT The most recent rSO2 reading from each sensor.

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

remains connected to AC power, the AC power indicator replaces the battery charging indicator.

8 CHANGE The percent change between the current rSO2 reading and

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

9 AUC Cumulative saturation below threshold. See Changing the

View to Show AUC on the Main Screen in the operator’s manual.

10 Signal Strength Indi‐

cator

11 Sensor/readings in

alarm state

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

13 Event mark Event marks indicate signicant occurrences during moni‐

14 Baseline values The current rSO2 baseline established for each tissue region

Reects the strength and stability of the signal that is used to make an rSO2 measurement.

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.

corresponding sensor icon. A horizontal red line indicates each alarm limit in the trend view graph. See Setting Alarm Limits in the operator’s manual.

toring. Event marks can be added to the trend graph at any time during monitoring and are displayed as vertical lines with ags. See Event Marks in the operator’s manual.

being 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 in the operator’s manual.

15 Alarm Audio button Indicates whether alarm audio is on, silenced, or paused.

Press to silence or pause alarm audio or to turn alarm audio back on. When an alarm occurs and alarm audio is silenced or paused, the button’s color corresponds to the highest-level alarm. See Alarm Indicators and Silencing or Pausing Alarms in the operator’s manual.

16 MARK EVENT button Press to add an event mark to the trend graph to indicate

a signicant occurrence during monitoring. Choose from a customizable list of events. See Event Marks in the operator’s manual.

17 Patient button While monitoring, press to return to the Set-up screen,

reposition on-screen sensors, or assign or modify a patient ID. See Set Up for Patient Monitoring, Repositioning On-Screen Sensors, and Assigning or Modifying the Patient ID in the operator’s manual.

18 Trend view The trend view shows the progression of rSO2 values over the

course of a case. Data is color-coded to the corresponding sensor icon. rSO2 values are presented on the vertical (y) axis. Time is presented on the horizontal (x) axis. See Trend View Management in the operator’s manual.

19 MENU button Press to access a variety of settings and functions depending

on whether or not sensors are connected and monitoring has begun. See Menu Structure in the operator’s manual.

2.4 Electrical

Power Input frequency 50 Hz to 60 Hz

100 VAC to 240 VAC ±10%, 1.5 A to 0.7 A maximum

3 Installation

3.1 Overview

This chapter contains supplementary information for installing the INVOS patient monitor (the “monitoring system”). Instructions for performing tasks that require service mode access, as well as instructions for installing the battery are provided. Use these instructions in conjunction with the information in the monitoring system’s operator’s manual.

Section 3.2, Safety Reminders, page 25

•

Section 3.3, Service Mode Menu Structure, page 25

•

Section 3.4, Setup, page 26

•

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: Shock hazard — This device must only be connected to a supply main with protective earth.

Warning: If you do not hear a tone at system start-up, discontinue use of the monitoring system and contact

Medtronic or a local Medtronic representative.

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

3.3 Service Mode Menu Structure

Table 2 lists the settings available through the monitoring system’s service mode. See Section 3.4.3.3, Entering Service Mode, page 29 for instructions for accessing these settings.

Table 2. Service Mode Menu Structure

Service

Mode

SETTINGS Tab SILENCE ALARMS AT STARTUP - See Section 3.4.3.4, Silencing Alarms at

Startup, page 37. ALARM REMINDER SIGNAL - See Section 3.4.3.5, Turning the Alarm Reminder

Signal On/O, page 38. ALARM AUDIO OFF/PAUSE DURATION - See Section 3.4.3.6, Changing Alarm

Silence Duration, page 39.

LINE FREQUENCY - See Section 3.4.3.7, Changing the Line Frequency, page 39. POST DURING SENSOR OFF - For system diagnostics only. CLEAR PASSWORD - Section 3.4.3.3, Entering Service Mode, page 29.

DATE/TIME Tab Calendar - See Section 3.4.3.8, Changing the Date, Time, and Date/Time Formats,

page 40. TIME - See Section 3.4.3.8, Changing the Date, Time, and Date/Time Formats,

page 40. TIME FORMAT - See Section 3.4.3.8, Changing the Date, Time, and Date/Time

Formats, page 40. DATE FORMAT - See Section 3.4.3.8, Changing the Date, Time, and Date/Time

Formats, page 40.

DISPLAY Tab LANGUAGE - See Section 3.4.3.9, Changing the Language, page 41.

ABOUT THIS MONITOR - See Section 5.7.2, Checking Software and Firmware

Versions, page 57.

NETWORK Tab UTILITIES Tab SETTINGS IMPORT SETTINGS FROM USB - See Section 3.4.3.11, Export‐

COMMUNICATION Tab

N/A (settings disabled)

ing/Importing Settings, page 42.

EXPORT SETTINGS TO USB - See Section 3.4.3.11, Export‐ ing/Importing Settings, page 42.

RESTORE FACTORY DEFAULTS - See Section 3.4.3.12, Restor‐ ing Factory Defaults, page 44.

LOGS EXPORT LOGS TO USB - See Section 6.2, Exporting Logs from

the Monitoring System, page 59.

UPDATES IMPORT FIRMWARE FROM USB - See Section 5.7, Software

and Firmware Updates, page 56. IMPORT SOFTWARE FROM USB - See Section 5.7, Software

and Firmware Updates, page 56.

SERIAL PORT - See Section 3.4.3.10, Setting the Serial Port Protocol, page 41.

3.4 Setup

Refer to the monitoring system’s operator’s manual for step-by-step setup instructions. As directed in the operator’s manual, refer to the following sections to perform tasks that require an authorized technician:

Section 3.4.1, Install the Battery, page 27

•

Section 3.4.2, Perform Functional Testing, page 28

•

Section 3.4.3, Set Institutional Defaults, page 28

•

3.4.1 Install the Battery

The monitoring system’s lithium-ion battery (PMAC71BAT) is shipped with the monitor, but not installed. Install and fully charge the battery prior to clinical use (see the operator’s manual for charging information).

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 10).

Figure 10. Battery Slot and Latch at Back of Monitor

1 Battery

2 Battery slot

3 Battery latch

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

4. With the battery completely inserted, slide the battery latch to the left to lock the battery in place (Figure 11).

Figure 11.

Battery Installed in Monitor

3.4.2 Perform Functional Testing

See Section 8.3, Functional Testing with the INVOS PM7100 Field Test Device, page 66.

3.4.3 Set Institutional Defaults

The following sections provide instructions for setting institutional defaults through the monitoring system’s service mode. After setting institutional defaults on a single device, you can export the settings to a USB ash drive and import the settings to additional devices. See Section 3.4.3.11, Exporting/Importing Settings, page 42.

Section 3.4.3.1, Institutional Settings - Factory Defaults, page 28

•

Section 3.4.3.3, Entering Service Mode, page 29

•

Section 3.4.3.4, Silencing Alarms at Startup, page 37

•

Section 3.4.3.5, Turning the Alarm Reminder Signal On/O, page 38

•

Section 3.4.3.6, Changing Alarm Silence Duration, page 39

•

Section 3.4.3.7, Changing the Line Frequency, page 39

•

Section 3.4.3.8, Changing the Date, Time, and Date/Time Formats, page 40

•

Section 3.4.3.9, Changing the Language, page 41

•

Section 3.4.3.10, Setting the Serial Port Protocol, page 41

•

Section 3.4.3.11, Exporting/Importing Settings, page 42

•

Section 3.4.3.12, Restoring Factory Defaults, page 44

•

3.4.3.1 Institutional Settings - Factory Defaults

Table 3 describes the institutional settings available through the monitoring system’s service mode.

Table 3. 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 See Section 3.4.3.4, Silencing Alarms at Startup, page 37.

Alarm reminder signal ON, OFF OFF

See Section 3.4.3.5, Turning the Alarm Re‐ minder Signal On/O, page 38.

Alarm audio o/pause du‐ ration

Line frequency 50 Hz, 60 Hz 60 Hz

POST during sensor o ON, OFF OFF

Date (Select from calendar) Coordinated Universal Time (UTC)

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

INDEFINITE, 2 MINS INDEFINITE - When silenced by the user,

alarms remain silent until the user unsi‐ lences them See Section 3.4.3.6, Changing Alarm Si‐ lence Duration, page 39.

See Section 3.4.3.7, Changing the Line Frequency, page 39.

For system diagnostics only. Do not set to ON when used in a clinical setting.

See Section 3.4.3.8, Changing the Date, Time, and Date/Time Formats, page 40.

MM DD YYYY

YYYY

Table 3. Institutional Settings (continued)

Item Available settings Factory default

See Section 3.4.3.8, Changing the Date, Time, and Date/Time Formats, page 40.

Time (Select hh:mm) N/A

See Section 3.4.3.8, Changing the Date, Time, and Date/Time Formats, page 40.

Time format 24 hr, 12 hr 12 hr

See Section 3.4.3.8, Changing the Date, Time, and Date/Time Formats, page 40.

Language DANISH, DUTCH, ENGLISH, FRENCH,

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

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

SETUP, VUE LINK

3.4.3.2 Operational Defaults - User Changeable

ENGLISH See Section 3.4.3.9, Changing the Lan‐ guage, page 41.

OFF See Section 3.4.3.10, Setting the Serial Port

Protocol, page 41.

Table 4 lists operational default settings that can be changed by the user. Refer to the monitoring system’s

operator’s manual for additional information.

Table 4. Operational Defaults

Item Available settings Default

Upper alarm limits OFF, ON OFF Lower alarm limits MANUAL, AUTO MANUAL Upper rSO2 limit 20 - 95 If ON, default is 90 Lower rSO2 limit MANUAL: 15 - 90

AUTO: 5 - 30 Alarm volume 1 - 10 5 Screen brightness 1 - 10 7 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 se‐

quence AUC threshold type FIXED, % BELOW BASELINE FIXED AUC threshold FIXED: 30 - 60

Autobaseline period 1, 2, 3, 4, 5 minutes 1 minute AUC display ON, OFF OFF

4, 3, or 2 sensors 4 sensors

% BELOW BASELINE: 0 - 30%

MANUAL: 40 AUTO: 20

FIXED: 50 % BELOW BASELINE: 25%

3.4.3.3 Entering Service Mode To enter service mode:

1. If the monitoring system is powered on, power it o by pressing the Power button on top of the monitor.

2. Power on the monitoring system. Figure 12 will appear during the start-up sequence:

Figure 12. Accessing Service Mode

3. Immediately press the service mode icon (wrench). If the service mode icon disappears, return to Step 1 in Section 3.4.3.3.

If a password has been set:

a. Enter password.

b. Press ENTER SERVICE MODE as seen in Figure 13.

Figure 13. Enter Password

c. If the password is incorrect, Figure 14 will appear.

Figure 14. Incorrect Password

d. After ve attempts with an incorrect password you will be prompted to contact the technical service

department to reset the password.

e. Press CLOSE to return to the monitoring application.

To change the password:

a. Press CHANGE PASSWORD, Figure 15 will appear.

Figure 15. Change Password

b. Enter the current password.

c. In the new password eld, enter the new password.

d. Press CONFIRM PASSWORD and enter the new password again.

e. Press CONFIRM PASSWORD.

f. If there are any errors, an error message will appear as seen in Figure 16.

Figure 16. Change Password Error Message

g. After ve attempts with an incorrect password you will be prompted to contact the technical service

department to reset the password.

h. Press CLOSE to return to the monitoring application.

To reset the password:

a. Press FORGOT PASSWORD on the Enter Password screen to bring up the Contact Service screen.

b. Make a note of the monitoring system serial number located on the screen as seen in Figure 17.

Figure 17. Contact Service Screen

c. Press REQUEST PASSWORD RESET.

d. Make a note or take a digital photo of the RESET CODE that appears on the screen as seen in

Figure 18.

Figure 18. Password Reset Screen

e. Send an email to rs.hqtsweb@medtronic.com

a. In the subject line write, "PM7100 Password reset request". b. Include the following in your email:

- Facility account number

- Facility shipping address

- Serial number of the monitoring system

- Reset code photo/reset code

f. Technical Services will send a reply email with a key le attached. g. Download the key le to a standard format, nonencrypted, FAT32 USB 2.0 ash drive. h. Once the key le is loaded on the USB drive, insert the USB drive into the USB 2.0 port on the

monitoring system as seen in Figure 19.

Figure 19. Insert USB Drive

i. If there is one or more errors, an error message will appear as seen in Figure 20.

Figure 20. Key File Error Message

j. Navigate back to the Password Reset screen (if necessary).

k. Press LOAD KEY FILE. The Services screen will appear as seen in Figure 21.

Figure 21. Service Screen

l. Press CLEAR PASSWORD. The system will indicate that the password has been cleared as seen in

Figure 22. Figure 22. Password Cleared

m. A new password can be set by powering o the monitor and then powering it back on.

If no password has been set:

a. From the Set Password screen, enter a password that meets the criteria listed on the screen as seen in

Figure 23.

Figure 23. Set Password Screen

b. Verify that the password is correct and press CONFIRM PASSWORD.

c. If there are no errors, the message PASSWORD SET will appear as seen in Figure 24.

Figure 24. Password Set

d. If there is one or more errors, an error message will appear as seen in Figure 25.

Figure 25. Password Error

e. Enter a password that meets the specied criteria and follow the previous steps to conrm the new

password.

f. Press CLOSE to return to the service mode screen.

4. At the Services screen, use the on-screen keypad to enter the password, then press ENTER SERVICE MODE.

Figure 26.

3.4.3.4 Silencing Alarms at Startup

By default, alarms generate an audible tone that can be silenced or paused by pressing the Alarm Audio button. If desired, you can set the alarm audio so that it is already silenced or paused when the monitoring system is turned on. The user has the option of reactivating alarm audio at any time during a case by pressing the Alarm Audio button. See the monitoring system’s operator’s manual for additional information.

Service Mode Settings

To turn the alarm audio o or on at startup:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press SETTINGS.

Figure 27. Service Mode - SETTINGS - SILENCE ALARMS AT STARTUP

3. Press the desired option under SILENCE ALARMS AT STARTUP.

4. If you are nished setting institutional defaults, press CLOSE. The monitoring system exits service mode and restarts.

3.4.3.5 Turning the Alarm Reminder Signal On/O

By default, there is no reminder signal when alarms are silenced. If desired, you can turn the reminder signal on. See the monitoring system’s operator’s manual for additional information.

To turn the alarm reminder signal on or o:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press SETTINGS.

Figure 28.

Service Mode - SETTINGS - ALARM REMINDER SIGNAL

3. Press the desired option under ALARM REMINDER SIGNAL.

4. If you are nished setting institutional defaults, press CLOSE. The monitoring system exits service mode and restarts.

3.4.3.6 Changing Alarm Silence Duration

By default, alarm silence duration is indenite. When the user silences an alarm by pressing the Alarm Audio button, alarm audio remains o until the user presses the Alarm Audio button again. If desired, you can set alarm silence duration to 2 minutes. See the monitoring system’s operator’s manual for additional information.

To change alarm silence duration:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press SETTINGS. Figure 29. Service Mode - SETTINGS - ALARM AUDIO OFF/PAUSE DURATION

3. Press the desired option under ALARM AUDIO OFF/PAUSE DURATION.

4. If you are nished setting institutional defaults, press CLOSE. The monitoring system exits service mode and restarts.

3.4.3.7 Changing the Line Frequency

If poor signal quality is reported by the monitoring system, it may be the result of a mismatch between the power line frequency and the monitoring system’s line frequency setting.

By default the line frequency is 60 Hz. This setting should match the AC power line input to reduce the eects of electrical noise on the monitoring system. If necessary, you can change this setting to 50 Hz.

To change the line frequency:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press SETTINGS.

Figure 30. Service Mode - SETTINGS - LINE FREQUENCY

3. Press the desired option under LINE FREQUENCY.

4. If you are nished setting institutional defaults, press CLOSE. The monitoring system exits service mode and restarts.

3.4.3.8 Changing the Date, Time, and Date/Time Formats

The date and time are set at the factory using the MM DD YYYY format for the date and the 12-hour format for the time.

Note: When the date or time is changed, all trend data and case histories are deleted. Refer to the monitoring system’s operator’s manual for information about exporting case histories for external storage.

To change the date, time, and date/time formats:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press DATE/TIME.

Figure 31.

Service Mode - DATE/TIME

3. Press the desired format next to DATE FORMAT.

4. Press the desired date in the on-screen calendar

5. Press the desired format next to TIME FORMAT.

6. Press the hours under TIME, then press the up or down arrow to change.

7. Press the minutes under TIME, then press the up or down arrow to change.

8. If you are nished setting institutional defaults, press CLOSE. The monitoring system exits service mode and restarts.

Note: If a saved case exists, the time cannot be changed to any time prior to that of 1 minute after the end time and date of the saved case. To enable the desired time setting, download the saved case to retain the information, and then delete the saved case.

3.4.3.9 Changing the Language

By default, the screen language is set to English. You can change the language to any of the options listed in

page 28

To change the language:

1. Enter service mode as described in

2. Press DISPLAY. Figure 32. Service Mode - DISPLAY - LANGUAGE

Section 3.4.3.3, Entering Service Mode, page 29

Table 3,

3. Scroll through the options in the LANGUAGE menu, and highlight the desired language.

4. If you are nished setting institutional defaults, press CLOSE. The monitoring system exits service mode and restarts.

3.4.3.10 Setting the Serial Port Protocol

The serial port on the monitoring system’s docking station can be used to transmit data to external devices such as a Philips multi-parameter system or a computer. See the monitoring system’s operator’s manual for additional information and instructions. The available serial port protocols are:

•

OFF — Use this setting for typical operation (no external data transfer).

•

PC LINK 1, PC LINK 2 — Use one of these settings when transferring data to a computer.

•

CLINICAL TEST SETUP — Medtronic use only.

•

VUE LINK — Use this setting when transferring data to a Philips module in a multi-parameter system.

To set the serial port protocol:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press COMMUNICATION.

Figure 33. Service Mode - COMMUNICATION - SERIAL PORT

3. Press the desired protocol under SERIAL PORT.

4. If you are nished setting institutional defaults, press CLOSE. The monitoring system exits service mode and restarts.

3.4.3.11 Exporting/Importing Settings

After setting institutional defaults on a single monitoring system, you can export the settings to a USB ash drive and import the settings to additional monitoring systems.

To export settings from a monitoring system:

1. As desired, change operational settings that do not require service mode access:

a. Refer to the monitoring system’s operator’s manual for the available operational settings.

b. Power on the monitoring system and set any of these options as desired. Refer to the operator’s

manual for instructions for setting these options.

c. Power o the monitoring system when nished.

2. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

3. Set all institutional defaults as desired following the instructions in Section 3.4.3, Set Institutional Defaults, page 28.

4. Press CLOSE. The monitoring system exits service mode and restarts.

5. Power o the monitoring system.

6. Re-enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

7. Press UTILITIES.

Figure 34. Service Mode - UTILITIES - EXPORT SETTINGS TO USB

8. Insert a USB ash drive into a USB port on the monitor or docking station. See page 20.

9. Press EXPORT SETTINGS TO USB. A progress bar appears during the export. When the screen indicates the export is complete, press FINISH.

Figure 35. Exporting Settings to USB - Export Complete

Figure 4, page 18

and

Figure 7,

10. Remove the USB ash drive.

11. Press CLOSE. The monitoring system exits service mode and restarts.

12. Power o the monitoring system.

To import settings to a monitoring system:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press UTILITIES.

Figure 36. Service Mode - UTILITIES - IMPORT SETTINGS FROM USB

3. Insert a USB ash drive into a USB port on the monitor or docking station. See page 20.

4. Press IMPORT SETTINGS FROM USB. A progress bar appears during the import. When the screen indicates the import is complete, press FINISH.

Figure 37. Importing Settings from USB - Import Complete

Figure 4, page 18

and

Figure 7,

5. Remove the USB ash drive.

6. Press CLOSE. The monitoring system exits service mode and restarts.

7. Verify that the new settings are in eect before powering o the monitoring system.

3.4.3.12 Restoring Factory Defaults

Factory defaults for institutional and operational settings are listed in Table 3, page 28 and Table 4, page 29.

To restore all factory default settings:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press UTILITIES.

Figure 38. Service Mode - UTILITIES - RESTORE FACTORY DEFAULTS

3. Press RESTORE FACTORY DEFAULTS.

4. At the conrmation screen, press RESTORE.

5. Press CLOSE. The monitoring system exits service mode and restarts.

4 Performance Considerations - EMI

4.1 Overview

This chapter contains information about optimizing the performance of the INVOS patient monitor (the “monitoring system”) under conditions of electromagnetic interference (EMI). Refer to the monitoring system’s operator’s manual for additional performance considerations related to patient conditions and sensor use.

Section 4.2, Safety Reminders, page 47

•

Section 4.3, EMI (Electromagnetic Interference), page 48

•

Section 4.4, Manufacturer’s Declaration, page 48

•

4.2 Safety Reminders

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 in) 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 specied 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

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.

4.3 EMI (Electromagnetic Interference)

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-denition 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 Section 4.4, Manufacturer’s Declaration, page 48.

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 o 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 dierent circuit from the other device(s).

• Check the line frequency setting for the monitoring system. The setting should match the AC power line input. See

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 Section 1.5.1, Technical Services, page 12.

Section 3.4.3.7, Changing the Line Frequency, page 39

4.4 Manufacturer’s Declaration

4.4.1 Electromagnetic Compatibility (EMC)

The monitoring system is suitable for prescription use only in the specied electromagnetic environments, in accordance with the IEC/EN 60601-1-2:2007 and IEC/EN 60601-1-2:2014 standards. The monitoring system requires special precautions during installation and operation for electromagnetic compatibility. In particular, the use of nearby mobile or portable communications equipment may inuence monitoring system performance.

Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not oer adequate protection to radio frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

4.4.1.1 Electromagnetic Emissions Guidelines and Compliance

Table 5. Electromagnetic Emissions Guidelines and Compliance

Guidance and manufacturer’s declaration—electromagnetic emissions

The monitoring system is intended for use in the electromagnetic environment specied below. The

customer or the user of the monitoring system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment guidance

Radiated emission CISPR 11/EN 55011, Class A, Group 1 The monitoring system uses RF energy only for

its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Conducted emis‐ sion

Harmonic emission IEC/EN 61000-3-2, Class A Voltage uctua‐

tions/ icker emis‐ sion

CISPR 11/EN 55011, Class A, Group 1 The monitoring system is suitable for use in all

establishments other than domestic and those directly connected to the public low-voltage

IEC/EN 61000-3-3, Section 4

power network that supplies buildings used for domestic purposes.

4.4.1.2 Electromagnetic Immunity Guidelines and Compliance

Table 6. Electromagnetic Immunity Guidelines and Compliance

Guidance and manufacturer’s declaration—electromagnetic immunity

The monitoring system is intended for use in the electromagnetic environment specied below. The

customer or the user of the monitoring system should assure that it is used in such an environment.

Immunity test IEC/EN 60601-1-2 test

level

Electrostatic discharge (ESD) IEC/EN 61000-4-2

Electric fast tran‐ sient/burst IEC/EN 61000-4-4

Surge IEC/EN 61000-4-5

Voltage dips and inter‐ rupts IEC/EN 61000-4-11

Power frequency H-eld immunity IEC/EN 61000-4-8

±8 kV contact ±15 kV air

±2 kV (100 kHz repetition rate) AC mains ±1 kV (100 kHz repetition rate) input/output >3 m

±1 kV line-line, AC mains ±2 kV line-ground, AC mains

100% reduction for 0.5 cy‐ cles (at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°) 100% reduction for 1.0 cy‐ cle (at 0°) 30% reduction for 25/30 cycles (at 0°) 100% reduction for 250/300 cycles (at 0°)

50 and 60 Hz, 30 A/m, x-, y-, and z-axes

Compliance level Electromagnetic envi‐

ronment guidance

±8 kV contact ±15 kV air

±2 kV (100 kHz repetition rate) AC mains ±1 kV (100 kHz repetition rate) input/output >3 m

±1 kV line-line, AC mains ±2 kV line-ground, AC mains

50 and 60 Hz, 30 A/m, x-, y-, and z-axes

Floor should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, the rel‐ ative humidity should be at least 30%.

Mains power quality should be that of a typi‐ cal commercial or hospital environment.

Mains power quality should be that of a typi‐ cal commercial or hospital environment. If the user requires con‐ tinued operation during power mains interrup‐ tions, it is recommended that the monitoring sys‐ tem be powered from an uninterruptible power supply or battery.

Power frequency magnet‐ ic elds should be at levels characteristic of a typical location in a typical com‐ mercial or hospital envi‐ ronment.

4.4.1.3 Recommended Separation Distance Calculations

Table 7. Recommended Separation Distance Calculations

Guidance and manufacturer’s declaration—electromagnetic immunity

The monitoring system is intended for use in the electromagnetic environment specied below. The

customer or the user of the monitoring system should assure that it is used in such an environment.

Immunity test IEC/EN 60601-1-2

test level

Conducted RF IEC/EN 61000-4-6

150 kHz to 80 MHz;

6 V

3 V

RMS

, ISM and ama‐

RMS

teur radio bands be‐

tween 0.15mHz and

80 MHz frequencies

Compliance level Electromagnetic environment guid‐

ance

3 V

RMS

150 kHz to 80 MHz;

6 V

, ISM and ama‐

RMS

teur radio bands be‐

tween 0.15mHz and 80 MHz frequencies

Portable and mobile RF communications

equipment should be used no closer to any

part of the monitoring system, including

cables, than the recommended separation

distance calculated from the equation ap‐

plicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2 √P

150 kHz to 80 MHz

where P is the maximum output power rat‐

ing of the transmitter in watts (W) accord‐ ing to the transmitter manufacturer and d

is the recommended separation distance in

meters (m). Field strengths from xed RF transmitters, as determined by an electromagnetic site

surveya, should be less than the compliance

level in each frequency rangeb.

Interference may occur in the vicinity of

equipment marked with the following sym‐

bol:

Radiated RF IEC/EN 61000-4-3

3 V/m

80 MHz to 2.7 GHz

3 V/m

80 MHz to 2.7 GHz

Portable and mobile RF communications

equipment should be used no closer to any

part of the monitoring system, including

cables, than the recommended separation

distance calculated from the equation ap‐

plicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2 √P

80 MHz to 800 MHz

d = 2.3 √P

800 MHz to 2.7 GHz

where P is the maximum output power rat‐

ing of the transmitter in watts (W) accord‐ ing to the transmitter manufacturer and d

is the recommended separation distance in

meters (m). Field strengths from xed RF transmitters, as determined by an electromagnetic site

surveya, should be less than the compliance

level in each frequency rangeb.

Table 7. Recommended Separation Distance Calculations (continued)

Guidance and manufacturer’s declaration—electromagnetic immunity

The monitoring system is intended for use in the electromagnetic environment specied below. The

customer or the user of the monitoring system should assure that it is used in such an environment.

Immunity test IEC/EN 60601-1-2

test level

Compliance level Electromagnetic environment guid‐

ance

Interference may occur in the vicinity of

equipment marked with the following sym‐

bol:

RF wireless proximity

See Table 8, page 51 See Table 8, page 51 0.3 m

elds

IEC/EN 61000-4-3 NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people.

Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the monitoring system is used exceeds the applicable RF compliance level above, the monitoring system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the monitoring system.

Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

Table 8. Test Specications for Enclosure Port Immunity to RF Wireless Communications Equipment

Test fre‐

quency

(MHz)

385 380 to 390 TETRA 400 Pulse modulation

Band

(MHz)

Service Modulation Max. power

(W)

1.8 0.3 27

Distance

(m)

Immunity

test level

(V/m)

18 Hz

450 430 to 470 GMRS 460, FRS

460

±5 kHz deviation

2 0.3 28

1 kHz sine 710 704 to 787 LTE Band 13, 17 Pulse modulation 745

217 Hz

0.2 0.3 9

780 810 800 to 960 GSM 800/900, 870 930

TETRA 800, iDEN

820, CDMA 850,

Pulse modulation

18 Hz

2 0.3 28

LTE Band 5 1720 1700 to 1990 GSM 1800; CDMA 1845 1970

1900; GSM 1900;

DECT; LTE Band 1,

3, 4, 25; UMTS

2450 2400 to 2570 Bluetooth, WLAN,

802.11 b/g/n,

Pulse modulation

217 Hz

Pulse modulation

217 Hz

2 0.3 28

Table 8. Test Specications for Enclosure Port Immunity to RF Wireless Communications Equipment (continued)

Test fre‐

quency

(MHz)

5240 5100 to 5800 WLAN 802.11 a/n Pulse modulation 5500 5785

4.4.1.4 Recommended Separation Distances

Table 9. Recommended Separation Distances

Recommended separation distances between portable and mobile RF communications equipment

The monitoring system is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the monitoring system can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile

RF communications equipment (transmitters) and the monitoring system as recommended below,

Rated maximum output power (P) of transmitter

in watts

100.00 12.00 12.00 23.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people.

Band

(MHz)

according to the maximum output power of the communications equipment.

0.01 0.12 0.12 0.23

0.10 0.38 0.38 0.73

1.00 1.20 1.20 2.30

10.00 3.80 3.80 7.30

Service Modulation Max. power

(W)

RFID 2450, LTE

Band 7

0.2 0.3 9

217 Hz

and the monitoring system

Separation distance according to frequency of transmitter in meters

d = 1.2 √P

150 kHz to 80 MHz

d = 1.2 √P

80 MHz to 800 MHz

Distance

(m)

d = 2.3 √P

800 MHz to 2.7 GHz

Immunity

test level

(V/m)

5 Product Maintenance

5.1 Overview

This chapter describes the maintenance schedule for the INVOS patient monitor (the “monitoring system”) and provides instructions for performing annual inspections. It also provides information about calibration and service life.

Section 5.2, Safety Reminders, page 53

•

Section 5.3, Maintenance Schedule, page 53

•

Section 5.4, Annual Inspection Procedures, page 54

•

Section 5.5, Service and Calibration, page 55

•

Section 5.6, Service Life, page 55

•

Section 5.7, Software and Firmware Updates, page 56

•

Section 5.8, Recycling and Disposal, page 58

•

5.2 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:

available from Medtronic. See the Accessories/Parts list in the monitoring system’s operator’s manual.

Caution:

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

Shock hazard — Device must only be connected to a supply main with protective earth.

Explosion hazard — When replacing the battery, do not use the incorrect type. Use only the battery

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

5.3 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 Section 1.5, Obtaining Technical Assistance, page 12.

Medtronic recommends the following checks at the indicated intervals.

Table 10. Maintenance Schedule

How often What to do

Each power-up Conrm speaker operation. The POST pass tone is an audible conrmation of proper

speaker performance. If the speaker does not function, alarm warning sounds will not be audible..

Every 3 months If the monitoring system is not in use, apply power and charge the battery.

For long-term storage, Medtronic recommends removing the battery pack from

the monitor. Annually Check the INVOS system. See Section 5.4, Annual Inspection Procedures, page 54. Annually Inspect all safety relevant labels for legibility. Contact Medtronic or a local Medtronic

representative, if labels are damaged or illegible. Annually Replace the reusable sensor cables (RSCs).See the monitoring system’s operator’s

manual for part number and ordering information. Every 2 years Replace the monitor’s battery. See the monitoring system’s operator’s manual for

part number and ordering information.

Table 10. Maintenance Schedule (continued)

How often What to do

After approximately 25,000 hours of operation

Annually Safety testing. See Chapter 7, Basic Safety Testing, page 61.

Replace the monitor. See Section 5.6, Service Life, page 55 for more information.

5.4 Annual Inspection Procedures

5.4.1 Mechanical Inspection Points

Inspect the following for damage, dirt, loose connectors, corroded or bent pins, uid contamination or stains, or damaged cords:

• Power supply and cord

• Reusable sensor cables (RSCs)

• Reusable infant sensor adapter cables (RICs)

• Preampliers and cables

• Monitor

• Battery

• Docking station

• Stand

5.4.2 Electrical Inspection Points

The LAN port on the bottom of the docking station (

Note:

devices to this port.

Table 11. Annual Maintenance - Electrical Inspection Points

Inspection

point

Power up/ power down

System selfdiagnostics

Battery back‐ up

1. Connect the monitoring system to AC power.

2. Verify that the blue power indicator on the docking station is illuminated (Figure 3, page 17).

3. Check that the battery status indicator at the top left of the monitor is illuminated (orange = charging; green = fully charged).

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

5. Verify that the POST pass tone sounds and the Set-up screen appears. Refer to the monitoring system’s operator’s manual.

6. Press the Power button to power o the monitoring system.

7. Verify that the screen goes completely dark. Note that the battery indicator on the monitor and the power indicator on the docking station remain illuminated as long as power is connected.

1. Connect the monitoring system to AC power.

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

3. Verify that the POST pass tone sounds and the Set-up screen appears. Refer to the monitoring system’s operator’s manual.

1. Connect the monitoring system to AC power.

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

Figure 7, page 20

Method

) is not used. Do not connect any

Table 11. Annual Maintenance - Electrical Inspection Points (continued)

Inspection

point

3. Note the battery status indicators on the monitor and on the screen (refer to the monitoring system’s operator’s manual). Charge the battery to full capacity.

4. Disconnect the monitoring system from AC power and verify that the monitoring system continues to run for at least 1 hour. If the battery does not support at least 1 hour of operation, replace the battery. See Section 3.4.1, Install the Battery, page 27.

VGA port (video out‐ put)

Serial port 1. Connect the monitoring system to AC power.

USB ports 1. Connect the monitoring system to AC power.

System func‐ tion

1. Connect the monitoring system to AC power.

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

3. Connect an external VGA monitor as described in Displaying Monitoring System Screens on an External Monitor in the operator’s manual.

4. Verify that monitoring system screens appear on the external monitor.

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

3. Refer to Transmitting Monitoring System Data to External Devices via the Serial Port in the operator’s manual for instructions for connecting devices.

4. Verify that the data is correctly transmitted.

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

3. Verify USB functionality by exporting settings to a USB ash drive (see Section 3.4.3.11, Exporting/Importing Settings, page 42).

4. Verify that the data has been correctly transmitted.

5. Repeat for all USB ports on the docking station and monitor.

Perform functional testing as described in Section 8.3, Functional Testing with the INVOS PM7100 Field Test Device, page 66.

Method

5.4.3 Functional Testing

See Section 8.3, Functional Testing with the INVOS PM7100 Field Test Device, page 66.

5.5 Service and Calibration

The monitoring system requires no routine service.

The monitoring system requires no calibration.

If service is necessary, contact Technical Services. See Section 1.5, Obtaining Technical Assistance, page 12.

5.6 Service Life

Discontinue use of the monitoring system if the system reports any unrecoverable technical alarms, the monitor is inoperative, or visible damage is present.

Service life of specic components:

• The monitor’s battery has a service life of approximately two years.

• The reusable sensor cables have a service life of approximately one year.

• The reusable infant sensor adapter cables have a service life of approximately one year.

• The preampliers have a service life of approximately ve years.

• The monitor’s LCD panel (screen) has a service life of approximately 25,000 hours of operation before the brightness is reduced to approximately 50% of initial brightness. To avoid diculty reading the screen, Medtronic recommends replacing the monitor at approximately 25,000 hours of operation.

5.7 Software and Firmware Updates

Medtronic may provide monitoring system software or rmware updates periodically. Software updates aect the monitor, while rmware updates aect the preamplier(s). You can update either software or rmware, or both, as needed.

Note: When updating both the monitor software and the preamplier rmware, the monitor software must be updated rst and the system rebooted prior to updating the preamplier rmware.

To inquire about updates, contact Medtronic or a local Medtronic representative. See

page 61

Note: If a preamplier failure is reported by the monitoring system, it may be the result of incompatibility between the preamplier and monitor. PM7100 preampliers with version 2.0.0.0 or greater are only compatible with PM7100 monitors that are version 2.0.0.0 or greater.

Note: When the software or rmware is updated:

• All trend data and case histories are deleted. Refer to the monitoring system’s operator’s manual for

• All settings are returned to their defaults. See Section 3.4.3, Set Institutional Defaults, page 28 for instructions for

5.7.1 Updating Monitor Software and Preamplier Firmware Note:

To begin the update:

information about exporting case histories for external storage.

setting institutional defaults through the monitoring system’s service mode.

Do not cancel a software or rmware update at any time.

1. Insert a USB ash drive containing a valid PM7100 software or rmware update image into the USB 2.0 port on the monitor or docking station. See Figure 4, page 18 and Figure 7, page 20.

2. Conrm the following:

• The monitoring system is connected to AC power (see AC Power in the operator’s manual).

• The monitor is in the docking station (see Insert the Monitor into the Docking Station in the operator’s manual).

• The preamplier(s) are connected to the monitoring system (see Connect the Preamplier(s) in the operator’s manual).

Section 7.2, Safety Reminders,

To update monitor software:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press UTILITIES.

Figure 39. Service Mode - UTILITIES - UPDATES

3. Press IMPORT SOFTWARE FROM USB. A progress bar appears.

4. An installer appears. Press Next.

5. At the Ready to Install the Program screen, press Install. A progress bar appears.

6. At the conrmation message, press OK. The monitoring system restarts.

If not updating rmware, skip to the "To complete the update" section.

To update preamplier rmware:

1. If the monitoring system is not already in service mode, enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29, and press UTILITIES. See Figure 39.

2. Press IMPORT FIRMWARE FROM USB. One or more progress bars appear and the preamplier( s) reset.

3. When the following message appears, press FINISH: IMPORT COMPLETE. PRESS FINISH OR REMOVE USB DRIVE TO RETURN TO PREVIOUS MENU.

4. Press CLOSE. The monitoring system restarts.

To complete the update:

1. Verify the update by checking the software and rmware versions as described in Section 5.7.2, Checking Software and Firmware Versions, page 57.

2. Remove the USB ash drive if you have not already done so.

5.7.2 Checking Software and Firmware Versions

After a software or rmware update, check the versions using the following procedure.

To check the current software and rmware versions:

1. Enter service mode as described in Section 3.4.3.3, Entering Service Mode, page 29.

2. Press DISPLAY.

Figure 40. Service Mode - DISPLAY - ABOUT THIS MONITOR

3. Press ABOUT THIS MONITOR. System information is displayed. Note: The rmware version is indicated as “Preamp Software Version.” If you are using two preampliers,

versions are displayed for both preampliers.

Figure 41.

4. Press CLOSE to exit service mode and restart the monitoring system.

5. See Section 3.4.3, Set Institutional Defaults, page 28 for instructions for setting institutional defaults through the monitoring system’s service mode.

ABOUT THIS MONITOR - System Information

5.8 Recycling and Disposal

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

Follow local government ordinances and recycling instructions regarding disposal or recycling of the monitoring system and its components, including its battery and accessories.

6 Exporting Logs

6.1 Overview

For troubleshooting purposes, you may be asked to export logs from the monitoring system and provide them to Medtronic Technical Services. After exporting logs to a USB ash drive, you can upload them to a computer.

6.2 Exporting Logs from the Monitoring System

To export logs from the monitoring system:

1. Enter service mode as described in

2. Press UTILITIES. Figure 42. Service Mode - UTILITIES - EXPORT LOGS TO USB

3. Insert a USB ash drive into the USB port on the monitor or docking station. See Figure 4, page 18 and Figure 7, page 20.

4. Press EXPORT LOGS TO USB. A progress bar appears during the export. When the screen indicates the export is complete, press FINISH.

Section 3.4.3.3, Entering Service Mode, page 29

Figure 43.

Exporting Logs to USB - Export Complete

5. Remove the USB ash drive.

6. Press CLOSE. The monitoring system exits service mode and restarts.

7 Basic Safety Testing

7.1 Overview

The INVOS patient monitor (the "monitoring system") has two serviceable components:

• PM7100 monitor

• PMPAMP71 preamplier

These components must be individually tested to ensure a state of safety and eectiveness. While the INVOS PM7100 eld test device (PM71IFTD) ensures the eectiveness of the system and should be used as a nal system test (see Section 8.3, Functional Testing with the INVOS PM7100 Field Test Device, page 66), the safety testing described in this chapter ensures the system remains compliant to the IEC/ANSI AAMI/CSA 60601-1 standards.

Internal safety testing should be performed by authorized technicians prior to any unit being returned to the eld after service inspection. External safety testing should be performed by authorized technicians per their internal safety and maintenance procedures.

Section 7.2, Safety Reminders, page 61

•

Section 7.3, Safety Tests - PM7100 Monitor, page 62

•

Section 7.4, Safety Test - PMPAMP71 Preamplier, page 64

•

7.2 Safety Reminders

Warning: High voltage is produced by test equipment during the tests described in this chapter. These tests can

be dangerous to the operator.

Warning: Do not touch the device under test, the test equipment, test cable, or any of the cable connections while the test equipment is in operation. Electric shock to the operator may result.

Notes:

• The components of the PM7100 monitor that are connected to protective earth are contained within the external power supply and are not accessible to the user. Exposed metal parts on the monitor are double-insulated from live parts. A ground continuity test should not be performed; doing so may

damage the equipment and void the warranty.

• The test conguration for safety testing the PM7100 monitor should not include the PMAC71DOC docking station, PMAC71STAND stand, or PMPAMP71 preamplier.

• The test conguration for safety testing the PMPAMP71 preamplier should not include the PM7100 monitor, PMAC71DOC docking station, or PMAC71STAND stand.

• PM71IFTD functional testing must be performed last to demonstrate eectiveness after safety testing of either the PM7100 monitor or PMPAMP71 preamplier. See Section 8.3, Functional Testing with the INVOS PM7100 Field Test Device, page 66.

7.3 Safety Tests - PM7100 Monitor

7.3.1 PM7100 Monitor Safety Tests - Recommended Test Conguration

Figure 44. PM7100 Monitor Safety Test Conguration

7.3.2 PM7100 Monitor AC Dielectric Withstand Voltage Test

This section provides test conditions and acceptance criteria for the AC dielectric withstand (Hipot) voltage test on the PM7100 monitor. The purpose of the AC dielectric withstand voltage test is to satisfy EC Medical Device Directive, UL, and CSA electrical safety requirements for the PM7100 monitor.

Test parameters and acceptance criteria for the AC dielectric withstand voltage test are listed in Table 12.

Table 12. AC Dielectric Withstand Voltage Test Parameters - PM7100 Monitor

Test Test parameters Parameter description

AC dielectric withstand voltage Voltage 1776 VAC

HI-limit 10.00 mA

LO-limit 0.00 mA

Ramp up 1.8 seconds

Dwell time 1.0 second

Ramp down 0.2 seconds

Record the milliamps and kilovolts on the service record when the test has nished.

7.3.3 PM7100 Monitor Insulation Resistance Test

This section provides test conditions and acceptance criteria for the insulation resistance (IR) test on the PM7100 monitor. The purpose of the IR test is to apply a lower DC voltage across dierent parts of the electronic design. The results are displayed in mega ohms (MΩ). The resistance is measured and then compared with the minimum acceptable value to assess pass or fail conditions.

Test parameters and acceptance criteria for the insulation resistance test are listed in Table 13.

Table 13. Insulation Resistance Test Parameters - PM7100 Monitor

Test Test parameters Parameter description

Insulation resistance Voltage 500 VAC

HI-limit N/A

LO-limit 2 mega ohms

Ramp up 0.1 seconds

Delay time 2 seconds

Ramp down 0 seconds

Record the mega ohms on the service record when the test has nished.

7.3.4 PM7100 Monitor Line Leakage Current Test

This section provides acceptance criteria for the line leakage current test on the PM7100 monitor. The purpose of the line leakage current test is to satisfy international, US, and Canadian electrical safety requirements for the PM7100 monitor chassis.

Test parameters and acceptance criteria for the line leakage current test are described in Table 14.

Table 14. Line Leakage Current Test Parameters - PM7100 Monitor

Leakage -

HI (µA)

100 0 264 1.0 Closed A (O) Closed IEC60601-1Probe-HI

500 0 264 1.0 Closed A (O) Open IEC60601-1Ground to

500 0 264 1.0 Closed A (O) Open IEC60601-1Probe-HI

1000 0 264 1.0 Open A (O) Open IEC60601-1Ground to

500 0 264 1.0 Open A (O) Closed IEC60601-1Probe-HI

100 0 264 1.0 Closed B (On) Closed IEC60601-1Probe-HI

500 0 264 1.0 Closed B (On) Open IEC60601-1Ground to

500 0 264 1.0 Closed B (On) Open IEC60601-1Probe-HI

1000 0 264 1.0 Open B (On) Open IEC60601-1Ground to

500 0 264 1.0 Open B (On) Closed IEC60601-1Probe-HI

Leakage -

LO (µA)

Voltage -

HI (VAC)

Delay

time (sec‐

onds)

Neutral Reverse Ground Meas. de‐

vice

Probe

to line

line

Current limits for Normal Condition (NC) and Single Fault Condition (SFC) are set per IEC 60601-1.

Record the microamps and volts on the service record when the test has nished.

7.4 Safety Test - PMPAMP71 Preamplier

7.4.1 PMPAMP71 Preamplier Safety Test - Recommended Test Conguration

Figure 45. PMPAMP71 Preamplier Safety Test Conguration

7.4.2 PMPAMP71 Preamplier AC Dielectric Withstand Voltage Test

This section provides test conditions and acceptance criteria for the AC dielectric withstand (Hipot) voltage test on the PMPAMP71 preamplier. The AC dielectric withstand voltage test is performed across all sensor input connections shorted together and all pins on host connector together.

Test parameters and acceptance criteria for the AC dielectric withstand voltage test are described in Table 15.

Table 15. AC Dielectric Withstand Voltage Test Parameters - PMPAMP71 Preamplier

Test Test parameters Parameter description

AC dielectric withstand voltage Voltage 3600 VAC

HI-limit 3.0 mA

LO-limit 0.1 mA

Ramp up 3 seconds

Dwell time 1 second

Ramp down 0.4 seconds

8 INVOS PM7100 Field Test Device (PM71IFTD)

POX_20606_A

8.1 Overview

This chapter describes the functionality and use of the INVOS PM7100 eld test device (PM71IFTD).

Section 8.2, PM71IFTD Battery Replacement, page 65

•

Section 8.3, Functional Testing with the INVOS PM7100 Field Test Device, page 66

•

Section 8.4, Maintenance for the INVOS PM7100 Field Test Device, page 67

•

8.2 PM71IFTD Battery Replacement

The eld test device requires two AA (1.5 V) alkaline batteries.

Figure 46. Battery Compartment Access

To replace the batteries:

1. Press and slide the battery compartment door down to expose the batteries (Figure 46).

2. Remove the batteries from the device.

3. Install the new batteries according to the polarity markings in the battery compartment.

4. Slide the battery compartment door to the fully closed position on the device.

8.3 Functional Testing with the INVOS PM7100 Field Test Device

8.3.1 Introduction

Use the INVOS PM7100 eld test device to test basic monitoring system functions. Do not use any other type of test device with the monitoring system. Do not attach the test device to the monitoring system when the system is in use on a patient.

For information about acquiring and using the INVOS PM7100 eld test device, contact Technical Services. See Section 1.5, Obtaining Technical Assistance, page 12.

There are two system congurations that can be tested:

• Two preampliers and four reusable sensor cables (RSCs)

• One preamplier and two RSCs

Follow the instructions in the test procedure that match your conguration.

8.3.2 Monitoring System Functional Test

This test can be performed for either a 1-preamplier or 2-preamplier conguration. For a 1-preamplier test, you will need just one INVOS PM7100 eld test device. For a 2-preamplier test, you will need two INVOS PM7100 eld test devices.

To set up the monitoring system for functional testing:

1. Set up the monitoring system as described in the following sections in the operator’s manual:

• Install the Battery

• Insert the Monitor into the Docking Station

• Connect the Preamplier(s)

• Connect the Reusable Sensor Cables (RSCs)

• Apply Power

2. Verify that the POST pass tone sounds and the Set-up screen appears.

Warning:

Medtronic or a local Medtronic representative. Do not perform functional testing.

Notes:

• All listed rSO2 values have acceptance criteria of ±2 (% rSO2).

• When rst connecting the test device to the reusable sensor cables (RSCs), you may see a transient check

• Depending on the alarm limit settings of the system being tested, rSO2 limit alarms may or may not be

To perform the functional test:

1. Set both channel values on the test device to 50, but DO NOT connect the RSCs.

2. Select the Sensor L circle on the monitoring screen.

3. Identify the RSC with the ashing blue LED and connect it to CH1 of the test device. Verify that the Sensor

4. Select the Sensor R circle on the monitoring screen.

5. Identify the RSC with the ashing blue LED and connect it to CH2 of the test device. Verify that the Sensor

6. If testing a 1-preamplier conguration, proceed to Step 12 in Section 8.3.2.

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

sensor alarm. Allow for a period of up to 10 seconds for the check sensor alarm to clear before proceeding.

observed during the test and can be ignored.

Note: The test device is battery powered. The LEDs next to the CHANNEL # illuminate when an rSO2 value is selected. If the LED does not illuminate, see Section 8.2, PM71IFTD Battery Replacement, page 65.

L circle indicates the value 50.

R circle indicates the value 50.

7. Set both channel values on the second test device to 50, but DO NOT connect the RSCs.

8. Select the Sensor S1 circle on the monitoring screen.

9. Identify the RSC with the ashing blue LED and connect it to CH1 of the second test device. Verify that the Sensor S1 circle indicates the value 50.

10. Select the Sensor S2 circle on the monitoring screen.

11. Identify the RSC with the ashing blue LED and connect it to CH2 of the second test device. Verify that the Sensor S2 circle indicates the value 50.

12. Select NEW DATA SET.

13. Change the values on all channels to 15. Allow up to 10 seconds for system response.

14. Verify that all channels on the monitor indicate an rSO2 value of 15.

15. Change the values on all channels to 50. Allow up to 10 seconds for system response.

16. Verify that all channels on the monitor indicate an rSO2 value of 50.

17. Change the values on all channels to 70. Allow up to 10 seconds for system response.

18. Verify that all channels on the monitor indicate an rSO2 value of 70.

19. Change the values on all channels to 95. Allow up to 10 seconds for system response.

20. Verify that all channels on the monitor indicate an rSO2 value of 95.

21. Change the values on all channels to 50. Allow up to 10 seconds for system response.

22. Verify that all channels on the monitor indicate an rSO2 value of 50.

23. Disconnect all RSCs from the test device(s).

24. Verify that there is a SENSOR NOT CONNECTED alarm for all channels on the monitor.

25. Press Dismiss in the message area.

26. Verify that the monitoring system returns to the sensor Set-up screen.

27. Power o the monitoring system.

28. Turn o all channels on the test device(s).

8.4 Maintenance for the INVOS PM7100 Field Test Device

The INVOS PM7100 eld test device does not require any calibration, as precision resistors are built into the design, and the system will remain stable in response for its intended lifecycle of 5000 cycles.

The INVOS PM7100 eld test device is battery powered. The LEDs next to the CHANNEL # illuminate when an rSO value is selected. If either LED does not illuminate, the device requires two replacement AA (1.5 V) alkaline batteries. See Section 8.2, PM71IFTD Battery Replacement, page 65 for battery replacement instructions. Battery replacement is the only required maintenance for the device.

Covidien llc,

*PT00158218B00*

15 Hampshire Street, Manseld, MA 02048 USA www.medtronic.com +1 800 635 5267 [T]

Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands.

Medtronic PM7100 Service Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

1 Introduction

1.1 Overview

1.2 Accessories/Parts List

Table 1. Monitoring System Accessory Part Numbers

1.3 Intended Audience

1.4 Safety Information

1.4.1 Explosion, Shock, and Toxicity Hazards Warning: Explosion hazard — Do not use the monitoring system in the presence of ammable anesthetics.

1.4.2 Patient Monitoring and Safety Warning: Always disconnect and remove the monitoring system and sensors during magnetic resonance

1.4.3 Operation Warning: Inspect the monitoring system and all accessories before use to ensure there are no signs of physical

1.4.4 Sensors, Cables, and Other Accessories Warning: The use of accessories, sensors, and cables other than those specied may result in poor performance

1.4.5 Electromagnetic Interference Warning: Electromagnetic emissions from the monitoring system may interfere with other critical devices.

1.4.6 Cleaning Caution: Do not autoclave or gas sterilize any components of the monitoring system.

1.5 Obtaining Technical Assistance

1.5.1 Technical Services

Start-up Screen Showing Code Version

1.5.2 Removing the INVOS Patient Monitor from the Clinical Space

1.5.3 Related Documents

1.6 Warranty Information

2 Product Overview

2.1 Overview

2.2 Product Description

2.3 Product Views

2.3.1 Full System

2.3.1.1 System Component Overview

Figure 2. INVOS Patient Monitor Components

2.3.2 Monitor Components

2.3.2.1 Monitor - Front

Figure 3. Monitor - Front

2.3.2.2 Monitor - Left Side

Figure 4. Monitor - Left Side

2.3.2.3 Monitor - Right Side

Figure 5. Monitor - Right Side

2.3.2.4 Monitor - Back

Figure 6. Monitor - Back

2.3.2.5 Docking Station

Docking Station - Bottom View

Figure 8. Docking Station - Connector for Monitor

2.3.2.6 Monitoring Screen

Figure 9. Sample Monitoring Screen Elements

2.4 Electrical

3 Installation

3.1 Overview

3.2 Safety Reminders

3.3 Service Mode Menu Structure

Table 2. Service Mode Menu Structure

3.4 Setup

3.4.1 Install the Battery

Figure 10. Battery Slot and Latch at Back of Monitor

Battery Installed in Monitor

3.4.2 Perform Functional Testing

3.4.3 Set Institutional Defaults

3.4.3.1 Institutional Settings - Factory Defaults

Table 3. Institutional Settings

3.4.3.2 Operational Defaults - User Changeable

Table 4. Operational Defaults

3.4.3.3 Entering Service Mode To enter service mode:

Figure 12. Accessing Service Mode

Figure 13. Enter Password

Figure 14. Incorrect Password

Figure 15. Change Password

Figure 16. Change Password Error Message

Figure 17. Contact Service Screen

Figure 18. Password Reset Screen

Figure 19. Insert USB Drive

Figure 20. Key File Error Message

Figure 21. Service Screen

Figure 22. Figure 22. Password Cleared

Figure 23. Set Password Screen

Figure 24. Password Set

Figure 25. Password Error

3.4.3.4 Silencing Alarms at Startup

Service Mode Settings

Figure 27. Service Mode - SETTINGS - SILENCE ALARMS AT STARTUP

Service Mode - SETTINGS - ALARM REMINDER SIGNAL

3.4.3.6 Changing Alarm Silence Duration