COVIDIEN PM1000N_OperatorsManual_EN_10104146E00 Nellcor Bedside Respiratory Patient Monitoring System Operator’s Manual
Operator’s Manual
Nellcor™
Bedside Respiratory Patient Monitoring System
COVIDIEN, COVIDIEN with logo, the Covidien logo and positive results for life are U.S. and
internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company.
©2013 Covidien. All rights reserved.
Microsoft and Windows CE are registered trademarks of Microsoft Corporation in the United
States and other countries.
The information contained in this manual is the sole property of Covidien and may not be
duplicated without permission. This manual may be revised or replaced by Covidien at any time
and without notice. It is the responsibility of the reader to have the most current applicable
version of this manual. If in doubt, contact Covidien Technical Services.
While the information set forth herein is believed to be accurate, it is not a substitute for the
exercise of professional judgment.
The equipment and software should only be operated and serviced by trained professionals.
Covidien’s sole responsibility with respect to the equipment and software, and its use, is as
stated in the limited warranty provided.
Nothing in this manual shall limit or restrict in any way Covidien’s right to revise or otherwise
change or modify the equipment and software described herein, without notice. In the
absence of an express, written agreement to the contrary, Covidien has no obligation to
furnish any such revisions, changes, or modifications to the owner or user of the equipment
and software described herein.
Table of Contents
1 Introduction
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.1 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . 1-5
1.4.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.4.2 On-Screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.5 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.6 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
2 Product Overview
2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.4 List of Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.5 Synopsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.6 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.6.1 Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.6.2 Monitoring Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.6.3 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.7 Labeling Symbology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
2.8 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2.8.1 Monitoring Screen Selection . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2.8.2 Monitoring Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
2.8.3 Visual Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
2.8.4 Audible Alarms and Indicators . . . . . . . . . . . . . . . . . . . . . . 2-13
2.9 Unique Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
2.9.1 SatSeconds™ Alarm Management Parameter . . . . . . . . . . . 2-14
2.9.2 OxiMax SPD™ Alert Parameter . . . . . . . . . . . . . . . . . . . . . . 2-15
2.9.3 Pulse Rate Delay Alarm Management Parameter . . . . . . . . . 2-15
2.9.4 Additional Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Operator’s Manual i
3 Installation
3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.3 Product Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.3.1 Mounting Options and Transport Considerations . . . . . . . . . 3-3
3.3.2 Connection to an AC Power Source . . . . . . . . . . . . . . . . . . . 3-4
3.3.3 Battery Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
3.3.4 Battery Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
3.3.5 Battery Power Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
3.4 Connection to Nellcor™ Sensors . . . . . . . . . . . . . . . . . . . 3-7
4 Operation
4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2.1 AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.2.2 Battery Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.2.3 Power Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.2.4 System Resets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.2.5 Automatic Shutdown and Power Off . . . . . . . . . . . . . . . . . . 4-6
4.3 Nellcor™ Sensor Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.3.1 Sensor Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.3.2 Sensor Detection Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
4.4 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
4.4.1 Default Monitoring Screen and Trend Data . . . . . . . . . . . . . . 4-9
4.4.2 Status Messages and Alarms in the Monitoring Status Field 4-10
4.4.3 Introduction to Menu Options . . . . . . . . . . . . . . . . . . . . . . 4-10
4.4.4 Menu Option Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
4.4.5 Monitoring Screen Layout Options . . . . . . . . . . . . . . . . . . . 4-41
4.4.6 Alarm Management and Status Messages . . . . . . . . . . . . . . 4-50
4.4.7 Audible Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . 4-53
4.4.8 Visual Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . 4-55
4.4.9 HELP Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-56
5 Trend Data Access
5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Trend Data Management . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2.1 Trend Data Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2.2 Real-time Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2.3 Historical Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
ii Operator’s Manual
5.3 Data Port Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
5.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
5.3.2 Typical Equipment Used for Connectivity . . . . . . . . . . . . . . 5-11
5.3.3 Data Port Configuration Information . . . . . . . . . . . . . . . . . . 5-12
5.3.4 Data Port Communications . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
5.4 Using the Nurse Call Interface . . . . . . . . . . . . . . . . . . . . 5-18
5.4.1 Nurse Call Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
5.4.2 Setting Nurse Call RS-232 Polarity . . . . . . . . . . . . . . . . . . . . 5-19
6 Performance Considerations
6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Oximetry Considerations . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2.1 Monitoring System Constraints . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2.2 Nellcor™ Sensor Performance Considerations . . . . . . . . . . . . 6-1
6.3 Patient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.4 Reducing EMI (Electromagnetic Interference) . . . . . . . . . 6-5
7 Product Maintenance
7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.3 Periodic Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.4 Service and Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.5 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.5.1 Monitoring System Transport and Storage . . . . . . . . . . . . . . 7-2
7.5.2 Removed Battery Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
8 Troubleshooting
8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 System Condition Categories . . . . . . . . . . . . . . . . . . . . . . 8-1
8.3 User Prompts and Messages . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.4 Alarms and Error Conditions . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.4.1 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.4.2 Correctable Error Conditions . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
8.5 Power Failure Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
8.6 Monitoring Screen Issues . . . . . . . . . . . . . . . . . . . . . . . . 8-12
8.7 Alarm Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
8.8 Communication Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
8.9 Operational Performance Issues . . . . . . . . . . . . . . . . . . . 8-14
Operator’s Manual iii
8.10 Hardware Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
8.11 System Errors and Software Issues . . . . . . . . . . . . . . . . 8-16
8.12 Non-Correctable Failures . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
8.13 Product Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17
9 Accessories
9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2 Nellcor™ Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2.1 Selecting a Nellcor™ Sensor . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2.2 Nellcor™ Sensor Features . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.2.3 Biocompatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.3 Optional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
10 Theory of Operations
10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
10.2 Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
10.3 Automatic Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
10.4 Functional Testers and Patient Simulators . . . . . . . . . . 10-2
10.5 Unique Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
10.5.1 Functional versus Fractional Saturation . . . . . . . . . . . . . . . . 10-3
10.5.2 Measured versus Calculated Saturation . . . . . . . . . . . . . . . . 10-4
10.5.3 Data Update Period, Data Averaging, and Signal Processing 10-4
10.6 System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
10.6.1 Nellcor™ Sensor Technology . . . . . . . . . . . . . . . . . . . . . . . 10-5
10.6.2 SatSeconds™ Alarm Management Parameter . . . . . . . . . . . 10-6
10.6.3 OxiMax SPD™ Alert Parameter . . . . . . . . . . . . . . . . . . . . . 10-10
10.6.4 Pulse Rate Delay Alarm Management Parameter . . . . . . . . 10-12
11 Product Specifications
11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.2 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.3 Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.3.1 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.3.2 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
11.3.3 Rating of Nurse Call Relay . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
11.4 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . 11-3
11.4.1 Operating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
11.4.2 Transport and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
iv Operator’s Manual
11.5 Sensor Accuracy and Ranges . . . . . . . . . . . . . . . . . . . . . 11-4
11.6 Sound Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
11.7 Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
11.8 Manufacturer’s Declaration and Guidance . . . . . . . . . . 11-6
11.8.1 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . 11-6
11.8.2 Ground Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
11.8.3 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
11.9 Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
A Clinical Studies (REF PMMOD30N)
A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.2 Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.2.1 Hypoxia Methodology (Accuracy, Low Saturation, and
Motion Studies) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.2.2 Low Saturation Methodology (Low Saturation Study Only) . . A-2
A.2.3 Motion Methodology (Motion Study Only) . . . . . . . . . . . . . . A-2
A.3 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
A.3.1 Accuracy Results (No Motion) . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.3.2 Accuracy Results (Low Saturation) . . . . . . . . . . . . . . . . . . . . A-24
A.3.3 Accuracy Results (Motion) . . . . . . . . . . . . . . . . . . . . . . . . . . A-29
A.4 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-39
A.4.1 No Motion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-39
A.4.2 Motion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-39
B Clinical Studies (REF GR101777)
B.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
B.2 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
B.3 Study Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
B.4 Study Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
B.5 Adverse Events or Deviations . . . . . . . . . . . . . . . . . . . . . . B-4
B.6 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
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List of Figures
Figure 2-1. Front Panel ................................................................................................... 2-3
Figure 2-2. Sample Monitoring Screen Elements ................................................. 2-4
Figure 2-3. Rear Panel ..................................................................................................... 2-6
Figure 2-4. Pleth View ..................................................................................................... 2-9
Figure 2-5. Trend View ...................................................................................................2-9
Figure 2-6. Combined Pleth and Trend View .......................................................2-10
Figure 2-7. Numbers Only (Blip) View .....................................................................2-11
Figure 3-1. Sensor Cable Insertion into Interface Cable .................................... 3-8
Figure 4-1. Sample POST Splash Screen .................................................................4-6
Figure 4-2. Sensor Type Message ............................................................................... 4-8
Figure 4-3. Default Monitoring Screen Layout ...................................................... 4-9
Figure 4-4. ALARM LIMITS Menu Options .............................................................4-17
Figure 4-5. Adjusting Alarm Limit Settings ...........................................................4-19
Figure 4-6. Setting SatSeconds Alarm Limits .......................................................4-20
Figure 4-7. Setting SPD Sensitivity ...........................................................................4-23
Figure 4-8. Setting Pulse Rate Delay .......................................................................4-24
Figure 4-9. MONITORING HISTORY Menu Options ............................................4-25
Figure 4-10. MONITORING HISTORY - TRENDS ......................................................4-26
Figure 4-11. Historical Trend Data Pop-Up ..............................................................4-26
Figure 4-12. MONITORING HISTORY - CLINICAL LOG ..........................................4-27
Figure 4-13. MONITORING HISTORY - HISTOGRAM .............................................4-28
Figure 4-14. MARK EVENT Menu Options ................................................................4-29
Figure 4-15. Marked Event and Pop-up in Trend View .......................................4-30
Figure 4-16. SOUND SETTINGS Menu Options .......................................................4-31
Figure 4-17. MONITORING SETTINGS Menu Options ..........................................4-32
Figure 4-18. Selecting Adult and Pediatric vs. Neonate Alarm Mode ...........4-34
Figure 4-19. Response Mode Selection Screen ......................................................4-35
Figure 4-20. Time and Date Selection Screen ........................................................4-36
Figure 4-21. Alarm Silence Duration Screen ...........................................................4-37
Figure 4-22. CONNECTIVITY SETTINGS Menu Options ........................................4-39
Figure 4-23. Monitoring Layout Options .................................................................4-41
Figure 4-24. Pleth Only View ........................................................................................4-42
Figure 4-25. Real-time Trend Only View ...................................................................4-44
Figure 4-26. Select Trends Options ............................................................................4-45
Figure 4-27. SpO2 and Pulse Rate Trend Data, 1 Hour .........................................4-45
Figure 4-28. SpO
Figure 4-29. Pulse Only Trend Data, 1 Hour ............................................................4-46
2 Only Trend Data, 1 Hour .............................................................4-46
Operator’s Manual vii
Figure 4-30. Combination Pleth and Trend View ..................................................4-48
Figure 4-31. Numbers Only (Blip) View .....................................................................4-49
Figure 4-32. Sample user prompt message: READY ...........................................4-51
Figure 4-33. Sample status message: MONITORING ...........................................4-51
Figure 4-34. High priority alarm: BATTERY CRITICALLY LOW ..........................4-51
Figure 4-35. Medium priority alarm: SpO2 LOW ....................................................4-51
Figure 4-36. Low priority alarm: SENSOR OFF ........................................................4-52
Figure 4-37. Sample Alarm Limit Violations ............................................................4-53
Figure 5-1. Graphical Trend Data Components (Historical Trend
Data Shown as Example) ......................................................................... 5-3
Figure 5-2. Sample Real-Time Data Output ............................................................ 5-4
Figure 5-3. Sample Historical Trend Data Export .................................................. 5-7
Figure 5-4. DB-15 Pin Layout .....................................................................................5-13
Figure 5-5. RJ-45 Receptacle ......................................................................................5-15
Figure 5-6. RJ-45 Pin Layout .......................................................................................5-15
Figure 5-7. USB Pin Layout ..........................................................................................5-16
Figure 5-8. Nurse Call Polarity Screen .....................................................................5-20
Figure 8-1. Ready Prompt ............................................................................................. 8-2
Figure 8-2. Sensor Disconnected Message and Help Screen ........................... 8-2
Figure 8-3. Stacked Alarm/Alerts ................................................................................ 8-3
Figure 8-4. Sample Speaker Failure Message ......................................................... 8-9
Figure 8-5. Sample System Error Screen ................................................................8-16
Figure 10-1. Oxyhemoglobin Dissociation Curve .................................................10-4
Figure 10-2. Series of SpO2 Events ..............................................................................10-6
Figure 10-3. First SpO2 Event: No SatSeconds Alarm ...........................................10-7
Figure 10-4. Second SpO2 Event: No SatSeconds Alarm ....................................10-8
Figure 10-5. Third SpO2 Event: Triggers SatSeconds Alarm ..............................10-9
Figure 10-6. Clinically Significant Desaturation Patterns ................................ 10-10
Figure A-1. Modified Bland-Altman for SpO2 (All Data - No Motion):
2 vs. (SpO2 - SaO2) ...............................................................................A-5
SaO
Figure A-2. Modified Bland-Altman for Pulse Rate (All Data - No Motion):
ECG HR vs. (Pulse Rate - ECG HR) ..........................................................A-6
Figure A-3. Modified Bland-Altman for SpO
2 vs. (SpO2 - SaO2) ...............................................................................A-7
SaO
2 - MAXA Sensor (No Motion):
Figure A-4. Modified Bland-Altman for SpO2 - MAXN Sensor (No Motion):
SaO
2 vs. (SpO2 - SaO2) ...............................................................................A-8
Figure A-5. Modified Bland-Altman for SpO
2 - MAXFAST Sensor (No Motion):
SaO2 vs. (SpO2 - SaO2) ...............................................................................A-9
Figure A-6. Modified Bland-Altman for SpO
2 vs. (SpO2 - SaO2) ............................................................................ A-10
SaO
2 - SC-A Sensor (No Motion):
viii Operator’s Manual
Figure A-7. Modified Bland-Altman for SpO2 - DS100A Sensor (No Motion):
SaO2 vs. (SpO2 - SaO2) ............................................................................ A-11
Figure A-8. Modified Bland-Altman for SpO
SaO
2 vs. (SpO2 - SaO2) ............................................................................ A-12
2 - OxiCliq-A Sensor (No Motion):
Figure A-9. Modified Bland-Altman for SpO2 - D-YSE Sensor (No Motion):
SaO2 vs. (SpO2 - SaO2) ............................................................................ A-13
Figure A-10. Modified Bland-Altman for Pulse Rate - MAXA Sensor
(No Motion): ECG HR vs. (Pulse Rate - ECG HR) ............................A-14
Figure A-11. Modified Bland-Altman for Pulse Rate - MAXN Sensor
(No Motion): ECG HR vs. (Pulse Rate - ECG HR) ............................A-15
Figure A-12. Modified Bland-Altman for Pulse Rate - MAXFAST Sensor
(No Motion): ECG HR vs. (Pulse Rate - ECG HR) ............................A-16
Figure A-13. Modified Bland-Altman for Pulse Rate - SC-A Sensor (No Motion):
ECG HR vs. (Pulse Rate - ECG HR) ....................................................... A-17
Figure A-14. Modified Bland-Altman for Pulse Rate - DS100A Sensor
(No Motion): ECG HR vs. (Pulse Rate - ECG HR) ............................A-18
Figure A-15. Modified Bland-Altman for Pulse Rate - OxiCliq-A Sensor
(No Motion): ECG HR vs. (Pulse Rate - ECG HR) ............................A-19
Figure A-16. Modified Bland-Altman for Pulse Rate - D-YSE Sensor (No Motion):
ECG HR vs. (Pulse Rate - ECG HR) ....................................................... A-20
Figure A-17. Correlation Plot for SpO2 (All Data - No Motion):
SaO2 vs. SpO2 ............................................................................................ A-21
Figure A-18. Correlation Plot for Pulse Rate (All Data - No Motion):
ECG HR vs. Pulse Rate ............................................................................ A-22
Figure A-19. Modified Bland-Altman for SpO2 (All Data - Low Saturation):
SaO2 vs. (SpO2 - SaO2) ............................................................................ A-25
Figure A-20. Modified Bland-Altman for Pulse Rate (All Data - Low Saturation):
ECG HR vs. (Pulse Rate - ECG HR) ....................................................... A-26
Figure A-21. Correlation Plot for SpO2 (All Data - Low Saturation):
2 vs. SpO2 ........................................................................................... A-27
SaO
Figure A-22. Correlation Plot for Pulse Rate (All Data - Low Saturation):
ECG HR vs. Pulse Rate ............................................................................ A-28
Figure A-23. Modified Bland-Altman for SpO
2 vs. (SpO2 - SaO2) ............................................................................ A-30
SaO
2 (All Data - Motion):
Figure A-24. Modified Bland-Altman for Pulse Rate (All Data - Motion):
ECG HR vs. (Pulse Rate - ECG HR) ....................................................... A-31
Figure A-25. Modified Bland-Altman for SpO2 - MAXA Sensor (Motion):
SaO2 vs. (SpO2 - SaO2) ............................................................................ A-32
Figure A-26. Modified Bland-Altman for SpO
2 vs. (SpO2 - SaO2) ............................................................................ A-33
SaO
2 - MAXN Sensor (Motion):
Operator’s Manual ix
Figure A-27. Modified Bland-Altman for Pulse Rate - MAXA Sensor (Motion):
ECG HR vs. (Pulse Rate - ECG HR) ....................................................... A-34
Figure A-28. Modified Bland-Altman for Pulse Rate - MAXN Sensor (Motion):
ECG HR vs. (Pulse Rate - ECG HR) ....................................................... A-35
Figure A-29. Correlation Plot for SpO2 (All Data - Motion):
SaO2 vs. SpO2 ............................................................................................ A-36
Figure A-30. Correlation Plot for Pulse Rate (All Data - Motion):
ECG HR vs. Pulse Rate ............................................................................ A-37
Figure B-1. Modified Bland-Altman Plot ..................................................................B-3
x Operator’s Manual
List of Tables
Table1-1. Safety Symbol Definitions .......................................................................1-2
Table2-1. Typical Packing List ....................................................................................2-2
Table2-2. Labeling Symbols and Descriptions .................................................... 2-7
Table2-3. Visual Alarm Properties ..........................................................................2-12
Table2-4. Audible Indicator Functions .................................................................2-14
Table4-1. Battery Power Status ................................................................................. 4-3
Table4-2. Menu icons and primary user interface features...........................4-11
Table4-3. Factory Default Settings.........................................................................4-14
Table4-4. Serial Connectivity Protocols................................................................4-39
Table5-1. Status Code Definitions ............................................................................ 5-6
Table5-2. Historical Trend Data Output Definitions ..........................................5-8
Table5-3. Trend Data Output - Encoded Alarm Values..................................... 5-9
Table5-4. Input and Output Configuration Options........................................5-11
Table5-5. Sample Equipment Types......................................................................5-11
Table5-6. DB-15 Signal Pinouts ...............................................................................5-13
Table5-7. RJ-45 Signal Pinouts.................................................................................5-16
Table5-8. USB Signal Pinouts ...................................................................................5-17
Table5-9. Nurse Call Relay Pin States ....................................................................5-19
Table8-1. Common User Prompts and Messages............................................... 8-4
Table8-2. Initial Alarm Priority for Errors................................................................ 8-5
Table8-3. Common Correctable Problems and Resolutions ........................8-10
Table8-4. Power Failure Issues.................................................................................8-11
Table8-5. Monitoring Screen Issues.......................................................................8-12
Table8-6. Alarm Issues ................................................................................................8-13
Table8-7. Common Prompts and Error Messages............................................8-14
Table8-8. Common Operational Performance Issues .....................................8-14
Table8-9. Common Prompts and Error Messages............................................8-15
Table9-1. Nellcor™ Sensor Models and Patient Sizes ........................................ 9-3
Table11-1. Nellcor™ Sensor Accuracy and Ranges .............................................11-4
Table11-2. Nellcor™ Sensor Operating Range and Power Dissipation........11-5
Table11-3. Sound Pressure in Decibels...................................................................11-5
Table11-4. Frequency Band, Output Power, and Modulation Type.............11-7
Table11-5. Electromagnetic Emissions Guidelines and Compliance ...........11-7
Table11-6. Electromagnetic Immunity Guidelines and Compliance ...........11-8
Table11-7. Recommended Separation Distance Calculations .......................11-9
Table11-8. Recommended Separation Distances............................................ 11-10
Table11-9. Sensor and Cable Length.................................................................... 11-11
Operator’s Manual xi
Table11-10. Earth and Enclosure Leakage Current Specifications ............... 11-12
Table11-11. Patient Applied and Patient Isolation Risk Current ................... 11-13
TableA-1. SpO
2 Accuracy Results (No Motion) .....................................................A-4
TableA-2. Pulse Rate Accuracy Results (No Motion)...........................................A-4
TableA-3. RMSD of SpO
2 per Decade (No Motion) ..........................................A-23
TableA-4. RMSD of SpO2 per Plateau (No Motion)........................................... A-23
TableA-5. SpO2 Accuracy Results (60 to 80% SaO2)......................................... A-24
TableA-6. Pulse Rate Accuracy Results (60 to 80% SaO2).............................. A-24
TableA-7. RMSD of SpO2 per Decade (Low Saturation) ................................. A-28
TableA-8. RMSD of SpO2 per Plateau (Low Saturation).................................. A-28
TableA-9. SpO2 Accuracy Results During Motion............................................. A-29
TableA-10. Pulse Rate Accuracy Results During Motion .................................. A-29
TableA-11. Percent Modulation During Motion ................................................. A-37
TableA-12. RMSD of SpO2 per Decade (Motion) ................................................. A-38
TableA-13. RMSD of SpO2 per Plateau (Motion) ................................................. A-38
TableB-1. Demographic Data.....................................................................................B-2
TableB-2. SpO2 Accuracy for Nellcor™ Sensors vs. CO-oximeters .................B-2
xii Operator’s Manual
1 Introduction
1.1 Overview
This manual contains information for collecting patient oxygen saturation data
while operating the Nellcor™ Bedside Respiratory Patient Monitoring System.
This manual applies to the following products:
GR101704
GR101704-RR
PM1000N
PM1000N-RR
1.2 Intended Audience
This manual provides information to health-care professionals acting as caregivers in a hospital or hospital-type setting for operation and maintenance of
the monitoring system. Refer to the institution for any additional training or
skill requirements beyond those identified here for operation and maintenance
of the monitoring system. Before operating, thoroughly read this manual.
1-1
Introduction
1.3.1 Safety Symbols
1.3 Safety Information
This section contains safety information requiring users to exercise appropriate
caution while using the monitoring system.
Table1-1.Safety Symbol Definitions
Symbol Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of
the product.
1.3.2 Warnings
WARNING:
Explosion hazard — Do not use in the presence of flammable anesthetics.
WARNING:
Shock hazard — Use only when connected to a grounded outlet to avoid
electric shock.
WARNING:
Use only Covidien-approved internal batteries.
WARNING:
The monitoring system is not defibrillator-proof. It may remain attached to
the patient during defibrillation or during use of an electrosurgical unit,
however, readings may be inaccurate during use in this environment and
shortly thereafter.
Note
Notes provide additional guidelines or information.
1-2 Operator’s Manual
WARNING:
Supplemental oxygen will attenuate patterns of desaturation. A patient’s
respiratory compromise can be proportionally more severe before patterns
appear in the saturation trend. Remain vigilant when monitoring a patient on
supplemental oxygen.
WARNING:
Do not silence or disable audible alarms or decrease the volume of the audible
alarm if patient safety could be compromised. Do not dim or disable visual
alarms if patient safety could be compromised.
WARNING:
Ensure the monitoring system is clear of any obstructions that prevent
awareness of visual or audible alarms. Failure to do so may result in
inadvertently missing a visual alarm or an inaudible alarm tone.
Safety Information
WARNING:
Do not use any monitoring system, sensor, cable, or connector that appears
damaged. Remove any damaged equipment from service for inspection by a
qualified service technician.
WARNING:
Do not lift by the sensor or interface cable. The cable may disconnect,
potentially dropping the monitoring system on a patient or damaging
surface.
WARNING:
When installing the AC power cord, ensure the cord is carefully positioned to
prevent tripping and entanglement.
WARNING:
Do not spray, pour, or spill any liquid on the monitoring system, its accessories,
connectors, switches, or openings in the chassis, since this may cause damage
to the monitoring system.
Operator’s Manual 1-3
Introduction
WARNING:
WARNING:
1.3.3 Cautions
Caution:
To ensure accurate performance and prevent device failure, do not subject to
extreme moisture, such as direct exposure to rain. Such exposure may cause
inaccurate performance or device failure.
The monitoring screen contains toxic chemicals. Do not touch a broken
enclosure or monitoring screen. Physical contact with a broken enclosure or
monitoring screen can result in transmission or ingestion of toxic substances.
When connecting the monitoring system to any instrument, verify proper
operation before clinical use. Both the monitoring system and the instrument
connected to it must utilize a grounded outlet. Any equipment connected to
the data interface must be certified according to the latest IEC/EN 60950 -1
standard for data-processing equipment, the latest IEC/EN 60601-1 standard
for electromedical equipment, or the latest IEC/EN safety standards relevant
to that equipment. All combinations of equipment must be in compliance
with Requirements for Medical Electrical Systems IEC Standard 60601-11:2007. Anyone who connects equipment to the data interface is configuring
a medical system and, therefore, is responsible for ensuring the system
complies with the Requirements for Medical Electrical Systems IEC/EN
Standard 60601-1-1:2007 and the electromagnetic compatibility IEC/EN
Standard 60601-1-2:2007. Accuracy may degrade if it is connected to
secondary I/O devices when the equipment is not connected to earth
reference.
Caution:
Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
1-4 Operator’s Manual
Obtaining Technical Assistance
1.4 Obtaining Technical Assistance
1.4.1 Technical Services
For technical information and assistance, if unable to correct a problem while
using the monitoring system, to order parts, or to order an Operator’s or
Service Manual, contact Covidien or a local Covidien representative.
Covidien Technical Services: Patient Monitoring
15 Hampshire Street
Mansfield, MA 02048 USA
1.800.635.5267, 1.925.463.4635 (toll)
or contact a local Covidien representative
www.covidien.com
When calling Covidien or a local Covidien representative, have the serial
number, as well as the code versions available.
To locate the serial number and code versions
1. Press MENU.
2. Press ABOUT THE MONITOR.
3. Locate the serial number under Monitor Information and code versions under
Software Information.
1.4.2 On-Screen Help
The monitoring system provides users with an on-screen help system for
various help topics. Reference To access on-screen help topics, p. 4-56.
Operator’s Manual 1-5
Introduction
1.5 Related Documents
Documentation is available online at www.covidien.com.
• Nellcor™ Sensor Instructions for Use — Guides sensor selection and usage.
Before attaching any of the various Covidien-approved Nellcor™ sensors to the
monitoring system, refer to their Instructions for Use.
• Nellcor™ Oxygen Saturation Accuracy Specification Grid — Provides
sensor-specific guidance related to desired SpO
ments.
• Nellcor™ Bedside Respiratory Patient Monitoring System Service
Manual — Provides information to qualified service technicians for use when
modifying, testing, troubleshooting, repairing, and upgrading the monitoring
system.
1.6 Warranty Information
2 saturation accuracy measure-
To obtain information, contact Covidien or a local Covidien representative.
Covidien Technical Services: Patient Monitoring
15 Hampshire Street
Mansfield, MA 02048 USA
1.800.635.5267, 1.925.463.4635 (toll)
or contact a local Covidien representative
www.covidien.com
Purchase of this instrument confers no express or implied license under any
Covidien patent to use that instrument with any sensor not manufactured or
licensed by Covidien llc.
1-6 Operator’s Manual
2 Product Overview
2.1 Overview
This chapter contains basic introductory information for operating the
Nellcor™ Bedside Respiratory Patient Monitoring System. The monitoring
system relies on unique oximetry technology and design in providing hospitals,
clinicians and caregivers accurate, timely data.
2.2 Product Description
The Nellcor™ Bedside Respiratory Patient Monitoring System provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate.
2.3 Indications for Use
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable
pulse oximeter intended for prescription use only as a continuous non-invasive
monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric,
and neonatal patients during both no motion and motion conditions, and for
patients who are well or poorly perfused. The monitoring system is intended
for use in hospitals, hospital-type facilities, and during intra-hospital transport.
The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of
adults to detect patterns of desaturation indicative of repetitive reductions in
airflow through the upper airway and into the lungs.
Note:
• Hospital use typically covers such areas as general care floors (GCFs), operating
rooms, special procedure areas, intensive and critical care areas within the hospital
and in hospital-type facilities. Hospital-type facilities include physician office-based
facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers.
•
Intra-hospital transport includes transport of a patient within the hospital or hospital-type
facility.
2-1
Product Overview
Use with any particular patient requires the selection of an appropriate Nellcor™
sensor. Reference
Monitoring system users can access trend information, change alarm limits,
adjust the internal time clock, select the communications protocol, and choose
alternative interface languages. Reference
The monitoring system operates on AC power or on an internal battery.
2.4 List of Components
The typical monitoring system carton ships with the following contents.
Nellcor™ Sensor Usage
, p. 4-7.
User Interface
Table2-1.Typical Packing List
Quantity Item
1 Nellcor™ Bedside Respiratory Patient Monitoring System
, p. 4-9.
1 DOC-10 interface cable
1 Operator’s Manual (applicable to country of sale) and/or compact disc
1 Hospital-grade power cord (applicable to country of sale)
2.5 Synopsis
Caregivers may use the monitoring system by connecting it to an interface
cable and a Nellcor™ sensor, then attaching the recommended sensor to a
patient. When the monitoring system detects a valid pulse, it enters monitoring
mode and displays patient parameters.
The movement of the blip bar or the plethysmographic waveform and the
flashing heart icon are visual indicators of real-time data. The pulse beep
tone is an audible indicator of the real-time patient data.
If the monitoring system detects an alarm condition, it provides both visual and
audible alarms. Reference Visual Alarms, p. 2-12, for visual alarm condition
behaviors. Reference Audible Alarms and Indicators, p. 2-13, for audible alarm
condition behaviors.
After monitoring is complete, remove the recommended sensor from the
patient.
2-2 Operator’s Manual
2.6 Product Views
2.6.1 Front Panel
Product Views
Figure2-1.Front Panel
1 Power on key Powers on and off 6 Type BF Indicates Type BF
applied part
2 AC indicator Indicates connection
to alternating current
power source
3 Battery condition
indicator
4 --- Speaker Issues audible alarms 9 Universal
5 --- Sensor port Houses interface
Operator’s Manual 2-3
Indicates battery is
charging
cable connector
7 Data port Houses DB-15 serial
connector
8 Ethernet port Houses RJ-45 Ethernet
receptacle
Houses USB connector
Serial Bus port
10 --- Parameter
module
(front)
Offers monitoring system
modular customization
Product Overview
2.6.2 Monitoring Screen
Note:
The following screen is a composite of elements that can appear during monitoring
system use. It does not represent an actual clinical scenario.
Figure2-2.Sample Monitoring Screen Elements
1 --- Monitor status field Contains patient information in various forms.
2 --- Alarm status field Contains prioritized alarms or user prompts.
3 --- Trend data type
button
4 Plethysmographic
waveform
5 --- Trend data time scale Contains time period for graphed trend data. Press “-” or “+” to
6 Battery fuel gauge Indicates remaining battery charge and lists percentage of total
7 Fast response mode
Icon
2-4 Operator’s Manual
Contains types of graphed trend data included.
This non-normalized waveform uses real-time sensor signals, reflecting relative pulsatile strength.
change the time period.
charge remaining. Fill color indicates acceptable, low, or at a critical
state of charge. Lightning bolt indicates monitoring system is connected to AC and charging if not fully charged.
Indicates algorithm response to SpO
seconds.
2 data changes in two to four
8 --- Date and time field Reflects current date and time.
Product Views
9 Baby icon (Neonate
Mode)
10 Audio alarm paused/
off icon
11 SatSeconds™ icon
and limit value
12 SpO
2 upper and lower
limits
13 Dynamic %SpO
2 value Indicates SpO2 saturation levels. Cyan SpO2 values zero during loss-
14 SPD icon & sensitivity
value
15 Pulse rate (BPM) upper
and lower limits
Indicates alarm limits are set to neonate limit values, not set to adult
limit values.
Yellow alarm silenced icon indicates Alarm Audio Paused. Red icon
indicates Alarm Audio OFF.
Fills in the clockwise direction with saturation readings outside limits
and empties counterclockwise when within SpO
2 limits. When com-
pletely full, it alarms.
Displays current upper and lower alarm limit settings to the right of
the dynamic SpO
2 value.
of-pulse conditions. Updates continue during Pulse Search.
Fills from bottom to top as patterns of desaturation in the SpO2
trend become more severe and empties from top to bottom as the
patterns become less severe. If the icon fills completely, an alarm
sounds.
Displays current upper and lower alarm limit settings to the right of
the dynamic pulse rate value.
16 Pulse rate (BPM) real-
time value
Indicates pulse rate in beats per minute. Green pulse rate values
zero during loss-of-pulse conditions.
17 Lock bar icon Provides option of locking out all response to monitoring screen
contact except the lock bar.
18 Interference indicator Lights when incoming signal is inadequate or degraded. Reference
Performance Considerations, p. 6-1.
19 Pulse search indicator Flashes during pulse search or lights continuously during loss-of-
pulse conditions.
20 Help information icon Provides access to on-screen help. Press for descriptions and sugges-
tions.
21 Trend data graph Contains patient trend data dictated by trend data type and trend
data time scale.
22 Menu selection icon Provides access to menus. Press to alter alarm limits, patient trend
data history, screen selections, connectivity settings, as well as audio
and visual control.
Operator’s Manual 2-5
Product Overview
23 Silence alarm icon Normally a white icon on grey background. Lights continuously as a
yellow icon on grey background with silenced audible alarm, and as
a disabled grey icon on grey background when audible alarms are
disabled. Silence duration (not shown) counts down on screen.
-- Pulse amplitude (blip
bar)
-- Pulse beat (heart) icon (Not shown in figure.) Flashes to indicate each real-time pulse beat.
2.6.3 Rear Panel
(Not shown in figure.) Indicates pulse beat and the relative (non-normalized) pulse amplitude in numbers only view. As the detected
pulse becomes stronger, more bars light with each pulse.
Figure2-3.Rear Panel
1 Equipotential terminal (Ground) 4 Carrying handle
2 AC power connector 5 Screw hole for adapter plate (4x)
3 Fuse drawer 6 Internal battery access
7 Parameter module (rear)
2-6 Operator’s Manual
2.7 Labeling Symbology
Table2-2.Labeling Symbols and Descriptions
Symbol Description Symbol Description
Must consult instructions for use Date of manufacture
Labeling Symbology
Caution, consult accompanying documents
Equipotential terminal (ground) Type BF applied part -
Fuse replacement: 1.5 amp Federal Communications Commission:
Protection against fluid ingress This side up
Atmospheric pressure limitations Keep dry
Temperature limitations Fragile
Humidity limitations Do not use during magnetic resonance
Electromagnetic interference may
occur in the vicinity of equipment
marked with this symbol
European Community (EC) authorized
representative
Proper waste disposal for electrical and
electronic equipment
Not defibrillator proof
Compliance with FCC
imaging
Catalog number
CSA – Canadian Standards Association
certification mark
CE – Conformité Européene authorization mark
0123 – TÜV SÜD Product Service
GmbH (notified body)
Australian wireless compliance mark Consult instructions for use
Operator’s Manual 2-7
Prescription only
Product Overview
2.8 User Interface
2.8.1 Monitoring Screen Selection
Screen Layout Introduction
Users receive monitoring system information via the monitoring screen. Users
may choose to adjust the monitoring screen layout as needed. Reference Mon-
itoring Screen Layout Options, p. 4-41. Institutions may specify an alternate
default. Institutional default settings require changes to the available options
in Service Mode by a qualified service technician.
Select the view that best suits the user, the location, and the situation. Users
should ensure optimal visibility and remain within audible range or engage a
remote monitoring system. Reference Nurse Call Feature, p. 5-18. The factory
default setting is the plethysmographic (pleth) view.
WARNING:
Ensure the monitoring screen is clear of any obstructions. Failure to do so may
reduce effective interpretation of alarms, messages, and user prompts.
Caution:
Verify the movement of the blip bar, plethysmographic waveform, or flashing
heart icon before accepting any monitoring system data as a current
measurement.
Note:
Prior to relocating or transporting the monitoring system, lock the monitoring screen
by pressing the icon on the lock bar until it locks. This prevents any unintentional
alteration. Once it is safe for further interaction with the monitoring screen, press the
icon on the lock bar until it unlocks and proceed. Reference To lock the monitoring
screen, p. 4-10.
2-8 Operator’s Manual
Plethysmographic (Pleth) View
Figure2-4.Pleth View
User Interface
Use this view for visually monitoring the plethysmographic (pleth) waveform.
Plethysmographic waveforms with peak to peak amplitudes less than ten pulse
amplitude units (PAUs) are associated to one another. Each time the monitoring system detects a pulse, the heart icon in the PR field flashes. Reference
Monitoring Screen Layout Options, p. 4-41.
Trend View
Figure2-5.Trend View
Operator’s Manual 2-9
Product Overview
Use this view for visually monitoring real-time trends. The trend data plots automatically update as monitoring system calculates each new trend point, where the
interval between calculations is based on the time scale selected. The real-time
trend monitoring screen includes SpO2 and/or pulse rate trend data plots, current
measured SpO2 and pulse rates. Each time the monitoring system detects a pulse,
the heart icon in the PR field flashes. Reference
p. 4-41.
Combined View (Pleth and Trend)
Monitoring Screen Layout Options
Figure2-6.Combined Pleth and Trend View
,
Use this view for simultaneously monitoring both plethysmographic waveform and
real-time trends. Reference
the pleth portion of the screen. Reference
Plethysmographic (Pleth) View
Trend View
, p. 2-9, for details on the
, p. 2-9, for details on
trend portion of the screen. Each time the monitoring system detects a pulse, the
heart icon in the PR field flashes. Reference
Monitoring Screen Layout Options
, p.
4-41.
2-10 Operator’s Manual
Numbers Only (Blip) View
Figure2-7.Numbers Only (Blip) View
User Interface
Use this view for visually monitoring the blip bar. The blip view includes a pulse
amplitude blip bar, current measured SpO2 and pulse rate, current upper and
lower SpO2 and pulse rate limits. Each time the monitoring system detects a
pulse, the blip bar moves. Reference Monitoring Screen Layout Options, p. 4-
41.
2.8.2 Monitoring Values
WARNING:
Failure to cover the sensor site with opaque material when operating under
high ambient light conditions may result in inaccurate measurements.
The monitoring system continuously assesses the relative strength of the signal
while monitoring patient SpO2 and pulse rate. Front panel values reflect the
data derived from the patient.
The algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate depending on measurement conditions.
1. Normal conditions — During normal measurement conditions, averaging time
is six to seven seconds, or approximately three seconds in Fast Mode.
2. Brief abnormal conditions — During conditions such as those caused by low
perfusion, interference (e.g., external interference such as ambient light or patient
movement), or a combination of these, the monitoring system automatically
Operator’s Manual 2-11
Product Overview
3. More severe conditions — As these conditions extend, the required amount of
2.8.3 Visual Alarms
extends the amount of data required beyond seven seconds. If the resulting
dynamic averaging time exceeds 20 seconds, the pulse search indicator lights and
remains solid, while SpO
period for SpO
Update alarm also appears.
data continues to increase. If the dynamic averaging time reaches 40 seconds,
several things occur.
• The pulse search indicator flashes to denote a loss-of-pulse condition.
• SpO2 and pulse rate zero.
• An audible alarm sounds, unless audible alarms are disabled.
2 and/or pulse rate exceeds 25 seconds, a low-priority Extended
2 and pulse rates update every second. If the data update
WARNING:
The monitoring system is intended only as an adjunct in patient assessment.
It must be used in conjunction with clinical signs and symptoms.
All alarm message elements flash during an alarm condition. Reference Status
Messages and Alarms in the Monitoring Status Field, p. 4-10.
High priority alarm Red Fast flash, 1.5 Hz
Medium priority alarm Yellow Slow flash, .5 Hz
Low priority alarm Yellow Steady
Note:
Caregivers may monitor the patient remotely. Reference
p. 5-18. For institutions allowing caregivers to turn off all audible alarms and minimize
or disable backlight brightness, refrain from reducing both audible and visual alarms
unless using a remote monitoring system. When using a remote monitoring system,
caregivers should still remain vigilant, periodically assessing patients.
Table2-3.Visual Alarm Properties
Category Color Frequency
Using the Nurse Call Interface
,
2-12 Operator’s Manual
2.8.4 Audible Alarms and Indicators
WARNING:
Pressing ALARM SILENCE will keep all but certain critical alarms from
sounding for the alarm silence duration period.
WARNING:
Should the caregiver silence an SPD alarm, this resets the index that tracks
repetitive patterns of desaturation and silences ALL alarms.
WARNING:
The monitoring system is intended only as an adjunct in patient assessment.
It must be used in conjunction with clinical signs and symptoms.
User Interface
Caution:
If the pulse beep tone does not sound with each pulse, the pulse beep volume
is turned off, the speaker is malfunctioning, or the signal is corrupt. Reset the
device.
Caution:
Should the caregiver fail to silence or clear a primary audible alarm within
two (2) minutes, the audible alarm escalates to a more frequent interval.
Audible indicators include pitched tones and beeps. Audible alarms vary,
depending on the priority of the alarm. Caregivers may choose to silence
alarms by pressing ALARM SILENCE. For any alarm condition still active for
more than two (2) minutes, the monitoring system will increase the urgency
level of the audible alarm signal by increasing its frequency.
Note:
Caregivers may monitor the patient remotely. Reference Using the Nurse Call
Interface, p. 5-18. For institutions allowing caregivers to turn off all audible alarms and
minimize or disable backlight brightness, refrain from reducing both audible and
visual alarms unless using a remote monitoring system. When using a remote
monitoring system, caregivers should still remain vigilant, periodically assessing
patients.
Operator’s Manual 2-13
Product Overview
Function Description
Alarm Silence Reminder A three tone sequence sounds approximately every three minutes when the alarm
Pulse Beep A single beep sounds for each detected pulse. The pitch of the pulse beep signal
High Priority Alarm A high-pitched, fast-pulsing tone at 4-second intervals. Examples: PULSE TIME-
Table2-4.Audible Indicator Functions
silence duration is OFF and alarm silence reminder is ON or when the alarm
volume is OFF.
changes with a point-by-point rise or fall in the saturation level.
OUT, BATTERY CRITICALLY LOW, or SYSTEM FAILURE.
Medium Priority Alarm
Low Priority Alarm A low-pitched, slow-pulsing tone at 16-second intervals. Examples: TREND DATA
SPD™ Alert Alarm A trio of quick high-, medium-, high-pitched tones at 2.5-second intervals indi-
Power-On Self-Test Pass A one-second tone indicates power on and successful completion of power-on
2.9 Unique Parameters
2.9.1 SatSeconds™ Alarm Management Parameter
A medium-pitched, pulsing tone at 8-second intervals. Examples: Violation of SpO2
or pulse rate limits, or BATTERY LOW.
LOST or EXTENDED UPDATE.
cates an SPD™ Alert alarm.
self-test.
The monitoring system monitors the percentage of hemoglobin binding sites
saturated with oxygen in the blood. With traditional alarm management, upper
2
and lower alarm limits are set to alarm at specific SpO
levels. When the SpO2
level fluctuates near an alarm limit, the alarm sounds each time it violates the
alarm threshold. SatSeconds monitors both degree and duration of desaturation
as an index of desaturation severity. Thus, the SatSeconds parameter helps distinguish clinically significant events from minor and brief desaturations that may
result in nuisance alarms. Reference
ter
, p. 10-6, for the theory behind how the SatSeconds parameter works. Refer-
SatSeconds™ Alarm Management Parameter Limits
ence
SatSeconds™ Alarm Management Parame-
, p. 4-19, for
information on controlling this parameter.
2-14 Operator’s Manual
The SatSeconds Safety Net
The SatSeconds “Safety Net” is for patients with saturation levels frequently
falling below the limit, but not staying below the limit long enough for the
SatSeconds time setting to be reached. When three or more limit violations
occur within 60 seconds, an alarm sounds even if the SatSeconds time setting
has not been reached.
2.9.2 OxiMax SPD™ Alert Parameter
The OxiMax SPD™ Alert (SPD) parameter detects patterns of desaturation in
adults that are indicative of repetitive reductions in airflow through a patient's
upper airway into the lungs. Relative reductions in a patient's minute ventilation
over a period of time may cause a progressive drop in alveolar partial pressure
of oxygen, leading to arterial desaturation. If these decreases in ventilation are
repetitive, they generate distinct patterns in the saturation trend. Patterns of
repetitive desaturation often develop gradually over time, increasing in severity.
Detection of patterns indicates that a patient might be suffering progressively
severe decrements in airflow that may increase in acuity if left untreated. Reference
OxiMax SPD™ Alert Parameter
OxiMax SPD™ Alert parameter works. Reference
Limits
, p. 4-21, for information on controlling this parameter.
, p. 10-10, for the theory behind how the
OxiMax SPD™ Alert Parameter
Unique Parameters
2.9.3 Pulse Rate Delay Alarm Management Parameter
The monitoring system also monitors pulse rate by determining the number of
pleth waves over unit time. With traditional alarm management, upper and
lower alarm limits are set for monitoring pulse rate. When pulse rates fluctuate
near an alarm limit, alarms trigger with each violation. Pulse Rate Delay allows
a period of threshold violation before the pulse rate alarm sounds. Thus, it distinguishes clinically significant events from minor and brief pulse rate limit violations that result in nuisance alarms.
Reference Pulse Rate Delay Alarm Management Parameter, p. 10-12, for the
theory behind how the Pulse Rate Delay parameter works. Reference Pulse
Rate Delay Alarm Management Parameter Limits, p. 4-24, for information on
controlling this parameter.
Operator’s Manual 2-15
Product Overview
2.9.4 Additional Parameters
The monitoring system is modular in design, so users may opt to add additional
parameters from Covidien. Each parameter comes with any documentation
specific to that parameter as an addendum to this manual.
To order an additional parameter from Covidien
1. Contact Covidien or a local Covidien representative. Reference Warranty Informa-
2. Place a purchase order for the desired parameter.
3. Receive the parameter kit.
4. Follow all included instructions after reviewing all enclosed documentation.
tion, p. 1-6.
Instructions may require contacting Covidien again for an activation key and
adhering the kit’s enclosed adhesive label to each monitoring system receiving the
additional parameter.
2-16 Operator’s Manual
3 Installation
3.1 Overview
This chapter contains information for the installation and set up of the
Nellcor™ Bedside Respiratory Patient Monitoring System, prior to first-time
usage by the clinician. Before operating the monitoring system, thoroughly
read the Operator's Manual.
Inspect the monitoring system for mechanical and functional damage or deterioration prior to every use. Do not use if it appears damaged or does not
perform as expected. Have a qualified service technician install and set up the
monitoring system after performing functional tests per the Service Manual.
3.2 Safety Reminders
WARNING:
Explosion hazard — Do not use the monitoring system in the presence of
flammable anesthetics.
WARNING:
Have a qualified service technician perform a safety and functional test prior
to use in a clinical setting.
WARNING:
To ensure patient safety, do not place the monitoring system in any position
where it might tip or fall on the patient. Do not allow direct contact with the
patient.
WARNING:
As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
3-1
Installation
WARNING:
WARNING:
WARNING:
Disconnect the monitoring system and sensor from the patient during
magnetic resonance imaging (MRI) scanning. Objects containing metal can
become dangerous projectiles when subjected to the strong magnetic fields
created by MRI equipment. Also, induced currents could potentially cause
burns.
To ensure accurate performance and prevent device failure, do not subject
the monitoring system to extreme moisture, such as direct exposure to rain.
Such exposure may cause inaccurate performance or device failure.
Do not connect the monitoring system to an electrical outlet controlled by a
wall switch, since this increases the risk of removal of AC power to the
monitoring system.
WARNING:
Use only Covidien-approved sensors and interface cables when connecting to
the sensor port. Connecting any other cable or sensor influences the accuracy
of sensor data, which may lead to adverse results.
WARNING:
Use only Covidien-approved interface cables with the monitoring system. Use
of another interface cable will adversely impact performance. Do not attach
any cable intended for computer use to the sensor port.
WARNING:
The monitoring system should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, observe the monitoring
system to verify normal operation in the desired configuration.
WARNING:
Ensure the monitoring system is clear of any obstructions that prevent
awareness of visual or audible alarms. Failure to do so may result in
inadvertently missing a visual alarm or an inaudible alarm tone.
3-2 Operator’s Manual
WARNING:
Do not lift the monitoring system by the interface cable or power cord. The
cable or cord may disconnect, potentially dropping the monitoring system on
a patient or a damaging surface.
Note:
The monitoring system incorporates watchdog timers that reset the monitoring
system in the event of software errors. Any temporary limit settings are retained in the
event of a watchdog reset.
3.3 Product Setup
The monitoring system receives power either from an AC connection
(80-263 VAC) or from a 7.2-volt, 11.6 ampere-hour battery. The monitoring
system internal battery can be used to power the monitoring system during
transport or when AC power is not available. The monitoring system communicates the transition from AC power to battery power or from battery power
to AC power via the AC power or battery indicator on the front panel.
Product Setup
A new, fully charged battery provides approximately six hours of monitoring
time under typical conditions.
3.3.1 Mounting Options and Transport Considerations
Users may choose from a variety of mounting configurations, including
adapter plates, wall mounts, and pole mounts. Reference Optional Equipment,
p. 9-4. Follow the installation instructions included with the mounting hardware.
Prior to intra-hospital transport, ensure the monitoring system interface is
locked to avoid any inadvertent changes. Reference To lock the monitoring
screen, p. 4-10.
Operator’s Manual 3-3
Installation
WARNING:
Caution:
Caution:
3.3.2 Connection to an AC Power Source
Do not connect the monitoring system to an electrical outlet controlled by a
wall switch, since this increases the risk of removal of AC power to the
monitoring system.
Use only a hospital-grade power cord.
Ensure the monitoring system is properly grounded when operating on AC
power. If uncertain whether the AC outlet is properly grounded, disconnect
the monitoring system from the outlet and use battery power. Contact a
qualified electrician to examine the outlet for ground connections.
Caution:
Do not block cooling vents.
Ensure the monitoring system remains connected to an AC power source
when not in use so a fully charged battery remains available for use at any time.
To connect to an AC power source
1. Plug the female connector end of the power cord into the power connector on
the rear of the monitoring system. Reference Rear Panel, p. 2-6.
2. Plug the male connector of the power cord into a properly grounded AC outlet.
3. Verify the monitoring system’s AC power indicator lights.
Note:
If the AC power indicator does not light, check the power cord, user-accessible fuses,
and AC power outlet.
3-4 Operator’s Manual
3.3.3 Battery Insertion
WARNING:
Use only Covidien-approved batteries installed by a qualified service technician.
The monitoring system ships with a separate internal battery. The battery must
be installed prior to use in a clinical setting. Ensure a qualified service technician inserts the battery and tests the monitoring system prior to use in a clinical
setting. Users should immediately, completely charge the battery prior to clinical use or temporary storage of the battery. Users should also remain vigilant
when running on battery power and reconnect to AC power during a low
battery state.
3.3.4 Battery Charge
Product Setup
WARNING:
Charge only with specified charger, according to instructions. Do not heat
above 80 ºC. Do not open battery, dispose of in fire, or short circuit. It may
ignite, explode, leak, or get hot, causing personal injury.
Caution:
To fully recharge a low or fully-depleted battery, connect the monitoring
system to an AC power outlet. Charge the battery for at least eight hours with
the monitoring system turned off or twelve hours with the monitoring
system turned on. Have a qualified service technician periodically check the
battery; if fewer than four bars light after fully charging the battery, the
technician should replace the battery. Recharge the battery at least every
three months, allowing the full charge time if it is the first recharge in several
weeks.
Note:
Whenever the monitoring system is connected to AC power, the battery is charging.
Excessive temperatures will cause battery cell failure. Continued excessive temperatures may trigger the thermal fuse, which permanently shuts down the
battery. Should this occur, replace the battery pack.
Operator’s Manual 3-5
Installation
To fully charge the battery
1. Connect the monitoring system to AC power. The monitoring system will not
power up without connection to AC power when the battery charge is below 4%.
2. Verify the monitoring system is off and the AC Power/Battery Charging indicator
lights. On AC power up, check the battery fuel gauge. If the gauge is empty or
only partially full, the battery begins charging. The monitoring system operates on
AC power while the battery is charging. When the monitoring system is fully
charged, the green battery fuel gauge registers 100%. Note that when the monitoring system is connected to AC, a lightning bolt appears in the battery fuel
gauge.
3. Until the battery recharges, the monitoring system displays the message, BATTERY
CRITICALLY LOW and supplies the additional information: THE MONITOR’S
BATTERY IS CRITICALLY LOW. THE MONITOR MAY SHUT DOWN IF AC POWER IS
LOST. DO NOT DISCONNECT MONITOR FROM AC POWER SOURCE. If AC power
is lost before the battery is charged past the critically low state, the monitoring
system will not produce a low battery alarm for the standard CRITICALLY LOW
BATTERY warning duration.
3.3.5 Battery Power Usage
WARNING:
Do not use monitoring system in a depleted battery condition.
Caution:
Should a low battery alarm sound, connect the monitoring system to an AC power
source and then silence the alarm by pressing ALARM SILENCE. If the monitoring
system is operated on an AC power source with a depleted battery and AC power
is subsequently lost, the monitoring system will shut down immediately.
The monitoring system will operate on battery when not connected to AC
power. Some usage conditions draw more power from the internal battery
than others. Duration of operation depends on the battery charge status.
Avoid power-intensive conditions for ideal battery usage. The following conditions will help achieve the longest battery life.
• No audible alarms sound
• No analog or serial output devices are attached to the monitoring system, includ-
ing serial data, analog output, and nurse call output
• 25% monitoring screen brightness setting
3-6 Operator’s Manual
Ensure the monitoring system remains connected to an AC power source
when not in use so a fully charged battery remains available for use at any time.
When any of the following conditions are present, the monitoring system
automatically shuts down.
• The monitoring system is running on battery power and the battery capacity
remaining reaches 0%.
•
The monitoring system has detected an internal temperature above 67 ºC or 153 ºF.
3.4 Connection to Nellcor™ Sensors
WARNING:
Use only Covidien-approved sensors and interface cables when connecting to
the sensor port. Connecting any other cable or sensor influences the accuracy
of sensor data, which may lead to adverse results.
Connection to Nellcor™ Sensors
The top of the monitoring system screen indicates the sensor type when connecting a recommended sensor to the monitoring system or when the monitoring system completes POST with an attached sensor. Reference Selecting a
Nellcor™ Sensor, p. 9-1.
Note:
Physiological conditions such as excessive patient movement, medical procedures, or
external agents such as dysfunctional hemoglobin, arterial dyes, low perfusion, dark
pigment, and externally applied coloring agents such as nail polish, dye, or pigmented
cream may interfere with the monitoring system’s ability to detect and display
measurements.
Note:
Sensor LED light emissions fall within Class 1 level, according to IEC 60825-1:2001.
To fully connect a Nellcor™ sensor
1. Firmly connect a Nellcor™ interface cable to the monitoring system’s sensor port.
Reference Front Panel, p. 2-3, to identify the port.
2. Open the plastic latch at the other end of the interface cable.
Operator’s Manual 3-7
Installation
Figure3-1.Sensor Cable Insertion into Interface Cable
3. Plug the interface cable and recommended sensor together.
4. Snap the plastic latch down over the connectors.
5. Apply the recommended sensor to the patient after reading the Instructions for
Use accompanying the sensor.
6. When the monitoring system detects a valid pulse, it enters the monitoring mode
and displays real-time patient data.
7. Detach the recommended sensor from the patient on completion of monitoring.
3-8 Operator’s Manual
4 Operation
4.1 Overview
This chapter identifies methods for collecting patient oxygen saturation data
while using the Nellcor™ Bedside Respiratory Patient Monitoring System. It
describes menu navigation, power on/off and monitoring screen options,
parameter ranges, Nellcor™ sensor attachments, and configuring default settings suitable for the specific care environment.
Schedule regular maintenance and safety checks with a qualified service technician every 24 months. In the case of mechanical or functional damage,
contact Covidien or a local Covidien representative.
4.2 Power
WARNING:
Explosion hazard — Do not use the monitoring system in the presence of
flammable anesthetics.
Caution:
Have a qualified service technician replace the internal battery every 24
months.
Caution:
Have a qualified service technician remove and store the internal battery if
users expect a significant period of disuse.
Caution:
A normal power cycle or complete discharge of the battery results in a reset
of all temporary user settings to factory or institutional default settings.
4-1
Operation
4.2.1 AC Power
When the user connects the monitoring system to an AC power source, if the
internal battery requires charging, the battery condition indicator on the front
panel lights until the internal battery reaches complete charge. In addition,
when the monitoring system is powered on, the battery fuel gauge on the
monitoring screen displays a lightning bolt indicating connection to AC.
If the user powers off the monitoring system while the internal battery is
charging, the battery condition indicator remains lit and the internal fan turns
on until charging completes. Reference Connection to an AC Power Source, p.
3-4.
4.2.2 Battery Power
Battery Status
WARNING:
Do not use monitoring system with a depleted battery or in a low voltage
condition.
Reference Battery Power Usage, p. 3-6, for details on initial internal battery
setup information.
The yellow BATTERY LOW warning flashes and a medium priority alarm sounds
when approximately 14% capacity remains on the existing battery charge. The red
BATTERY CRITICALLY LOW warning flashes and a high priority alarm sounds when
approximately 4% capacity remains on the existing battery charge. The battery will
drain completely and the monitoring system will shut down if not connected to AC
power during a critically low battery condition. Reference
4-3, for a description of the low and critical battery conditions.
To cancel a visual or audible battery condition alarm, connect the monitoring
system to an AC power source. The low battery warning status remains as long
as the battery is in a low voltage condition or until the caregiver presses
DISMISS ALARM for the low battery alarm message.
Battery Power Status
, p.
4-2 Operator’s Manual
Battery Fuel Gauge
WARNING:
Do not use monitoring system with a depleted battery or in a low voltage
condition.
Caution:
Should a low battery alarm sound, connect the monitoring system to an AC
power source and then silence the alarm by pressing ALARM SILENCE. If the
monitoring system is operated on an AC power source with a depleted
battery and AC power is subsequently lost, the monitoring system will shut
down immediately.
The monitoring system runs on an internal battery when not connected to an
AC power source. A battery fuel gauge displays the remaining battery power.
Power
When connected to AC power, the battery fuel gauge displays a lightning bolt
while charging and at full charge.
Reference
p. 3-6.
Note:
The battery is recyclable. Do not dispose of the battery by placing it in the regular
trash. Dispose of the battery in accordance with local guidelines and regulations or
contact Covidien to arrange for disposal.
Note:
As the battery is used and recharged over time, the amount of time between the onset
of low battery alarms and the monitoring system shut-off may become shorter.
None Green Normal Status — Indicates 15-100% (approximately 15
BATTERY LOW Yellow Low Status — Indicates 5-14% (approximately 15 minutes)
Connection to an AC Power Source
Table4-1.Battery Power Status
Message Color Power Charge Status
minutes to 6 hours) battery capacity remains.
battery capacity remains.
, p. 3-4. Reference
1
Battery Power Usage
,
BATTERY CRITICALLY
LOW
1. The levels listed are based on a new battery. Continued battery charge and discharge eventually reduces capacity. For
example, a battery two years old may provide only 75% of the capacity of a new battery.
Operator’s Manual 4-3
Red Critical Status — Indicates 1-4% (approximately 5 minutes)
battery capacity remains.
Operation
4.2.3 Power Up
Power Prerequisites
Caution:
If any pixel in the monitoring screen does not light at power up, do not use
the monitoring system. Instead, contact a qualified service technician,
Covidien, or a local Covidien representative.
Caution:
During POST (immediately after power-up), confirm that all pixels in the
monitoring screen turn on and the monitoring system speaker sounds a
sequence of three ascending tones. After the POST process completes,
confirm that a single one-second tone sounds.
Before using the monitoring system in a clinical setting, ensure the monitoring
system is safe and working properly. Verify proper working condition at each
power up by following the directions for powering up the monitoring system.
To do so, carefully view the splash screen during power on. Verify there are no black
gaps on the monitoring screen during power-on self-test (POST) or when every pixel on
the screen is completely lit. Should users observe any black gaps or unlit pixels, do not
use the monitoring system before having the monitoring system serviced.
Power-on Self-Test (POST)
WARNING:
Have a qualified service technician perform a safety and functional test prior
to use in a clinical setting.
WARNING:
Ensure the monitoring system is clear of any obstructions that prevent
awareness of visual or audible alarms. Failure to do so may result in
inadvertently missing a visual alarm or an inaudible alarm tone.
WARNING:
If the power-on self-test (POST) pass tone does not sound, do not use the
monitoring system. Instead, contact Covidien or a local Covidien representative.
4-4 Operator’s Manual
WARNING:
Power-up performance tests verify both power-on self-test (POST) and
power-on defaults and alarm range limits. Reference Factory Default Alarm
Limit Settings and Parameters, p. 4-17.
At power on, the monitoring system performs a power-on self-test (POST), which
tests the circuitry and functions, then proceeds to the default monitoring screen.
Reference
and the monitoring system is ready to register and record patient trend data. Reference
Connection to Nellcor™ Sensors
Note:
Physiological conditions such as excessive patient movement, medical procedures, or external
agents such as dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and
externally applied coloring agents such as nail polish, dye, or pigmented cream may interfere
with the monitoring system’s ability to detect and display measurements.
Pleth View
Power
, p. 4-41. Attach a sensor cable and a recommended sensor
, p. 3-7.
Note:
In addition to serving as the POST pass verification, the POST pass tone also functions
as an audible confirmation that the speaker is performing properly. If the speaker does
not function, the alarm warning sounds cannot be heard.
Note:
For standard usage, connect sensor cables prior to turning on the monitoring system.
Have a qualified service technician perform any functional testing prior to usage.
To power up the monitoring system
1. Connect the monitoring system to an AC power source.
2. Verify the monitoring system is off and the AC Power Indicator lights.
3. Turn on the monitoring system by pressing the POWER ON key.
4. Within ten seconds, all pixels should illuminate. The monitoring screen should
display a corporate logo and the firmware version of the monitoring system.
5. Observe the monitoring screen for the POST splash screen, which appears for
approximately five (5) seconds.
6. Listen for three ascending tones then a one-second beep, indicating proper oper-
ation of the speaker and successful completion of power-on self-test.
Operator’s Manual 4-5
Operation
Figure4-1.Sample POST Splash Screen
If the monitoring system detects an internal problem during the POST process,
an error tone sounds and the monitoring system displays an error message.
Reference Troubleshooting, p. 8-1.
Note:
Physiological conditions such as excessive patient movement, medical procedures, or
external agents such as dysfunctional hemoglobin, arterial dyes, low perfusion, dark
pigment, and externally applied coloring agents such as nail polish, dye, or pigmented
cream may interfere with the monitoring system’s ability to detect and display
measurements.
4.2.4 System Resets
If the monitoring system issues a system reset, based on triggering the watchdog timer, all temporary settings are retained. Neither factory nor institutional
default settings are impacted.
4.2.5 Automatic Shutdown and Power Off
Automatic Shutdown
When any of the following conditions are present, the monitoring system
automatically shuts down.
• The monitoring system is running on battery power and the battery capacity
remaining reaches 0%.
•
The monitoring system has detected an internal temperature above 67 ºC or 153 ºF.
4-6 Operator’s Manual
Power Off
To turn off the monitoring system, only hold the POWER ON key long enough
for three descending tones to sound. Then the screen darkens and the monitoring system powers off.
4.3 Nellcor™ Sensor Usage
Reference Selecting a Nellcor™ Sensor, p. 9-1, for identifying the proper recommended sensor. Consider all possible variables. If in doubt, contact Covidien or a local Covidien representative. Reference Connection to Nellcor™
Sensors, p. 3-7, for connecting the proper recommended sensor.
4.3.1 Sensor Detection
Nellcor™ Sensor Usage
WARNING:
Use only Covidien-approved interface cables with the monitoring system. Use
of another interface cable will adversely impact performance. Do not attach
any cable intended for computer use to the sensor port.
WARNING:
Use only Covidien-approved sensors and interface cables when connecting to
the sensor port. Connecting any other cable or sensor influences the accuracy
of sensor data, which may lead to adverse results.
Caution:
If the pulse beep tone does not sound with each pulse, the pulse beep volume is set
to zero, the speaker is malfunctioning, or the signal is corrupt. Reset the device.
A “SENSOR ATTACHED: xxxx” message appears for between four and six
seconds when users first connect a recommended sensor. The message identifies the type of sensor connected to the monitoring system. Sensor type
determines any action messages in the sensor message(s) function.
Operator’s Manual 4-7
Operation
Figure4-2.Sensor Type Message
The monitoring system displays dashes for %SpO2 and Pulse Rate while searching for a valid pulse. For optimal performance, allow the monitoring system to
search and lock onto a pulse for approximately five to ten seconds.
When the monitoring system detects a valid pulse, it enters monitoring mode
and displays patient parameters.
The movement of the blip bar or the plethysmographic waveform and the
flashing heart icon are visual indicators of real-time data. The pulse beep
tone is an audible indicator of the real-time patient data.
When users first apply a recommended sensor to a patient, the monitoring
system may lose a pulse signal. Upon loss of the pulse signal, the monitoring
system posts an alarm.
4.3.2 Sensor Detection Failure
Upon successful completion of the POST process, the monitoring system
sounds a one-second tone indicating it has passed POST.
Should the monitoring system fail to detect a recommended sensor, it displays a
user prompt indicating it is in the ready state and the caregiver should attach a recommended sensor to both the patient and the monitoring system.
4-8 Operator’s Manual
4.4 User Interface
4.4.1 Default Monitoring Screen and Trend Data
Users receive monitoring system information via the monitoring screen. This is
particularly relevant to real-time and historical patient trend data, which may
appear as a plethysmographic waveform, a blip bar, a graph, or saturation and
pulse rate values, depending on the accessed monitoring screen. Reference
Monitoring Screen Layout Options, p. 4-41, to understand real-time trend
data. Reference MONITORING HISTORY Menu, p. 4-25, to understand online
historical trend-data. Reference Trend Data Management, p. 5-1, to better
manage both real-time and historical trend data. Should the monitoring
system detect corrupt trend data, it notifies the caregivers with a TREND DATA
LOST message.
User Interface
Users may choose to adjust the monitoring screen layout as needed, and institutions may specify an alternate default. Institutional default settings require
changes to the available options in Service Mode by a qualified service technician. Reference Monitoring Screen Layout Options, p. 4-41.
Figure4-3.Default Monitoring Screen Layout
Operator’s Manual 4-9
Operation
4.4.2 Status Messages and Alarms in the Monitoring Status Field
Users receive monitoring system information via the monitoring screen. The
primary area is the monitoring status field. Background color provides an additional status cue. Reference Alarm Management and Status Messages, p. 4-50.
• User prompts — This status type with a gray background prompts users to
perform some action to obtain patient data.
• Active status — This status type notifies users of the current, active monitoring
system state. Green background indicates normal status, cyan background indicates the user has selected the menu option, listing main menu items in grey.
• Alarm status —
This status type identifies alarm conditions from highest to lowest
priority. If multiple alarms occur while users are choosing menu options, the vertical
alarm list of messages appears with the highest priority alarms at the top. If more
than three alarms are active, the list collapses into a single VIEW ALL ALARMS line
containing the total number of active alarms. Each alarm contains a MORE INFO
button. Pressing the MORE INFO button provides a detailed explanation and any
corrective action required.
a. High priority alarms — Alarm message appears on flashing red back-
ground. High priority alarms appear first when multiple alarms occur simultaneously.
b. Medium priority alarms — Alarm message appears on flashing yellow
background. Medium priority alarms appear after high priority alarms and
before low priority alarms.
c. Low priority alarms — Alarm message appears on steady yellow back-
ground. Low priority alarms appear after high or medium priority alarms.
4.4.3 Introduction to Menu Options
Interact with and customize the monitoring system using the monitoring
screen buttons. Confirm the monitoring screen is unlocked by checking for the
unlocked icon on the lock bar.
To lock the monitoring screen
1. Locate the lock bar at the lower right of the monitoring screen.
2. Press and hold the unlocked icon.
3. Observe the progression of green lights to either side of the unlocked icon until
all three on each side light.
4. Ensure the icon now appears as a locked icon.
4-10 Operator’s Manual
To unlock the monitoring screen
1. Locate the lock bar at the lower right of the monitoring screen.
2. Press and hold the locked icon.
3. Observe the progression of green lights to either side of the locked icon until all
three on each side light.
4. Ensure the icon now appears as an unlocked icon.
Press MENU to access any submenus. Use the scroll bar or adjustment arrows
to select or change options. Reference Menu Option Selection, p. 4-12.
Table4-2.Menu icons and primary user interface features
Icons available during standard operation
SILENCE ALARM icon Press to silence ANY current alarms for the alarm silence duration
period. After silencing an alarm, press again to reactivate the
alarm. To adjust alarm silence duration requires a qualified
service technician. Remains available at all times.
User Interface
DISMISS ALARM icon Press to dismiss an alarm if available. Not all alarms have the
dismiss option. Such alarms require user resolution or service.
MENU icon Press to access current menu functions, including alarm limits,
monitoring history, monitoring screen selections, audio controls,
and connectivity settings.
HELP icon Press to access on-screen help.
LOCK bar with lock icon Press until the lock icon appears to prevent access to monitoring
system options, with the exception of SILENCE ALARM. Press
until the unlocked icon appears to permit access to make desired
changes.
Menu items available during menu selection
CANCEL or EXIT MENU icon Press to return to the monitoring screen without altering the
current selection.
BACK icon Press BACK to return to the previous menu level without exiting
the selected menu area entirely.
CLEAR HISTORY icon Press CLEAR HISTORY to delete any stored historical trend data.
Operator’s Manual 4-11
Operation
Table4-2.Menu icons and primary user interface features (Continued)
Icons available during standard operation
SAVE CHANGES icon Press SAVE CHANGES to retain any selection and return to mon-
itoring.
ADJUST UP, DOWN arrows During menu selection, press to increment up or down. During
selection of variable parameters, press to incrementally increase
or decrease the specified parameter.
ADJUST slider bar During menu selection, slide to scroll up or down to access upper
or lower menu options.
4.4.4 Menu Option Selection
Menus and Submenus
The user interface provides for customization. Press MENU to access various
menus and submenus, then save any desired changes. Changes occur immediately after users press SAVE CHANGES.
2 Set Upper and Lower SpO2 Alarm Limits
SpO
Pulse Rate (PR) Set Upper and Lower PR Alarm Limits
ALARM LIMITS
Menu
MONITORING HISTORY
Menu
MARK EVENT
Menu
SatSeconds Set SatSeconds Alarm Limit Threshold
SPD Set SPD Sensitivity Setting
Pulse Rate Delay Set PR Delay Threshold
Use to view and clear
historical monitoring
data
Use to add event
markers to trend
data
Trends
Clinical Log
Histogram
Intervention
Medication
Observation
Transfer
4-12 Operator’s Manual
SOUND SETTINGS
Menu
User Interface
Alarm Volume Set - (softer) or + (louder)
Pulse Beep Volume Set - (softer) or + (louder) and OFF
Button Click Volume Set - (softer) or + (louder) and OFF
MONITORING SETTINGS
Menu
Alarm Mode
Response Mode
Time and Date
Alarm Silence Duration Set Alarm Silence duration
Monitoring Layout
Screen Brightness Set - (less bright) or + (more bright)
Remote Settings
Adult alarm settings
Neonate alarm settings
NORMAL response mode
FAST response mode
Time settings (+ or -)
Date settings (+ or -)
Date format (DD/MM/YY, MM/DD/YY, or
YY/MM/DD)
Pleth and Trend view
Pleth Only view
Trend Only view
Numbers Only (Blip) view
Set to WLAN (ASCII or SPDout)
Set to LAN (ASCII or SPDout)
Set to disconnected
ASCII (9600 or 19200 baud)
CONNECTIVITY SETTINGS
Menu
Serial Connection
Nurse Call Set to normally - or normally +
DATA EXPORT Menu Use to export trend history data to alternate sources
ABOUT THE MONITOR Menu Identify model, software, parameter, and network Information
Operator’s Manual 4-13
Clinical (19200 baud)
SPDout (19200 or 115200 baud)
Philips (19200 baud)
Off
Operation
Factory Defaults and Institutional Defaults
Each monitoring system ships to the customer with settings established at the
factory. These are factory default settings.
Institutions may choose to modify such settings without losing those changes
at power reset or power off. Such institutional default settings must be set
and tested by a qualified service technician prior to use in a clinical setting.
Table4-3.Factory Default Settings
Option Adult Defaults Neonate Defaults
Alarm mode Adult
Allow alarm limit adjustments Yes
Alarm silence duration 120 Seconds
Alarm disabled reminder Yes, every three minutes
Allow silence duration OFF No
Allow alarm audio OFF No
Sensor alarm priorities:
- Sensor Disconnect
- Sensor Off
- Sensor Failure
Note: Each alarm may have different
institutional default priorities (high,
medium, or low).
%SpO
2 lower alarm limit 85%
%SpO
2 upper alarm limit 100% 95%
SatSeconds 100 OFF
Allow SatSeconds Yes
SPD sensitivity 1 Always OFF
SPD audio alert Yes Always OFF
Allow SPD Yes No
Pulse rate lower alarm limit 40 BPM 90 BPM
Low
Pulse rate upper alarm limit 170 BPM 190 BPM
Pulse rate delay Off
Allow pulse rate delay Yes
4-14 Operator’s Manual
Table4-3.Factory Default Settings (Continued)
Option Adult Defaults Neonate Defaults
Alarm volume 75%
Pulse beep volume 50%
Button click volume 50%
Screen brightness 75%
Allow backlight OFF No
Wake display on alarm Yes
Monitoring screen layout Pleth
User Interface
Vital sign colors %SpO
Displayed language English
Response mode Normal
Historical trend scale 1 hour
Real-time trend scale 1 hour
Real-time trend display
Nurse call polarity Normally high (+)
Remote protocol Disconnected
Serial protocol ASCII, 9600 baud
Note:
Some values cannot be saved as power-on defaults. Attempts to save such values as
default result in an INVALID tone. Users may alter such limits for current patients, but
limits return to factory or institutional defaults at power-off.
2: Cyan, Pulse BPM: Green
SpO
2 and Pulse
Operator’s Manual 4-15
Operation
ALARM LIMITS Menu
WARNING:
Ensure alarm limits are appropriate for the patient being monitored with each
use of the monitoring system.
WARNING:
Do not silence or disable audible alarms or decrease the volume of the audible
alarm if patient safety could be compromised. Do not dim or disable visual
alarms if patient safety could be compromised.
WARNING:
Supplemental oxygen will attenuate patterns of desaturation. A patient’s
respiratory compromise can be proportionally more severe before patterns
appear in the saturation trend. Remain vigilant when monitoring a patient on
supplemental oxygen.
WARNING:
Only change the alarm threshold setting levels under the supervision of a
qualified clinician.
WARNING:
Do not preset different or inappropriate alarm limits for the same or similar
equipment in any single area, since this may compromise patient safety.
WARNING:
Only use the SPD parameter with adult patients. Do not use on neonate
patients. In Neonate Mode, the SPD parameter remains OFF.
Caution:
Do not set alarm limits to extreme values that render the monitoring system
useless. Ensure alarm limits are appropriate for each patient.
Caution:
Use of the SPD parameter does not change the need to set threshold limits
appropriate to the patient being monitored.
Select standard monitoring system alarm limits for either adults or neonates.
Reference To set the alarm mode, p. 4-34, for setting adult or neonate modes.
4-16 Operator’s Manual
The monitoring system ships with factory default settings. Factory default
alarm settings fall into two groups: adult and neonate. The monitoring system
can be set to use adult-pediatric alarm limit settings or neonate alarm limit settings as the institutional default. Any temporary changes to the ALARM LIMITS
menu remain active until power off or power loss greater than 30 seconds.
Have a qualified service technician set institutional default settings that differ
from factory default settings as described in the Service Manual.
Note:
The ability to adjust the alarm limit default settings can be enabled or disabled by
qualified service personnel as described in the Service Manual.
User Interface
Figure4-4.ALARM LIMITS Menu Options
Factory Default Alarm Limit Settings and Parameters
• SpO2 Limits —
The neonate default upper limit is 95% and the lower limit is 85%. If neonate mode
is enabled, the Baby icon will appear between the threshold setting values. An alarm
sounds each time patient saturation violates these alarm limits. Reference
temporary SpO
• Pulse Rate Limits — The adult default upper limit is 170 bpm and lower limit is
40 bpm. The neonate default upper limit is 190 bpm and the lower limit is
90 bpm. If neonate mode is enabled, the Baby icon will appear between the
threshold setting values. An alarm sounds each time patient pulse rate violates
these alarm limits. Reference To set temporary SpO2 and pulse rate alarm limit set-
tings, p. 4-18.
Operator’s Manual 4-17
The adult default upper limit is 100% and the lower limit is 85%.
To set
2
and pulse rate alarm limit settings
, p. 4-18.
Operation
• SatSeconds™ Alarm Management — The adult default SatSeconds™ value is
100 SatSeconds. The neonate default SatSeconds™ value is OFF. An alarm sounds
based on a violation of SatSeconds™ alarm limits. Reference To set SatSeconds
alarm limit, p. 4-20.
• Saturation Pattern Detection (SPD) — The SPD™ Alert parameter is not indi-
cated for use on pediatric patients, but on adult patients only. This option is not
available for neonates. The adult default SPD alarm sensitivity is a value of one (1)
for most sensitive to patterns of desaturation. Reference To set OxiMax SPD™
Alert (SPD) sensitivity, p. 4-22. When the SPD™ Alert parameter is enabled, the
SatSeconds™ parameter is automatically enabled with a setting of 100.
• Pulse Rate Delay parameter — Use the pulse rate delay parameter to distin-
guish clinically significant alarms from minor nuisance alarms. The default setting
is OFF. Reference Pulse Rate Delay Alarm Management Parameter Limits, p. 4-24.
Temporary Alarm Limits
The initial values in the limits screen are the factory default settings or are the
institutional default settings set by qualified service personnel. Reference
Factory Default Settings, p. 4-14. Any changes to these settings are temporary;
settings return to the factory or institutional default values after power cycle.
Note:
Limit changes remain in effect as long as the monitoring system retains power, but
return to the factory or institutional default limit settings at power off. Limit changes
also return to factory or institutional defaults when the alarm mode is changed (e.g.,
from Adult to Neonate). Only qualified service personnel may configure and save
institutional defaults as described in the
To set temporary SpO2 and pulse rate alarm limit settings
1.
While in normal monitoring mode, press MENU.
2. Press ALARM LIMITS.
3. Select either SpO2 or PULSE RATE. All lower threshold values must be at least one
digit lower than the upper limit threshold, so change lower thresholds first.
Default limit settings depend on the selected patient mode.
4. Slide the bar up or down until reaching the desired value.
Service Manual
.
4-18 Operator’s Manual
Figure4-5.Adjusting Alarm Limit Settings
User Interface
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
7. Ensure the selected limit value appears in the appropriate limit area.
SatSeconds™ Alarm Management Parameter Limits
For mild or brief SpO2 limit violations, use the SatSeconds parameter to reduce
nuisance alarms.
• SatSeconds icon — With the parameter enabled, the SatSeconds circle icon fills
in the clockwise direction as the alarm management system detects SpO2 readings
outside of the limit setting. The circle icon empties in counterclockwise direction
when SpO
priority alarm sounds.
• SatSeconds trend data — The trend history captures the SatSeconds violation
and identifies each SatSeconds alarm activation period. Caregivers should view
2 readings are within limits. When the icon fills completely, a medium
Operator’s Manual 4-19
Operation
the data to examine SatSeconds violations in the trend data history. Reference
Real-time Trend Data, p. 5-2.
• SatSeconds alarms — SatSeconds alarm settings include both audible and visual
alarms.
– Audible alarm — Once an audible alarm occurs, the monitoring system will
continue to alarm until the caregiver clears the alarm.
– Visual alarm — Once a SatSeconds alarm occurs, a medium priority alarm
message flashes.
To set SatSeconds alarm limit
1.
While in normal monitoring mode, press MENU.
2. Press ALARM LIMITS.
3. Press SATSECONDS.
4. Select the desired limit. The choices are 10, 25, 50, 100 SatSeconds or OFF. The
default setting is 100.
Figure4-6.Setting SatSeconds Alarm Limits
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
4-20 Operator’s Manual
7. Ensure selected limit value underneath the SatSeconds circle icon matches the
desired limit just set.
Note:
The ability to adjust SatSeconds default settings can be enabled or disabled by
qualified service personnel as described in the Service Manual.
Note:
Press HELP to display a SatSeconds alarm help dialogue.
OxiMax SPD™ Alert Parameter Limits
WARNING:
Supplemental oxygen will attenuate patterns of desaturation. A patient’s
respiratory compromise can be proportionally more severe before patterns
appear in the saturation trend. Remain vigilant when monitoring a patient on
supplemental oxygen.
User Interface
WARNING:
Only use the SPD parameter with adult patients. Do not use on neonate
patients. In Neonate Mode, the SPD parameter remains OFF.
Reference OxiMax SPD™ Alert Parameter, p. 10-10, for specifics on how the
SPD parameter works. The SPD parameter can be disabled as an institutional
default. The SPD parameter communicates information to the caregiver about
patterns of desaturation in a variety of ways.
• SPD icon —
trend in adults, caregivers are alerted to these patterns via a visual indicator, and
optionally, an audio alarm. The triangle icon for SPD appears on the monitoring
system when the parameter is enabled. The triangle fills from bottom to top as patterns become more severe. The triangle empties from top to bottom as the patterns
become less severe. When the icon fills completely, an alarm sounds. With SPD
enabled, the default setting is ON with the sensitivity set to 1. The parameter can
be turned off in the LIMITS menu. Caregivers can select from three alarm sensitivity
settings: 1 (most sensitive), 2 (medium sensitivity) or 3 (least sensitive), with 1 resulting in more alarms and 3 resulting in fewer alarms. The rate at which the SPD icon
fills depends on the SPD sensitivity setting.
• SPD trend data — The trend history captures the SPD patterns and identifies
SatSeconds and SPD alarms activation periods. Once patterns exceed the SPD
limit, an SPD ALERT alarm message will flash. Caregivers should view the data to
examine SatSeconds and SPD patterns in the trend data history. Reference Real-
time Trend Data, p. 5-2.
When the SPD parameter detects patterns of desaturation in the SpO2
Operator’s Manual 4-21
Operation
• SPD alarms — SPD alarm settings include both audible and visual alarms.
– Audible alarm — Once an audible SPD ALERT alarm occurs, the monitoring
system will continue to alarm for up to six (6) minutes after the alarm triggers
or until the caregiver clears the alarm.
– Visual alarm — Once an SPD ALERT alarm occurs, a low priority SPD ALERT
alarm message flashes.
When the indicator reaches capacity, indicating the SPD limit has been
reached, an audible alarm sounds and an alarm message flashes. The default
setting of one (1) is the most sensitive to desaturation patterns and results in
more frequent alarms. For less frequent alarms, use a less sensitive setting of
two (2) or three (3).
Note:
To disable audible alarms, contact a qualified service technician.
Note:
Unrecognized repetitive reductions in airflow through the upper airway occur in some
clinically significant scenarios. Patients exhibiting sleep apnea symptoms were used in
studies to validate the SPD™ Alert parameter. The presence of repetitive reductions
in airflow was scored using a standard diagnostic polysomnogram. Study results
indicate SPD is a sensitive marker in detecting repetitive reductions in airflow.
Note:
Prior to changing SPD sensitivity settings, clear all alarms.
Note:
Enabling SPD automatically sets the SatSeconds value to 100.
To set OxiMax SPD™ Alert (SPD) sensitivity
The SPD sensitivity setting establishes a threshold for how sensitive the monitoring system is to patterns of desaturation.
1.
While in normal monitoring mode, press MENU.
2. Press ALARM LIMITS.
3. Press SATURATION PATTERN DETECTION (SPD).
4-22 Operator’s Manual
4. Select the desired sensitivity setting. The choices are 1, 2, 3, or OFF. The default
setting is 1. The setting of one (1) is the most sensitive to patterns of desaturation,
but may also lead to more alarms. The setting of two (2) is moderately sensitive to
patterns of desaturation. The setting of three (3) is the least sensitive to desaturation patterns, but may result in fewer alarms.
Figure4-7.Setting SPD Sensitivity
User Interface
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
7. Ensure selected sensitivity value underneath the SPD triangle icon matches the
desired limit just set.
Note:
Press HELP to display a SPD alarm help dialogue for online assistance.
Operator’s Manual 4-23
Operation
Pulse Rate Delay Alarm Management Parameter Limits
Reference Pulse Rate Delay Alarm Management Parameter, p. 10-12, for specifics on how the pulse rate delay parameter works. To use the Pulse Rate Delay
parameter, set the traditional alarm management upper and lower pulse rate
alarm limits. Then, set the Pulse Rate Delay. The Pulse Rate Delay limit controls
the time the pulse rate level crosses either limit before an audible alarm
sounds.
To set pulse rate delay
1.
While in normal monitoring mode, press MENU.
2. Press ALARM LIMITS.
3. Press PULSE RATE DELAY.
4. Select the desired delay. The choices are 5, 10, or OFF. The setting of five (5) or
ten (10) provides a five or ten second alarm delay, respectively. The default setting
is OFF.
Figure4-8.Setting Pulse Rate Delay
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
4-24 Operator’s Manual
MONITORING HISTORY Menu
Figure4-9.MONITORING HISTORY Menu Options
User Interface
Use this menu to review historical monitoring data, including:
• Trends — View historical trend data with time frames ranging from the previous
15 minutes to the previous 48 hours. The default view is 1 hour.
• Clinical log — View a list of monitor readings, marked events, and alarms from
the last 48 hours. Note that the monitor readings that appear in the log indicate
status changes such as initial readings after power-up or transitions between
alarm states.
• Histograms — View graphical data representing the percentage of time SpO2
and pulse rate values were measured in specific ranges. Select time frames
ranging from the previous 15 minutes to the previous 48 hours. The default view
is 1 hour.
Trend Data
To view historical trend data
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING HISTORY.
3. Press TRENDS.
4. Review the visible trend field.
Operator’s Manual 4-25
Operation
Figure4-10.MONITORING HISTORY - TRENDS
•
Change the visible time scale by pressing the - or + keys next to the trend time
scale indicator. The options are 15 minutes, 30 minutes, 1 hour, 2 hours, 4
hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours. The default is 1
hour.
• Scroll left or right using the arrows or the scroll bar for any additional historical
trend data.
• View specifics for visible trend data by touching the screen at the area of inter-
est. A pop-up appears.
Figure4-11.Historical Trend Data Pop-Up
4-26 Operator’s Manual
• Press CLEAR HISTORY to delete the trend data and then confirm or CANCEL
to retain historical trend data.
5. Press EXIT to return to normal monitoring.
Clinical Log
To view the clinical log
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING HISTORY.
3. Press CLINICAL LOG.
4. Review the log entries.
Figure4-12.MONITORING HISTORY - CLINICAL LOG
User Interface
Scroll up or down through the entries using the arrows or the scroll bar.
•
• For logs with numerous entries, use the buttons at the top of the log to move
among the first, previous, next, and last pages of entries.
• Press CLEAR HISTORY to delete the log entries and then confirm or CANCEL
to retain the log entries.
5. Press EXIT to return to normal monitoring.
Operator’s Manual 4-27
Operation
Histograms
To view histograms
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING HISTORY.
3. Press HISTOGRAM.
4. Review the histograms.
Figure4-13.MONITORING HISTORY - HISTOGRAM
Change the time scale by pressing the - or + keys next to the histogram time
•
scale indicator. The options are 15 minutes, 30 minutes, 1 hour, 2 hours, 4
hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours. The default is 1
hour.
• Press CLEAR HISTORY to delete the histograms and then confirm or CANCEL
to retain the histograms.
5. Press EXIT to return to normal monitoring.
4-28 Operator’s Manual
MARK EVENT Menu
Use this menu to mark clinically significant events, such as interventions, medication, observations, and transfers, during patient monitoring. Marked events
are stored in the monitoring history and are indicated by a white diamond in
the trend view.
To mark an event
1.
While in normal monitoring mode, press MENU.
2. Press MARK EVENT.
3. Select the type of event to be marked.
Figure4-14.MARK EVENT Menu Options
User Interface
4. Press SAVE CHANGES.
5. Press EXIT to return to normal monitoring.
A white diamond marks the event in the trend view. Touching the screen at the
marked event displays pop-up information, including the type of marked event.
Operator’s Manual 4-29
Operation
Figure4-15.Marked Event and Pop-up in Trend View
SOUND SETTINGS Menu
Select volume levels for alarms, pulse beep, and sound effects in increments or
decrements of 25 percent.
Note:
Any adjustment of volume levels results in an issued sound not only to indicate the
change, but also to indicate functionality of the speaker and audible alarm signal.
4-30 Operator’s Manual
Figure4-16.SOUND SETTINGS Menu Options
User Interface
Alarm volume — Adjust the volume to the desired level by pressing the minus
•
or plus icon. Save the change to retain the change made. Options for volume settings are 25, 50, 75, and 100 percent. The default setting is 75 percent. Some
institutions may allow caregivers to disable audible alarms.
• Pulse beep volume — Adjust the volume to the desired level by pressing the
minus or plus icon. Save the change to retain the change made. Options for
volume settings are OFF, 25, 50, 75, and 100 percent. The default setting is 50
percent.
• Button click volume — Adjust the volume to the desired level by pressing the
minus or plus icon. Save the change to retain the change made. Options for
volume settings are OFF, 25, 50, 75, and 100 percent. The default setting is 50
percent.
Operator’s Manual 4-31
Operation
MONITORING SETTINGS Menu
WARNING:
The monitoring system is intended only as an adjunct in patient assessment.
It must be used in conjunction with clinical signs and symptoms.
Use this menu to set the alarm mode, response mode, institution time and
date, alarm silence duration, monitoring layout, and screen brightness.
Figure4-17.MONITORING SETTINGS Menu Options
Alarm Mode — Use to set the alarm settings for adult and pediatric patients or
•
for neonates. The factory default alarm mode is ADULT, which does not have any
indicator. The institutional default may be set to ADULT or NEONATE. Reference
Alarm Mode, p. 4-34.
– Adult Alarm Mode — This alarm mode establishes adult upper and lower
default alarm threshold settings.
– Neonate Alarm Mode — This alarm mode establishes neonate upper and
lower default alarm threshold settings. When users select the neonate alarm
mode, the Baby icon appears between the appropriate alarm limit threshold
values.
• Response Mode — The response mode establishes the rate at which the moni-
toring system responds to changes in SpO
the calculation of pulse rate or recording of trend data, which occurs at one-
4-32 Operator’s Manual
2 saturation levels, but does not affect
second intervals. The response mode, however, may impact SPD alarm behavior.
The default response mode is NORMAL. Reference Response Mode, p. 4-35.
– Normal Response Mode — Responds to changes in blood oxygen satura-
– Fast Response Mode — Responds to changes in blood oxygen saturation
Note:
• Time and Date — Use to set time, date, and date format. Reference Time and
Date, p. 4-36.
tion in five (5) to seven (7) seconds.
levels in two (2) to four(4) seconds. This can be particularly helpful for situations that require close monitoring. The Fast Response Mode icon in italics
appears near the SpO
2 value.
When in FAST response mode, the monitoring system may produce more
SpO
2 and pulse rate alarms. Response mode may also impact SPD alarm
behavior.
User Interface
• Alarm Silence Duration — Use to set total time allocated for silencing an alarm.
Reference Alarm Silence Duration, p. 4-37.
• Monitoring Layout — Select the desired monitoring screen layout from the
available options: Pleth only, Trend only, Pleth and trend, or Blip layouts. The Pleth
view is the default. Reference Monitoring Screen Layout Options, p. 4-41.
– PLETH and TREND — Access a split screen containing both the plethysmo-
graphic (pleth) waveform and the trend data simultaneously. Reference Com-
bination Pleth and Trend View, p. 4-47.
– PLETH ONLY — Access plethysmographic (pleth) waveform display view.
Reference Pleth View, p. 4-41.
– TREND ONLY — Access trend data display view. Reference Real-Time Trend
View, p. 4-43.
– NUMBERS ONLY (Blip) — Access blip bar display view. Reference Numbers
Only (Blip) View, p. 4-49.
• Screen brightness — Adjust the screen brightness of the monitoring system
screen to suit each individual situation. This option does not remain after power
cycle, but returns to default brightness. Some institutions may allow caregivers to
disable visual alarms by turning screen brightness OFF. Reference Screen Bright-
ness, p. 4-38.
Operator’s Manual 4-33
Operation
Note:
Caregivers may monitor the patient remotely. Reference Using the Nurse Call
Interface, p. 5-18. For institutions allowing caregivers to turn off all audible alarms and
minimize or disable backlight brightness, refrain from reducing both audible and
visual alarms unless using a remote monitoring system. When using a remote
monitoring system, caregivers should still remain vigilant, periodically assessing
patients.
Alarm Mode
To set the alarm mode
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press ALARM MODE.
4.
Select the desired alarm setting. The factory default setting is ADULT ALARM SETTINGS.
Figure4-18.Selecting Adult and Pediatric vs. Neonate Alarm Mode
5. Press SAVE CHANGES to save the selected setting.
6. Press YES to confirm.
4-34 Operator’s Manual
7. Press EXIT.
8. If changing from Adult to Neonate mode, confirm that the Baby icon appears
between upper and lower alarm limit threshold settings.
Response Mode
To set the response mode
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press RESPONSE MODE.
Figure4-19.Response Mode Selection Screen
User Interface
4. Select FAST response mode. The default setting is NORMAL response mode.
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
7. Ensure the FAST icon appears near the SpO2 value.
8. Use the same procedure to revert back to NORMAL, selecting that option for
step 4 and ensuring the FAST icon is no longer visible for step 7.
Operator’s Manual 4-35
Operation
Time and Date
To set the time and date
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press TIME AND DATE.
4. Select the desired field for the time or date.
Figure4-20.Time and Date Selection Screen
5. Increment or decrement to set the proper values.
6.
Select the desired date format by repeatedly pressing the DATE FORMAT field to
scroll through the various format options until locating the desired one. Options are
the default DD/MM/YY format or the alternate MM/DD/YY or YY/MM/DD formats.
7. Press SAVE CHANGES to save the selected setting.
8. Press YES to confirm.
9. Press EXIT.
4-36 Operator’s Manual
Alarm Silence Duration
To set the alarm silence duration
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press ALARM SILENCE DURATION.
4. Select the desired number of seconds: 30, 60, 90, 120, or OFF.
Note:
By default, setting the alarm silence duration to OFF is disabled. However,
institutions may choose to enable this setting.
User Interface
Figure4-21.Alarm Silence Duration Screen
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
Operator’s Manual 4-37
Operation
Monitoring Layout
Reference Monitoring Screen Layout Options, p. 4-41 for instructions for
selecting the monitoring view.
Screen Brightness
To adjust the screen brightness
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press SCREEN BRIGHTNESS.
4. Increment or decrement to obtain the desired backlight brightness.
Note:
Any of the following conditions turns on the backlight if the backlight is dimmed:
• Pressing the monitoring screen
• Any alarm, as long as the WAKE DISPLAY ON ALARM is not set to OFF
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
4-38 Operator’s Manual
CONNECTIVITY SETTINGS Menu
Use this menu to select the proper communication protocol for attaching the
monitoring system to external devices. The monitoring system provides a
bedside monitor communication for interfacing with the listed protocols.
Figure4-22.CONNECTIVITY SETTINGS Menu Options
User Interface
Remote Settings —
•
Provides flexible connectivity to a remote system. Options
include variants for WLAN and LAN, as well as Disconnected. Default is DISCONNECTED.
• Serial — Provides flexible connectivity to a serial port. Options include ASCII, Clin-
ical, variants for SPDout, Philips, and OFF. Default is ASCII at 9600 baud.
Table4-4.Serial Connectivity Protocols
Communication Protocol Baud Rate
ASCII 9600
19200
Clinical 19200
Philips Vuelink 19200
SPDout 19200
115200
• Nurse Call — Provides connectivity to a Nurse Call connection. Ensure there is no
audible alarm. Then, select either option. The default is normally high (+). Select
Normally + to set voltage from +5 VDC to +12 VDC. Select Normally - to set
voltage from -5 VDC to -12 VDC. Voltages switch polarity when the audible alarm
sounds.
Operator’s Manual 4-39
Operation
DATA EXPORT Menu
Use this menu to obtain the trend data history, including any event markers.
This requires an external USB flash drive to export trend data. View the trend
data file using any number of standard software packages to parse the data,
review the data, and compile reports from the data. The trend data can be analyzed using the Nellcor™ Analytics Tool (NAT). Reference Trend Data Access,
p. 5-1.
ABOUT THE MONITOR Menu
Use this menu to obtain model number and firmware revision level information
prior to contacting Covidien or a local Covidien representative.
• Monitor Information — This field contains the monitoring system model
number and serial number.
• Software Information — This field contains the software version and current
firmware revision running on the monitoring system.
• Parameter Information — This field contains the parameter name and number.
• Network Information — This field contains the LAN and WLAN IP addresses.
4-40 Operator’s Manual
4.4.5 Monitoring Screen Layout Options
Select the preferred method of viewing real-time data. Reference Monitoring
Screen Selection, p. 2-8. Selections last until power-cycle or until users manu-
ally select another monitoring screen from the monitoring layout options.
Figure4-23.Monitoring Layout Options
User Interface
Pleth View
Use this monitoring screen for visual monitoring information in waveform. The
plethysmographic (pleth) monitoring screen contains a “wiper bar” plethysmographic waveform. Plethysmographic waveforms with peak to peak amplitudes less than ten pulse amplitude units (PAUs) are associated. Reference
Theory of Operations, p. 10-1, for a description of the pleth waveform. This
view also reflects current measured SpO
2 and pulse rates and also indicates
upper and lower limit settings. When the monitoring system is not attached to
AC power, it runs on the internal battery. A battery fuel gauge indicates
remaining internal battery charge.
• SatSeconds™ parameter — For mild or brief SpO2 limit violations, use the
SatSeconds parameter to reduce nuisance alarms. With the SatSeconds parameter
enabled, the monitoring screen includes a circle icon and its setting. The SatSeconds alarm limit value appears just below the circle icon. When the SatSeconds
parameter is enabled, the circle icon fills in the clockwise direction as the alarm
management system detects SpO
icon empties in counterclockwise direction when SpO2 readings are within limits.
When the icon fills completely, a medium-priority alarm sounds. Reference
SatSeconds™ Alarm Management Parameter Limits, p. 4-19.
2 readings outside of the limit setting. The circle
Operator’s Manual 4-41
Operation
• SPD parameter — Use the SPD™ alert (SPD) parameter to detect patterns of
desaturation in the SpO2 trend in adults. Using the SPD™ Alert parameter also
triggers the SatSeconds parameter. With the SPD parameter enabled, the monitoring screen includes both triangle and circle icons and their settings. The SPD
alarm sensitivity value appears just below the triangle icon. When the SPD parameter is enabled, the triangle icon fills from bottom to top as desaturation patterns
develop. The triangle icon empties from top to bottom as patterns dissipate.
When the icon fills completely, a low-priority alarm sounds. The monitoring
system will sound the SPD alarm sooner if the SPD alarm sensitivity is set to the
default value of one (1). A less sensitive setting will result in less frequent alarms.
Reference OxiMax SPD™ Alert Parameter Limits, p. 4-21.
Figure4-24.Pleth Only View
To select the pleth view
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press MONITORING LAYOUT.
4. Select PLETH ONLY.
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
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Real-Time Trend View
Use this monitoring screen for visual monitoring information related to realtime trends. The trend data plots automatically update as the monitoring
system calculates each new trend point, where the interval between calculations is based on the time scale selected. The real-time trend monitoring screen
includes SpO2 and/or pulse rate trend data plots, current measured SpO2 and
pulse rates. Each time the monitoring system detects a pulse, the heart icon
flashes. Should the monitoring system detect corrupt trend data, it notifies the
caregivers with a TREND DATA LOST message.
This view also reflects current measured SpO2 and pulse rates and also indicates upper and lower limit settings. When the monitoring system is not
attached to AC power, it runs on the internal battery. A battery fuel gauge
indicates remaining internal battery charge.
• SatSeconds™ parameter — For mild or brief SpO2 limit violations, use the
SatSeconds parameter to reduce nuisance alarms. With the SatSeconds parameter
enabled, the monitoring screen includes a circle icon and its setting. The SatSeconds alarm limit value appears just below the circle icon. When the SatSeconds
parameter is enabled, the circle icon fills in the clockwise direction as the alarm
management system detects SpO
icon empties in counterclockwise direction when SpO2 readings are within limits.
When the icon fills completely, a medium-priority alarm sounds. Reference
SatSeconds™ Alarm Management Parameter Limits, p. 4-19.
2 readings outside of the limit setting. The circle
User Interface
• SPD parameter — Use the SPD™ alert (SPD) parameter to detect patterns of
desaturation in the SpO
triggers the SatSeconds parameter. With the SPD parameter enabled, the monitoring screen includes both triangle and circle icons and their settings. The SPD
alarm sensitivity value appears just below the triangle icon. When the SPD parameter is enabled, the triangle icon fills from bottom to top as desaturation patterns
develop. The triangle icon empties from top to bottom as patterns dissipate.
When the icon fills completely, a low-priority alarm sounds. The monitoring
system will sound the SPD alarm sooner if the SPD alarm sensitivity is set to the
default value of one (1). A less sensitive setting will result in less frequent alarms.
Reference OxiMax SPD™ Alert Parameter Limits, p. 4-21.
2 trend in adults. Using the SPD™ Alert parameter also
Isolate oxygenation (SpO2) or pulse trend data or view them both together
(SpO2 + Pulse).
Operator’s Manual 4-43
Operation
Figure4-25.Real-time Trend Only View
To select the trend view
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press MONITORING LAYOUT.
4. Select the TREND ONLY option.
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
To select the type of trend data displayed
1. Follow the steps listed for selecting the trend monitoring screen.
2. Press the trend data type button. Reference Monitoring Screen, p. 2-4.
3. Select the trend data to be displayed. The default is to display both SpO2 and Pulse
Rate.
4. Press SAVE CHANGES to save the selected setting.
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Figure4-26.Select Trends Options
User Interface
SpO2 and Pulse Rate checked — View oxygenation (SpO2) and pulse
•
(PULSE) trend data simultaneously for a specified length of time.
Figure4-27.SpO2 and Pulse Rate Trend Data, 1 Hour
Operator’s Manual 4-45
Operation
• SpO2 only checked — Isolate oxygenation (SpO2) trend data for a specified
length of time. Dashed yellow lines indicate alarm limits.
Figure4-28.SpO2 Only Trend Data, 1 Hour
• Pulse Rate only checked — Isolate pulse (PR) trend data for a specified
length of time. Dashed yellow lines indicate alarm limits.
Figure4-29.Pulse Only Trend Data, 1 Hour
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To set up the trend time scale
1. Follow the steps listed for selecting the trend monitoring screen.
2. Press “-” or “+” on either side of the time scale indication to the right of the Trend
field until the desired time scale appears. The options are 15 minutes, 30 minutes,
1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours.
The default is 1 hour.
Combination Pleth and Trend View
Use this default monitoring screen for visual monitoring information related to
both pleth and real-time trends.
The pleth field contains a “wiper bar” plethysmographic waveform. Plethysmographic waveforms with peak to peak amplitudes less than ten pulse amplitude units (PAUs) are associated. Reference Theory of Operations, p. 10-1, for
a description of the pleth waveform.
User Interface
The real-time trend field can include SpO2 and/or pulse rate trend data plots,
depending on user preference. The default is for viewing both SpO2 and pulse
rate trend data plots.The trend data plots automatically update as the monitoring system calculates each new trend point, where the interval between calculations is based on the time scale selected.
This view also reflects current measured SpO2 and pulse rates and also indicates upper and lower limit settings. When the monitoring system is not
attached to AC power, it runs on the internal battery. A battery fuel gauge
indicates remaining internal battery charge.
• SatSeconds™ parameter — For mild or brief SpO2 limit violations, use the
SatSeconds parameter to reduce nuisance alarms. With the SatSeconds parameter
enabled, the monitoring screen includes a circle icon and its setting. The SatSeconds alarm limit value appears just below the circle icon. When the SatSeconds
parameter is enabled, the circle icon fills in the clockwise direction as the alarm
management system detects SpO
icon empties in counterclockwise direction when SpO
When the icon fills completely, a medium-priority alarm sounds. Reference
SatSeconds™ Alarm Management Parameter Limits, p. 4-19.
• SPD parameter — Use the SPD™ alert (SPD) parameter to detect patterns of
desaturation in the SpO
2 trend in adults. Using the SPD™ Alert parameter also
triggers the SatSeconds parameter. With the SPD parameter enabled, the monitoring screen includes both triangle and circle icons and their settings. The SPD
alarm sensitivity value appears just below the triangle icon. When the SPD parameter is enabled, the triangle icon fills from bottom to top as desaturation patterns
develop. The triangle icon empties from top to bottom as patterns dissipate.
When the icon fills completely, a low-priority alarm sounds. The monitoring
system will sound the SPD alarm sooner if the SPD alarm sensitivity is set to the
2 readings outside of the limit setting. The circle
2 readings are within limits.
Operator’s Manual 4-47
Operation
default value of one (1). A less sensitive setting will result in less frequent alarms.
Reference OxiMax SPD™ Alert Parameter Limits, p. 4-21.
Figure4-30.Combination Pleth and Trend View
To select the pleth and trend view
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press MONITORING LAYOUT.
4. Select the PLETH AND TREND option.
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
Reference p. 4-44 to select the type of trend data displayed. Reference p. 4-47
to set the trend data time scale.
4-48 Operator’s Manual
Numbers Only (Blip) View
Use this monitoring screen for visual monitoring information in blip bar (numbers only) form. This view also reflects current measured SpO2 and pulse rates
and also indicates upper and lower limit settings. When the monitoring system
is not attached to AC power, it runs on the internal battery. A battery fuel
gauge indicates remaining internal battery charge.
• SatSeconds™ parameter — For mild or brief SpO2 limit violations, use the
SatSeconds parameter to reduce nuisance alarms. With the SatSeconds parameter
enabled, the monitoring screen includes a circle icon and its setting. The SatSeconds alarm limit value appears just below the circle icon. When the SatSeconds
parameter is enabled, the circle icon fills in the clockwise direction as the alarm
management system detects SpO
icon empties in counterclockwise direction when SpO
When the icon fills completely, a medium-priority alarm sounds. Reference
SatSeconds™ Alarm Management Parameter Limits, p. 4-19.
• SPD parameter — Use the SPD™ alert (SPD) parameter to detect patterns of
desaturation in the SpO2 trend in adults. Using the SPD™ Alert parameter also
triggers the SatSeconds parameter. With the SPD parameter enabled, the monitoring screen includes both triangle and circle icons and their settings. The SPD
alarm sensitivity value appears just below the triangle icon. When the SPD parameter is enabled, the triangle icon fills from bottom to top as desaturation patterns
develop. The triangle icon empties from top to bottom as patterns dissipate.
When the icon fills completely, a low-priority alarm sounds. The monitoring
system will sound the SPD alarm sooner if the SPD alarm sensitivity is set to the
default value of one (1). A less sensitive setting will result in less frequent alarms.
Reference OxiMax SPD™ Alert Parameter Limits, p. 4-21.
2 readings outside of the limit setting. The circle
2 readings are within limits.
User Interface
Figure4-31.Numbers Only (Blip) View
Operator’s Manual 4-49
Operation
To select the numbers only (blip) view
1.
While in normal monitoring mode, press MENU.
2. Press MONITORING SETTINGS.
3. Press MONITORING LAYOUT.
4. Select the NUMBERS ONLY option.
5. Press SAVE CHANGES to save the selected setting.
6. Press EXIT.
4.4.6 Alarm Management and Status Messages
The status field at the top of the monitoring screen contains information describing overall monitoring system status and any active alarms. If multiple alarms
occur during user interaction with a menu or dialog box, the list of alarm messages collapses to a single line listing the total number of alarms currently active.
Cancellation or dismissal of an alarm message requires user intervention,
whereas status messages do not. The message identifies the alarm or status. If
it is an alarm, it offers users a MORE INFO button, which when pressed, provides
detailed data and a means to correct the situation or clear the alarm.
The monitoring system comes with factory default alarm limit thresholds for
adult-pediatric patients and for neonate patients. Reference Factory Default
Alarm Limit Settings and Parameters, p. 4-17. Institutions may opt for setting
institutional default settings to override the factory defaults. In addition, users
may also temporarily change alarm limits. Any temporary changes to alarm
limit thresholds revert back to default alarm limit settings after power-off. Reference Temporary Alarm Limits, p. 4-18.
Note:
There are no delays associated with any alarm conditions that exceed ten (10) seconds
unless otherwise specified.
4-50 Operator’s Manual
Message Types
Messages begin at the top of the status field and continue to tile downward
until reaching three lines.
Note:
Not all high-priority alarms have a DISMISS option. If this is the case, it is a serious error
and requires the user to resolve the issue or return the monitoring system to Covidien
or a qualified service technician.
• User prompt or status messages — User prompts requiring user intervention
appear as white text on a grey bar. The READY status message is the most
common of this type. Status messages require no user intervention and appear as
white text on a green background. The MONITORING status message is the most
common of this type.
User Interface
Figure4-32.Sample user prompt message: READY
Figure4-33.Sample status message: MONITORING
High priority alarm messages — High priority alarms take precedence over any
•
other alarm messages, so appear first. If more than one high priority alarm occurs
within quick succession, alarm messages appear in order of occurrence. High priority alarms appear in a flashing, red bar in the status field.
Figure4-34.High priority alarm: BATTERY CRITICALLY LOW
Medium priority alarm messages — Medium priority alarms take precedence
•
over low priority alarm messages. If more than one medium priority alarm occurs
within quick succession, alarm messages appear in order of occurrence. Medium
priority alarms appear in a flashing, yellow bar in the status field.
Figure4-35.Medium priority alarm: SpO2 LOW
Operator’s Manual 4-51
Operation
• Low priority alarm messages — Low priority alarms take precedence over user
prompt and status messages. If more than one low priority alarm occurs within
quick succession, alarm messages appear in order of occurrence. Low priority
alarms appear in a steady, yellow bar in the status field.
Figure4-36.Low priority alarm: SENSOR OFF
To correct a user prompt
1. Read the recommended action portion of the message.
2. Take the recommended action. The monitoring system triggers off the corrective
action and automatically clears the message.
3. For multiple messages, press NEXT to view each message in order of priority.
To correct an alarm message
1. Press the MORE INFO button for the top, most important alarm message.
2. Read the alarm message description.
3. Take the recommended action.
4. Clear the alarm message by pressing the EXIT or DISMISS ALARM button.
Limit Threshold Violation Indicators
The monitoring system reports real-time patient data. If that data falls outside
the alarm limit thresholds, a threshold violation occurs. This triggers an alarm
condition, resulting in a visual alarm. Reference Visual Alarms, p. 2-12. An
audible alarm also results, unless a SILENCE ALARM (Audio Paused) or an
AUDIO OFF condition exists. Reference Audible Alarm Management, p. 4-53.
• SpO2 — The monitoring system reports real-time blood oxygen saturation that
falls within the upper and lower limit thresholds as a cyan value on a black background. If a threshold violation occurs, the value turns black on a yellow background.
• Pulse (BPM) — The monitoring system reports real-time pulsations that fall
within the upper and lower limit thresholds as a green value on a black background. If a threshold violation occurs, the value turns black on a yellow background.
4-52 Operator’s Manual
Figure4-37.Sample Alarm Limit Violations
1 Saturation below lower threshold 6 Silence Alarm icon, not active
2 Pulse rate below lower threshold 7 SatSeconds alarm present
User Interface
3 Patterns of desaturation present 8 Current saturation value, low
4 SPD Alert alarm icon 9 SPD Alert alarm present
5 SatSeconds alarm icon 10 Current pulse rate value, low
4.4.7
Audible Alarm Management
WARNING:
Do not silence or disable audible alarms or decrease the volume of the audible
alarm if patient safety could be compromised. Do not dim or disable visual
alarms if patient safety could be compromised.
Audible indicators include pitched tones and beeps. Audible alarms vary,
depending on the priority of the alarm. Caregivers may choose to silence
alarms by pressing ALARM SILENCE. For any alarm condition still active for
more than two (2) minutes, the monitoring system will increase the urgency
level of the audible alarm signal by increasing its frequency.
Note:
Caregivers may monitor the patient remotely. Reference Using the Nurse Call
Interface, p. 5-18. For institutions allowing caregivers to turn off all audible alarms and
minimize or disable backlight brightness, refrain from reducing both audible and
Operator’s Manual 4-53
Operation
visual alarms unless using a remote monitoring system. When using a remote
monitoring system, caregivers should still remain vigilant, periodically assessing
patients.
SILENCE ALARM
The factory default setting provides both visual and audible alarms for alarm
conditions. Institutions may choose to temporarily silence audible alarms and
rely on visual alarms. To do so, caregivers may press the SILENCE ALARM icon.
The default duration for SILENCE ALARM is two (2) minutes. To alter the default
duration, a qualified service technician must set an alternate institutional default
setting in the Service Mode. Reference
Alarm Silence Duration
, p. 4-37 to tem-
porarily change this duration.
SILENCE ALARM remains available at all times. Reference Introduction to Menu
Options, p. 4-10.
• Not active — If SILENCE ALARM is not active, the SILENCE ALARM icon remains
white on a grey background.
• Active — If SILENCE ALARM is active, the SILENCE ALARM icon turns yellow on
a grey background and posts the time remaining. A yellow alarm icon above the
alarm limits indicates an active SILENCE ALARM status.
ALARM AUDIO OFF
The factory default setting provides both visual and audible alarms for alarm
conditions. Institutions may choose to turn off audible alarms and rely on visual
alarms. To allow caregivers to turn off audible alarms, a qualified service technician must alter this alarm system setting in Service Mode.
• Not active — If Alarm Silence Duration OFF is not active, it does not appear on
the monitoring screen. Instead, the SILENCE ALARM icon remains white on a grey
background.
• Active — If Alarm Silence Duration OFF is active, the AUDIO OFF icon replaces the
SILENCE ALARM icon. The AUDIO OFF icon is yellow on a grey background. A red
alarm icon above the alarm limits indicates an active ALARM AUDIO OFF status.
4-54 Operator’s Manual
Note:
Caregivers may turn off audio SPD alerts in addition to ALARM AUDIO OFF. This also
requires access to the Service Mode by a qualified service technician.
Note:
For institutions preferring visual alarms only, yet allowing caregivers to minimize or
disable backlight brightness, it may prove useful to have a qualified service technician
verify the WAKE DISPLAY ON ALARM option remains enabled.
4.4.8 Visual Alarm Management
WARNING:
The monitoring system is intended only as an adjunct in patient assessment.
It must be used in conjunction with clinical signs and symptoms.
User Interface
The factory default setting provides both visual and audible alarms for alarm conditions. Institutions may choose to allow caregivers to turn off or dim the backlight,
thus also dimming visual alarms. The factory default is to enable the WAKE
DISPLAY ON ALARM option. The monitoring system then returns to full brightness
during an alarm condition. Reference
Note:
Caregivers may monitor the patient remotely. Reference Using the Nurse Call
Interface, p. 5-18. For institutions allowing caregivers to turn off all audible alarms and
minimize or disable visual alarms or backlight brightness, refrain from reducing both
audible and visual alarms unless using a remote monitoring system. When using a
remote monitoring system, caregivers should still remain vigilant, periodically
assessing patients.
Note:
For institutions preferring visual alarms only, yet allowing caregivers to minimize or
disable backlight brightness, have a qualified service technician verify the WAKE
DISPLAY ON ALARM option remains enabled.
Screen Brightness
, p. 4-38.
Operator’s Manual 4-55
Operation
4.4.9 HELP Option
To access on-screen help topics
1.
Press HELP. The appropriate help dialog window appears.
2. Review the help dialog box for guidance.
3. Press EXIT to return to normal monitoring.
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