Coviden Nellcor Series Operator's Manual
Operator’s Manual
Nellcor
TM
Bedside SpO2 Patient Monitoring System
© 2018 Covidien. All rights reserved. COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S.
and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other
brands are trademarks of a Covidien company.
Table of Contents
1 Introduction
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2.1 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.2.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
1.2.3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
1.3 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.3.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5
1.3.2 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5
1.4 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
2 Product Overview
2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.4 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.4.1 Front Panel and Display Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
2.4.2 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
2.4.3 Product and Carton Label Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
3 Installation
3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.3 Unpacking and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.4 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.4.1 Connecting to Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
3.4.2 Using the Internal Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
3.4.3 Connecting a Nellcor™ Pulse Oximetry Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
4 Operation
4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.3 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.3.1 Turning on the Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.3.2 Turning off the Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
4.4 Menu Options Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.4.1 Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
4.4.2 QUICK ACCESS Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
4.4.3 OPTIONS Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
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4.4.4 ALARM/LIMITS Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10
4.4.5 PATIENT MODE Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
4.4.6 SpO
WAVEFORM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
2
4.5 Managing Alarms and Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
4.5.1 Audible Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
4.5.2 Visual Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
4.6 Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
4.7 Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
5 Data Management
5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Tabular Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.3 Graphical Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.4 External Data Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.4.1 Nurse Call Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.4.2 Trend Data Download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
5.4.3 Firmware Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
6 Performance Considerations
6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Oximetry Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2.1 Pulse Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
6.2.2 Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.3 Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1
6.3.2 Patient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.3.3 Sensor Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.3.4 Reducing EMI (Electromagnetic Interference) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
7 Preventive Maintenance
7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.3 Recycling and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.4 Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.5 Periodic Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
7.6 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
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Table of Contents
8 Troubleshooting
8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.3 Error Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.4 Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
9 Accessories
9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2 Nellcor™ Pulse Oximetry Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.3 Optional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
9.4 Biocompatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3
10.5.3 Data Update Period, Data Averaging, and Signal Processing . . . . . . . . . . . . . . . . . . . . . . . . . .10-4
10.6 SatSeconds™ Alarm Management Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
10.6.1 First SpO
10.6.2 Second SpO
10.6.3 Third SpO
10.6.4 The SatSeconds™ Safety Net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
2
Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6
2
Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
2
11 Product Specifications
11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.2 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.3 Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
11.4 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
11.5 Tone Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
11.6 Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
11.7 Sound Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
11.8 Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
11.9 Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
11.9.1 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6
11.9.2 Sensor and Cable Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11
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11.9.3 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11
11.10 Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
A Clinical Studies
A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.2 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.3 Study Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.4 Study Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.5 Adverse Events or Deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.6 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
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List of Tables
Table1-1.Safety Symbol Definitions...............................................................................1-1
Table2-1.Display Colors ......................................................................................................2-6
Table2-2.Symbol Descriptors ...........................................................................................2-7
Table3-1.Standard Items ....................................................................................................3-2
Table4-1.Menu Structure and Available Options......................................................4-5
Table4-2.Alarm Conditions ............................................................................................ 4-15
Table4-3.Audio Status...................................................................................................... 4-16
Table4-4. Parameter Ranges and Factory Defaults ............................................... 4-17
Table5-1.Nurse Call Relay Pins States for NORMALLY + .........................................5-5
Table5-2.Nurse Call Relay Pins States for NORMALLY –..........................................5-5
Table5-3.Operating Status Codes................................................................................... 5-9
Table8-1.Common Problems and Resolutions ..........................................................8-2
Table9-1.Nellcor™ Pulse Oximetry Sensor Models and Patient Sizes ................9-2
Table11-1.Transport, Storage, and Operating Condition Ranges.................... 11-2
Table11-2.Tone Definitions............................................................................................ 11-3
Table11-3.Trends ............................................................................................................... 11-4
Table11-4.Pulse Oximetry Sensor Accuracy and Ranges .................................... 11-5
Table11-5.Sound Pressure in Decibels....................................................................... 11-5
Table11-6.Electromagnetic Emissions Guidelines................................................. 11-7
Table11-7.Electromagnetic Immunity Guidelines ................................................. 11-8
Table11-8.Recommended Separation Distances................................................... 11-9
Table11-9.Test Specifications for Enclosure Port Immunity to RF
Wireless Communications Equipment..................................................11-10
Table11-10.Cables and Sensors..................................................................................11-11
Table11-11.Earth Leakage and Touch Current......................................................11-12
Table11-12.Patient Leakage Current ........................................................................11-13
TableA-1.Demographic Data........................................................................................... A-2
TableA-2.SpO
Accuracy for Nellcor™ Sensors vs. CO-oximeters....................... A-2
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vi Operator’s Manual
List of Figures
Figure2-1. Front and Side Panel Components ......................................................................... 2-3
Figure2-2. Display Components.................................................................................................... 2-4
Figure2-3. Rear Panel Components ............................................................................................. 2-7
Figure3-1.Connecting a Pulse Oximetry Sensor to Interface Cable ................................. 3-6
Figure4-1.Sample Initial Screen..................................................................................................... 4-3
Figure4-2.Save Change Screen...................................................................................................... 4-4
Figure4-3.QUICK ACCESS SpO
Figure4-4.QUICK ACCESS PR Menu with Alarm Audio OFF................................................. 4-6
Figure4-5.Volume Selection............................................................................................................ 4-8
Figure4-6.Volume Selection............................................................................................................ 4-8
Figure4-7.Response Mode Menu.................................................................................................. 4-9
Figure4-8.Delete All Trend Data Menu Item ...........................................................................4-10
Figure4-9.Alarm/Limits Menu Options .....................................................................................4-11
Figure4-10.Patient Mode Menu...................................................................................................4-12
Figure4-11.Highlighting the Waveform Display Area .........................................................4-13
Figure4-12.SpO
Waveform Menu .............................................................................................4-13
2
Figure5-1.Tabular Trend Data Screen.......................................................................................... 5-1
Figure5-2.Graphical Trend Data Screen...................................................................................... 5-2
Figure5-3.Nurse Call Interface Pin Layout.................................................................................. 5-4
Figure5-4.Trend Data Download Option ................................................................................... 5-7
Figure5-5.Trend Data Download Status..................................................................................... 5-8
Figure5-6.Sample Trend Data Printout.....................................................................................5-10
Figure5-7.Sample Bridge Driver Installer Window ...............................................................5-11
Figure5-8.Sample New Hardware Wizard Screen .................................................................5-12
Figure5-9.Sample DEVICE MANAGER Button Under Hardware Tab ..............................5-13
Figure5-10.Sample Hardware List in Device Manager Window ......................................5-14
Figure5-11.Sample Initial USB to UART Bridge Properties Window...............................5-15
Figure5-12.Sample Baud Rate List Under Port Settings Tab.............................................5-16
Figure10-1.Oxyhemoglobin Dissociation Curve ...................................................................10-4
Figure10-2.Series of SpO
Figure10-3.First SpO
Figure10-4.Second SpO
Figure10-5.Third SpO
2
Event: No SatSeconds™ Alarm..........................................................10-6
2
Event: No SatSeconds™ Alarm ...................................................10-7
2
Event: Triggers SatSeconds™ Alarm .............................................10-8
2
FigureA-1.Modified Bland-Altman Plot.......................................................................................A-3
Menu with Audio Alarm Selected .................................. 4-6
2
Events................................................................................................10-5
Operator’s Manual vii
Page Left Intentionally Blank
viii Operator’s Manual
1 Introduction
1.1 Overview
This manual contains information for operating the Nellcor™ bedside SpO2 patient monitoring
system.
Note:
Before use, carefully read this manual, accessory Instructions for Use, and all precautionary information
and specifications.
1.2 Safety Information
This section contains important safety information related to general use of the Nellcor™
bedside SpO
throughout the manual. The Nellcor™ bedside SpO2 patient monitoring system will be referred
to as the “monitoring system” throughout this manual.
patient monitoring system. Other important safety information appears
2
1.2.1 Safety Symbols
Symbol Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.
Caution
Identifies conditions or practices that could result in damage to the equipment or
other property.
Note
Notes provide additional guidelines or information.
Table1-1.Safety Symbol Definitions
1-1
Introduction
1.2.2 Warnings
WARNING:
Explosion hazard — Do not use the monitoring system in the presence of flammable anesthetics.
WARNING:
Explosion hazard — Do not use the battery with other manufacturer's batteries. Do not use
different types or models of batteries such as dry batteries, nickel-metal hydride batteries, or
Lithium-ion batteries together.
WARNING:
Do not use any monitoring system or pulse oximetry cables, sensors, or connectors that appear
damaged.
WARNING:
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
WARNING:
Do not simultaneously touch the patient and the signal input, signal output, or any other
connectors.
WARNING:
Do not lift or carry the monitoring system by the pulse oximetry sensor or pulse oximetry interface
cable. The cable may disconnect and cause the monitoring system to drop on a patient or cause
damage to monitoring system surfaces.
WARNING:
To ensure patient safety, do not place the monitoring system in any location where it might drop
on the patient.
WARNING:
The LCD panel contains toxic chemicals. Do not touch broken LCD panels. Physical contact with a
broken LCD panel can result in transmission or ingestion of toxic substances.
WARNING:
Always disconnect and remove the monitoring system and sensors during magnetic resonance
imaging (MRI) scanning. Attempting to use the monitoring system during an MRI procedure could
cause burns or adversely affect the MRI image or the monitoring system's accuracy.
1-2 Operator’s Manual
WARNING:
The monitoring system is intended only as an adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.
WARNING:
The values displayed by the monitoring system can be affected by patient conditions, excessive
patient movement, sensors, environmental conditions, and nearby external electromagnetic
conditions.
WARNING:
The monitoring system is intended for use in a hospital or hospital-type environment by trained
medical personnel.
WARNING:
Failure to cover the pulse oximetry sensor site with opaque material in high ambient light
conditions may result in inaccurate measurements. Refer to the appropriate sections of this
manual for specific safety information.
Safety Information
WARNING:
The monitoring system is not defibrillator-proof. It may remain attached to the patient during
defibrillation or during use of an electrosurgical unit; readings may be inaccurate during
defibrillation and shortly thereafter.
WARNING:
The monitoring system may retain trend data from multiple patients if transferring the
monitoring system from one patient to another.
WARNING:
Any connections between this monitoring system and other devices must comply with applicable
medical systems safety standards such as IEC 60601-1. Failure to do so could result in unsafe
leakage current and grounding conditions.
WARNING:
Do not silence or decrease the volume of the audible alarm if patient safety could be
compromised.
WARNING:
Do not preset different alarm limits for the same or similar equipment within a single area.
Operator’s Manual 1-3
Introduction
1.2.3 Cautions
Caution:
The monitoring system may not operate properly if it is operated or stored at conditions outside
the ranges stated in this manual, or if it is subjected to excessive shock or dropping.
Caution:
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. Never
place fluids on the monitoring system. If fluid spills on the monitoring system, remove batteries,
wipe dry immediately, and have it serviced to ensure no hazard exists.
Caution:
Accessory equipment connected to the monitoring system's data interface must be certified
according to IEC 60950-1 for data-processing equipment. All combinations of equipment must be
in compliance with IEC 60601-1 Requirements for Medical Electrical Systems. Anyone who
connects additional equipment to the signal input or signal output port configures a medical
system and is therefore responsible for ensuring the system complies with the requirements of IEC
60601-1, IEC 60601-1-2:2007, and IEC 60601-1-2:2014.
Caution:
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 be connected to a
grounded outlet.
Caution:
For best product performance and measurement accuracy, use only accessories supplied or
recommended by Covidien. Use accessories according to the manufacturer's instructions for use and
institutional standards. Use only accessories that have passed the recommended biocompatibility
testing in compliance with ISO10993-1.
Caution:
Where the integrity of the external protective conductor in the installation or its arrangement is in
doubt, the monitoring system operates from its battery.
Caution:
This monitoring system generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference to other
devices in the vicinity.
Caution:
Inspect the monitoring system and all accessories before use to ensure there are no signs of
physical damage or improper function. Do not use if damaged.
1-4 Operator’s Manual
Obtaining Technical Assistance
Obtaining Technical Assistance
1.3
1.3.1 Technical Services
For technical information and assistance, 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,
or contact a local Covidien representative
www.covidien.com
When calling Covidien or a local Covidien representative, have the monitoring system serial
number available. Provide the firmware version number listed at power-on self-test (POST).
1.3.2 Related Documents
Nellcor™ Bedside SpO2 Patient Monitoring System Operator’s Manual —
Provides basic information
for operating the monitoring system and troubleshooting errors or malfunctions. Before using the
monitoring system, thoroughly read this manual.
Nellcor™ Pulse Oximetry Sensor Instructions for Use — Guides sensor selection and usage. Before
attaching any of the various Covidien-approved pulse oximetry sensors to the monitoring system,
refer to the individual Instructions for Use.
Saturation Accuracy Grid — Provides sensor-specific guidance related to desired SpO
accuracy measurements. Available online at
Nellcor™ Bedside SpO
Patient Monitoring System Service Manual — Provides information to
2
www.covidien.com.
saturation
2
qualified service technicians for use when servicing the monitoring system.
1.4 Warranty Information
The information contained in this document is subject to change without notice. Covidien makes
no warranty of any kind with regard to this material, including, but not limited to, the implied
warranties or merchantability and fitness for a particular purpose. Covidien shall not be liable for
errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this material.
Operator’s Manual 1-5
Introduction
Page Left Intentionally Blank
1-6 Operator’s Manual
2 Product Overview
2.1 Overview
WARNING:
Patient conditions may result in erroneous readings. If the measurements are suspect, verify the
reading using another clinically accepted measurement method.
This chapter contains basic information about the Nellcor™ bedside SpO2 patient monitoring
system. The monitoring system relies on unique oximetry technology and design to provide
hospitals, clinicians, and caregivers accurate, timely data, which includes a number of
parameters.
• Arterial blood oxygen saturation (SpO
relative to the sum of oxyhemoglobin and deoxyhemoglobin
• Pulse rate (PR) — Detected heart pulsations in beats per minute
• Plethysmographic waveform (Pleth) — A non-normalized waveform that represents relative
pulsatile strength
• Operating status — State of the monitoring system, including alarm conditions and messages
• Patient data — Real-time trend data on the current patient
• Sensor messages — Detected real-time information on attached patient sensor
2.2 Product Description
The Nellcor™ bedside SpO2 patient monitoring system provides continuous, noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
) — Functional measure of oxygenated hemoglobin
2
2-1
Product Overview
Indications for Use
2.3
WARNING:
The monitoring system is intended only as an adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.
The Nellcor™ Bedside SpO2 Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
The Nellcor™ Bedside SpO2 Patient Monitoring System is intended for prescription use only with
neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in
hospitals, hospital-type facilities, and intra-hospital transport.
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.
2-2 Operator’s Manual
Product Views
2.4
2.4.1 Front Panel and Display Components
Front and Side Panels
Figure2-1. Front and Side Panel Components
Product Views
1 Silence Alarm button Press to toggle between disabling and re-enabling the
audible alarm. Reference Menu Options Navigation, p. 4-3.
2 Return button Press to exit a menu displayed on the screen and go to the
main screen. Reference Menu Options Navigation, p. 4-3.
3 Power On/Off button Press and hold to turn on or off the monitoring system,
using AC power or Lithium-ion batteries. Reference Menu
Options Navigation, p. 4-3.
4 USB port (USB A type) Use USB interface for firmware upgrades.
5 USB port (mini USB B type) Use mini-USB interface for trend data downloads.
6 Jog dial Use to navigate and control display and monitoring
system functions.
7 LCD display panel Use to monitor all graphic and numeric patient
information as well as status conditions and warning
messages.
8 SpO
connector Use to connect to the interface cable and SpO2 sensor.
2
Operator’s Manual 2-3
Product Overview
Display
Figure2-2. Display Components
1 Upper and lower alarm limits Reflects upper and lower SpO
and pulse rate alarm limits. An
2
alarm sounds each time patient saturation or pulse rate values
violate these alarm limits.
2 SpO
real-time value Indicates hemoglobin oxygen saturation levels. Current upper
2
and lower alarm limit settings appear as smaller values to the
left of the dynamic SpO
value.
2
3 Time Indicates the current time in hours, minutes, and seconds.
4 Pulse amplitude (blip bar) Indicates pulse beat and the relative (non-normalized) pulse
amplitude. As the detected pulse becomes stronger, more bars
light with each pulse.
5 SatSeconds™ icon The SatSeconds™ feature provides alarm management for mild
or brief SpO
limit violations. When the SatSeconds™ feature is
2
enabled, the SatSeconds™ icon fills in the clockwise direction as
the SatSeconds™ alarm management system detects SpO
2
readings outside of the limits setting. The SatSeconds™ icon
empties in the counterclockwise direction when SpO
readings
2
are within limits. When the SatSeconds™ icon reaches full, a
medium priority alarm sounds. The adult default setting is 100.
Reference SatSeconds™ Alarm Management Feature, p. 10-5.
6 Alarm silenced icon
The yellow icon indicates Alarm Silenced. This indicator also
shows the time remaining in the alarm silence period.
Audio OFF icon
The red icon indicates Audio OFF.
7 Pulse rate real-time value Displays the pulse rate in beats per minute. Current upper and
lower alarm limit settings appear as smaller values to the left of
the dynamic pulse rate value.
2-4 Operator’s Manual
Product Views
8 Battery status icon Displays the battery charge remaining on an internal 5- or 10-
hour battery.
• Charged Battery — A steady green battery icon indicates
the monitoring system is running on internal battery
power and the battery is fully charged.
• Low Battery — A low priority alarm occurs when the
remaining battery power is only enough for 15 minutes of
operation. The flashing yellow alarm message Low
Battery appears. Users cannot silence this alarm while
running on battery power. Connect the monitoring
system to AC power to stop the alarm.
• Critically Low-Battery — A high priority alarm occurs for
about five (5) minutes before the monitoring system shuts
off. The flashing red alarm message Critically Low-
Battery appears. When no charge remains, the
monitoring system automatically shut down. Connect the
monitoring system to AC power to avoid any loss of trend
data or settings.
9 AC power indicator Lights continuously when connected to AC power.
10 Battery charge indicator Lights when the monitoring system is charging an internal 5- or
10-hour battery.
11 Interference indicator Lights when the monitoring system detects degraded quality in
the incoming signal.It is common for it to intermittently light as
the monitoring system dynamically adjusts the amount of data
required for measuring SpO
and pulse rate. When lit
2
continuously, the monitoring system has extended the amount
of data required for measuring SpO
and pulse rate. In this case,
2
fidelity in tracking rapid changes in these values may be
reduced.
1
12 Sensor disconnect indicator Appears when the sensor is not connected to the monitoring
system.
13 Sensor off indicator Appears when the sensor is not on the patient.
14 Sensor message indicator Appears when the sensor is invalid.
15 Options menu area Visible when users utilize the jog dial to select various menu
options for customizing options and features.
16 Alarm limits menu icon Select to customize audible alarm limits.
Operator’s Manual 2-5
Product Overview
17 Patient mode area Reflects the current patient mode selected.
• Adult mode — Visible in the patient mode area when the
alarm limits are set to adult limit values. This is the default
mode.
• Pediatric mode — Visible in the patient mode area when
the alarm limits are set to pediatric limit values.
• Neonatal mode — Visible in the patient mode area when
the alarm limits are set to neonate limit values.
18 Plethysmographic (pleth)
waveform
This non-normalized waveform uses real-time sensor signals,
reflecting relative pulsatile strength of incoming signals.
19 Informative message area Contains messages to notify the user of a condition or a request
for action.
1. Degradation can be caused by ambient light, poor sensor placement, electrical noise, electrosurgical interference, patient activity, or other
causes.
Table2-1.Display Colors
Color Condition Function
Cyan numeric
Yellow numeric Pulse rate value
Steady
SpO
value and plethysmographic waveform
2
Black background General background
Red background
High priority alarm condition
Flashing
Yellow background Alarm condition
Green font
Informative message
Steady
Yellow font Low or medium priority message
Red font Flashing High priority message
Green, yellow, or red battery icon Steady Normal, low, or critically low battery status
2-6 Operator’s Manual
2.4.2 Rear Panel
Product Views
Figure2-3. Rear Panel Components
1 Equipotential terminal 3 Battery cover
2 Nurse call port 4 AC power connector
2.4.3
Product and Carton Label Symbols
Symbol Description Symbol Description
Type BF Data port
Equipotentiality Date of manufacture
Prescription only device Keep dry
Attention, consult accompanying
documents
Atmospheric pressure limitations UL listed
Table2-2.Symbol Descriptors
Fragile
Humidity limitations CE Mark
Operator’s Manual 2-7
Product Overview
Table2-2.Symbol Descriptors (Continued)
Symbol Description Symbol Description
Temperature limitations Manufacturer
This side up EU representative
Must consult instructions for use
Protection against fluid ingress
Proper waste disposal for electrical and
electronic equipment
2-8 Operator’s Manual
3 Installation
3.1 Overview
This chapter contains information for the installation and set up of the Nellcor™ bedside SpO2
patient monitoring system prior to first-time usage.
3.2 Safety Reminders
WARNING:
Ensure the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm
tone.
WARNING:
To ensure accurate performance and prevent device failure, do not expose the monitoring
system to extreme moisture, such as direct exposure to rain. Such exposure may cause
inaccurate performance or device failure. Reference Product Specifications, p. 11-1.
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:
Do not use any monitoring system, pulse oximetry sensor, cables, or connectors that appear
damaged.
WARNING:
Use only Nellcor™-approved pulse oximetry sensors and pulse oximetry cables when connecting
to the sensor connector. Connecting any other cable or sensor influences the accuracy of sensor
data, which may lead to adverse results.
WARNING:
Use only the Nellcor™ pulse oximetry interface cable with the monitoring system. Use of another
interface cable will adversely affect performance.
3-1
Installation
Caution:
Follow local government ordinances and recycling instructions regarding disposal or recycling of
device components, including its accessories.
3.3 Unpacking and Inspection
The monitoring system is shipped in a single carton. Examine the carton carefully for evidence of
damage. Contact Covidien Technical Services immediately if the carton appears damaged. Do not
return all packing material and the monitoring system prior to contacting Covidien. Reference
Technical Services, p. 1-5.
Note:
A qualified service technician should verify the performance of the monitoring system following the
procedures outlined in the Nellcor™ bedside SpO
installation in a clinical setting.
The monitoring system ships with a set of standard items, but may also include a number of
optional accessories. Check the shipping carton for all items listed on the packing list.
patient monitoring system Service Manual prior to initial
2
Note:
Contact Covidien Technical Services for pricing and ordering information.
Table3-1.Standard Items
Item Quantity
Nellcor™ bedside SpO
Nellcor™ pulse oximetry interface cable 1
Compact disc (CD) and/or Operator's Manual
Lithium-ion battery pack, M-BPL-1 (21) 5 hour 1
AC power cord 1
1. Covidien provides soft copy of monitoring system manuals on a compact disc for easy access and
print-on-demand. Order a printed Nellcor™ bedside SpO
Manual at no cost or a printed Nellcor™ bedside SpO
fee from Covidien Technical Services or a local Covidien representative.
patient monitoring system 1
2
1
patient monitoring system Operator’s
2
patient monitoring system Service Manual for a
2
1
3-2 Operator’s Manual
Setup
3.4
WARNING:
In the USA, do not connect to an electrical outlet controlled by a wall switch, since this increases
the risk of AC power loss to the monitoring system.
Caution:
The monitoring system must be connected to an appropriate power source.
Caution:
If the integrity of the AC power source is in doubt, ensure the monitoring system internal battery
is fully charged.
3.4.1 Connecting to Power
The monitoring system operates on AC power or on a charged internal battery. Prior to
connecting to power, perform a safety check of the equipment. Reference Periodic Safety Checks,
p. 7-3.
Setup
To connect the AC power cable:
1. Ensure the AC outlet is properly grounded and supplies the specified voltage and frequency (100-
2. Connect the female connector end of the AC power cord to the AC power connector on the
3. Plug the male connector end of the AC power cord into a properly grounded AC outlet.
4. If necessary, connect grounding wire.
5. Ensure the Battery Charge Indicator lights.
Note:
Even if the monitoring system is not turned on, the Battery Charge Indicator lights when the AC power
cord is connected into a mains outlet. Reference Troubleshooting, p. 8-1, if the battery charging indicator
does not light when connected to power.
To troubleshoot an unlit Battery Charge Indicator:
1. Check the power cord.
240V~ 50-60 Hz).
monitoring system's rear panel.
• Connect the grounding wire connector to the rear panel’s equipotential terminal.
• Attach the clip end of the grounding wire to the grounding terminal on the wall.
2. Check the AC power inlet.
Operator’s Manual 3-3
Installation
3. Check the power/ mains outlet.
4. Ensure the internal battery is properly installed and charged.
5. Contact a qualified service technician or a local supplier for assistance.
3.4.2 Using the Internal Battery
WARNING:
The amount of time between the low battery alarm and power off becomes shorter as the battery
accumulates charge/discharge cycles.
Note:
Remove the battery if the monitoring system is not likely to be used for six (6) months.
Note:
Covidien strongly recommends fully recharging the battery whenever the time between recharges
exceeds six (6) months.
Note:
The monitoring system may not operate if the battery charge is critically low.
Note:
Covidien strongly recommends keeping the monitoring system connected to AC power during
continuous operation or to recharge the internal battery.
Note:
Recharging the battery over a period of time may shorten the time between the low battery alarm and power
off. Have a qualified service technician periodically check the internal battery or replace it if necessary.
The monitoring system has an internal battery that powers the monitoring system when AC
power is not available. The monitoring system cannot operate with a fully discharged battery. A
lit battery status icon indicates the monitoring system is running on battery power.
Prior to using the internal battery, perform a safety check of the equipment. Reference Periodic
Safety Checks, p. 7-3.
A new, fully charged optional battery will provide its optimal number of operational hours under
these normal conditions:
• Operating in Normal mode (Measuring SpO
and PR with plethysmograph display)
2
• Setting for pulse beep indicator is ON (pulse volume:4 (Default))
3-4 Operator’s Manual
•
• Experiencing no alarm condition
• Operating at ambient temperature of 25°C (±5°C)
Note:
Two types of battery are available: the standard 5- hour and optional 10-hour.
Note:
Even if the monitoring system is turned off, the Battery Charge Indicator remains lit while the battery
recharges.
Note:
A full charge of a depleted battery takes more than four (4) hours for a 5-hour battery or eight (8) hours for
a 10-hour battery.
Plug the monitoring system into an AC outlet to charge the battery for a minimum of three (3) minutes
prior to turning on any monitoring system with a completely discharged battery. When operating on
internal battery, the monitoring system battery status icon indicates the battery charge condition.
Setup
Setting for SatSeconds™ is ON
To charge the internal battery:
1. Connect the monitoring system to AC power to charge a low or depleted battery. Reference
Connecting to Power, p. 3-3.
2. Verify the Battery Charge Indicator lights.
3.4.3 Connecting a Nellcor™ Pulse Oximetry Sensor
WARNING:
Incorrect application or use of an SpO
too tightly, apply supplemental tape, or leave a sensor too long on one place. Inspect the sensor
site as directed in the Instructions for Use to ensure skin integrity, correct positioning, and adhesion
of the sensor.
sensor can cause tissue damage. Do not wrap the sensor
2
WARNING:
Do not use any other cables to extend the length of the Covidien-approved interface cable.
Increasing the length will degrade signal quality and may lead to inaccurate measurements.
WARNING:
Use only the Covidien-approved pulse oximetry sensor and interface cables. Use of another cable
can have an adverse effect on performance. Do not attach any cable intended for computer use to
the sensor port.
Operator’s Manual 3-5
Installation
WARNING:
Failure to cover the applied pulse oximetry sensor with opaque material while operating under
high ambient light conditions may result in inaccurate measurements.
Caution:
For best product performance and measurement accuracy, use only accessories supplied or
recommended by Covidien. Use accessories according to the Instructions for Use. Use only
accessories that have passed the recommended biocompatibility testing in compliance with
ISO10993-1.
Prior to connecting a sensor, perform a safety check of the equipment. Reference Periodic Safety
Checks, p. 7-3. Reference Nellcor™ Pulse Oximetry Sensors, p. 9-1, for details regarding sensor
selection.
To fully connect a Nellcor™ pulse oximetry sensor:
1.
Select an appropriate compatible Nellcor™ pulse oximetry sensor for the patient and desired application. When
selecting a sensor, consider the patient's weight and activity, adequacy of perfusion, availability of sensor sites,
need for sterility, and anticipated duration of monitoring.
2. Carefully apply the sensor to the patient after reading the Instructions for Use accompanying the sensor.
3. Connect the interface cable to the sensor port on the front of the panel and firmly connect the
A Sensor Message occurs when the device cannot obtain an SpO2 level or a pulse rate.
Note:
If the sensor is not connected firmly, the monitoring system could lose signal from patient.
Note:
Physiological conditions, medical procedures, or external agents that may interfere with the monitoring
system’s ability to detect and display measurements include dysfunctional hemoglobin, arterial dyes, low
perfusion, dark pigment, and externally applied coloring agents, such as nail polish, dye, or pigmented
cream.
Observe all warnings and cautions in the Instructions for Use.
interface cable to the pulse oximetry sensor. When the monitoring system detects a valid pulse, it
enters monitoring mode and displays real-time patient data.
Figure3-1.Connecting a Pulse Oximetry Sensor to Interface Cable
3-6 Operator’s Manual
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