Coviden Nellcor Series User manual

Operator’s Manual
Nellcor
Bedside SpO2Patient Monitoring System
TM

© 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.

Operator’s Manual i
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

ii Operator’s Manual
4.4.4 ALARM/LIMITS Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10
4.4.5 PATIENT MODE Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12
4.4.6 SpO
2
WAVEFORM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13
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

Operator’s Manual iii
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
2
Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-5
10.6.2 Second SpO
2
Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6
10.6.3 Third SpO
2
Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
10.6.4 The SatSeconds™ Safety Net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
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

iv Operator’s Manual
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

Operator’s Manual v
List of Tables
Table1-1.Safety Symbol Definitions...............................................................................1-1
Table2-1.Display Colors......................................................................................................2-6
Table2-2.Symbol Descriptors ...........................................................................................2-7
Table3-1.Standard Items....................................................................................................3-2
Table4-1.Menu Structure and Available Options......................................................4-5
Table4-2.Alarm Conditions ............................................................................................ 4-15
Table4-3.Audio Status...................................................................................................... 4-16
Table4-4. Parameter Ranges and Factory Defaults ............................................... 4-17
Table5-1.Nurse Call Relay Pins States for NORMALLY + .........................................5-5
Table5-2.Nurse Call Relay Pins States for NORMALLY –..........................................5-5
Table5-3.Operating Status Codes...................................................................................5-9
Table8-1.Common Problems and Resolutions ..........................................................8-2
Table9-1.Nellcor™ Pulse Oximetry Sensor Models and Patient Sizes ................9-2
Table11-1.Transport, Storage, and Operating Condition Ranges.................... 11-2
Table11-2.Tone Definitions............................................................................................ 11-3
Table11-3.Trends ............................................................................................................... 11-4
Table11-4.Pulse Oximetry Sensor Accuracy and Ranges .................................... 11-5
Table11-5.Sound Pressure in Decibels....................................................................... 11-5
Table11-6.Electromagnetic Emissions Guidelines................................................. 11-7
Table11-7.Electromagnetic Immunity Guidelines ................................................. 11-8
Table11-8.Recommended Separation Distances................................................... 11-9
Table11-9.Test Specifications for Enclosure Port Immunity to RF
Wireless Communications Equipment..................................................11-10
Table11-10.Cables and Sensors..................................................................................11-11
Table11-11.Earth Leakage and Touch Current......................................................11-12
Table11-12.Patient Leakage Current ........................................................................11-13
TableA-1.Demographic Data........................................................................................... A-2
TableA-2.SpO2Accuracy for Nellcor™ Sensors vs. CO-oximeters....................... A-2

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vi Operator’s Manual

Operator’s Manual vii
List of Figures
Figure2-1. Front and Side Panel Components ......................................................................... 2-3
Figure2-2. Display Components.................................................................................................... 2-4
Figure2-3. Rear Panel Components ............................................................................................. 2-7
Figure3-1.Connecting a Pulse Oximetry Sensor to Interface Cable ................................. 3-6
Figure4-1.Sample Initial Screen..................................................................................................... 4-3
Figure4-2.Save Change Screen...................................................................................................... 4-4
Figure4-3.QUICK ACCESS SpO2Menu with Audio Alarm Selected .................................. 4-6
Figure4-4.QUICK ACCESS PR Menu with Alarm Audio OFF................................................. 4-6
Figure4-5.Volume Selection............................................................................................................ 4-8
Figure4-6.Volume Selection............................................................................................................ 4-8
Figure4-7.Response Mode Menu.................................................................................................. 4-9
Figure4-8.Delete All Trend Data Menu Item ...........................................................................4-10
Figure4-9.Alarm/Limits Menu Options .....................................................................................4-11
Figure4-10.Patient Mode Menu...................................................................................................4-12
Figure4-11.Highlighting the Waveform Display Area .........................................................4-13
Figure4-12.SpO2Waveform Menu .............................................................................................4-13
Figure5-1.Tabular Trend Data Screen.......................................................................................... 5-1
Figure5-2.Graphical Trend Data Screen...................................................................................... 5-2
Figure5-3.Nurse Call Interface Pin Layout.................................................................................. 5-4
Figure5-4.Trend Data Download Option ................................................................................... 5-7
Figure5-5.Trend Data Download Status..................................................................................... 5-8
Figure5-6.Sample Trend Data Printout.....................................................................................5-10
Figure5-7.Sample Bridge Driver Installer Window ...............................................................5-11
Figure5-8.Sample New Hardware Wizard Screen .................................................................5-12
Figure5-9.Sample DEVICE MANAGER Button Under Hardware Tab ..............................5-13
Figure5-10.Sample Hardware List in Device Manager Window ......................................5-14
Figure5-11.Sample Initial USB to UART Bridge Properties Window...............................5-15
Figure5-12.Sample Baud Rate List Under Port Settings Tab.............................................5-16
Figure10-1.Oxyhemoglobin Dissociation Curve ...................................................................10-4
Figure10-2.Series of SpO2Events................................................................................................10-5
Figure10-3.First SpO2Event: No SatSeconds™ Alarm..........................................................10-6
Figure10-4.Second SpO2Event: No SatSeconds™ Alarm ...................................................10-7
Figure10-5.Third SpO2Event: Triggers SatSeconds™ Alarm .............................................10-8
FigureA-1.Modified Bland-Altman Plot.......................................................................................A-3

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viii Operator’s Manual

1-1
1 Introduction
1.1 Overview
This manual contains information for operating the Nellcor™ bedside SpO2patient 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 SpO2patient monitoring system. Other important safety information appears
throughout the manual. The Nellcor™ bedside SpO2patient monitoring system will be referred
to as the “monitoring system” throughout this manual.
1.2.1 Safety Symbols
Table1-1.Safety Symbol Definitions
Symbol Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.
Caution
Identifies conditions or practices that could result in damage to the equipment or
other property.
Note
Notes provide additional guidelines or information.

Introduction
1-2 Operator’s Manual
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.

Safety Information
Operator’s Manual 1-3
WARNING:
The monitoring system is intended only as an adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.
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.
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.

Introduction
1-4 Operator’s Manual
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.

Obtaining Technical Assistance
Operator’s Manual 1-5
1.3 Obtaining Technical Assistance
1.3.1 Technical Services
For technical information and assistance, contact Covidien or a local Covidien representative.
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 SpO2Patient 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 SpO2saturation
accuracy measurements. Available online at www.covidien.com.
Nellcor™ Bedside SpO2Patient Monitoring System Service Manual — Provides information to
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.
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

Introduction
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1-6 Operator’s Manual

2-1
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 SpO2patient 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 (SpO2) — Functional measure of oxygenated hemoglobin
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 SpO2patient monitoring system provides continuous, noninvasive
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

Product Overview
2-2 Operator’s Manual
2.3 Indications for Use
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 SpO2Patient Monitoring System is indicated for the continuous non-
invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
The Nellcor™ Bedside SpO2Patient 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.

Product Views
Operator’s Manual 2-3
2.4 Product Views
2.4.1 Front Panel and Display Components
Front and Side Panels
Figure2-1. Front and Side Panel Components
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 SpO2connector Use to connect to the interface cable and SpO2sensor.

Product Overview
2-4 Operator’s Manual
Display
Figure2-2. Display Components
1 Upper and lower alarm limits Reflects upper and lower SpO2and pulse rate alarm limits. An
alarm sounds each time patient saturation or pulse rate values
violate these alarm limits.
2 SpO2real-time value Indicates hemoglobin oxygen saturation levels. Current upper
and lower alarm limit settings appear as smaller values to the
left of the dynamic SpO2value.
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 SpO2limit violations. When the SatSeconds™ feature is
enabled, the SatSeconds™ icon fills in the clockwise direction as
the SatSeconds™ alarm management system detects SpO2
readings outside of the limits setting. The SatSeconds™ icon
empties in the counterclockwise direction when SpO2readings
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
Audio OFF icon
The yellow icon indicates Alarm Silenced. This indicator also
shows the time remaining in the alarm silence period.
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.