Covidien Nellcor User manual

Operator’s Manual
Nellcor
Bedside SpO2Patient Monitoring System
TM

© 2012 Covidien. COVIDIEN, COVIDIEN with logo, Covidien logo and Nellcor™ are U.S. and/
or internationally registered trademarks of Covidien llc.
This document contains proprietary information that is protected by copyright. All rights
reserved. Reproduction, adaptation, or translation without prior written permission is prohib-
ited, except as allowed under the copyright laws.

iii
1 Introduction
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2.1 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.2.3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1.3 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . .6
1.3.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.3.2 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.4 Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.5 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
2 Product Overview
2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
2.4 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
2.4.1 Front Panel and Display Components . . . . . . . . . . . . . . . . . . .11
2.4.2 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
2.4.3 Product and Carton Label Symbols . . . . . . . . . . . . . . . . . . . . .16
3 Installation
3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
3.3 Unpacking and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . .18
3.4 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
3.4.1 Connecting to Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
3.4.2 Using the Internal Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
3.4.3 Connecting a Nellcor™ Pulse Oximetry Sensor . . . . . . . . . . . .22
4 Operation
4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
4.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
4.3 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
4.3.1 Turning on the Monitoring System . . . . . . . . . . . . . . . . . . . . .26
4.3.2 Turning off the Monitoring System . . . . . . . . . . . . . . . . . . . . .27
4.4 Menu Options Navigation . . . . . . . . . . . . . . . . . . . . . . . . . .28
Table of Contents

iv
4.4.1 Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
4.4.2 QUICK ACCESS Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
4.4.3 OPTIONS Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
4.4.4 ALARM/LIMITS Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
4.4.5 PATIENT MODE Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
4.4.6 SpO2WAVEFORM Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
4.5 Managing Alarms and Alarm Limits . . . . . . . . . . . . . . . . . .40
4.5.1 Audible Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
4.5.2 Visual Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
4.6 Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
4.7 Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
5 Data Management
5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
5.2 Tabular Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
5.3 Graphical Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
5.4 External Data Communication . . . . . . . . . . . . . . . . . . . . . .47
5.4.1 Nurse Call Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
5.4.2 Trend Data Download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
5.4.3 Firmware Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
6 Performance Considerations
6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
6.2 Oximetry Considerations . . . . . . . . . . . . . . . . . . . . . . . . . .63
6.2.1 Pulse Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
6.2.2 Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
6.3 Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . .64
6.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
6.3.2 Patient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
6.3.3 Sensor Performance Considerations . . . . . . . . . . . . . . . . . . . .65
6.3.4 Reducing EMI (Electromagnetic Interference) . . . . . . . . . . . . .67
6.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . .68
7 Preventive Maintenance
7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
7.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
7.3 Recycling and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
7.4 Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70

v
7.5 Periodic Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
7.6 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
8 Troubleshooting
8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
8.2 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
8.3 Error Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
8.4 Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
9 Accessories
9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
9.2 Nellcor™ Pulse Oximetry Sensors . . . . . . . . . . . . . . . . . . .77
9.3 Optional Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
9.4 Biocompatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . .80
10 Theory of Operations
10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
10.2 Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
10.3 Automatic Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
10.4 Functional Testers and Patient Simulators . . . . . . . . . . . .82
10.5 Unique Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
10.5.1 Functional versus Fractional Saturation . . . . . . . . . . . . . . . . . .83
10.5.2 Measured versus Calculated Saturation . . . . . . . . . . . . . . . . . .84
10.5.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
10.5.4 Data Update Period, Data Averaging, and Signal Processing . .84
10.6 SatSeconds™ Alarm Management Feature . . . . . . . . . . . .85
10.6.1 First SpO2Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
10.6.2 Second SpO2Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
10.6.3 Third SpO2Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
10.6.4 The SatSeconds Safety Net . . . . . . . . . . . . . . . . . . . . . . . . . . .89
11 Product Specifications
11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
11.2 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
11.3 Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
11.4 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . .92
11.5 Tone Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

vi
11.6 Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . .94
11.7 Sound Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
11.8 Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
11.9 Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . .96
11.9.1 BasicsElectromagnetic Compatibility (EMC) . . . . . . . . . . . . . . .96
11.9.2 Sensor and Cable Compliance . . . . . . . . . . . . . . . . . . . . . . .100
11.9.3 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
A Clinical Studies
A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
A.2 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
A.3 Study Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
A.4 Study Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
A.5 Adverse Events or Deviations . . . . . . . . . . . . . . . . . . . . . .105
A.6 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106

vii
Table 1-1. Safety Symbol Definitions ..................................................................................1
Table 2-1. Display Colors ......................................................................................................14
Table 2-2. Symbol Descriptors ........................................................................................... 16
Table 3-1. Standard Items .................................................................................................... 19
Table 4-1. Menu structure and available options ....................................................... 29
Table 4-2. Alarm Conditions ............................................................................................... 40
Table 4-3. Audio Status ......................................................................................................... 42
Table 4-4. Parameter Ranges and Factory Defaults .................................................. 43
Table 5-1. Operating Status Codes ................................................................................... 54
Table 8-1. Common Problems and Resolutions .......................................................... 74
Table 9-1. Nellcor™ Pulse Oximetry Sensor Models and Patient Sizes ................ 78
Table 11-1. Transport, Storage, and Operating Condition Ranges ........................ 92
Table 11-2. Tone Definitions ................................................................................................ 93
Table 11-3. Trends ................................................................................................................... 94
Table 11-4. Pulse Oximetry Sensor Accuracy and Ranges ........................................ 95
Table 11-5. Sound Pressure in Decibels ........................................................................... 95
Table 11-6. Electromagnetic Emissions Guidelines ..................................................... 97
Table 11-7. Electromagnetic Immunity Guidelines ..................................................... 98
Table 11-8. Recommended Separation Distances ....................................................... 99
Table 11-9. Cables and Sensors ........................................................................................100
Table 11-10. Earth and Enclosure Leakage Current Specifications ......................101
Table 11-11. Patient Applied and Patient Isolation Risk Current ..........................102
Table A-1. Demographic Data ..........................................................................................104
Table A-2. SpO2Accuracy for Nellcor™ Sensors vs. CO-oximeters ......................104
List of Tables

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ix
Figure2-1. Front and Side Panel Components .................................................. 11
Figure2-2. Display Components ............................................................................ 12
Figure2-3. Rear Panel Components ...................................................................... 15
Figure3-1. Connecting a Pulse Oximetry Sensor to Interface Cable .......... 23
Figure4-1. Sample Initial Screen ............................................................................. 27
Figure4-2. Save Change Screen .............................................................................. 28
Figure4-3. QUICK ACCESS SpO2Menu with Audio Alarm Selected ........... 30
Figure4-4. QUICK ACCESS PR Menu with Alarm Audio OFF ......................... 31
Figure4-5. Volume Selection .................................................................................... 32
Figure4-6. Volume Selection .................................................................................... 33
Figure4-7. Response Mode Menu .......................................................................... 34
Figure4-8. Delete All Trend Data Menu Item ..................................................... 35
Figure4-9. Alarm/Limits Menu Options ................................................................ 37
Figure4-10. Patient Mode Menu ............................................................................... 38
Figure4-11. Highlighting the Waveform Display Area ...................................... 39
Figure4-12. SpO2Waveform Menu ........................................................................... 39
Figure5-1. Tabular Trend Data Screen .................................................................. 45
Figure5-2. Graphical Trend Data Screen .............................................................. 47
Figure5-3. Nurse Call Interface Pin Layout .......................................................... 49
Figure5-4. Trend Data Download Option ............................................................ 51
Figure5-5. Trend Data Download Status ............................................................. 52
Figure5-6. Sample Trend Data Printout ............................................................... 55
Figure5-7. Sample Bridge Driver Installer window .......................................... 57
Figure5-8. Sample New Hardware Wizard Screen ............................................ 57
Figure5-9. Sample DEVICE MANAGER button under hardware tab .......... 59
Figure5-10. Sample Hardware list in Device Manager window ..................... 60
Figure5-11. Sample Initial USB to UART Bridge Properties Window ............ 61
Figure5-12. Sample Baud rate list under Port Settings tab ............................. 62
Figure10-1. Oxyhemoglobin Dissociation Curve ................................................ 84
Figure10-2. Series of SpO2Events ............................................................................. 85
Figure10-3. First SpO2Event: No SatSeconds Alarm .......................................... 86
Figure10-4. Second SpO2Event: No SatSeconds Alarm ................................... 87
Figure10-5. Third SpO2Event: Triggers SatSeconds Alarm ............................. 88
FigureA-1. Modified Bland-Altman Plot ............................................................105
List of Figures

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x

1
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 Directions 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 SpO2
Patient 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
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 touch signal input, signal output or other connectors, and the patient
simultaneously.
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.

Safety Information
Operator’s Manual 3
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.
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 measured values of the monitoring system can be affected by patient
conditions, excessive patient movement, sensors, environmental conditions,
and nearby electromagnetic external 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. Pulse
oximetry readings and pulse signals can be affected by certain environmental
conditions, pulse oximetry sensor application errors, and certain patient
conditions. 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.

Introduction
4 Operator’s Manual
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.
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 Standard 60950-1 for data-processing
equipment. All combinations of equipment must be in compliance with IEC
Standard 60601-1:2005 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 Standard 60601-1:2005 and IEC
Standard 60601-1-2:2007.

Safety Information
Operator’s Manual 5
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 directions for use and institutional standards. Use only
accessories that have passed the recommended biocompatibility testing in
compliance with ISO10993-1.
The use of accessories, sensors, and cables other than those specified may
result in inaccurate readings of the monitoring system and increased emission
and/or decreased electromagnetic immunity of the monitoring system.
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.

Introduction
6 Operator’s Manual
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 troubleshoot-
ing errors or malfunctions. Before using the monitoring system, thoroughly read the
this manual.
Nellcor™ Pulse Oximetry Sensor Directions 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 Directions 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 — Pro-
vides information to qualified service technicians for use when servicing the mon-
itoring system.
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

Revision History
Operator’s Manual 7
1.4 Revision History
The documentation part number and revision number indicate its current edi-
tion. The revision number changes when Covidien prints a new edition. Minor
corrections and updates incorporated at reprint do not cause a change in the
revision number. Extensive changes may require a new document part number.
1.5 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 fur-
nishing, performance, or use of this material.

Introduction
8 Operator’s Manual
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9
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 (SpO2) — Functional measure of oxygenat-
ed 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 rep-
resents 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
10 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 con-
tinuous non-invasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate. The Nellcor™ Bedside SpO2Patient Moni-
toring System is intended for prescription use only with neonatal, pediatric,
and adult patients, and for patients who are well or poorly perfused, in hospi-
tals, 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 hospi-
tal, 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 hos-
pital-type facility.