Operator’s Manual

Nellcor
TM

Bedside SpO2 Patient Monitoring System

© 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.
Table of Contents
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

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 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
SpO2 WAVEFORM Menu
4.4.6 . . . . . . . . . . . . . . . . . . . . . . . . . . . .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

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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 SpO2 Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
10.6.2 Second SpO2 Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
10.6.3 Third SpO2 Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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

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 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

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List of Tables
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. SpO2 Accuracy for Nellcor™ Sensors vs. CO-oximeters ......................104

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viii
List of Figures
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 SpO2 Menu 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.   SpO2 Waveform 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 SpO2 Events ............................................................................. 85
Figure 10-3.   First SpO2 Event: No SatSeconds Alarm .......................................... 86
Figure 10-4.   Second SpO2 Event: No SatSeconds Alarm ................................... 87
Figure 10-5.   Third SpO2 Event: Triggers SatSeconds Alarm ............................. 88
Figure A-1.   Modified Bland-Altman Plot ............................................................105

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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 SpO2 Patient 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.

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 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.

2 Operator’s Manual
 Safety Information

 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.

Operator’s Manual 3
Introduction

 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.

4 Operator’s Manual
 Safety Information

 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.

Operator’s Manual 5
Introduction

1.3 Obtaining Technical Assistance

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 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

SpO2 saturation accuracy measurements. Available online at www.covidien.com.

Nellcor™ Bedside SpO2 Patient Monitoring System Service Manual — Pro-

vides information to qualified service technicians for use when servicing the mon-
itoring system.

6 Operator’s Manual
 Revision History

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.

Operator’s Manual 7
Introduction

Page Left Intentionally Blank

8 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 (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 SpO2 Patient Monitoring System provides continuous,
noninvasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate.

9
Product Overview

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 SpO2 Patient 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 SpO2 Patient 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.

10 Operator’s Manual
 Product Views

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 Alarm Audio Paused Press to toggle between disabling and re-enabling the
button audible alarm. Reference Menu Options Navigation, p.
4-28.

2 Return button Press to exit a menu displayed on the screen and go to

the main screen. Reference Menu Options Navigation,
p. 4-28.

3 Power On/Off button Press and hold to turn on or off the monitoring
system, using AC power or Lithium-ion batteries. Ref-
erence Menu Options Navigation, p. 4-28.

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 of display and monitoring

system functions.

7 LCD display panel Use to monitor all graphic and numeric patient infor-
mation as well as status conditions and warning mes-
sages.

8 SpO2 connector Use to connect to the interface cable and SpO2 sensor.

Operator’s Manual 11
Product Overview

Display

Figure 2-2.   Display Components

1 Upper and lower alarm limits Reflects upper and lower SpO2 and pulse rate alarm limits.
An alarm sounds each time patient saturation or pulse rate
values violate these alarm limits.

2 SpO2 real-time value Indicates hemoglobin oxygen saturation levels. Current

upper and lower alarm limit settings appear as smaller
values to the left of the dynamic SpO2 value.

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 SpO2 limit 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 Sat-
Seconds icon empties in the counterclockwise direction
when SpO2 readings are within limits. When the SatSec-
onds icon reaches full, a medium priority alarm sounds. The
adult default setting is 100. Reference SatSeconds™ Alarm
Management Feature, p. 10-85.

6 Alarm active icon Appears, along with an alarm message, when patient
values violate an alarm limit threshold. Audible and visual
alarms occur. Reference Alarm limits menu area, p. 2-14,
for additional alarm icons.

12 Operator’s Manual
 Product Views

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.

8 Battery status icon Displays the battery charge remaining on an internal 5- or

10-hour battery.
• Charged Battery — A steady green battery icon indi-
cates 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 pause
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 intermit-
tently light as the monitoring system dynamically adjusts
the amount of data required for measuring SpO2 and pulse
rate. When lit continuously, the monitoring system has
extended the amount of data required for measuring SpO2
and pulse rate. In this case, fidelity in tracking rapid changes
in these values may be reduced.1

12 Sensor off indicator Appears when the sensor is not on the patient.

13 Sensor disconnect indicator Appears when the sensor is not connected to the monitor-
ing system.

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.

Operator’s Manual 13
Product Overview

16 Alarm limits menu area Reflects the current audible alarm status.
• Alarm Audio Paused — Visible in the alarm limits
menu area when the audible alarm is paused for a
period of time.

• Alarm Audio Off — Visible in the alarm limits menu

area when the audible alarm is disabled.

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 Informative message area Contains messages to notify the user of a condition or a

request for action.

19 Plethysmographic (pleth) This non-normalized waveform uses real-time sensor sig-

waveform nals, reflecting relative pulsatile strength of incoming sig-
nals.

1. Degradation can be caused by ambient light, poor sensor placement, electrical noise, electrosurgical interference, patient activity, or
other causes.

Table 2-1.  Display Colors

Color Condition Function

Cyan numeric SpO2 value and plethysmographic waveform

Yellow numeric Steady Pulse rate value

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

14 Operator’s Manual
 Product Views

2.4.2 Rear Panel

Figure 2-3.   Rear Panel Components

1 Equipotential terminal 3 Battery cover

2 Nurse call port 4 AC power connector

Operator’s Manual 15
Product Overview

2.4.3 Product and Carton Label Symbols

Table 2-2.  Symbol Descriptors

Symbol Description Symbol Description

Type BF Data port

Equipotentiality Date of manufacture

Prescription only device Keep dry

Attention, consult accompanying

Fragile
documents

Atmospheric pressure limitations UL listed

Humidity limitations CE Mark

Temperature limitations Manufacturer

This side up EU representative

Must consult instructions for use Consult instructions for use

Proper waste disposal for electrical

Protection against fluid ingress
and electronic equipment

16 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. 11-91.

 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.

17
Installation

 WARNING:
Use only the Nellcor™ pulse oximetry interface cable with the monitoring
system. Use of another interface cable will adversely affect performance.

 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. 1-6.

 Note:
A qualified service technician should verify the performance of the monitoring system
following the procedures outlined in the Nellcor™ Bedside SpO2 Patient Monitoring
System Service Manual prior to initial installation in a clinical setting.

18 Operator’s Manual
 Setup

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.

 Note:
Contact Covidien Technical Services for pricing and ordering information.

Table 3-1.  Standard Items

Item Quantity

Nellcor™ Bedside SpO2 Patient Monitoring System 1

Nellcor™ pulse oximetry interface cable 1

Compact Disc (CD) and/or Operator's Manual 1 1

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 SpO2 Patient Monitoring System
Operator’s Manual at no cost or a printed Nellcor™ Bedside SpO2 Patient Monitoring System
Service Manual for a fee from Covidien Technical Services or a local Covidien representative.

3.4 Setup

 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.

Operator’s Manual 19
Installation

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. Refer-
ence Periodic Safety Checks, p. 7-72.
To connect the AC power cable:
1. Ensure the AC outlet is properly grounded and supplies the specified voltage and
frequency (100-240V~ 50-60 Hz).

2. Connect the female connector end of the AC power cord to the AC power con-
nector on the monitoring system's rear panel.

3. Plug the male connector end of the AC power cord into a properly grounded AC
outlet.

4. If necessary, connect grounding wire.

• 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.

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. 8-73, if the battery charging indicator does not light when
connected to power.
To troubleshoot an unlit Battery Charge Indicator:
1. Check the power cord.

2. Check the AC power inlet.

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.

20 Operator’s Manual
 Setup

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. 7-72.
A new, fully charged optional battery will provide its optimal number of oper-
ational hours under these normal conditions:
• Operating in Normal mode (Measuring SpO2 and PR with plethysmograph display)

• Setting for pulse beep indicator is ON (pulse volume:4 (Default))

Operator’s Manual 21
Installation

• Setting for SatSeconds is ON

• 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.
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. 3-20.

2. Verify the Battery Charge Indicator lights.

3.4.3 Connecting a Nellcor™ Pulse Oximetry Sensor

 WARNING:
Incorrect application or use of an SpO2 sensor can cause tissue damage. Do
not wrap the sensor too tightly, apply supplemental tape, or leave a sensor
too long on one place. Inspect the sensor site as directed in the Directions for
Use to ensure skin integrity, correct positioning, and adhesion of the sensor.

 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.

22 Operator’s Manual
 Setup

 WARNING:
Use only the Covidien-approved pulse oximetry sensor and interface cables.
Use of another cables can have an adverse effect on performance. Do not
attach any cable intended for computer use to the sensor port.

 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
Directions 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. Refer-
ence Periodic Safety Checks, p. 7-72. Reference Nellcor™ Pulse Oximetry Sen-
sors, p. 9-77, for details regarding sensor selection.
To fully connect an 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 dura-
tion of monitoring.

2. Carefully apply the sensor to the patient after reading the Directions for Use
accompanying the sensor. Observe all warnings and cautions in the Directions for
Use.

3. Connect the interface cable to the sensor port on the front of the panel and firmly
connect the 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.

Figure 3-1.  Connecting a Pulse Oximetry Sensor to Interface Cable

Operator’s Manual 23
Installation

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.

24 Operator’s Manual
4 Operation

4.1 Overview
This chapter identifies methods for viewing and collecting patient oxygen sat-
uration data using the Nellcor™ Bedside SpO2 Patient Monitoring System.
Before operating the monitoring system, thoroughly read this manual.

4.2 Safety Reminders

 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:
Tissue damage can be caused by incorrect application or use of a pulse
oximetry sensor. Do not wrap the pulse oximetry sensor too tightly, apply
supplemental tape, or leave it too long on one place. Inspect the pulse
oximetry sensor site as directed in the Directions for Use to ensure skin
integrity, correct positioning, and adhesion.

 WARNING:
Keep patients under close surveillance when monitoring. It is possible,
although unlikely, that radiated electromagnetic signals from sources
external to the patient and the monitoring system can cause inaccurate
measurement readings. Do not rely entirely on the monitoring system's
readings for patient assessment.This device has been tested and found to
comply with the limits for medical devices related to IEC 60601-1-2: 2007.
These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.

 WARNING:
For best product performance and measurement accuracy, use only
accessories supplied or recommended by Covidien. Use accessories according
to their respective Directions for Use.

25
Operation

 WARNING:
Do not use damaged pulse oximetry sensors. Do not use with exposed optical
components. Do not immerse completely in water, solvents, or cleaning
solutions, since pulse oximetry sensors and connectors are not waterproof.
Do not sterilize by irradiation, steam or ethylene oxide. Refer to the cleaning
instructions in the Directions for Use for reusable sensors.

 Caution:
Do not attach any cable intended for computer use to the sensor port
connector.

 Caution:
The sensor disconnect error message and associated alarm indicate the pulse
oximetry sensor is either disconnected or has faulty wiring. Check the
connection and, if necessary, replace it, the pulse oximetry cable, or both.

4.3 User Interface

4.3.1 Turning on the Monitoring System

 WARNING:
Ensure the speaker is clear of any obstruction. Failure to do so may result in
an inaudible tone.

 Caution:
If any indicator or display element does not light, or the speaker does not sound,
do not use the monitoring system. Instead, contact a qualified service technician.
Before using the monitoring system in a clinical setting, ensure the monitoring
system is working properly and is safe to use.
When the monitoring system completes power-on self-test (POST), a POST pass tone
sounds. This functions as an audible confirmation of proper speaker performance. If the
speaker does not function, the alarm warning sounds remain inaudible.

 Note:
Pressing any button should result in either a valid or an invalid tone. If a button press
fails to emit a tone, contact a qualified service technician.

26 Operator’s Manual
 User Interface

To power on the monitoring system:

1. Press the Power On/Off Button for more than one (1) second.

2. Ensure the software version, the SpO2 alarm indicator, and the pulse rate alarm
indicator light for approximately two (2) seconds.

Figure 4-1.  Sample Initial Screen

3. Ensure the POST pass tone sounds when POST completes.

 Note:
Do not use the monitoring system should a repeating, high-pitched alarm tone occur at
power on. Instead, please contact Technical Services or a qualified service technician.

4.3.2 Turning off the Monitoring System

After using the monitoring system, turn it off safely.

To turn off the monitoring system:
1. Press the Power On/Off button on the right of the device for approximately one second.

2. Observe the message System is shutting down on the screen.

 Note:
Press the Power On/Off button for at least 15 seconds to turn off the monitoring
system after any situation involving continuous resets or a system lock.

Operator’s Manual 27
Operation

4.4 Menu Options Navigation

Navigating menu options on the monitoring system requires manual manipu-
lation of the three buttons and the jog dial.
Press the desired interface button.
1. Power On/Off button — Press and hold this blue button to power on or to
power off the monitoring system. This button illuminates at power on and
remains lit until power off.

2. Return button — Press this green button for less than two (2) seconds to exit
menu items and return to the main monitoring screen. This button illuminates at
power on and remains lit until power off.

3. Alarm Audio Paused button — Press this orange button for less than two (2)
seconds to disable or re-enable audible alarms. This button illuminates at power
on and remains lit until power off.

Rotate or press the jog dial to navigate among various portions of the screen
and to select menu items.

 Note:
If a user presses and holds the RETURN button while accessing a menu item, but before
saving any changes, the monitoring system requires the user to confirm a cancellation
of all pending changes. A user prompt appears and the user must either save all pending
changes (save new value) or cancel all pending changes (return to previous value) before
taking any other action.

Figure 4-2.  Save Change Screen

28 Operator’s Manual
 Menu Options Navigation

1. Navigation — Rotate the jog dial clockwise or counter-clockwise until a colored

highlight surrounds the desired area. Any rotation of the jog dial either navigates
or changes the desired option setting.

2. Selection — Press the jog dial to select that desired area, then continue rotating
the jog dial until highlighting the desired menu option, then press again.

The LCD display panel also users with easy-to-read numeric values for patient
oxygen saturation and pulse rate in cyan and yellow, respectively. Reference
Table 2-1.   on page 2-14.

4.4.1 Menu Structure

Table 4-1.  Menu structure and available options

Item Available Selections Default

QUICK ACCESS ALARM LIMITS Menus

SpO2 Menu SatSeconds™ alarm management setting (Off, 10, 25, 50, 100) 100

Upper (21-100) SpO2 alarm limit Depends on

Lower (20-99) SpO2 alarm limit patient
Alarm Inhibition for SpO2 alarms mode. Ref-
erence
PULSE RATE (PR) Menu Upper (30-245) pulse rate alarm limit Table 4-4.  
Lower (25-240) pulse rate alarm limit on page 43
Alarm Inhibition for pulse rate alarms

OPTIONS Menu

VOLUME Alarm Volume (1-8) 5

Key Beep Volume (Off, 1-7) 4

Pulse Volume (Off, 1-7) 4

MODE (Response Mode) Normal, Fast Normal

TREND DATA DOWNLOAD Start (Cancel or Return), Return --

DELETE ALL TREND DATA No, Yes --

SERVICE MENU (For qualified service technicians only) --

ALARM/LIMITS Menu

SpO2 LIMITS options Upper (21-100) SpO2 alarm limit Depends on

Lower (20-99) SpO2 alarm limit patient
Alarm Inhibition for SpO2 alarms mode. Ref-
PULSE RATE LIMITS options Upper (30-245) pulse rate alarm limit erence
Lower (25-240) pulse rate alarm limit Table 4-4.  
Alarm Inhibition for pulse rate alarms on page 43.

Operator’s Manual 29
Operation

Table 4-1.  Menu structure and available options (Continued)

Item Available Selections Default

SATSECONDS option SatSeconds™ alarm management setting 100

(Off, 10, 25, 50, 100)

PATIENT MODE Menu

ADULT option Sets Alarm Limits to standard default thresholds for adult
patients
Reference
PEDIATRIC option Sets Alarm Limits to standard default thresholds for pediatric
Table 4-4.  
patients
on page 43.
NEONATE option Sets Alarm Limits to standard default thresholds for neonate
patients

SpO2 WAVEFORM Menu

SWEEP SPEED option 6.25 mm/s, 12.5 mm/s, 25.0 mm/s 25.0 mm/s

TABULAR TREND option Tabular trend view of trend data

--
GRAPHICAL TREND option Graphical trend view of trend data

4.4.2 QUICK ACCESS Menus

For quick access to alarm limit settings, use the menu options listed here.
1. SpO2 Menu — Provides access to SpO2 alarm limit settings, alarm inhibition, and
SatSeconds alarm management option. Reference ALARM/LIMITS Menu, p. 4-35,
for basic information. The adult default setting for the SatSeconds alarm manage-
ment option is 100. Other options include OFF, 10, 25, and 50. Reference SatSec-
onds™ Alarm Management Feature, p. 10-85.

Figure 4-3.  QUICK ACCESS SpO2 Menu with Audio Alarm Selected

30 Operator’s Manual
 Menu Options Navigation

2. PR Menu — Provides access to pulse rate (PR) alarm limit settings and alarm inhi-
bition. Reference ALARM/LIMITS Menu, p. 4-35.

Figure 4-4.  QUICK ACCESS PR Menu with Alarm Audio OFF

To select alarm limit settings via Quick Access menus:

1. Rotate the jog dial until the white highlight appears over the SpO2 or the pulse
rate (PR) real-time value field.

2. Press the jog dial.

3. Rotate the jog dial until reaching the desired field.

• Available SpO2 alarm limit thresholds

– SatSeconds™ alarm management values include OFF, 10, 25, 50, 100. The default
value is 100. Reference SatSeconds™ Alarm Management Feature, p. 10-85.

– Upper and lower SpO2 alarm limit thresholds

– SpO2 alarm inhibition to disable audible alarms for SpO2 limit violations

• Pulse Rate alarm limits

– Upper and lower pulse rate alarm limit thresholds

– Pulse rate alarm inhibition to disable audible alarms for pulse rate limit vio-
lations

4. Press the jog dial to select the field.

Operator’s Manual 31
Operation

5. Rotate the jog dial to change the field.

6. Exit the menu using either of the listed strategies.

• Rotate the jog dial to highlight the Return option and press the jog dial.

• Press the Return button until the LCD returns to its original screen.

4.4.3 OPTIONS Menu

Caregivers may choose from Volume, Mode, or Trend Data menu options.
To access the OPTIONS Menu:
1. Rotate the jog dial to highlight the OPTIONS Menu icon.

2. Press the jog dial to access the OPTIONS Menu.

Volume

Access this menu option to adjust volume controls.

To set the desired audible tone volume:
1. Access the OPTIONS Menu.

2. Rotate the jog dial to highlight VOLUME.

Figure 4-5.  Volume Selection

3. Press the jog dial to access Alarm Volume, Key Beep Volume, or Pulse Volume.

32 Operator’s Manual
 Menu Options Navigation

• Alarm Volume controls the volume (1-8) of alarms.

• Key Beep Volume controls the volume (0ff, 1-7) of any button press.

• Pulse Volume controls the volume (0ff, 1-7) of the plethysmographic waveform.

4. Rotate the jog dial to select the desired volume level.

5. Press the jog dial to save the desired volume level.

Figure 4-6.  Volume Selection

Mode (Response Mode)

The response mode (Normal or Fast) establishes the rate at which the monitor-
ing system responds to changes in the SpO2 data.The calculation of pulse rate
and the recording of trend data are not affected. The response mode setting
does not affect the algorithm’s calculation of pulse rate, nor does it influence
the recording of trend data which occurs at one-second intervals. The default
setting is the Normal Response Mode.
To set response mode:
1. Access the OPTIONS Menu.

2. Rotate the jog dial to highlight MODE.

3. Press the jog dial to select Normal or Fast response mode.

• Normal response mode — Responds to changes in blood oxygen saturation

within five (5) to seven (7) seconds.

Operator’s Manual 33
Operation

• Fast response mode — Responds to changes in blood oxygen saturation

within two (2) to four (4) seconds. This mode can be particularly helpful for
situations that require close monitoring.

Figure 4-7.  Response Mode Menu

 Note:
When in the Fast Response Mode, the monitoring system may produce more SpO2
and pulse rate alarms than expected.

Trend Data Download

Access this menu option to download patient trend data. Reference Trend
Data Download, p. 5-49.

Delete All Trend Data

Access this menu option to delete all patient trend data from memory.
To delete all trend data:
1. Access the OPTIONS Menu.

2. Rotate the jog dial to highlight DELETE ALL TREND DATA.

34 Operator’s Manual
 Menu Options Navigation

Figure 4-8.  Delete All Trend Data Menu Item

3. At the prompt “Are you sure you want to delete all trend data?” choose one of
the following options.

• Press the jog dial to select NO and keep all trend data.

• Rotate the jog dial to select YES, then press to delete all trend data.

• Rotate the jog dial to select RETURN, then press to access the OPTIONS menu.

Service Menu

Only a qualified service technician may change Service Menu settings. A pass
code is required for access. Refer to the Service Manual for instructions.

4.4.4 ALARM/LIMITS Menu

 WARNING:
Do not pause the audible alarm or decrease its volume if patient safety could
be compromised.

 WARNING:
Check alarm limits to ensure they are appropriate for the patient being
monitored with each use. Ensure alarm limits do not exceed the standard
thresholds set by the institution.

Operator’s Manual 35
Operation

 WARNING:
Do not preset different alarm limits for the same or similar equipment within
a single area.

Caregivers may choose to adjust SpO2 and pulse rate (PR) alarm thresholds
from default values as necessary. These changes remain in effect until modified
again or until a power cycle occurs. Changes to the SpO2 and pulse rate (PR)
alarm thresholds appear in their respective numerical area. In addition, caregiv-
ers may choose to use the SatSeconds™ alarm option to manage the frequen-
cy of SpO2 alarm limit violations by adjusting the SatSeconds™ setting. The
higher the value, the less frequent the alarm.
SpO2 numerical area — Indicates hemoglobin oxygen saturation levels. The
display value flashes zeros during loss-of-pulse alarms and flashes the SpO2 value
on a yellow background when saturation is outside the alarm limits. During pulse
searches, the monitoring system continues to update the display. Current upper
and lower alarm limit settings appear as smaller values to the left of the dynamic
SpO2 value. Reference Factory Defaults, p. 4-43, for default alarm limit settings.

Pulse Rate (PR) numerical area — Displays the pulse rate in beats per minute
(bpm). The display value flashes zeros during loss-of-pulse alarms and flashes the
pulse rate value on a yellow background when the pulse rate is outside of the
alarm limits. During Pulse Search, the monitoring system continues to update the
display. Pulse rates outside of the pulse rate range of 20 to 250 bpm are displayed
as 0 and 250, respectively. Current upper and lower alarm limit settings appear as
smaller values to the left of the dynamic pulse rate value. Reference Factory
Defaults, p. 4-43, for default alarm limit settings.

To set alarm limits:

1. Rotate the jog dial to highlight the ALARM LIMITS icon.

2. Press the jog dial to display the ALARM/LIMITS Menu.

• Alarm Limits include pulse rate (PR) and SpO2 alarm limit ranges.

• The SatSeconds™ Alarm option provides alarm management of SpO2 alarm

limit violations.

• The alarm inhibit icon provides caregivers with the option of inhibiting the
alarm for SpO2 and/or pulse rate alarms.

3. Rotate the jog dial to highlight the desired option.

4. Press the jog dial to select the desired option.

36 Operator’s Manual
 Menu Options Navigation

Figure 4-9.  Alarm/Limits Menu Options

5. Rotate the jog dial to change the desired option value. Reference Menu Structure, p.
4-29, for adult, pediatric, and neonate limit options.

• Available SpO2 alarm limit thresholds

– Upper and lower SpO2 alarm limit thresholds

– SpO2 alarm inhibition to disable audible alarms for SpO2 limit violations

• Pulse Rate alarm limits

– Upper and lower pulse rate alarm limit thresholds

– Pulse rate alarm inhibition to disable audible alarms for pulse rate limit violations

• SatSeconds™ alarm management values include OFF, 10, 25, 50, 100. The
default value is 100. Reference SatSeconds™ Alarm Management Feature, p.
10-85.

6. Press the jog dial to save the desired value.

7. Rotate the jog dial to highlight another desired option or to RETURN to the OPTIONS
menu.

4.4.5 PATIENT MODE Menu

Access this menu option to select the desired PATIENT MODE: Adult, Pediatric
or Neonatal.

Operator’s Manual 37
Operation

To set patient mode:

1. Rotate the jog dial to highlight the Patient Mode icon.

2. Press the jog dial to display PATIENT MODE.

Figure 4-10.  Patient Mode Menu

3. Rotate the jog dial to highlight the desired mode option: Adult, Pediatric or Neo-
natal. Use the appropriate patient mode and pulse oximetry sensor based on body
weight. Reference the pulse oximetry sensor Directions for Use.

Adult: Use for adults.

Pediatric: Use for children.
Neonatal: Use for newborns.
4. Press the jog dial to save the desired mode.

5. Press the RETURN button to exit PATIENT MODE.

4.4.6 SpO2 WAVEFORM Menu

Caregivers may choose to set sweep speed of the plethysmographic waveform

and opt to view the tabular or graphical trend screen.
To access the WAVEFORM Menu:
1. Rotate the jog dial to highlight the waveform display area.

38 Operator’s Manual
 Menu Options Navigation

Figure 4-11.  Highlighting the Waveform Display Area

2. Press the jog dial to display the SpO2 WAVEFORM Menu.

Figure 4-12.  SpO2 Waveform Menu

• Sweep Speed — Access to set the speed at which the SpO2 waveform trace
moves across the screen. The higher the sweep speed value, the more data
appears on the screen. Sweep Speed options are 6.25 mm/s, 12.5 mm/s and
25.0 mm/s.

• Tabular Trend — Access to display the tabular trend view. Reference Tabular
Trend Data, p. 5-45.

• Graphical Trend — Access to display the graphical trend view. Reference

Graphical Trend Data, p. 5-46.

Operator’s Manual 39
Operation

4.5 Managing Alarms and Alarm Limits

 WARNING:
Do not pause the audible alarm or decrease its volume if patient safety could
be compromised.

 WARNING:
Check alarm limits to ensure they are appropriate for each patient being
monitored with each use. Ensure alarm limits do not exceed the standard
thresholds set by the institution.

 WARNING:
Ensure the speaker is clear of any obstruction. Failure to do so could result
inaudible alarm tone.
When the monitoring system detects certain conditions that require user
attention, the monitoring system enters an alarm state.
The monitoring system uses both visual and audible indicators to identify high-
priority, medium-priority, and low-priority alarms. Audible alarms include
pitched tones, beeps, and a buzzing tone. High priority alarms take precedence
over medium- and low-priority alarms. Reference Troubleshooting, p. 8-73.

Table 4-2.  Alarm Conditions

Priority Rate Color Messages

High Sounds every 4 s Red SpO2 Loss of Pulse

Steady message,
Fast flashing numeric Critically Low-Battery condition

Medium Sounds every 8 s Yellow High Pulse Rate limits violated

Steady message,
Slow flashing numeric Low Pulse Rate limits violated

High SpO2 limits violated

Low SpO2 limits violated

Low Steady yellow SpO2 Cable/Sensor Disconnect

Sounds every 16 s
SpO2 Sensor Off

Low Battery

Technical System Error: EEE 001

40 Operator’s Manual
 Managing Alarms and Alarm Limits

Table 4-2.  Alarm Conditions (Continued)

Priority Rate Color Messages

Informative -- -- SpO2 Pulse search

Signal Artifact Detected

Abnormally shut down last time

Alarm audio OFF, Alarm audio paused

Press Return Button to Exit...

 Note:
The audible and visual alarms on the monitoring system, used in conjunction with
clinical signs and symptoms, are the primary source for notifying medical personnel
that a patient alarm condition exists.

 Note:
If the monitoring system fails to perform as specified, contact Covidien Technical
Services, a qualified service technician, or a local supplier for assistance.

4.5.1 Audible Alarm Indicators

 WARNING:
Do not pause the audible alarm or decrease its volume if patient safety could
be compromised.

Audible alarm indicators include pitched tones and beeps. Caregivers may
choose to pause the audible alarm for the established Alarm Audio Paused
period of 30, 60, 90 or 120 seconds. Visual alarms continue during this time.
The factory default for audible alarm silence period is 60 seconds. To set one
of the listed alternate periods as an institutional default, have a qualified
service technician set the desired period via the SERVICE Menu.

 Note:
Alarm delays should not exceed 10 seconds other than as specified in this manual.

Operator’s Manual 41
Operation

Table 4-3.  Audio Status

Alarm Icon Status

Alarm active

Alarm audio paused

Alarm audio OFF

To pause an audible alarm:

1. Press the Alarm Audio Paused button to immediately pause the alarm tone. The
alarm resumes after the Alarm Audio Paused period, if the alarm condition
remains.

2. Take the appropriate corrective action.

 Note:
Press the Alarm Audio Paused button to cancel audible alarms caused by technical
errors. Audible alarms for battery failure and physiological alarms cannot be canceled
without appropriate corrective action.
To re-enable the audio tones during the Alarm Audio Paused period, press
the Alarm Audio Paused button again. If another alarm occurs during the
Alarm Audio Paused period, the monitoring system re-enables all audio
tones.
To pause an audible alarm:
1. Press the Alarm Audio Paused button.

2. To cancel, press the Alarm Audio Paused button again.

If the Alarm Audio Paused period is enabled, the audible alarm is not active
for the specified time interval and the Alarm Audio Paused icon appears
above the appropriate alarm limit icon.

 Note:
To disable limit violation alarms, use the Alarm Limits menus. Reference ALARM/
LIMITS Menu, p. 4-35.

42 Operator’s Manual
 Factory Defaults

4.5.2 Visual Alarm Indicators

Visual alarms appear on the screen in order of highest priority, regardless of

any audible alarm status. Reference Table 4-2.   on page 4-40.

4.6 Factory Defaults

The monitoring system ships with factory default settings. To set different insti-
tutional default settings, contact a qualified service technician.

Table 4-4.   Parameter Ranges and Factory Defaults

Parameter Ranges/Selection Factory Default

Adult Pediatric Neonatal

SpO2

%SpO2 Upper Alarm Limit 21 to 100% (1% steps) 100% 95%

%SpO2 Lower Alarm Limit 20 to 99% (1% steps) 90% 85%

%SpO2 Limit Alarm Inhibition On, Off Off

SatSeconds™ Alarm Off, 10, 25, 50, 100 100

Pulse Rate

Pulse Rate Upper Alarm Limit 30 to 245 bpm (5 bpm steps) 170 bpm 200 bpm

Pulse Rate Lower Alarm Limit 25 to 240 bpm (5 bpm steps) 50 bpm 75 bpm 100 bpm

PR Limit Alarm Inhibition On, Off Off

Tabular Trends

Scroll 1, 5, 100, 500 1

Graphical Trends

SpO2 On, Off On

PR On, Off On

Others

Patient Mode Adult, Pediatric, Neonatal Adult

Alarm Volume 1, 2, 3, 4, 5, 6, 7, 8 5

Key Beep Volume Off, 1, 2, 3, 4, 5, 6, 7 4

Pulse Volume Off, 1, 2, 3, 4, 5, 6, 7 4

Operator’s Manual 43
Operation

Table 4-4.   Parameter Ranges and Factory Defaults (Continued)

Parameter Ranges/Selection Factory Default

Adult Pediatric Neonatal

Date/Time Settings1 yy/mm/dd, mm/dd/yy, dd/mm/yy yy/mm/dd

Alarm Audio Paused1 30, 60, 90, 120 s 60 s

Alarm Audio Reminder1 OFF, 3, 10 min 3 min

Mode (Response Mode) Normal, Fast Normal

Trend Data Download Baud Rates: 19200, 38400, 57600, 19200 bps
Settings1 115200 bps

Protocol: ASCII 1, ASCII 2 ASCII 1

Sweep Speed 6.25, 12.5, 25.0 mm/s 25.0 mm/s

Power On Settings1 Factory default, Last Settings, Institu- Last Settings

tional Defaults

Language1 Chinese, Czech, Danish, Dutch, Eng- English

lish, Finnish, French, German, Greek,
Italian, Japanese, Korean, Norwe-
gian, Polish, Portuguese, Russian,
Slovakian, Spanish, Swedish, Turkish
1. To alter this parameter, a qualified service technician must access the Service Menu, as described in the Service Manual.

4.7 Maintenance Reminder

Schedule regular maintenance and safety checks with a qualified service tech-
nician every 24 months. Reference Periodic Safety Checks, p. 7-72. In the case
of mechanical or functional damage, contact Covidien or a local Covidien rep-
resentative. Reference Obtaining Technical Assistance, p. 1-6.

44 Operator’s Manual
5 Data Management

5.1 Overview
This chapter contains information for accessing patient trend data obtained
using the Nellcor™ Bedside SpO2 Patient Monitoring System. Trend data can
be viewed anytime patient trend is stored in the monitoring system.
The monitoring system stores up to 96 hours of trend data. When the moni-
toring system begins measuring vital signs, it saves data every four (4) seconds.
It also saves all physiological alarm conditions and errors. Trend data history
remains in memory even if the monitoring system is powered off. The moni-
toring system stores new data over the oldest data when the buffer is full.

5.2 Tabular Trend Data

The monitoring system presents trend information in tabular format for all
monitored parameters when users enable this option. The newest data values
appear at the top.

Figure 5-1.  Tabular Trend Data Screen

45
Data Management

To select Tabular Trend:

1. Rotate the jog dial to highlight the waveform area.

2. Press the jog dial to display the SpO2 WAVEFORM Menu.

3. Select Tabular Trend.

To scroll through Tabular Trend Data:

1. Rotate the jog dial to scroll through the trend data.

• Clockwise rotation moves forward to newer data.

• Counterclockwise rotation moves backward to older data.

2. Press the jog dial again to adjust the scroll granularity. Larger values scroll through
more data faster.

 Note:
To scroll most efficiently, adjust the scroll granularity more than once. For
instance, use the +/-500 to scroll quickly to the desired time stamp, then press the
jog dial again to reach the +/-1 to scroll through each individual event in that time
period.

3. After reviewing trend data, press the RETURN button to exit the tabular trend
view.

5.3 Graphical Trend Data

The monitoring system presents trend information in a single graph for all
monitored parameters when users enable this option. The vertical range of a
graphical trend appears as a fixed value. The horizontal range is 24 minutes.
The newest data values appear to the right.
To select Graphical Trend:
1. Rotate the jog dial to highlight the waveform area.

2. Press the jog dial to display the SpO2 Waveform Menu.

3. Select Graphical Trend.

46 Operator’s Manual
 External Data Communication

Figure 5-2.  Graphical Trend Data Screen

To scroll through Graphical Trend Data:

1. Rotate the jog dial to highlight Scroll.

2. Press the jog dial to activate scrolling.

3. Rotate the jog dial to scroll through the trend data.

• Clockwise rotation moves forward to newer data.

• Counterclockwise rotation moves backward to older data.

4. After reviewing trend data, press the RETURN button to exit the graphical trend
view.

5.4 External Data Communication

 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 may result in unsafe leakage current and grounding
conditions.
The monitoring system provides external connectors on the right and rear
panels to support data communication.
• Nurse call interface (RJ11) — Allows caregivers to remotely monitor patient
alarms via the nurse call system of the institution.

Operator’s Manual 47
Data Management

• USB interface — Enables firmware upgrades. Reference the Service Manual.

• Mini USB interface — Enables trend data downloads and connection to a per-
sonal computer (PC).

5.4.1 Nurse Call Interface

 WARNING:
Do not use the nurse call feature as the primary source of alarm notification.
The audible and visual alarms of the monitoring system, used in conjunction
with clinical signs and symptoms, are the primary sources for notifying
medical personnel that an alarm condition exists.

 WARNING:
The nurse call feature does not function with Alarm Audio Paused.

 Caution:
Test the nurse call function prior to use, especially when setting up the
monitoring system in a new location. One way to test the nurse call function
is to create an alarm condition (for example, sensor disconnect) and verify the
nurse call system properly activates.

 Note:
Communication (Nurse Call Interface) is limited to inside a single institution.
The nurse call feature of the monitoring system works in conjunction with the
nurse call system of the institution when the monitoring system sounds an
audible alarm. It is operational regardless of whether the monitoring system
uses AC power or battery power, as long as a proper connection between the
nurse call port and the host system exists.

48 Operator’s Manual
 External Data Communication

Figure 5-3.  Nurse Call Interface Pin Layout

1 Nurse call normally closed

2 Nurse call common lead

3 Nurse call normally open

The nurse call feature utilizes a relay closure to signal the nurse station during
alarm conditions. Pins 2 and 3 provide a relay that closes during alarm condi-
tions. Pins 1 and 2 provide a relay that opens during alarm conditions. Pin 2 is
a common lead for both relays.
To connect the nurse call cable:
1. Grasp the RJ11 end of the cable.

2. Firmly insert into the nurse call port.

3. Attach the alternate end of the cable into the host system.

5.4.2 Trend Data Download

 Caution:
Anyone who connects a PC to the data output port configures a medical
system and is therefore responsible for ensuring that the system complies
with the requirements of IEC Standard 60601-1-1 and the electromagnetic
compatibility IEC Standard 60601-1-2.

Operator’s Manual 49
Data Management

 Caution:
Signal artifacts, secondary to a variety of external factors, may compromise
the presence or accuracy of the displayed values.

Connect the mini-USB port to a PC for downloading trend data. Any PC con-
nected to the data port must be certified according to IEC Standard 60950. All
combinations of equipment must be in compliance with IEC Standard 60601-
1-1 system requirements. Use either ASCII communication protocol.
• Nellcor™ ASCII protocol (ASCII 1)

• ASCII format compatible with several spreadsheet programs (ASCII 2)

 Note:
Users may choose to import patient trend data to a spreadsheet program. To do so,
users must export trend data using the ASCII 2 format option. Have a qualified service
technician set this option prior to attempting a data download.

System Compatibility Prerequisites

• Windows Vista/XP/Server 2003/2000

• Pentium 100 MHz CPU

• 256 MB RAM

• HyperTerminal or equivalent software

Hardware
• Mini-USB data download cable

• CD, if USB driver required

The COM port on the side of the monitoring system provides access to collect-
ed trend data. Data transfer relies on existing communication software drivers
for USB-based devices already on the computer, so should not require any
modification of the drivers used by the USB interface. If, for some reason, the
computer does not have the correct USB driver, use the device driver provided
on the product CD or from Technical Services. Reference COM port USB Driver
Alternatives, p. 5-56.

50 Operator’s Manual
 External Data Communication

 Note:
Any trend data download relies on either factory default settings or institutional
default settings established by a qualified service technician prior to usage. This
includes baud rate and communication protocol selection.
To download trend data
1. Power on the monitoring system by pressing the button.

2. Rotate the jog dial to highlight the OPTIONS Menu icon.

3. Press the jog dial to access the OPTIONS Menu.

4. Rotate the jog dial to select the TREND DATA DOWNLOAD submenu option.

Figure 5-4.  Trend Data Download Option

5. Press the jog dial to access the TREND DATA DOWNLOAD Menu.

6. Connect a mini-USB cable from the monitoring system to the computer.

a. Grasp the mini-USB end of the cable.

b. Firmly insert into the bottom mini-USB data port.
c. Firmly insert the USB end of the cable into a USB port on the host system.
7. Ensure the computer properly identifies the monitoring system. If it does not, follow
the procedure for loading the appropriate driver. Reference To install a USB driver
from the compact disc, p. 5-56.

8. Launch HyperTerminal. Reference p. 5-52.

Operator’s Manual 51
Data Management

9. Press the jog dial again, since the item highlighted is the START option.The status
bar indicating total percentage of the download appears and the START option,
immediately changes to a CANCEL option.

 Note:
Users may choose to cancel the download operation at any point in the download
process by selecting CANCEL and then RETURN.

Figure 5-5.  Trend Data Download Status

10. Confirm the monitoring system is sending trend data to a personal computer (PC)
by observing the computer screen for a scrolling trend data record. If no trend
data values appear, check connectivity and ensure the personal computer con-
tains HyperTerminal software. If this is all operational, verify patient trend data
history exists on the monitoring system. Contact Technical Services or a qualified
service technician for assistance.

11. Wait for the OUTPUT COMPLETE message to indicate the download is complete.

12. Save patient trend data to the personal computer disk or to an alternate source,
depending on institutional requirements.

To launch HyperTerminal
1. Click the START menu in the main task bar.

2. Mouse over the PROGRAMS submenu, then ACCESSORIES, then COMMUNICA-

TIONS, then the HYPERTERMINAL option.

52 Operator’s Manual
 External Data Communication

 Note:
If this is the first time the HyperTerminal program launches, it will prompt the user
to set it as the default Telnet program. Depending on institutional requirements,
users may choose YES or NO.

3. Click the HYPERTERMINAL option.

4. When the Connect Description window opens, type in the desired file name in the
Name field.

5. Locate the proper icon by scrolling all the way to the far right of the icon field.

6. Select the icon.

7. Click the OK button.

 Note:
If the personal computer is not connected via the USB to mini-USB cable to the
monitoring system, the proper COM port option will not appear in the list.

8. When the Connect To window opens, find the CONNECT USING option and click
the down arrow to identify possible modem options.

9. Select the desired COM port.

10. Click the OK button.

11. In the COM PROPERTIES window, set the appropriate values.

a. Set the baud rate (bits per second) to match the monitoring system. The
factory default baud rate is 19200 bits per second (bps).
b. Ensure the data bit is set to 8.
c. Ensure the parity bit is set to none.
d. Ensure the stop bit is set to 1.
e. Ensure the flow control is set to none.
12. Click the OK button.

 Note:
To test for trend data download connectivity, proceed with the download by
pressing the START option. If no data values appear in HyperTerminal, try a

Operator’s Manual 53
Data Management

different COM port, select the FILE menu, click NEW CONNECTION, and select a
different COM port until data values scroll across the HyperTerminal screen.

To interpret downloaded trend data:

1. Examine trend data on the HyperTerminal screen, in a spreadsheet, or on a print-
out from the personal computer.

Table 5-1.  Operating Status Codes

Code Definition Code Definition

AO Alarm off PH Pulse rate upper limit alarm

AS Alarm silence PL Pulse rate lower limit alarm

BU Battery in use PS Pulse search

LB Low battery SD Sensor disconnect

LM Loss of pulse with signal artifact SH Saturation rate upper limit alarm

LP Loss of pulse SL Saturation rate lower limit alarm

ID Signal artifact detected SO Sensor off

MO Signal artifact

54 Operator’s Manual
 External Data Communication

Figure 5-6.  Sample Trend Data Printout

1 Product column headings Data source, firmware version, and system settings

2 Patient data column headings Lists appropriate time and data headings

3 Time column Real-time clock date and time stamp

4 Output Complete Message indicating completion of trend data download

5 %SpO2 Current saturation value

6 PR Current pulse rate

7 PA Current pulse ampltitude

8 Status Operating status of the monitoring system

2. Ensure patient data settings coincide with expected settings. This would include
the version of firmware and its CRC code, which should be all zeros; the current
method of viewing the data: waveform, trend, or graph; alarm limit settings;
patient mode; and SatSeconds setting.

3. Scan the time, SpO2, or PR column until reaching the events of interest.

4. Match the operating status codes to the following table for pertinent system infor-
mation. Reference Operating Status Codes, p. 5-54.

Operator’s Manual 55
Data Management

COM port USB Driver Alternatives

• Load the appropriate driver from the product CD into the connected computer.

• Contact Technical Services or a local Covidien representative.

 Note:
The following graphics are representative of the screens users may encounter while
installing a USB driver from the compact disc. Individual operating system languages
may vary.
To install a USB driver from the compact disc
1. Insert the Nellcor™ Bedside SpO2 Patient Monitoring System compact disc (CD)
into the designated personal computer (PC).

2. Copy the COVIDIEN USB to UART Bridge Driver zip file to the PC, installing it in
the desired program folder.

3. Right-click on the zipped folder.

4. Select EXTRACT ALL.

5. Open the extracted folder.

6. Launch the Driver Installer executable.

 Note:
To change the location of the driver, select the desired mapping by clicking
CHANGE INSTALL LOCATION.

7. Click INSTALL.

56 Operator’s Manual
 External Data Communication

Figure 5-7.  Sample Bridge Driver Installer window

8. Reboot the PC for changes to take effect.

9. Connect the monitoring system to the PC, firmly engaging the USB end to the PC
and the mini-USB to the monitoring system.

10. Allow the PC to sense the new hardware and load the InstallShield Wizard, which
guides users through the entire setup process. Do not click the CANCEL button.

Figure 5-8.  Sample New Hardware Wizard Screen

11. At the prompt from the InstallShield Wizard, click on the NEXT button to copy the
driver to the PC.

Operator’s Manual 57
Data Management

12. When the InstallShield Wizard provides the end-user license agreement, read it
carefully, then click the button for accepting the terms of the license.

13. Click NEXT to formally accept the agreement.

14. Review the Destination Folder mapping. To change the destination, click BROWSE
and select the desired mapping.

15. Click NEXT to formally accept the Destination Folder mapping.

16. Click INSTALL in the resulting driver installer window. Do not click the CANCEL
button

 Note:
If Windows Security pops up, select the option to install the driver anyway.

17. Click the OK button to complete the installation in the resulting Success window.

18. Reboot the PC for changes to take effect.

19. From the START menu, click the Settings menu option and select the Control
Panel option.

20. Select the System option to open the System Properties window.

21. Click the Hardware tab, then the DEVICE MANAGER button.

58 Operator’s Manual
 External Data Communication

Figure 5-9.  Sample DEVICE MANAGER button under hardware tab

22. Select the Ports option from the resulting list.

Operator’s Manual 59
Data Management

Figure 5-10.  Sample Hardware list in Device Manager window

23. Double click the Silicon Labs CP210x USB to UART Bridge option.

 Note:
The listed COM port should match the HyperTerminal COM port designation.
Reference To launch HyperTerminal, p. 5-52.

60 Operator’s Manual
 External Data Communication

Figure 5-11.  Sample Initial USB to UART Bridge Properties Window

24. Click the Port Settings tab.

25. Set the bits per second to one of four possible baud rates: 19200, 38400, 57600,
or 115200. The factory default is 19200 bps.

Operator’s Manual 61
Data Management

Figure 5-12.  Sample Baud rate list under Port Settings tab

26. Click the OK button to complete the process.

27. Reference To download trend data, p. 5-51, and proceed to step 8, utilizing
HyperTerminal to connect to the monitoring system.

5.4.3 Firmware Upgrades

Contact a qualified service technician to perform any firmware upgrade to the

monitoring system, as described in the Service Manual.

62 Operator’s Manual
6 Performance Considerations

6.1 Overview
This chapter contains information about optimizing the performance of the
Nellcor™ Bedside SpO2 Patient Monitoring System.
Verify the performance of the monitoring system by following the procedures
outlined in the Service Manual. Have a qualified service technician perform
these procedures prior to initial installation in a clinical setting.

6.2 Oximetry Considerations

 WARNING:
Pulse oximetry readings and pulse signals can be affected by certain ambient
environmental conditions, pulse oximetry sensor application errors, and
certain patient conditions.

6.2.1 Pulse Rates

The monitoring system only reports pulse rates between 20 and 250 bpm.
Detected pulse rates above 250 bpm appear as 250. Detected pulse rates
below 20 appear as a zero (0).

6.2.2 Saturation

The monitoring system reports saturation levels between 1% and 100%.

63
Performance Considerations

6.3 Performance Considerations

6.3.1 Overview

This section contains information for optimizing the performance of the moni-
toring system.
Verify the performance of the monitoring system by following the procedures
outlined in the SRC-MAX Pulse Oximetry Functional Tester Technical Manual.
Have a qualified service technician perform these procedures prior to initial
installation in a clinical setting and every 24 months as part of preventive main-
tenance. Reference Service, p. 7-72.

6.3.2 Patient Conditions

Application issues and certain patient conditions can affect the measurements
of the monitoring system and cause the loss of the pulse signal.
• Anemia — Anemia causes decreased arterial oxygen content. Although SpO2
readings may appear normal, an anemic patient may be hypoxic. Correcting
anemia can improve arterial oxygen content. The monitoring system may fail to
provide an SpO2 reading if hemoglobin levels fall below 5 gm/dl.

• Dysfunctional hemoglobins — Dysfunctional hemoglobins such as carboxyhemo-

globin, methemoglobin, and sulphemoglobin are unable to carry oxygen. SpO2
readings may appear normal; however, a patient may be hypoxic because less
hemoglobin is available to carry oxygen. Further assessment beyond pulse oxime-
try is recommended.

• Additional possible patient conditions may also influence measurements.

1. Poor peripheral perfusion

2. Excessive patient activity

3. Venous pulsations

4. Dark skin pigment

5. Intravascular dyes, such as indocyanine green or methylene blue

6. Externally applied coloring agents (nail polish, dye, pigmented cream)

7. Defibrillation

64 Operator’s Manual
 Performance Considerations

6.3.3 Sensor Performance Considerations

 WARNING:
Pulse oximetry readings and pulse signal can be affected by certain ambient
conditions, sensor application errors, and certain patient conditions.

 WARNING:
Tissue damage can be caused by incorrect application or inappropriate
duration of use of a pulse oximetry sensor. Inspect the sensor site as directed
in the Directions for Use.

 WARNING:
Use only Covidien-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, since this may lead to
adverse results.

 WARNING:
Failure to cover the pulse oximetry sensor site with opaque material in high
ambient light conditions may result in inaccurate measurements.

Inaccurate Sensor Measurement Conditions

A variety of conditions can cause inaccurate Nellcor™ pulse oximetry sensor

measurements.
• Incorrect application of the pulse oximetry sensor
• Placement of the pulse oximetry sensor on an extremity with a blood pressure cuff,
arterial catheter, or intravascular line

• Ambient light

• Failure to cover the pulse oximetry sensor site with opaque material in high ambient
light conditions

• Excessive patient activity

• Dark skin pigment

• Intravascular dyes or externally applied coloring, such as nail polish or pigmented

cream

Operator’s Manual 65
Performance Considerations

Signal Loss

Loss-of-pulse signal can occur for several reasons.

• Pulse oximetry sensor applied too tightly

• Inflation of a blood pressure cuff on the same extremity as the attached pulse
oximetry sensor

• Arterial occlusion proximal to the pulse oximetry sensor

• Poor peripheral perfusion

Recommended Usage

Select an appropriate Nellcor™ pulse oximetry sensor, apply it as directed, and

observe all warnings and cautions presented in the Directions for Use accom-
panying the sensor. Clean and remove any substances such as nail polish from
the application site. Periodically check to ensure that the sensor remains prop-
erly positioned on the patient.
High ambient light sources such as surgical lights (especially those with a xenon
light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and
direct sunlight can interfere with the performance of a Nellcor™ pulse oxime-
try sensor. To prevent interference from ambient light, ensure that the sensor
is properly applied, and cover the sensor site with opaque material.
If patient activity presents a problem, try one or more of the following remedies to
correct the problem.
• Verify the Nellcor™ pulse oximetry sensor is properly and securely applied.

• Move the sensor to a less active site.

• Use an adhesive sensor that improves patient skin contact.

• Use a new sensor with fresh adhesive backing.

• Keep the patient still, if possible.

If poor perfusion affects performance, consider using the Nellcor™ forehead

SpO2 sensor (Max-Fast), which provides superior detection in the presence of
vasoconstriction. Nellcor™ forehead SpO2 sensors work particularly well on
supine patients and mechanically ventilated patients. During low perfusion
conditions, Nellcor™ forehead SpO2 sensors reflect changes to SpO2 values up
to 60 seconds earlier than digit sensors.

66 Operator’s Manual
 Performance Considerations

6.3.4 Reducing EMI (Electromagnetic Interference)

 WARNING:
Keep patients under close surveillance when monitoring. It is possible,
although unlikely, that radiated electromagnetic signals from sources
external to the patient and the monitoring system can cause inaccurate
measurement readings.

 WARNING:
Any radio frequency transmitting equipment or other nearby sources of
electrical noise may result in disruption of the monitoring system.

 WARNING:
Large equipment using a switching relay for its power on/off may affect
monitoring system operation. Do not operate the monitoring system in such
environments.

 WARNING:
The monitoring system is designed for use in environments in which the
signal can be obscured by electromagnetic interference. During such
interference, measurements may seem inappropriate or the monitoring
system may not seem to operate correctly.

 Caution:
This device has been tested and found to comply with the limits for medical
devices related to IEC 60601-1-2: 2007. These limits are designed to provide
reasonable protection against harmful interference in a typical medical
installation.
Because of the proliferation of radio frequency transmitting equipment and
other sources of electrical noise in health care environments (for example, elec-
trosurgical units, cellular phones, mobile two-way radios, electrical appliances,
and high-definition television), it is possible that high levels of such interfer-
ence due to close proximity or strength of a source may result in disruption of
monitoring system performance.
Disruption may be evidenced by erratic readings, cessation of operation, or
other incorrect functioning. If this occurs, survey the site of use to determine
the source of this disruption, then take the appropriate actions to eliminate the
source.

Operator’s Manual 67
Performance Considerations

• Turn equipment in the vicinity off and on to isolate the offending equipment.

• Reorient or relocate the interfering equipment.

• Increase the separation between the interfering equipment and the monitoring
system.

• Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.

The monitoring system generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with these instructions,
may cause harmful interference with other susceptible devices in the vicinity.
Contact Technical Services for assistance.

6.4 Obtaining Technical Assistance

For technical information and assistance, contact Technical Services or a qual-
ified service technician. Reference Obtaining Technical Assistance, p. 1-6.

68 Operator’s Manual
7 Preventive Maintenance

7.1 Overview
This chapter describes the steps required to maintain, service, and properly
clean the Nellcor™ Bedside SpO2 Patient Monitoring System.

7.2 Cleaning

 WARNING:
Do not spray, pour, or spill any liquid on the monitoring system, its
accessories, connectors, switches, or openings in the chassis.

 WARNING:
Remove batteries from the monitoring system before cleaning.
For surface cleaning and disinfection of the monitoring system, follow institu-
tional procedures or the recommended actions below.
• Surface cleaning — Surface clean the monitoring system by using a soft cloth
dampened with a commercial, nonabrasive cleaner. Lightly wipe the top, bottom,
and front surfaces of the monitoring system lightly.

• Disinfection — Use a soft cloth saturated with a solution of 10% chlorine bleach
in tap water, lightly wiping the surface of the monitoring system.

For sensors, follow cleaning instructions in the directions for use shipped with
those components. Before attempting to clean a Nellcor™ pulse oximetry
sensor, read the Directions for Use enclosed with the sensor. Each sensor
model has cleaning instructions specific to that sensor. Follow the pulse oxim-
etry sensor cleaning and disinfecting procedures in the particular sensor's
Directions for Use.
Avoid spilling liquid on the monitoring system, especially in connector areas,
but if a spill occurs, clean and thoroughly dry the monitoring system before
reuse. If in doubt about monitoring system safety, refer the monitoring system
to a qualified service technician for examination.

69
Preventive Maintenance

7.3 Recycling and Disposal

When the monitoring system, battery, or accessories reach the end of useful
life, recycle or dispose of the equipment according to appropriate local and
regional regulations.

7.4 Battery Maintenance

 WARNING:
Explosion hazard — Do not use the battery with other manufacturer's
batteries, different types or models of batteries such as dry batteries, nickel-
metal hydride batteries, or Lithium-ion batteries together.

 WARNING:
Explosion hazard — Do not connect the battery reversed in positive (+) and
negative (-) terminals. Do not charge the battery with polarities reversed.

 Caution:
Covidien strongly recommends recharging the battery when it has not been
recharged for six (6) or more months.

 Caution:
Follow local government ordinances and recycling instructions regarding
disposal or recycling of device components, including batteries.

 Caution:
Do not short-circuit the battery, as it may generate heat. To avoid short-
circuiting, do not let the battery come in contact with metal objects at any
time, especially during transport.

 Caution:
Do not solder the battery directly. Heat applied during soldering may damage
the safety vent in the battery's positive cover.

 Caution:
Do not deform the battery by applying pressure. Do not throw, hit, drop, fold
or impact the battery.

70 Operator’s Manual
 Battery Maintenance

 Caution:
Do not use any chargers not specified by Covidien.

 Caution:
Do not mistreat the battery, or use the battery in applications not
recommended by Covidien.

 Caution:
Keep the battery out of reach of children to avoid any accidents.

 Caution:
If there are any problems with the battery, immediately put the monitoring
system in a safe place and contact a qualified service technician.

 Note:
The service menu displays the number of deep discharge cycles seen by the battery.
The monitoring system records a deep discharge cycle when the battery reaches the
voltage after a “critically low battery” alarm issues. Reference the Service Manual.

 Note:
Remove the battery if anticipating long periods of time between use or if storing the
monitoring system.

 Note:
Storing the monitoring system for a long period without charging the battery may
degrade battery capacity. A full charge of a depleted battery takes over four (4) or
eight (8) hours, depending on the battery.
Regularly check the battery to ensure optimal performance.
• Charge the lithium-ion battery if the monitoring system has not been used for six
(6) months. To charge the battery, connect the monitoring system to AC power.

• Have a qualified service technician replace the monitoring system's lithium-ion

battery every two (2) years. Reference the Service Manual for battery replacement
and general service instructions.

Operator’s Manual 71
Preventive Maintenance

7.5 Periodic Safety Checks

Covidien recommends a qualified service technician perform the following
checks every 24 months.
• Inspect the equipment for mechanical and functional damage or deterioration.

• Inspect the safety relevant labels for legibility. Contact Covidien or a local Covidien
representative, if labels are damaged or illegible.

• Ensure all user interface keys, cables, and accessories function normally.

7.6 Service

 WARNING:
Only a qualified service technician should remove the cover or access any
internal components.

 Caution:
Dispose of monitoring system in accordance with local requirements and
regulations.
The monitoring system requires no routine service other than cleaning, battery
maintenance, and service activity mandated by the institution. For more infor-
mation, reference the Service Manual.
• The monitoring system requires no calibration.

• Have a qualified service technician replace the battery at least every two (2) years.
• If service is necessary, contact Technical Services or a qualified service technician.
Reference Obtaining Technical Assistance, p. 1-6.

72 Operator’s Manual
8 Troubleshooting

8.1 Overview
This chapter describes how to troubleshoot common problems while using the
Nellcor™ Bedside SpO2 Patient Monitoring System.

8.2 General

 WARNING:
Check the patient's vital signs by alternate means should there be any doubt
about the accuracy of any measurement. Request a qualified service
technician confirm the monitoring system is functioning correctly.

 WARNING:
Only a qualified service technician should remove the cover or access any
internal components.
If the monitoring system detects an error, it displays an appropriate error code.
The Service Manual lists all error codes. If an error occurs, check and reseat all
power connections and ensure the battery is fully charged. If the error persists,
write down the error code and contact Technical Services or a qualified service
technician.

73
Troubleshooting

8.3 Error Conditions

Table 8-1.  Common Problems and Resolutions

Problem Resolution

Battery Charging Indicator not Check power cord

lit Check battery
Check AC power inlet
Check power/ mains outlet

Sensor Message Reference Performance Considerations, p. 6-63.

SpO2 Pulse search Check patient status; keep patient still, check for perfusion
Check all connections
Signal Artifact Detected Reposition sensor
SpO2 Sensor Off Check or change adhesive wrap
Choose alternate site
SpO2 Cable/Sensor Disconnect
Warm site
SpO2 Loss of Pulse Cover sensor
Use forehead, nasal, or ear sensor (adult patient only)
Use Nellcor™ adhesive sensor
Secure cable
Secure with headband (MAX-FAST)
Remove nail polish
Loosen sensor (too tight)
Isolate external interference (electrosurgical device, cell phone)
Replace the cable and/or sensor
Clean site (MAX-R)

No response to Power On/Off Press the Power On/Off button for more than one (1) second.
button press Ensure the power cord is properly connected to the outlet.
Ensure AC indictor blinks.
Ensure it does not share the same AC power source with other equipment.
If the error continues, contact Technical Services or a qualified service tech-
nician.

No response to button press Verify whether the Return button has not been pressed during normal
screen.
If the error continues, contact Technical Services or a qualified service tech-
nician.

Frozen at POST after power on Power cycle by pressing the Power On/Off button.
If the error continues, contact Technical Services or a qualified service tech-
nician.

System is frozen If the system freezes, it generates beep tone. Press the power button over
15 seconds for force quit the system.
If the error continues, contact Technical Services or a qualified service tech-
nician.

74 Operator’s Manual
 Error Conditions

Table 8-1.  Common Problems and Resolutions (Continued)

Problem Resolution

Blank screen Ensure buttons light. If not, press the Power On/Off button to turn on.
Check if AC indicator lights or blinks.
Use the same AC power source with other equipment to check for power.
If the error continues, contact Technical Services or a qualified service tech-
nician.

Screen does not function prop- Do not use the monitoring system; contact a qualified service technician or
erly and the power-on beep Covidien Technical Services.
tones do not sound

No sound generation Verify setting point of volume is not 0 or 1.

Verify alarm setup is not set to audible alarm paused.
If the error continues, contact Technical Services or a qualified service tech-
nician.

Abnormally shut down last Check any temporary settings such as alarm limits, response mode, and
time message patient mode, since resets invoke factory or institutional default settings.
Press the Power On/Off button to reset system power.
If the error continues, contact Technical Services or a qualified service tech-
nician.

Date and Time incorrect Set the time in the Options Menu.
Check if date setting format follows locale.
If the system displays wrong date and time even after power reset, it means
internal battery for power backup is dead.
If the error continues, contact Technical Services or a qualified service tech-
nician.

System consumes battery Ensure proper connection between power cord and wall socket.
power even with AC power Check if AC indicator lights or blinks.
connection
Use the same AC power source with other equipment to check for power.
Replace the power cord.
If the error continues, contact Technical Services or a qualified service tech-
nician.

Low Battery / Critically Low- Connect the system to AC power until the internal battery is fully charged.
Battery condition Ensure the system power cord is connected to the wall socket properly.
Check if AC indicator lights or blinks.
Use the same AC power source with other equipment to check for power.
Check the date of manufacture (DOM) of battery.
If the error continues, contact Technical Services or a qualified service tech-
nician.

Operator’s Manual 75
Troubleshooting

Table 8-1.  Common Problems and Resolutions (Continued)

Problem Resolution

Questionable readouts of Reference Performance Considerations, p. 6-63.

patient physiological measure- Check patient status.
ments, wrongly tagged or
Replace sensor or cable, if necessary.
missing patient data
Check all connections and reposition, if necessary.
Remove sources of electromagnetic interference.
Remove excessive ambient light.

Data port does not function Ensure USB cable firmly connected.
properly Disconnect USB cable, reset system power, then reconnect.
Ensure baud rate settings for both monitoring system and PC are the same.
Check hardware tab in PC 'System Registration Information'; verify normal
status.
Check COM port.
Re-install the bridge driver provided by Covidien.

Experiencing EMI interference Reference Reducing EMI (Electromagnetic Interference), p. 6-67.

Technical System Error Do not use the monitoring system; contact a qualified service technician or
Covidien Technical Services.

Reference Managing Alarms and Alarm Limits, p. 4-40, for any issues related
to alarm conditions.

8.4 Return
Contact Covidien or a local Covidien representative for shipping instructions,
including a Returned Goods Authorization (RGA) number. Reference Obtain-
ing Technical Assistance, p. 1-6. Unless otherwise instructed by Covidien, it is
not necessary to return the sensor or other accessory items with the monitor-
ing system. Pack the monitoring system in its original shipping carton. If the
original carton is not available, use a suitable carton with the appropriate
packing material to protect it during shipping. Return the monitoring system
by any shipping method that provides proof of delivery.

76 Operator’s Manual
9 Accessories

9.1 Overview
This chapter contains information for selecting the appropriate pulse oximetry
sensor for use with the Nellcor™ Bedside SpO2 Patient Monitoring System.

9.2 Nellcor™ Pulse Oximetry Sensors

 WARNING:
Before use, carefully read the pulse oximetry sensor Directions for Use,
including all warnings, cautions, and instructions.

 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 the sensor data, which may lead to adverse
results.

 WARNING:
Do not use a damaged pulse oximetry sensor or pulse oximetry cable. Do not
use a sensor with exposed optical components.

 WARNING:
Tissue damage can be caused by incorrect application or duration of use of a
pulse oximetry sensor. Inspect the sensor site periodically as directed in the
sensor Directions for Use.

 WARNING:
Pulse oximetry readings and pulse signal can be affected by certain ambient
environmental conditions, sensor application errors, and certain patient
conditions.

77
Accessories

 WARNING:
Do not immerse or wet the pulse oximetry sensor.

 Caution:
Nellcor™ adhesive pulse oximetry sensors are intended for single-patient use
only. Do not reuse pulse oximetry sensors.

When selecting a Nellcor™ pulse oximetry sensor, consider the following

items: patient’s weight and activity level, the adequacy of perfusion, and the
available sensor sites, the need for sterility, and the anticipated duration of
monitoring. Use the following table for selection or contact Covidien or a local
Covidien representative. Reference Sensor Performance Considerations, p. 6-
65. Use the Nellcor™ pulse oximetry interface cable to connect the pulse oxim-
etry sensor to the monitoring system.

Table 9-1.  Nellcor™ Pulse Oximetry Sensor Models and Patient Sizes

Nellcor™ Pulse Oximetry Sensor SKU Patient

Size

Nellcor™ Preemie SpO2 Sensor, non-adhesive (Single-patient use) SC-PR <1.5 kg

Nellcor™ Neonatal SpO2 Sensor, non-adhesive (Single-patient use) SC-NEO 1.5 to 5 kg

Nellcor™ Adult SpO2 Sensor, non-adhesive (Single-patient use) SC-A >40 kg

Nellcor™ Adult-Neonatal SpO2 Sensor with Wraps (Reusable with adhesive) OXI-A/N <3 or >40 kg

Nellcor™ Pediatric-Infant SpO2 Sensor with Wraps (Reusable with adhesive) OXI-P/I 3 to 40 kg

Nellcor™ Pediatric SpO2 Sensor, Two Piece (Sterile, single-use only) P 10 to 50 kg

Nellcor™ Neonatal-Adult SpO2 Sensor, Two Piece (Sterile, single-use only) N <3 or >40 kg

Nellcor™ Adult SpO2 Sensor, Two Piece (Sterile, single-use only) A > 30 kg

Nellcor™ Neonatal-Adult SpO2 Sensor (Sterile, single-use only) MAX-N <3 or >40 kg

Nellcor™ Infant SpO2 Sensor (Sterile, single-use only) MAX-I 3 to 20 kg

Nellcor™ Pediatric SpO2 Sensor (Sterile, single-use only) MAX-P 10 to 50 kg

Nellcor™ Adult SpO2 Sensor (Sterile, single-use only) MAX-A >30 kg

Nellcor™ Adult XL SpO2 Sensor (Sterile, single-use only) MAX-AL >30 kg

78 Operator’s Manual
 Optional Equipment

Table 9-1.  Nellcor™ Pulse Oximetry Sensor Models and Patient Sizes (Continued)

Nellcor™ Pulse Oximetry Sensor SKU Patient

Size

Nellcor™ Adult SpO2 Nasal Sensor (Sterile, single-use only) MAX-R >50 kg

Nellcor™ Forehead SpO2 Sensor MAX-FAST >10 kg

Nellcor™ Adult SpO2 Sensor, Reusable (Nonsterile) DS-100A >40 kg

Nellcor™ SpO2 Sensor, Multisite Reusable (Nonsterile) D-YS >1 kg

Nellcor™ SpO2 Ear Clip, Reusable (Nonsterile) D-YSE >30 kg

Nellcor™ Pediatric SpO2 Clip, Reusable (Nonsterile) D-YSPD 3 to 40 kg

 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.

9.3 Optional Equipment

Contact Covidien or a local Covidien representative for more information
about optional equipment for use with the monitoring system.

Adapter Plate—Fits standard, com-

mercially available GCX brackets and
securely mounts the monitoring system
to a wall bracket or a roll stand.

Operator’s Manual 79
Accessories

GCX Wall Mount Arm and

Channel—Attaches to the adapter
plate, which attaches to the arm.

GCX Roll Stand—Attaches to the

adapter plate.

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

9.4 Biocompatibility Testing

Biocompatibility testing has been conducted on Nellcor™ pulse oximetry
sensors in compliance with ISO 10993-1, Biological Evaluation of Medical
Devices, Part 1: Evaluation and Testing. The pulse oximetry sensors have
passed the recommended biocompatibility testing and are therefore in compli-
ance with ISO 10993-1.

80 Operator’s Manual
10 Theory of Operations

10.1 Overview
This chapter explains the theory behind operations of the Nellcor™ Bedside
SpO2 Patient Monitoring System.

10.2 Theoretical Principles

The monitoring system uses pulse oximetry to measure functional oxygen sat-
uration in the blood. Pulse oximetry works by applying a Nellcor™ pulse oxim-
etry sensor to a pulsating arteriolar vascular bed, such as a finger or toe. The
sensor contains a dual light source and a photodetector.
Bone, tissue, pigmentation, and venous vessels normally absorb a constant
amount of light over time. The arteriolar bed normally pulsates and absorbs
variable amounts of light during the pulsations. The ratio of light absorbed is
translated into a measurement of functional oxygen saturation (SpO2).
Ambient conditions, sensor application, and patient conditions can influence
the ability of the pulse oximeter to accurately measure SpO2. Reference Perfor-
mance Considerations, p. 6-63.
Pulse oximetry is based on two principles: oxyhemoglobin and deoxyhemoglo-
bin differ in their absorption of red and infrared light (measured using spectro-
photometry), and the volume of arterial blood in tissue (and hence, light
absorption by that blood) changes during the pulse (registered using plethys-
mography). A monitoring system determines SpO2 by passing red and infrared
light into an arteriolar bed and measuring changes in light absorption during
the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LED) in
the sensor serve as light sources; a photo diode serves as the photo detector.
Since oxyhemoglobin and deoxyhemoglobin differ in light absorption, the
amount of red and infrared light absorbed by blood is related to hemoglobin
oxygen saturation.
The monitoring system uses the pulsatile nature of arterial flow to identify the
oxygen saturation of arterial hemoglobin. During systole, a new pulse of arte-

81
Theory of Operations

rial blood enters the vascular bed, and blood volume and light absorption
increase. During diastole, blood volume and light absorption reach their lowest
point. The monitoring system bases its SpO2 measurements on the difference
between maximum and minimum absorption (measurements at systole and
diastole). By doing so, it focuses on light absorption by pulsatile arterial blood,
eliminating the effects of nonpulsatile absorbers such as tissue, bone, and
venous blood.

10.3 Automatic Calibration

Because light absorption by hemoglobin is wavelength dependent and
because the mean wavelength of LEDs varies, a monitoring system must know
the mean wavelength of the pulse oximetry sensor's red LED to accurately
measure SpO2.
During monitoring, the monitoring system’s software selects coefficients that
are appropriate for the wavelength of that individual sensor's red LED; these
coefficients are then used to determine SpO2.
Additionally, to compensate for differences in tissue thickness, the light inten-
sity of the sensor's LEDs is adjusted automatically.

 Note:
During certain automatic calibration functions, the monitoring system may briefly
display a flat line on the plethysmographic waveform. This is a normal operation and
does not require any user intervention.

10.4 Functional Testers and Patient Simulators

Some models of commercially available bench top functional testers and
patient simulators can be used to verify the proper functionality of Covidien
Nellcor™ monitoring systems, sensors, and cables. Reference the individual
testing device's operator's manual for the procedures specific to the model of
tester used. While such devices may be useful for verifying that the sensor,
cabling, and monitoring system are functional, they are incapable of providing
the data required to properly evaluate the accuracy of a system's SpO2 mea-
surements.
Fully evaluating the accuracy of the SpO2 measurements requires, at a mini-
mum, accommodating the wavelength characteristics of the sensor and repro-
ducing the complex optical interaction of the sensor and the patient’s tissue.

82 Operator’s Manual
 Unique Technologies

These capabilities are beyond the scope of known bench top testers. SpO2
measurement accuracy can only be evaluated in vivo by comparing monitoring
system readings with values traceable to SaO2 measurements obtained from
simultaneously sampled arterial blood using a laboratory CO-oximeter.
Many functional testers and patient simulators have been designed to inter-
face with the monitoring system's expected calibration curves and may be suit-
able for use with monitoring systems and/or sensors. Not all such devices,
however, are adapted for use with the OxiMax™ digital calibration system.
While this will not affect use of the simulator for verifying system functionality,
displayed SpO2 measurement values may differ from the setting of the test
device. For a properly functioning monitoring system, this difference will be
reproducible over time and from monitoring system to monitoring system
within the performance specifications of the test device.

10.5 Unique Technologies

10.5.1 Functional versus Fractional Saturation

This monitoring system measures functional saturation where oxygenated

hemoglobin is expressed as a percentage of the hemoglobin that can transport
oxygen. It does not detect significant amounts of dysfunctional hemoglobin,
such as carboxyhemoglobin or methemoglobin. In contrast, hemoximeters
such as the IL482 report fractional saturation where oxygenated hemoglobin
is expressed as a percentage of all measured hemoglobin, including measured
dysfunctional hemoglobins. To compare functional saturation measurements
to those from a monitoring system that measures fractional saturation, frac-
tional measurements must be converted using the listed equation.


 = ---------------------------------  100
100 –   +  

 functional saturation  %carboxyhemoglobin

 fractional saturation  %methemoglobin

Operator’s Manual 83
Theory of Operations

10.5.2 Measured versus Calculated Saturation

When calculating saturation from a blood gas partial pressure of oxygen (PO2),
the calculated value may differ from the SpO2 measurement of a monitoring
system. This usually occurs when saturation calculations exclude corrections
for the effects of variables such as pH, temperature, the partial pressure of
carbon dioxide (PCO2), and 2,3-DPG, that shift the relationship between PO2
and SpO2.

Figure 10-1.  Oxyhemoglobin Dissociation Curve

10.5.3

1 % Saturation Axis 3 Increased pH; Decreased temperature, PCO2, and 2,3-DPG

2 PO2 (mmHg) Axis 4 Decreased pH; Increased temperature, PCO2, and 2,3-DPG

10.5.4 Data Update Period, Data Averaging, and Signal Processing

The advanced signal processing of the OxiMax™ algorithm automatically extends

the amount of data required for measuring SpO2 and pulse rate depending on the
measurement conditions. The OxiMax™ algorithm automatically extends the
dynamic averaging time required beyond seven (7) seconds during degraded or dif-
ficult measurement conditions caused by low perfusion, signal artifact, ambient
light, electrocautery, other interference, or a combination of these factors, which

84 Operator’s Manual
 SatSeconds™ Alarm Management Feature

results in an increase in the dynamic averaging. If the resulting dynamic averaging

time exceeds 20 seconds for SpO2, the algorithm sets the pulse search bit while
continuing to update SpO2 and pulse rate values every second.
As such measurement conditions extend, the amount of data required may
continue to increase. If the dynamic averaging time reaches 40 seconds, and/
or 50 seconds for pulse rate, a low priority alarm state results: the algorithm
sets the Pulse Timeout bit and the monitoring system reports a zero saturation
indicating a loss-of-pulse condition, which should result in an audible alarm.

10.6 SatSeconds™ Alarm Management Feature

The monitoring system monitors the percentage of hemoglobin binding sites
saturated with oxygen in the blood. With traditional alarm management, upper
and lower alarm limits are set to alarm at specific SpO2 levels. When the SpO2
level fluctuates near an alarm limit, the alarm sounds each time it violates the
alarm threshold. SatSeconds monitors both degree and duration of desaturation
as an index of desaturation severity. Thus, the SatSeconds feature helps distin-
guish clinically significant events from minor and brief desaturations that may
result in nuisance alarms.
Consider a series of events leading to a violation of the SatSeconds alarm limit.
An adult patient experiences several minor desaturations, then a clinically sig-
nificant desaturation.

Figure 10-2.  Series of SpO2 Events

a First SpO2 Event

b Second SpO2 Event

c Third SpO2 Event

Operator’s Manual 85
Theory of Operations

10.6.1 First SpO2 Event

Consider the first event. Suppose the SatSeconds alarm limit is set to 25. The
patient’s SpO2 drops to 79% and the duration of the event is two (2) seconds
before saturation again exceeds the lower alarm threshold of 85%.

6% drop below the lower alarm limit threshold

x 2 second duration below the lower threshold

12 SatSeconds; no alarm

Because the SatSeconds alarm limit is set to 25 and the actual number of Sat-
Seconds equals 12, there is no audible alarm.

Figure 10-3.  First SpO2 Event: No SatSeconds Alarm

86 Operator’s Manual
 SatSeconds™ Alarm Management Feature

10.6.2 Second SpO2 Event

Consider the second event. Suppose the SatSeconds alarm limit is still set to
25. The patient’s SpO2 drops to 84% and the duration of the event is 15
seconds before saturation again exceeds the lower alarm threshold of 85%.

1% drop below the lower alarm limit threshold

x15 second duration below the lower threshold

15 SatSeconds; no alarm

Because the SatSeconds alarm limit is set to 25 and the actual number of Sat-
Seconds equals 15, there is no audible alarm.

Figure 10-4.  Second SpO2 Event: No SatSeconds Alarm

Operator’s Manual 87
Theory of Operations

10.6.3 Third SpO2 Event

Consider the third event. Suppose the SatSeconds alarm limit is still set to 25.
During this event, the patient’s SpO2 drops to 75%, which is 10% below the
lower alarm threshold of 85%. Since the patient’s saturation does not return
to a value over the lower alarm threshold within 2.5 seconds, an alarm sounds.

10% drop below the lower alarm limit threshold

x2.5 second duration below the lower threshold

25 SatSeconds; results in an alarm

At this level of saturation, the event cannot exceed 2.5 seconds without invok-
ing a SatSeconds alarm.

Figure 10-5.  Third SpO2 Event: Triggers SatSeconds Alarm

88 Operator’s Manual
 SatSeconds™ Alarm Management Feature

10.6.4 The SatSeconds Safety Net

The SatSeconds “Safety Net” is for patients with saturation levels frequently
below the limit, but not staying below the limit long enough for the SatSec-
onds time setting to be reached. When three or more limit violations occur
within 60 seconds, an alarm sounds even if the SatSeconds time setting has
not been reached.

Operator’s Manual 89
Theory of Operations

Page Left Intentionally Blank

90 Operator’s Manual
11 Product Specifications

11.1 Overview
This chapter contains physical and operational specifications of the
Nellcor™ Bedside SpO2 Patient Monitoring System. Ensure all product require-
ments are met prior to installation of the monitoring system.

11.2 Physical Characteristics

Enclosure

Weight 1.6 kg (3.5 lbs.) including battery

Dimensions 255 × 82 × 165 mm (10.04 x 3.23 x 6.50 in)

Display

Screen size 109.22 mm (4.3 in), measured diagonally

Screen type TFT LCD, white LED backlight, viewing cone of 30º and
optimal viewing distance of 1 meter

Resolution 480 × 272 pixel

Controls

Dial Jog dial control

Buttons Power On/Off, Alarm Audio Paused, Return

Alarms

Categories Patient status and system status

Priorities Low, medium and high

Notification Audible and visual

Setting Default and individual

Alarm volume level 45 to 80 dB

91
Product Specifications

11.3 Electrical

Battery power requirement AC 100-240VAC, 50/60Hz, 45 VA

Voltage and capacity of Li-Ion, 5 hour1 10.8 V/ 2200 mAh

Voltage and capacity of Li-Ion, 10hour1 10.8 V/4400 mAh

Compliance 91/157/EEC

Fast-acting fuse 2A 32VAC,/DC

Fast-acting fuse 500 mA 32VAC/50DC

1. New batteries typically provide the stated duration when operating in Normal Response Mode, with
pulse beep, the SatSeconds feature enabled, with no external communication, no audible alarms, and
at 25 ºC ± 5ºC.

11.4 Environmental Conditions

 Note:
The system may not meet its performance specifications if stored or used outside the
specified temperature and humidity range.

Table 11-1.  Transport, Storage, and Operating Condition Ranges

Transport and Storage Operating Conditions

Temperature -20 ºC to 60 ºC, 5 ºC to 40 ºC

(-4 ºF to 140 ºF) (41 ºF to 104 ºF)

Altitude -304 to 6,096 m, -170 to 4,877 m,

(-1,000 to 20,000 ft.) (-557 to 16,000 ft.)

Pressure 50 kPa to 106 kPa, 58 kPa to 103 kPa,

(14.7 in. Hg to 31.3 in. Hg) (17.1 in. Hg to 30.4 in. Hg)

Relative 15% to 93% non-condensing

humidity

92 Operator’s Manual
 Tone Definition

11.5 Tone Definition

Table 11-2.  Tone Definitions

Tone Category Description

High Priority Alarm Tone

Volume level Adjustable (level 1-8)

Pitch (± 20Hz) 976 Hz

Pulse width (± 20msec) 150 msec (IEC60601-1-8)

Number of pulses in burst 10, interburst interval of 4 sec (IEC60601-1-8)

Repetitions Continually

Medium Priority Alarm Tone

Volume level Adjustable (level 1-8)

Pitch (± 20Hz) 697 Hz

Pulse width (± 20msec) 150 msec (IEC60601-1-8)

Number of pulses in burst 3, interburst interval of 8 sec (IEC60601-1-8)

Repetitions Continually

Low Priority Alarm Tone

Volume level Adjustable (level 1-8)

Pitch (± 20Hz) 488 Hz

Pulse width (± 20msec) 250 msec (IEC60601-1-8)

Number of pulses 1, interburst interval of 16 sec (IEC60601-1-8)

Repetitions Continually

Alarm Reminder Tone

Volume level Not changeable

Pitch (± 20Hz) 800 Hz

Pulse width (± 20msec) 200 msec

Number of pulses 1 pulse per 1 second, 3 min ~ 10 min interburst

Repetitions Continually

Operator’s Manual 93
Product Specifications

Table 11-2.  Tone Definitions (Continued)

Tone Category Description

Key Beep

Volume level Adjustable (Off, level 1-7),

(Invalid key presses are ignored)

Pitch (± 20Hz) 440 Hz (valid), 168 Hz (invalid)

Pulse width (± 20msec) 110 msec

Number of pulses N/A

Repetitions No repeat

POST Pass Tone

Volume level Not changeable

Pitch (± 20Hz) 813 Hz

Pulse width (± 20msec) 1500 msec

Number of pulses N/A

Repetitions No repeat

11.6 Performance Specifications

Table 11-3.  Trends

Types Graphical and Tabular

Memory Saves total 88000 data events

Saves date and time, alarm conditions,
pulse rate, and SpO2 measurements

Graphical Format Total 2 graphs

A graph for SpO2 parameters
A graph for Pulse Rate parameters

Tabular Format One table for all parameters

Display 5 lists

94 Operator’s Manual
 Sound Pressure

Table 11-4.  Pulse Oximetry Sensor Accuracy and Ranges

Range Type Range Values

Measurement Ranges

SpO2 saturation range 1% to 100%

Pulse rate range 20 to 250 beats per minute (bpm)

Perfusion range 0.03% to 20%

Display sweep speed 6.25 mm/sec, 12.5 mm/sec, 25.0 mm/sec

Measurement Accuracy

Pulse rate accuracy 20 to 250 beats per minute (bpm) ±3 digits

SpO2 saturation accuracy1 70% to 100% ±2 digits, neonates: ±3 digits

Operating Range and Dissipation

Red Light Wavelength Approximately 660 nm

Infrared Light Wavelength Approximately 900 nm

Optical Output Power Less than 15 mW

Power Dissipation 52.5 mW

1. Monitoring system measurements are statistically distributed; about two-thirds of
monitoring system measurements can be expected to fall in this accuracy (ARMS) range.
Reference the Clinical Studies section for test results. For a complete listing of SpO2 accuracy
across the full line of available Nellcor™ sensors, contact Covidien, a local Covidien
representative, or locate it online at www.covidien.com.

11.7 Sound Pressure

Table 11-5.  Sound Pressure in Decibels

Volume Setting

Alarm Type High (7-8) Med High (5-6) Med Low (3-4) Low (1-2)

High Priority 83.6-87.4 dB 74.1-77.9 dB 65.6-69.5 dB 57.6-61.1 dB

Medium Priority 82.0-84.7 dB 70.2-74.8 dB 64.5-66.9 dB 53.6-57.9 dB

Low Priority 77.2-81.7dB 69.5-72.6 dB 60.1-63.8 dB 50.8-56.0 dB

Operator’s Manual 95
Product Specifications

11.8 Product Compliance

Standards Compliance EN ISO 9919:2009, EN ISO 80601-2-61:2011

EN IEC 60601-1:2005
EN IEC 60601-1-2:2nd edition
EN IEC 60601-1:1998 + A1:1991 + A2:1995
EN 60601-1:1990 + A11:1993 + A12:1993 + A13:1996
CAN/CSA C22.2 No. 601.1 M90
UL 60601-1: 1st edition

Equipment Classifications

Type of Protection against electric shock Class I (internally powered)

Degree of Protection against electric shock Type BF - Applied part

Mode of Operation Continuous

Electromagnetic Compatibility IEC 60601-1-2:2007

Liquid Ingress IPX2

Degree of Safety Not suitable for use in the presence of flammable anesthetics

11.9 Manufacturer’s Declaration

11.9.1 Electromagnetic Compatibility (EMC)

 WARNING:
The use of accessories, pulse oximetry sensors, and cables other than those
specified may result in inaccurate readings of the monitoring system and
increased emission of the monitoring system.

 Caution:
For best product performance and measurement accuracy, use only
accessories supplied or recommended by Covidien. Use accessories according
to the Directions for Use. 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.

96 Operator’s Manual
 Manufacturer’s Declaration

The monitoring system is suitable for prescription use only in the electromag-
netic environments specified in the standard. Use the monitoring system in
accordance with the electromagnetic environments described.

Electromagnetic Emissions

Table 11-6.  Electromagnetic Emissions Guidelines

Emissions Test Compliance Electromagnetic Environment Guidance

RF emissions Group 1, The oximeter is suitable for use in all establishments.

CISPR 11 Class B

Harmonic emissions Class A The oximeter is suitable for use in all establishments.
IEC/EN 61000-3-2

Voltage fluctuation/ Complies The oximeter is suitable for use in all establishments.
flicker emissions
IEC/EN 61000-3-3

Operator’s Manual 97
Product Specifications

Electromagnetic Immunity

 Note:
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

Table 11-7.  Electromagnetic Immunity Guidelines

Immunity IEC/EN 60601-1-2 Compliance Electromagnetic Environment

Test Test Level Level Guidance

Electrostatic ± 6 kV contact ± 6 kV contact Floor should be wood, concrete,

discharge (ESD) ± 8 kV air ± 8 kV air or ceramic tile. If floors are
IEC/EN 61000-4-2 covered with synthetic material,
the relative humidity should be
at least 30%.

Electric fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial and/
IEC/EN 61000-4-4 ± 1 kV for input/ ± 1 kV for input/ or hospital environment.
output lines output lines

Surge ± 1 kV differential ± 1 kV differen- Mains power quality should be

IEC/EN 61000-4-5 mode tial mode that of a typical commercial and/
± 2 kV common ± 2 kV common or hospital environment.
mode mode

Voltage dips, short <5% UT <5% UT Mains power quality should be

interruptions and (>95% dip in UT) (>95% dip in UT) that of a typical commercial and/
voltage variations for 0.5 cycle for 0.5 cycle or hospital environment.
on power supply If the user requires continued
IEC/EN 61000-4-11 40% UT 40% UT operation during power mains
(60% dip in UT) for (60% dip in UT) interruption, power from an
5 cycles for 5 cycles uninterruptible power supply, or
battery.
70% UT 70% UT
Note: UT is the AC main’s
(30% dip in UT) for (30% dip in UT) voltage prior to application of
25 cycles for 25 cycles the test level.
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 seconds for 5 seconds

Power frequency 3 A/m 3 A/m It may be necessary to position

(50/60 Hz) magnetic further from the sources of
field power frequency magnetic fields
IEC/EN 61000-4-8 or to install magnetic shielding.

98 Operator’s Manual
 Manufacturer’s Declaration

Table 11-8.  Recommended Separation Distances

Immunity IEC/EN 60601-1-2 Compliance Electromagnetic Environ-

Test Test Level Level ment Guidance

Frequency of Equation for Separation

Transmitter Distance (d)

Conducted RF 3 Vrms 3 Vrms

150 kHz 150 kHz d = 1.2 P
IEC/EN 61000-4-6
80 MHz 80 MHz 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m

80 MHz 80 MHz d = 1.2 P
IEC/EN 61000-4-3
800 MHz 800 MHz 80 MHz to 800 MHz

3 V/m 3 V/m
800 MHz 800 MHz d = 2.3 P
2.5 GHz 2.5 GHz 800 MHz to 2.5 GHz

Rated Maximum Separation Distance in Meters

Output Power (P) of
Transmitter in Watts 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.10 0.38 0.38 0.73

1.00 1.20 1.20 2.30

10.00 3.80 3.80 7.30

100.00 12.00 12.00 23.00

For transmitters rated at a maximum output power not listed above, estimate
the separation distance (d) using the equation in the corresponding column,
where P is the maximum output [power rating of the transmitter in watts (W)]
according to the transmitter manufacturer.

 Note:
Portable and mobile RF communications equipment can affect medical electrical
equipment. Such RF equipment should be used no closer to any part of the monitoring
system, including cables, than the recommended separation distance calculated from
the equation appropriate for the frequency of the transmitter.

Operator’s Manual 99
Product Specifications

11.9.2 Sensor and Cable Compliance

 WARNING:
The use of accessories, sensors, and cables other than those specified may
result in inaccurate readings of the monitoring system and increased emission
of the monitoring system.

Table 11-9.  Cables and Sensors

Item Maximum Length

Sensors

Pulse oximetry sensor cable 1.6 ft. (0.5 m)

Cables

Power cable 10.0 ft. (3.0 m)

Nurse call cable 5.9 ft. (1.8 m)

Pulse oximetry interface cable 10.0 ft. (3.0 m)

11.9.3 Safety Tests

Ground Integrity

100 milliohms or less

Leakage Current

The following tables display the maximum earth and enclosure leakage current
allowed, as well as patient leakage.

100 Operator’s Manual

 Manufacturer’s Declaration

Table 11-10.  Earth and Enclosure Leakage Current Specifications

Earth Leakage Current

IEC 60601-1
Neutral ANSI/AAMI
Condition AC Line Polarity Line Cord Line Cord IEC 60601-1 ES 60601-1: 2005

Normal Normal Closed Closed 500 µA 300 µA

Single Fault Open Closed 1000 µA

Closed Open

Normal Reversed Closed Closed 500 µA 300 µA

Single Fault Open Closed 1000 µA

Closed Open

Enclosure Leakage Current

Neutral Power Line IEC 60601-1

Condition AC Line Polarity Line Cord Ground ANSI/AAMI ES 60601-1: 2005

Normal Normal Closed Closed 100 µA

Single Fault Open Closed 500 µA

Closed Open

Normal Reversed Closed Closed 100 µA

Single Fault Open Closed 500 µA

Closed Open

Operator’s Manual 101

Product Specifications

Table 11-11.  Patient Applied and Patient Isolation Risk Current

Patient Applied Risk Current

IEC 60601-1
Power Line ANSI/AAMI
Condition AC Line Polarity Neutral Line Ground Cable ES 60601-1: 2005

Normal Normal Closed Closed 100 µA

Single Fault Open Closed 500 µA

Closed Open

Normal Reversed Closed Closed 100 µA

Single Fault Open Closed 500 µA

Closed Open

Patient Isolation Risk Current

IEC 60601-1
Power Line ANSI/AAMI
Condition AC Line Polarity Neutral Line Ground Cable ES 60601-1: 2005

Single Fault Normal Closed Closed 5000 µA

Reversed Closed Closed

102 Operator’s Manual

A Clinical Studies

A.1 Overview
This appendix contains data from clinical studies conducted for the Nellcor™
sensors used with the Nellcor™ Bedside SpO2 Patient Monitoring System.
One (1) prospective, controlled hypoxia clinical study was conducted to demon-
strate the accuracy of Nellcor™ sensors when used in conjunction with the
Nellcor™ Bedside Respiratory Patient Monitoring System. The study was per-
formed with healthy volunteers at a single clinical laboratory. Accuracy was estab-
lished by comparison to CO-oximetry.

A.2 Methods
Data from 11 healthy volunteers were included in the analysis. Sensors were
rotated on digits and brow to provide a balanced study design. SpO2 values
were continuously recorded from each instrument while inspired oxygen was
controlled to produce five steady state plateaus at target saturations of approx-
imately 98, 90, 80, 70 and 60%. Six arterial samples were taken 20 seconds
apart at each plateau resulting in a total of approximately 30 samples per sub-
ject. Each arterial sample was drawn over two (2) respiratory cycles (approxi-
mately 10 seconds) while SpO2 data were simultaneously collected and marked
for direct comparison to CO2. Each arterial sample was analyzed by at least two
of the three IL CO-oximeters and a mean SaO2 was calculated for each sample.
End tidal CO2, respiratory rate, and respiratory pattern were continuously mon-
itored throughout the study.

103
Clinical Studies

A.3 Study Population

Table A-1.  Demographic Data

Type Class Total

Male 5
Gender
Female 6

Caucasian 8

Hispanic 2
Race
African American 1

Asian 0

Age -- 19-48

Weight -- 108-250

Very light 2

Olive 5
Skin pigment
Dark olive/Medium black 3

Extremely dark/Blue black 1

A.4 Study Results

Accuracy was calculated using the root mean square difference (RMSD).

Table A-2.  SpO2 Accuracy for Nellcor™ Sensors vs. CO-oximeters

SpO2 MAX-A MAX-N MAX-FAST

Decade
Data Arms Data Arms Data Arms
Points Points Points

60-70 71 3.05 71 2.89 71 2.22

70-80 55 2.35 55 2.32 55 1.28

80-90 48 1.84 48 1.73 48 1.48

90-100 117 1.23 117 1.68 117 0.98

104 Operator’s Manual

 Adverse Events or Deviations

Figure A-1.  Modified Bland-Altman Plot

Test Sensor; Avg CO-oximeter value 70-100% SpO2

1 2
Avg CO-oximeter value 70-100% SpO2

Oximetry board with MAX-A sensor Trendline of MAX-A sensor

Oximetry board with MAX-N sensor Trendline of MAX-N sensor

Oximetry board with MAX-FAST sensor Trendline of MAX-FAST sensor

A.5 Adverse Events or Deviations

The study was conducted as expected with no adverse events and no devia-
tions from the protocol.

Operator’s Manual 105

Clinical Studies

A.6 Conclusion
The pooled results indicate that for a saturation range of 60-80% for SpO2, the
acceptance criterion was met for the monitoring system when tested with
MAX-A, MAX-N and MAX-FAST sensors. The pooled results indicate that for a
saturation range of 70-1 00% for SpO2, the acceptance criterion was met.

106 Operator’s Manual

Index
A G
Accessory Ground Integrity Specification ................ 100
Adapter Plate .......................................... 79
GCX Roll Stand ........................................ 79 I
GCX Vertical Wall Mount Arm ............... 79 Indicator
Alarm audio paused ................................... 42 AC power ................................................. 13
Alarm limits menu area ............................. 14 Battery charge ............................. 13, 20, 22
Anemia ........................................................ 64 Interference ............................................. 13
Sensor disconnect ................................... 13
B Sensor message ....................................... 13
Biocompatibility Testing ............................ 80 Sensor off ................................................ 13
Button Intended Use ............................................... 10
Alarm audio paused ............................... 11
Power ...................................................... 11 M
Return ...................................................... 11 Measured Saturation .................................. 84
Message, Sensor ......................................... 24
C Monitoring System
Cables ........................................................ 100 Intended use ........................................... 10
Calculated Saturation ................................ 84 Product description ................................... 9
Calibration .................................................. 72 Related documents ................................... 6
Caution Warranty ................................................... 7
Accessory equipment ................................ 4
Accuracy .................................................... 5 N
Battery disposal ...................................... 72 Nellcor™ pulse oximetry sensor
Conductor integrity .................................. 5 Connection .............................................. 22
Equipment inspection .............................. 5 Disinfection ............................................. 69
Excessive environmental conditions ........ 4 Performance considerations ................... 65
Liquid ingress ............................................ 4
Radio frequency energy ........................... 5 O
Verify proper operation ........................... 5 Operating conditions
Cleaning ...................................................... 69 Altitude ................................................... 92
Colors, Display ............................................ 14 Relative humidity .................................... 92
Controls ........................................... 11, 14, 15 Temperature ........................................... 92
Current Oximetry Considerations
Leakage (Earth and Enclosure) ............ 100 Pulse rate ................................................. 63
Risk (Patient Applied and Isolation) .... 102 Saturation ................................................ 63
Oximetry Overview ..................................... 81
D
Disinfecting ................................................. 69 P
Dysfunctional Hemoglobins ...................... 64 Performance Considerations
Electromagnetic interference ................ 67
E Patient conditions ................................... 64
Earth Leakage Current Specifications ..... 100 Sensor ...................................................... 65
Electromagnetic Compatibility (EMC) Performance Verification ..................... 63, 64
Electromagnetic Emissions ..................... 97 Physical Characteristics ............................... 95
Electromagnetic Immunity ..................... 98
RF Equipment .......................................... 99 R
Separation Distances .............................. 99 RF Equipment ............................................. 99
Electromagnetic Interference .................... 67
S
F SatSeconds alarm management .......... 30, 85
Feature Saturation
Nurse call interface ................................. 48 Calculated ................................................ 84
SatSeconds™ Alarm Management ........ 85 Fractional ................................................. 83
Trend data download ............................. 49 Functional ................................................ 83
Fractional Saturation ................................. 83 Measured ................................................. 84
Front Panel ..................................... 11, 12, 96 Selecting a Sensor ....................................... 78
Functional Saturation ................................ 83

107
 Service, Returning your Oximeter .............76
Specifications
Electrical ..................................................95
Physical ............................................91, 103
Storage
Altitude ....................................................92
Relative humidity ....................................92
Temperature ............................................92
Symbols
Atmospheric pressure .............................16
Attention .................................................16
CE mark ....................................................16
Data port .................................................16
Date of manufacture ..............................16
Equipotentiality ......................................16
EU representative ....................................16
Fragile ......................................................16
Humidity limitations ...............................16
Keep dry ..................................................16
Manufacturer ..........................................16
Prescription only .....................................16
Temperature limitations .........................16
This side up ..............................................16
Type BF ....................................................16
UL listed ...................................................16

T
Tabular Trend Data ....................................46
Technical Assistance .....................................6
Transport
Altitude ....................................................92
Relative humidity ....................................92
Temperature ............................................92
Troubleshooting, Technical Assistance ........6

W
Warning
Broken LCD panel .....................................2
Explosion hazard .......................................2
High ambient light conditions .................3
Liquid ingress ............................................4
Silencing ....................................................4
Use of non-approved equipment .......5, 97

108
Part No. 10006048 Rev B (A7213-1) 07/2012

© 2012 Covidien.

 Covidien llc
15 Hampshire Street, Mansfield, MA 02048 USA.
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www.covidien.com [T] 1.800.NELLCOR