Clsi HS3 A

HS3-A
Vol. 25 No. 5
Replaces HS3-P
Vol. 21 No. 6
Pulse Oximetry; Approved Guideline
Pulse oximetry is a widely used device for the clinical assessment of arterial oxygenation
and pulse rate. The clinical applications, quality assessment, and limitations are discussed
in this guideline.
A guideline for global application developed through the Clinical and Laboratory
Standards Institute consensus process.
Clinical and Laboratory Standards Institute
Providing NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards
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HS3-A
ISBN 1-56238-562-3
Volume 25 Number 5 ISSN 0273-3099
Philip S. Clifford, PhD
Steven J. Barker, PhD, MD
Robert J. Kopotic, MSN, RN, RRT, FAARC
David Lovejoy, MS, AAS
Carl D. Mottram, RRT, RPFT, FAARC
Abstract
CLSI document HS3-A—Pulse Oximetry; Approved Guideline provides recommendations for the use of pulse oximeters
according to the path of workflow: decisions which need to be made before initiating monitoring; concerns during monitoring;
interpretation of the data; and information management. Considerations that should accompany use of these instruments,
including a thorough summary of the limitations of existing technology, have also been outlined.
Clinical and Laboratory Standards Institute (CLSI). Pulse Oximetry; Approved Guideline. CLSI document HS3-A (ISBN 1-
56238-562-3). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898
USA, 2005.
The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through
two or more levels of review by the healthcare community, is an ongoing process. Users should expect revised editions of any
given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or
guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents. Current editions are
listed in the CLSI catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is
not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax:
610.688.0700; E-Mail: exoffice@ clsi.org; Website: www.clsi.org
Number 5 HS3-A
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Reproduced with permission, from CLSI publication HS3-A—Pulse Oximetry; Approved

Guideline (ISBN 1-56238-562-3). Copies of the current edition may be obtained from
Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA.
Permission to reproduce or otherwise use the text of this document to an extent that exceeds the
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Copyright ©2005. Clinical and Laboratory Standards Institute.
Suggested Citation
(Clinical and Laboratory Standards Institute. Pulse Oximetry; Approved Guideline. CLSI document
HS3-A [ISBN 1-56238-562-3]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898 USA, 2005.)
Proposed Guideline
April 2001
Approved Guideline
January 2005
ISBN 1-56238-562-3
ISSN 0273-3099
ii
Volume 25 HS3-A
Committee Membership
Area Committee on Healthcare Services

Judy Dye, MA Jeannie Miller, BSN, MPH Staff
Chairholder Centers for Medicare & Medicaid
Univ. of Arizona Medical Center Services Clinical and Laboratory Standards
Tucson, Arizona Baltimore, Maryland Institute
Wayne, Pennsylvania
Carl D. Mottram, BA, RRT, RPFT, Peter L. Minetti
FAARC Fujirebio Diagnostics, Inc.
Jennifer K. McGeary, MT(ASCP),
Vice-Chairholder Malvern, Pennsylvania
MSHA
Mayo Clinic Staff Liaison
American Assn. for Respiratory Care Advisors
Rochester, Minnesota Donna M. Wilhelm
Lucia M. Berte, MA, MT(ASCP), SBB
Editor
Bernard M. Branson, MD Quality Systems Consultant
Centers for Disease Control and Westminster, Colorado
Melissa A. Lewis
Prevention
Assistant Editor
Atlanta, Georgia Susan Blonshine, RRT, RPFT, FAARC
TechEd
Barbara M. Goldsmith, PhD Mason, Michigan
Alliance Laboratory Services
Cincinnati, Ohio Robert K. McNamee
Dianon Systems, Inc.
Hector Lozano Stratford, Connecticut
Respironics, Inc.
Murrysville, Pennsylvania
Acknowledgements
The Clinical and Laboratory Standards Institute gratefully acknowledges the working group experts and
institutions listed below for their insight and advice in preparing the previous edition of this guideline.
Philip S. Clifford, PhD – Medical College of Wisconsin, Milwaukee, WI

Steven J. Barker, PhD, MD – University of Arizona, Tucson, AZ
Robert J. Kopotic, MSN, RN, RRT, FAARC – on assignment by American Association of Respiratory
Care, San Diego, CA
David Lovejoy, MS, AAS – SpectRx Inc., Norcross, GA
Carl D. Mottram, RRT, RPFT, FAARC – Mayo Clinic, Rochester, MN
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Contents
Abstract ....................................................................................................................................................i
Committee Membership........................................................................................................................ iii
Foreword .............................................................................................................................................. vii
1 Scope..........................................................................................................................................1
2 Introduction................................................................................................................................1
3 Definitions .................................................................................................................................3
4 Premonitoring ............................................................................................................................4
4.1 Indications for Use........................................................................................................4
4.2 Environment of Use ......................................................................................................4
4.3 Patient Assessment .......................................................................................................4
4.4 Instrument .....................................................................................................................4
4.5 Sensor and Sensor Site Selection and Preparation........................................................5
5 Monitoring/Testing Session .......................................................................................................6
5.1 Duration ........................................................................................................................6
5.2 Instrument Settings .......................................................................................................7
5.3 Quality of Signal...........................................................................................................8
5.4 Troubleshooting ............................................................................................................9
6 Interpretation............................................................................................................................10
6.1 Performance: Accuracy and Reliability ......................................................................10
6.2 Sources of Error ..........................................................................................................11
6.3 Interpretation of SpO2 Data ........................................................................................14
6.4 Summary.....................................................................................................................15
7 Information Management.........................................................................................................15
7.1 Patient Records ...........................................................................................................15
7.2 Memory Capacity .......................................................................................................16
7.3 Remote Use.................................................................................................................16
References.............................................................................................................................................17
Summary of Comments and Subcommittee Responses........................................................................20
Summary of Delegate Comments and Committee Responses ..............................................................30
The Quality System Approach..............................................................................................................32
Related CLSI/NCCLS Publications ......................................................................................................33
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Foreword
The ease of use, noninvasive nature, and low cost associated with pulse oximeters have resulted in their
widespread use in diverse clinical settings by a wide variety of medical personnel, including physicians,
nurses, respiratory care practitioners/therapists, paramedics, and other allied health personnel. There are
certain principles that should guide the use of these instruments regardless of the setting. Concern has
been expressed regarding the general lack of basic understanding by caregivers of the related physiology,
technical operation, and limitations of pulse oximetry.1,2 Some conclude that inadequate knowledge of
pulse oximetry could compromise patient safety and contribute to morbidity.3,4 This document presents
guidance for the use of pulse oximeters and is organized on the basis of the path of workflow: decisions
which need to be made before initiating monitoring; concerns during monitoring; interpretation of the
data; and information management. The major goal of the committee is to highlight the considerations
which should accompany use of these instruments, including a summary of the limitations of existing
technology. This guideline is not intended to be an examination of pulse oximetry literature nor a detailed
description of the technology. For this, the reader is referred to the device documentation and review
articles.5-8
Key Words
Hemoglobin, oximetry, oxygen, oxygen saturation, oxyhemoglobin, oxyhemoglobin saturation
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1 Scope
CLSI document HS3—Pulse Oximetry describes important premonitoring, monitoring, and
postmonitoring activities in the path of workflow for pulse oximetry, including clinical applications,
quality assessment, and limitations.
This guideline is intended for use by all individuals involved in the path of workflow for pulse oximetry
including physicians, nurses, other authorized practitioners, and allied health professionals.
This guideline is not intended to be an examination of pulse oximetry literature nor a detailed description
of the technology.
2 Introduction
Multiwavelength laboratory oximeters use spectrophotometric absorption of a blood specimen to
determine the percentage of hemoglobin saturated with oxygen and the percentage of dyshemoglobins.
Pulse oximetry is a noninvasive method of estimating the arterial oxygen saturation and pulse rate from
pulsatile absorption signals derived from a sensor placed on the skin. The principle is based on the fact
that oxy- and deoxyhemoglobin have different absorption spectra (see Figure 1), at the commonly used
wavelengths of 660 nm (red light) and 905 to 940 nm (infrared light).
Figure 1. Absorption Spectra of Oxy- and Deoxyhemoglobin
The sensor consists of light sources (light-emitting diodes) at the red and infrared wavelengths and a
photodetector (photodiode). When light from the sensor passes into the tissue, a portion is absorbed and
the photodetector measures the residual. A fixed amount of light (DC) is absorbed by tissue, including
nonpulsatile blood, and a modulating amount (AC) is absorbed by the pulsating arterial inflow (see Figure 2).
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Clinical and Laboratory Standards Institute. All rights reserved. 1
Number 5 HS3-A
Figure 2. Schematic Representation of Light Absorption in Perfused Tissue. Open and dark circles
represent oxygenated and deoxygenated red blood cells, respectively. Note that the amount of modulated light due to
the arterial signal is tiny relative to the large amount of light absorbed by other components (the typical range of AC
is 0.5 to 5%). [Adapted from Ohmeda Model 3700 Pulse Oximeter Service Manual (1986:22). Reprinted with
permission from GE Healthcare.]
The ratio (R) is quantitatively related to the oxygen saturation of arterial blood measured in a laboratory
oximeter.
AC red /DC red
R=
ACinfrared /DCinfrared
Since the mathematical relationship between oxygen saturation and R is not fixed, pulse oximeter
manufacturers calibrate their devices empirically using a laboratory oximeter and arterial blood from
healthy human volunteers.
The current generation of pulse oximeters is unable to distinguish abnormal hemoglobin species and
therefore only estimate functional oxygen saturation.
oxyhemoglobin
Functional oxygen saturation = • 100
(oxyhemoglobin + deoxyhemoglobin )
In contrast, laboratory oximeters use multiple wavelengths that distinguish abnormal derivatives of
hemoglobin and will calculate fractional oxygen saturation among other parameters (e.g., Hb).
oxyhemoglobin
Fractional oxygen saturation = • 100
(oxyhemoglobin + deoxyhemoglobin + COHb + MetHb + SulfHb)
Thus, it is apparent that pulse oximeter estimates of oxygen saturation (SpO2) will not be accurate in the
presence of dyshemoglobins (see Section 6.2.3). Pulse oximeters that purport to measure fractional
saturation assume a fixed value for dyshemoglobins, which may not be correct for a given patient and
which can differ from SpO2 readings obtained by other brands.9
Clinical use of pulse oximeters involves patients of all ages and is associated with minimal risk. Pulse
oximetry should be performed by trained personnel who exercise sound judgment in selecting the site and
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2 Clinical and Laboratory Standards Institute. All rights reserved.
Volume 25 HS3-A
sensor, interpreting the results, and formulating subsequent clinical decisions. (See Section 4.5.3.1 for
safety information.)
3 Definitions
Dyshemoglobin//dysHb – A hemoglobin form that is not functionally capable of reversible
physicochemical association with oxygen; NOTE: The known dyshemoglobins affecting pulse oximetry
are carboxyhemoglobin (COHb), methemoglobin (MetHb), and sulfhemoglobin (SulfHb).
Hemoglobin//Hb//Hgb – The iron-containing red pigment-protein of erythrocytes; NOTE: Hemoglobin

occurs most commonly with the iron in the ferrous (II) state in two forms: deoxygenated
(deoxyhemoglobin, HHb) and oxygenated (oxyhemoglobin, O2Hb), which work in concert to transport
oxygen to and from the tissues.
Laboratory oximeter – A device using multiple wavelengths of light to determine the concentration of
hemoglobin derivatives (e.g., O2Hb, HHb, COHb, MetHb, and SulfHb) within a specimen of blood;
NOTE: Measurement of the percent saturation of hemoglobin by oxygen contained in arterial blood
(SaO2) is used to validate SpO2.
Oxygen content – The sum of substance concentrations of the oxygen bound to hemoglobin as O2Hb and
the amount dissolved in the blood (intra- and extracellular, i.e., PO2).
Oxygen saturation – The amount of oxyhemoglobin in blood expressed as a percent fraction of the
amount of hemoglobin able to bind oxygen (oxyhemoglobin plus deoxyhemoglobin); that is,
cO 2 Hb
SO2 = • 100
cO 2 Hb + cHHb
Partial pressure//Tension – The force that a gas, G, in a mixture of gases would exert if it occupied the
same volume as the entire mixture at the same temperature; NOTE: In the human body, the pressure of
oxygen that would exist in a hypothetical ideal gas phase in equilibrium with arterial blood is symbolized
as PaO2.
Perfusion – The presence of blood flow.
Pulse oximeter – A noninvasive device that measures wavelengths of light passing through pulsatile
arterial blood to estimate the SaO2 and pulse rate.
Pulse rate – The PR value is derived by a pulse oximeter and expressed in beats per minute (bpm).
SaO2 – Oxygen saturation of arterial blood.
Sensor – The part of the pulse oximeter applied to the patient that contains the light source(s) and
detector(s); NOTE: This term is used interchangeably with the term “probe.”
SpO2 – In pulse oximetry, an estimate of the arterial oxygen saturation arrived at by measuring the
relative absorption of red and infrared light by pulsating arterial blood.
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4 Premonitoring
4.1 Indications for Use
The fundamental indication for use of pulse oximetry is to prevent tissue hypoxia. The most thorough
assessment of a subject’s oxygenation status occurs via direct analysis of blood, which may include the
measurement of arterial and venous blood gases with laboratory oximetry. These analyses are performed
at different frequencies depending upon the clinical need, but each method carries a degree of risk.
Intermittent punctures and intravascular catheters may be a source of embolism, infection, hemorrhage,
and tissue trauma.10 Handling blood also presents exposure to blood-borne pathogens (refer to the most
current edition of CLSI/NCCLS document M29—Protection of Laboratory Workers from Occupationally
Acquired Infections for additional information).
A pulse oximeter minimally displays SpO2 in %, an estimate of the functional arterial oxygen saturation
(SaO2), and pulse rate (PR) in beats per minute (bpm). Pulse oximeters do not require user calibration and
if working satisfactorily, the sensor can be left on for hours without injury or loss of accuracy. These
features have enabled routine use of pulse oximetry for a variety of monitoring conditions. A trend of the
SpO2 data can be helpful: 1) between periods of direct arterial blood analysis, especially in those at risk
for dynamic shifts in oxygenation (e.g., hypoxia, apnea); 2) when being supported by mechanical
ventilation or receiving a respiratory depressant11,12; and 3) where sampling and analysis of blood would
be impractical (e.g., patient transport, exercise testing for titration of supplemental oxygen).13
4.2 Environment of Use
Pulse oximetry is prescribed by a physician, and its use should be medically supervised. The personnel
directly responsible for its application should be trained and competent in the setup, short- and long-term
use, the assessment of data reliability, and the limitations of the device. As an example, pulse oximetry is
used during exercise testing to correctly titrate oxygen therapy for activities of daily living. In this setting,
perfusion and/or motion artifact can produce false-negative and false-positive results.13
Pulse oximetry is used across the spectrum of patient ages. The areas of known utility of pulse oximetry
within a hospital or patient care facility include but are not limited to: the emergency department;
intensive care; patient transport; exercise; wherever an anesthetic (including conscious sedation) is in use;
and diagnostic laboratories (e.g., pulmonary and sleep). Other areas of use include onsite care outside the
hospital or patient care facility (e.g., ambulance, home care, field response site).
4.3 Patient Assessment
The performance of a pulse oximeter can be adversely affected by the patient/sensor interface (i.e., the
site selected and type of sensor). It is essential to select a sensor that is appropriate for the chosen
monitoring site and that the sensor is correctly aligned and securely fitted to the site. The site should also
be well perfused, and free of known artifact sources (e.g., deep skin pigmentation, nail polish, tattoos,
extraneous light, intravascular dyes, venous congestion,14 motion).
4.4 Instrument
A pulse oximeter is comprised of a sensor and a monitor, which may be combined in a single assembly.
The most commonly used type of sensor (i.e., transmittance) has the photodetector positioned opposite
the light source. The reflectance pulse oximeter has the photodetector and light source positioned in a
planar arrangement. Pulse oximeters are available as hand-held or stand-alone units, modules integrated
in multiparameter monitors, and pager or telemetry systems.
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4.4.1 Calibration/Maintenance
Pulse oximeters cannot be calibrated by the user in the same sense as an invasive blood pressure
transducer. The basic relationship between optical signals and the displayed value of SpO2 and PR is
determined by the manufacturer for a given combination of pulse oximeter and sensor, which is stored
permanently in the device.
For pulse oximeters, no simulators are available that have proven adequate for calibration of SpO2.15 The
interaction of light and human tissue, upon which pulse oximetry depends, is complex. Thus, the primary
available method for determining the accuracy of an SpO2 reading is to compare it with measurements of
arterial blood using a laboratory oximeter. PR can be tested with a simulator or directly from the patient
via auscultation, palpated pulse, or an ECG monitor. However, like SpO2, PR cannot be calibrated by
anyone other than the manufacturer.
To prevent damage, soaking or immersing the pulse oximeter sensor in any liquid should be avoided
unless specifically recommended by the sensor manufacturer. If a sensor is damaged in any way, it should
be replaced.
4.5 Sensor and Sensor Site Selection and Preparation
Transmittance-type sensors have the advantage of ease of user placement and use of sites that are
generally well perfused. However, they can be a source of patient entanglement and are prone to motion
artifact. When placed in a central body position, the reflectance-type sensors are typically more
responsive, less prone to motion, and well tolerated by the patient, but are faced with inherently weaker
signals from which to detect patient values.
The points below should be considered when choosing a sensor application site:
• Choose a site that is well perfused and will completely cover the sensor’s detector window.
• The site should be cleaned of debris and be dry prior to sensor placement.
• The index, middle, or ring fingers of the nondominant hand are preferred sites for children and adults.
The great toe or the adjacent toe may be used on patients whose hands are unavailable. The forehead
is a suggested site for reflectance technology sensors. An earlobe or the bridge of the nose can also be
used with the appropriate sensor. In neonates, the palm, great toe, or lateral aspect of the foot are
preferred as sensor sites.
• Ideally, the extremity should be free of a blood pressure cuff and intravenous or intra-arterial
catheters. This will minimize the problems related to weak arterial pulse signals and venous
congestion at the sensor site.14
• In cases of poor perfusion, local rewarming of sensor sites may restore adequate signal quality.
Covering the sensor site with a nonrestrictive bootie (neonatal use) or glove, placing the site under a
warming device, or correcting the cause of poor perfusion can improve blood flow to the area and
pulse oximetry performance.
• In the presence of bright light sources (e.g., direct sunlight, surgical lamps, infrared warming lamps,
and phototherapy lights), covering the sensor site with an opaque material will minimize the potential
for ambient light interference, which can cause inaccurate readings.16
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Users should refer to the manufacturer’s instructions for specifics on the use of a given sensor for the type
of patient and potential sensor site.
4.5.1 Sensor Application
Users should follow manufacturers’ instructions when securing a sensor to a site. Use of additional tape
or constrictive bandaging has been associated with skin injury.17 Pulse oximetry sensors are designed so
that the light source and photodetector are positioned to allow proper fit over varying thicknesses of
tissue. When applied to the selected area, the optical components must be properly aligned across a
capillary bed. Malpositioning of the sensor can affect accuracy.18,19
4.5.2 Duration of Use
The application sites for sensors should be checked for proper adhesion, skin integrity, and adequate
circulation at least once every eight hours and changed or repositioned, as appropriate. Sensors applied
too tightly with adhesive or with a pressure clip may cause damage in less time.20 Also, the potential for
tissue damage is higher in poorly perfused patients.21 Users should follow the manufacturer’s instructions
for use in combination with clinical judgment.
4.5.3 Patient Activity
Reusable, clip-style sensors are generally less secure on active patients. Single-patient use, adhesive-
backed sensors provide a stable, “second-skin” fit that maintains secure positioning of the sensor’s optical
components and allows the sensor to move with the patient. With active patients, these sensors may
provide greater monitoring reliability.22 Alternately, consideration may be given to applying the sensor or
an appropriate alternative sensor to a less active site.
4.5.3.1 Safety
Pulse oximetry has a history of safe clinical use extending beyond two decades. However, off-label use
and inappropriate clinical application can increase the hazards. Known safety concerns include pressure
ischemia,21 burns,23,24 burns associated with photodynamic therapy,25 and burns associated with
inappropriate use in an MRI scanner.26
Pulse oximeter sensors may be a source of contamination.27 Sensors are available in sterile packaging
from some manufacturers. The adhesives and materials used in the construction of disposable and
reusable sensors are generally latex-free, but should be verified by the user in conditions of known
sensitivity.
As with any patient monitoring device that uses wire leads, there can be a risk of entanglement. There is a
need for ongoing assessment of the sensor site, type of sensor used, methods used to capture and display
the values, and device used in order to limit the complications and optimize the performance of pulse
oximetry.
5 Monitoring/Testing Session
5.1 Duration
A minimum of 60 seconds is needed from the time the SpO2 and PR display stabilizes to assess the
quality of the detected signal in order to ensure the reliability of the measured values. Refer to Sections
5.3 and 5.4 for information on assessment of signal quality and associated troubleshooting.
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5.2 Instrument Settings
5.2.1 Alarm Settings/Management
The alarm limits of a pulse oximeter are generally configurable. Current clinical thinking suggests a
default low SpO2 alarm limit between 85 and 90% to ensure patient safety.28 The default alarm settings,
which may be indicated continuously or available via user selection, vary depending upon the age of the
patient (see Table 1). Users should verify that the alarm settings are appropriate for the patient.
Table 1. Typical Default Alarm Limits

Adult Mode Neonate Mode
SpO2 (%) Pulse Rate (bpm) SpO2 (%) Pulse Rate (bpm)
high low high low high low high low
off, 100 85-90 130-170 off, 40-55 off, 95-100 80-90 180-200 60-100
If a pulse oximeter is provided with an alarm for SpO2 or PR, then a low SpO2 alarm should be present.5
Units employed for neonatal monitoring should have a high SpO2 alarm as an additional safety feature.
The volume of a patient monitor alarm should be 85 dBA at 1 meter to meet the goal of “sufficiently
audible with respect to distances and competing noise within the unit.”29 This design recommendation has
been adopted, but allows the user to mute an audible alarm or reduce its volume.5 However, disabling
auditory alarms requires deliberate action by the user, and the monitor should indicate that an audible
alarm has been silenced.
5.2.2 Alarm Management
If the optical signal falls below a manufacturer-determined threshold, which can be common with poor
perfusion (i.e., low signal) and sensor site motion (i.e., high noise), the device is unable to determine
accurate pulse and saturation values. When this occurs, some devices will “freeze” the last reliable value,
and indicate the problem either by a flashing display or an error message such as “poor signal.” Other
instruments will display no value at all, and give only the error message or a flashing display. In either
case, it is imperative that the user recognizes that the oximeter is not displaying a current value. To reduce
the incidence of false alarms, some manufacturers have lengthened signal-averaging intervals. The user is
cautioned that such practice can result in missing true alarms (see Section 5.2.3). Similarly, some alarm
management methods are reported to miss the detection of hypoxemia and bradycardia.30 More recently,
some manufacturers have incorporated advanced signal processing technology designed to identify and
reject artifact that could otherwise be mistaken for a pulse, even in conditions of low perfusion.31 Others
now determine SpO2 independent of PR, but only display SpO2 if PR is present.
5.2.3 Signal Averaging and Data Storage
Signal averaging is the process of averaging instantaneous values over a given interval (for pulse
oximetry, usually in seconds). The technique of signal averaging can reduce artifactual fluctuations in
SpO2, but an unintended effect is that the display of real changes in SpO2 is blunted (see Figure 3).
Particularly in apnea of prematurity but also found in adult sleep apnea, episodes of hyperventilation often
follow each apnea, leading to acute resaturation/desaturation epochs.32 The result is that long signal
averaging times during assessment of desaturation events can lead to underestimating the number of
events by up to 60% when compared to a control.33 The signal-averaging interval should be adjusted by
the user to minimize nuisance alarms while maintaining the desired sensitivity to changes in SpO2.
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Figure 3. Effects of Signal Averaging Time Upon the Enunciation of a True Alarm. The 8-, 12-, and
16-second setting would not have alarmed at a threshold of 80%.
Many systems have the capability to store and retrieve information from memory. The data storage
capacity of a pulse oximeter should be adequate to cover the desired study period. Note that to eliminate
the chance of mixing patient data, the resident memory of the oximeter must be erased prior to placement
on the subject. The user may need to be aware of the sampling rate for data storage, since this may affect
resolution of the data. The sampling rate should be frequent enough to ensure that significant events are
not missed. It is common for devices used for the study of pulse oximetry during sleep to capture the data
at intervals of ≤4 seconds. Less frequent sampling could result in meaningful events being missed.34
5.3 Quality of Signal
Assessment of the quality of the signal is paramount to interpretation of the data. Poor signal quality
occurs when the arterial pulsations are small compared to the background of physiological components
(see Figure 2) and nonphysiological noise. These may be the result of vasoconstriction, venous
congestion, low blood pressure, and/or high noise levels, which would include motion, ambient light,
electrical interference, or other factors.35,36
5.3.1 Indicators of Signal Quality
A constant amount of light (DC) from the pulse oximeter is absorbed by skin, other tissues, and
nonpulsatile blood, while a variable amount of light (AC) is absorbed by a pulsating arterial inflow. The
pulsatile signal (or pulse strength) indexed against the nonpulsatile signal and expressed in percent
(AC/DC x 100) is commonly referred to as the perfusion index (PI). While the PI can be useful in
assessing local perfusion,37 motion, vascular pharmacokinetics (peripheral constrictors and dilators), as
well as the presence of hypothermia, local vasospasm, or emboli can adversely affect use of the PI as an
indicator of global perfusion. Some oximeters display plethysmographic waveforms or bar graphs to
assist the user in assessing pulse strength or signal quality. The magnitude of the waveform or pulse
amplitude bar graph may assist the user in determining if there is an adequate signal. However, some
pulse oximeters normalize the plethysmographic waveform, so the height of the waveform may not be a
good indicator of pulse strength or signal quality.38 It is important to note that most pulse oximeters use
the infrared channel to display the plethysmographic waveform. As a patient desaturates, more infrared
light is absorbed and thus the “pulse strength” may appear to have attenuated.
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The shape of the plethysmographic waveform can also be used as an indicator of the quality of the signal
and should approximate an arterial blood pressure waveform. If provided, visual inspection of the
plethysmographic waveform can allow the user to detect motion or electrical artifact. Pulse oximeters
have been recently introduced with claims of tolerance to certain motion and low perfusion conditions. In
such devices, the data can be accurate even when displaying a corrupted plethysmograph. An indicator of
signal quality is often present on such devices and can prompt the operator of spurious data.39
Agreement between the pulse oximeter-displayed PR and another source (e.g., auscultation, palpated
pulse, ECG monitor) also provides some confirmation of adequate signal quality. However, a disparity in
the pulse oximeter PR and the heart rate displayed on an ECG monitor may exist in patients with valvular
disease, intracardiac balloon pump, and cardiac bypass.40,41
5.4 Troubleshooting
Known external factors, which can affect the quality of SpO2 data, include but are not limited to:
• intense ambient light;
• electrical interference from nerve stimulators or electrocautery instrumentation42,43;
• malpositioning of the probe18,19; and
• placement over pulsating arteries.44
The user should be familiar with troubleshooting recommendations for the specific oximeter make and
model being used. Table 2 is a highlight of the common problems, causes, and corrective actions.
Table 2. Guidelines for Troubleshooting

Problem Causes Action
No pulsations or Patient cable or sensor is defective or Check sensor connection or try a new
plethysmographic waveform not connected cable.
Sensor malpositioned Reposition sensor.
Poorly perfused site Rub site vigorously for 20 to 30 seconds.
Select alternate site.
Tissue too thick (e.g., callous or
scleroderma)
Low-quality signal Sensor malpositioned Reposition sensor.
Poorly perfused site Rub site vigorously for 20 to 30 seconds.
Select alternate site.
SpO2 value is erratic Sensor malpositioned Reposition sensor.
Patient motion Change to site prone to less motion.
Pulse rate is erratic Sensor malpositioned Reposition sensor.
Patient motion Change to site prone to less motion.
Correlate PR with ECG.
Cardiac arrhythmia
Motion artifact noted on Patient motion Change to site prone to less motion.
plethysmographic waveform Stabilize sensor and/or sensor cable.
Electronic interference noted on Electrocautery or other electrical Interference can be reduced by moving
plethysmographic waveform devices the unit and sensor away from the
surgical site or electrical device.
When troubleshooting routines have been exhausted and the pulse oximetry data do not correlate with the
clinical presentation of the patient, an arterial blood specimen should be obtained for analysis of
functional saturation. (Refer to the most current edition of CLSI/NCCLS document H11— Procedures
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for the Collection of Arterial Blood Specimens for additional information on collection, handling, and
transport of arterial blood specimens.) The calculated saturation derived from a blood gas analyzer should
not be used for a reference of SpO2 values.
6 Interpretation
The correct interpretation of data provided by the pulse oximeter is a vital step in making patient care
decisions. Pulse oximeters are subject to various measurement errors, both random and systematic. The
user should be aware of the sources of these errors in order to predict when they are likely to occur. In
addition, to interpret pulse oximeter data, the user should understand the basic physiology of arterial
hemoglobin oxygen saturation. This section will briefly review pulse oximeter accuracy and reliability,
sources of error, and the uses and limitations of arterial oxygen saturation data.
6.1 Performance: Accuracy and Reliability
6.1.1 Accuracy
The calibration algorithm built into the pulse oximeter is based upon experimental data obtained from
healthy adult volunteers who were made hypoxemic by breathing low-oxygen gas mixtures. Pulse
oximeter absorbance values were then compared to direct measurements of oxygen saturation made on
arterial blood samples using a multiwavelength laboratory oximeter. The pulse rate is referenced against
ECG heart rate, thoracic auscultation, or palpating the pulse. Since the pulse oximeter is programmed
with one universal calibration curve for all patients, it is subject to errors caused by differences between
patients (between-subject error), as well as random errors due to measurement imprecision (within-
subject error). Calculated SO2 values from a blood gas analyzer should not be used to assess oxygenation
status because of potential error. Only the functional oxygen saturation value from a laboratory oximeter
should be a qualified reference for SpO2.
To validate pulse oximeter readings, incorporate or assess agreement between SpO2 and arterial
oxyhemoglobin saturation (SaO2) obtained by direct measurement—these measurements should be
initially performed simultaneously and then periodically reevaluated in relation to the patient’s clinical
state.7 Most pulse oximeter manufacturers provide a value of uncertainty for SpO2 expressed as ± one
standard deviation. Given a typical specification of ±2% from 70 to 100%, roughly 68% of the measured
SpO2 values would fall within 2% of the functional saturation as measured in arterial blood by a
laboratory oximeter. However, 32% of SpO2 values would fall outside of the 2% window; that is, 32% of
the time, the pulse oximeter error would be greater than 2%. With the realities of clinical use, comparison
of pulse oximeter SpO2 to blood SaO2 values reveals a larger error.45
A pulse oximeter is approvable if it is on average accurate to within 3% of a CO-oximeter based upon

SaO2 levels ranging from 70 to 100%. Here, accuracy is defined by “the root-mean square between the
pulse and CO-oximeter values.”46 Engineers know this as “rms error” or “root mean square error,” a way
of averaging the absolute values of errors over the full measurement range (Arms). The Arms statistic
accounts for between- and within-subject variation and the bias.
n
∑ (SpO 2i − S Ri )
2
Arms = i =1
n
where n is the number of data pairs in the sample, SpO2i is the ith SpO2 datum, and SRi is the ith reference datum
(i.e., functional SaO2 value).
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The bias (b) is a value for each SpO2 and is calculated as follows:
bi = SpO 2 − S Ri
The Arms value is the square root of the sum of each squared difference between the displayed and
reference values (i.e., bias) divided by the number of samples. By substitution, the formula can be
simplified as follows:
n
∑ (b i )
2
Arms = i =1
n
A minimum of in vivo (i.e., clinical) testing with 20 paired SaO2 to SpO2 measurements equally
distributed over the range of claimed accuracy from ten subjects and that one subject be darkly
pigmented.
6.1.2 Reliability
Pulse oximeters do not always provide continuous, real-time data. If the signal-to-noise ratio falls below a
manufacturer-determined threshold, the device will be unable to determine an accurate value. In this state,
some devices will “freeze” the last value they were able to calculate, and indicate the problem either by a
flashing display or an error message such as “poor signal.” Other instruments will display no value at all,
and give only the error message or flashing display. In either case, it is imperative that the user recognizes
that the oximeter is not displaying a current scenario value. It is common that as the oxygen saturation
value falls, the SpO2 absolute accuracy decreases, until at very low saturations the pulse oximeter
becomes a trend monitor only, with no specified accuracy. This does not diminish the value of the
instrument at low saturations; for example, when the reading is 40%, the user is most interested in
knowing whether SpO2 is trending up or down.
This type of signal loss varies with both the clinical scenario and the technology of the instrument.
Although initial studies based on review of the handwritten records reported low overall dropout rates of
1.1%47 and 2.5%,48 a retrospective review of computerized anesthesia records revealed continuous gaps of
>10 minutes in pulse oximetry data for 9.2% of cases.49 It is noteworthy that the failure rate is higher in
more seriously ill patients, making the device more likely to fail in those patients for whom the user needs
it most.50,51 This phenomenon has prompted manufacturers to develop new methods of processing the
pulse oximeter signal, in order to improve performance at low signal-to-noise ratios. The user should be
aware that some alarm management methods have been associated with delayed or missed identification
of hypoxemia and bradycardia.30
6.2 Sources of Error
There are a number of clinical situations in which the pulse oximeter will predictably provide erroneous
data. The user with a grasp of the fundamental operating principles of the instrument readily understands
these errors. Common error sources include those listed below.
6.2.1 Ambient Light Interference
The pulse oximeter transmits light into vascular tissue and analyzes the residual light with a
photodetector. Ambient light from the room can also reach the photodetector and produce its own signal.
If this ambient light signal fluctuates, the instrument may interpret it as a pulsatile absorbance signal from
the patient, which can deteriorate both the accuracy and reliability of the SpO2 and PR readings. The best
solution to this problem is to shield the photodetector from ambient light by covering the sensor with an
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opaque barrier.16 For example, in the operating room, this may be as simple as placing a towel or drape
over the patient’s hand.
6.2.2 Intravenous Dye Injection
Pulse oximeters are designed to determine the ratios of only two light absorbers in the blood:
deoxyhemoglobin (HHb) and oxyhemoglobin (O2Hb) (see Figure 1). If additional light absorbing
substances are present in the blood, the pulse oximeter may produce an erroneous SO2 reading.52
Methylene blue dye is an excellent example of this problem. When methylene blue was injected
intravenously in healthy volunteers, SpO2 readings as low as 4% resulted.53 Spurious readings have also
been attributed to the intraoperative use of isosulfan blue (lymphazurin) to identify axillary lymph
nodes.54
6.2.3 Dyshemoglobins
Like intravenous dyes, abnormal hemoglobins in the blood such as carboxyhemoglobin (COHb) and
methemoglobin (MetHb) will absorb light (see Table 3 and Figure 4). The presence of additional
hemoglobins will cause errors in the SpO2 reading if these dyshemoglobins absorb light at one or both of
the pulse oximeter wavelengths.52,55,56
Table 3. Effects of Dyshemoglobins on SpO2 Values

Component Normal Cause of Raised Effect on SpO2
Amount Concentration
Inhaled from exposure to COHb is read as SpO2 and displaces O2 on Hb, so
COHb <2% combustion source (e.g., SpO2 remains 90 to 95% range even at lethal
automotive exhaust or fire) COHb levels.
Metabolic disease or excess MetHb absorbs light at both oximeter
MetHb <1% inhaled nitric oxide therapy wavelengths, and at high levels tends to force the
(iNO) SpO2 reading towards a value of 85%.
In contrast, laboratory oximeters use multiple wavelengths (from 7 to 256) to measure functional oxygen
saturation (the SpO2 correlate) as well as dyshemoglobins.57
Extinction Coefficient
Figure 4. Absorption Spectra of Dys-, Oxy-, Deoxyhemoglobin Derivatives
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The influence of fetal hemoglobin on the SpO2 reading is insubstantial at an SaO2 >70%, but at an SaO2
<25%, a significant underestimation of some 5% can be found.58 The effects of sickle hemoglobin on
SpO2 readings are inconclusive due to the difficulties in obtaining either clinical or volunteer data in these
patients.59
6.2.4 Venous Pulsations
Conventional pulse oximeters assume that the pulsatile light absorbance signal is caused entirely by
fluctuations in arterial blood volume. However, venous blood volume can also pulsate in some settings,
producing erroneously low SpO2 readings and an inaccurate PR.15,60,61 An oximeter with an ear, nose, or
forehead sensor used on a patient who is in steep Trendelenburg or lithotomy position can be subject to
this type of error.
6.2.5 Low Peripheral Perfusion
If there are no detectable absorbance pulsations found in the tissue by the sensor, the pulse oximeter
cannot function. As the amplitude of the arterial pulsations decreases, all pulse oximeters eventually fail
to measure.36,62 Hypotension, cold extremities, and severe vascular disease are some factors that reduce
both peripheral pulsations and pulse oximeter signal. When the pulse oximeter fails because of low signal,
the user should confirm the patient’s hemodynamic stability. Once this is verified, the user should try
alternative sensor sites, or attempt to improve the peripheral pulsations.
6.2.6 Motion Artifact
Patient motion can cause pulsations in venous blood volume,61 detected by the pulse oximeter as pulsatile
light absorbencies, which can result in either erroneous SpO2 and PR readings or no reading at all. Some
types of motion also degrade the integrity of the optical signal by moving sensor components relative to
one another or relative to the tissue. To minimize the effects of motion, the user should place the sensor
on a site least likely to move, secure the sensor and lead wire well, and (in an environment of high
ambient light) cover the sensor and site with an opaque barrier. Manufacturers are developing new signal
processing technologies aimed at reducing the effects of motion artifact.
Advances in pulse oximetry technology resulting in proven clinical benefits have related to managing the
data postsignal acquisition (i.e., software). Manufacturers’ methods are proprietary but involve use of
either or both time and frequency domain analysis to extract and display the best possible information
under challenging clinical conditions. Unlike the earlier pulse oximeters, pulse rate algorithms are often
performed independent of the SpO2 calculation.31,63
6.2.7 Sensor Malpositioning
If the pulse oximeter sensor is not properly applied or is moved from its correct position, signal-to-noise
ratio may deteriorate. This can produce either erroneous SpO2 values or complete loss of signal.18,19 The
user should apply the sensor as recommended by the manufacturer, and should recheck sensor positioning
after patient movement or repositioning, or whenever suspicious values of SpO2 or PR are obtained.
6.2.8 Electrosurgical Unit (ESU)
The electrocautery or electrosurgical unit (ESU) is a very powerful source of modulated electrical
interference in the operating room. Earlier pulse oximeters were especially prone to this type of
interference, and would not function at all during ESU activation or for up to 30 seconds thereafter.
Newer oximeters use more powerful filtering methods to remove this high-frequency noise from the
detector signal. Therefore, ESU interference is seldom a serious problem with newer oximeters, unless the
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ESU electrode is located very close to the oximeter sensor or its cable. The user should move the sensor
and cable as far as possible from the ESU electrode to minimize this interference.43
6.2.9 Anemia
Mild to moderate levels of anemia have no significant effect upon the accuracy or reliability of pulse
oximetry. However, severe anemia (total hemoglobin <10 g/dL) can cause the pulse oximeter to
underestimate actual saturation with a bias of about 5%.64,65
6.2.10 Nail Polish, Skin Pigmentation, and Tattoos
Nail polishes and tattoos can be troublesome to pulse oximetry in that SpO2 accuracy can be affected by a
background color close to that of oxy- and deoxyhemoglobin.52 Mood-type nail polish can cause
thermogenic spectral changes, which can also confuse correct calculation of SpO2. The user should
remove the polish or seek a site where nail polish and tattoos are not present. While there have been
reports of skin pigmentation as a suspected source of SpO2 interference,66 others claim no relationship
exists.67
6.3 Interpretation of SpO2 Data
If the pulse oximeter is working properly and displaying an accurate SpO2 value, what inferences can the
user make from these measurements? The answer to this question requires examination of the role of
oxygen saturation in the overall oxygen transport process.
6.3.1 The Oxyhemoglobin Dissociation Curve
Arterial hemoglobin oxygen saturation (SaO2) is related to oxygen tension (PaO2) by the oxyhemoglobin
dissociation curve, shown in Figure 5.
Figure 5. The Oxyhemoglobin Dissociation Curve
Two properties of this relationship are especially important to the interpretation of pulse oximetry. First,
the SaO2 value reaches a plateau at PaO2 values in the 60 to 70 mmHg range. When PaO2 varies above
this range, SaO2 will not change significantly. For example, a patient breathing 50% oxygen might have a
PaO2 value of 300 mmHg. If that patient’s endotracheal tube is inadvertently moved into the right
mainstem bronchus, the PaO2 will fall, usually to the 100 to 200 mmHg range. In that case, the SaO2 and
SpO2 will not change measurably. This is a fundamental limitation of oxygen saturation measurements;
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they do not reflect trends in PaO2 when the value of the latter is above 70 mmHg.68 This is of practical
concern in the treatment of neonates where the consequences of elevated PaO2 could be blinding
(retinopathy of prematurity) or lethal (closure of the ductus arteriosus in a heart defect).69 Hence, pulse
oximetry must never be relied on to prevent hyperoxemia.
The second important property of the dissociation curve is its variable shifting to the right or left by other
factors in the blood such as temperature, pH, PCO2, 2,3-DPG, fetal Hb, or dyshemoglobins (see Figure 5).
This phenomenon assists in the uptake of oxygen from the lungs and delivery to tissues. Because of these
factors, the SpO2 reading cannot be used to reliably calculate PaO2. Therefore, the calculated saturation
derived from a blood gas analyzer should not be used for a reference of SpO2 values. Only the functional
oxygen saturation value from a laboratory oximeter should be a qualified reference for SpO2. Moreover,
CLSI/NCCLS document C46—Blood Gas and pH Analysis and Related Measurements recommends that
calculated SO2 values from a blood gas analyzer not be used to assess oxygenation status because of
potential error.
6.3.2 Oxygen Transport
The pulse oximeter estimates how much of the hemoglobin in arterial blood is saturated with oxygen, but
does not directly indicate how much oxygen is contained in the arterial blood. The quantity of oxygen
carried in the arterial blood is described by the relationship:
2
(
CaO = 1.39 mL g • [Hb] • SaO
2
)+ (0.003 mL dL mmHg • PaO )
2
where CaO2 is expressed in mL/dL and the unit of measure for Hb is g/dL and for PaO2 is mmHg.
Since almost all the oxygen carried in the blood is bound to hemoglobin, a reduction in the concentration
of hemoglobin in the blood (anemia) will reduce the oxygen content just as decreased saturation does. It
must be emphasized that knowing the SpO2 does not provide information about oxygen delivery to tissue,
which is the product of arterial oxygen content (CaO2) and cardiac output.70 That is, the pulse oximeter
does not indicate whether an adequate amount of oxygen is reaching the vital organs or other tissues.
6.4 Summary
The development of pulse oximeters has been an important advance in monitoring patient oxygen status.
Ease of use and relatively low cost have resulted in the widespread clinical application of this technology
for detecting oxygenation status. To properly interpret pulse oximeter measurements, the user should
know both the sources of measurement error and the physiology of arterial hemoglobin saturation.
Knowledge of the sources of error will enable the user to predict situations in which erroneous readings
are likely, and then verify the accuracy by means of other clinical data, such as arterial blood analysis
ECG heart rate. A grasp of the physiology of oxygen saturation and transport will allow the user to
maximize clinical value from pulse oximetry while being aware of its limitations.
7 Information Management
7.1 Patient Records
Pulse oximetry results should be recorded with the date and time of measurement in the patient’s medical
record and should include but are not limited to7:
• SpO2 values;
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• inspired oxygen concentration or supplemental oxygen flow and the specific type of delivery device
(e.g., nasal cannula, pulsed-conservation device);
• pulse rate;
• sensor site and comment about signal quality; and
• patient’s position (e.g., supine, sitting, standing) and activity (e.g., rest, ambulatory, shivering).
Documentation of data into an electronic environment or laboratory information system should allow for
the entry of the details listed above.
7.2 Memory Capacity
Many systems have the capability to store and retrieve information from memory. The data storage
capacity required is dependent on the duration of monitoring and the sampling frequency. Some
automated recordkeeping systems incorporate continuous capture of pulse oximetry data. The reason(s)
for lost or spurious data should be recorded to reduce the likelihood of formulating erroneous conclusions
during the postevaluation phase of monitoring. To reduce the chance of combining data from multiple
patients into one patient’s record, it is prudent to erase the data storage memory at the conclusion of each
use.
7.3 Remote Use
If the clinician desires to monitor a patient remotely, some pulse oximeters interface with other systems to
allow this feature. Linking via a nurse call output, pager network, or telemetry system can allow use of a
pulse oximeter as a surveillance tool in an unattended manner.
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Moller JT, Pedersen T, Rasmussen LS, et al. Randomized evaluation of pulse oximetry in 20,802 patients: I. Anesthesiology.
1993;78(3):436-444.
49
Reich DL, Timcenko A, Bodian CA, et al. Predictors of pulse oximetry failure. Anesthesiology. 1996;84(4):859-864.
50
Pulse oximetry for perioperative monitoring: Systematic review of randomized, controlled trials. Anesth Analg. 2003;96(2):426-431.
51
Severinghaus JW, Naifeh KH, Koh SO. Errors in 14 pulse oximeters during profound hypoxia. J Clin Mon. 1989;592:72-81.
52
Ralston AC, Webb RK, Runciman WB. Potential errors in pulse oximetry. III: Effects of interferences, dyes, dyshaemoglobins and other
pigments. Anaesthesia. 1991;46(4):291-295.
53
Scheller MS, Unger RJ, Kelner MJ. Effects of intravenously administered dyes on pulse oximetry readings. Anesthesiology.
1986;65(5):550-552.
54
Coleman RL, Whitten CW, O’Boyle J, Sidhu B. Unexplained decrease in measured oxygen saturation by pulse oximetry following injection
of lymphazurin 1% (isosulfan blue) during a lymphatic mapping procedure. J Surg Oncol. 1999;70(2):126-129.
55
Barker SJ, Tremper KK. The effect of carbon monoxide inhalation on pulse oximetry and transcutaneous PO2. Anesthesiology.
1987;66(5):677-679.
56
Barker SJ, Tremper KK, Hyatt J. Effects of methemoglobinemia on pulse oximetry and mixed venous oximetry. Anesthesiology.
1989;70(1):112-117.
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Nijland R, Jongsma HW, Nijhuis JG, Oeseburg B, Zijlstra WG. Notes on the apparent discordance of pulse oximetry and multi-wavelength
haemoglobin photometry. Acta Anaesthesiol Scand. 1995;37(Suppl 107):49-52.
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Zijlstra WG, Buursma A, Meeuwsen-van der Roest WP. Absorption spectra of human fetal and adult oxyhemoglobin, deoxyhemoglobin,
carboxyhemoglobin, and methemoglobin. Clin Chem. 1991:37(9);1633-1638.
59
Rackoff WR, Kunkel N, Silber JH, Asakura T, Ohene-Frempong K. Pulse oximetry and factors associated with hemoglobin oxygen
desaturation in children with sickle cell disease. Blood. 1993;81(12):3422-3427.
60
Kim JM, Arakawa K, Benson KT, Fox DK. Pulse oximetry and circulatory kinetics associated with pulse volume amplitude measured by
photoelectric plethysmography. Anesth Analg. 1986;65(12):1333-1339.
61
Barker SJ, Shah NK. The effects of motion on the performance of pulse oximeters in volunteers. Anesthesiology. 1997;86(1):101-108.
62
Lawson D, Norley I, Korbon G, Loeb R, Ellis J. Blood flow limits and pulse oximeter signal detection. Anesthesiology. 1987;67(4):599-
603.
63
Palreddy S. Signal processing algorithms. In: Webster JG, ed. Design of Pulse Oximeters. Bristol, UK, and Philadelphia, PA: Institute of
Physics Publishing; 1997:129ff.
64
Severinghaus JW, Koh SO. Effect of anemia on pulse oximeter accuracy at low saturation. J Clin Monit. 1990;6(2):85-88.
65
Lee S, Tremper KK, Barker SJ. Effects of anemia on pulse oximetry and continuous mixed venous hemoglobin saturation monitoring in
dogs. Anesthesiology. 1991;75(1):118-122.
66
Ries AL, Prewitt LM, Johnson JJ. Skin color and ear oximetry. Chest. 1989;96(2):287-290.
67
Bothma PA, Joynt GM, Lipman J, et al. Accuracy of pulse oximetry in pigmented patients. S Afr Med J. 1996;86(5 Suppl):594-596.
68
Barker SJ, Tremper KK, Hyatt J, Heitzmann H. Comparison of three oxygen monitors in detecting endobronchial intubation. J Clin Monit.
1988;4(4):240-243.
69
Poets CF, Urschitz MS, Bohnhorst B. Pulse oximetry in the neonatal intensive care unit (NICU): Detection of hyperoxemia and false alarm
rates. Anesth Analg. 2002;94(S1):41-43.
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Keogh BF. When non-invasive monitoring of the acutely ill is not enough. Anesth Analg. 2002;94(S1):96-99.
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Clinical and Laboratory Standards Institute consensus procedures include an appeals process that
is described in detail in Section 8 of the Administrative Procedures. For further information,
contact the Executive Offices or visit our website at www.clsi.org.
Summary of Comments and Subcommittee Responses

HS3-P: Pulse Oximetry; Proposed Guideline
General
1. In NCCLS document C25-A, all quantities relevant to pulse oximetry have been clearly described and defined. Therefore,
my first recommendation is to make the pulse oximeter document fully consistent with document C25-A.
• HS3 is consistent with CLSI/NCCLS document C46—Blood Gas and pH Analysis and Related Measurements, which
replaces C25.
2. The document should not continue to fight against the misconceptions and misinterpretations which surround the perhaps
too rapid introduction of pulse oximeters into clinical practice. It can be made more simple and clear by cutting out
everything that originates from the confusion of the past, and by just giving a straightforward description of instruments and
techniques, accuracy, limits, and sources of error. If it is still deemed necessary to mention what cannot be accomplished by
means of a pulse oximeter, it should be relegated to an addendum.
• The committee disagrees with the commenter. As indicated in the Foreword, there is a general lack of understanding
of this technology. See reference 1.
Section 2, Introduction (Formerly Section 1)
3. For consistency with NCCLS document C25-A, in Figure 1, “deoxyhemoglobin (HHb)” should be changed to
“deoxyhemoglobin.” In the figure’s legend, “hemoglobin extinction curve” should be changed to “absorption spectra of
common hemoglobin derivatives.”
• The suggested changes have been incorporated.
4. For consistency with NCCLS document C25-A, in the legend for Figure 2, “red blood cells” should be replaced with
“hemoglobin.”
• The diagram represents red blood cells, not free hemoglobin; therefore, the text has been maintained.
5. The second paragraph states, “…due to absorption by skin, tissues, and nonpulsatile blood…” Considering that skin is a
tissue, perhaps “other tissues” would be more correct.
• The text has been modified to read, “A fixed amount of light (DC) is absorbed by tissue, including nonpulsatile blood,
and a modulating amount (AC) is absorbed by the pulsating arterial inflow.”
6. In the second paragraph, replace the phrase, “part of the body within the sensor” with “tissues at the application site.” Also,
replace “signal” (DC) with “attenuation” (DC).
• The phrase “part of the body within the sensor” has been replaced with the term “tissue.” However, use of the term
“attenuation” does not describe the model presented in Figure 2; therefore, the wording has been maintained.
7. The second paragraph should be deleted as it contains several errors. The first sentence suggests that in case of being able to
distinguish dyshemoglobins, a pulse oximeter should not measure oxygen saturation, SO2=cO2Hb/cO2HhB. However, this is the
only quantity an oximeter should measure, and always has measured before somebody came up with the erroneous idea that
fractional oxyhemoglobin, FO2Hb=cO2Hb/ctHb, is the physiologically relevant quantity. It is not, because SO2 is physiologically
related to pO2 as shown in the oxygen dissociation curve. The second sentence states that multiwave hemoglobin
photometers (“co-oximeters”) calculate FO2Hb. They do, but several such instruments also display SO2. NCCLS document
C25-A even states in Section 6.2.1, “Oxygen saturation (SO2) and fractional oxyhemoglobin (FO2Hb) are to be reported
simultaneously, on the same specimen…”
The third sentence does not follow from the second one. The presence of dyshemoglobins in the sample only influences the
measurement because of their light-absorbing properties. The fourth sentence reinforces the confusion the document wants
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to combat. An instrument should not be called an oximeter, because it measures FO2Hb; oximeters measure SO2. Moreover,
what are the physiological reasons for measuring FO2Hb in vivo?
Instead of this paragraph, the following text might be inserted: “The introduction of the pulse principle solved in a single
stroke the two main problems that had caused oximetry to remain a complicated technique requiring special care to attain
reliable results: the necessity to differentiate between blood and nonblood in the lightpath, and the presence in the lightpath
of arterial, capillary, and venous blood, while the arterial SO2 is the relevant quantity to be determined. By using only the
variable part of the light that has passed through the tissue, a signal is obtained that is representative for the arterial blood
and that contains the same information as obtained by conventional oximeters, but without the cumbersome preparatory
manipulations, and with the advantage that the results are not dependent on a single adjustment procedure before the start of
the actual measurements.”
• The intent of the second paragraph is to indicate that pulse oximeters are not capable of distinguishing abnormal
hemoglobin species. The committee recognizes that this terminology is not consistent with CLSI/NCCLS document
C46; however, it is common clinical usage and is consistent with ISO/FDIS 9919, Medical electrical equipment-
Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
Because pulse oximeters use only two wavelengths, they are not capable of distinguishing abnormal hemoglobin
species and thus, by definition, cannot measure FO2Hb.
The committee believes the wording, as presented, is appropriate and has maintained the original language.
8. Paragraph 3: The notation used in the calculations is confusing. We suggest modification as follows:
Functional oxygen saturation = [oxyhemoglobin/(oxyhemoglobin + deoxyhemoglobin)]
Fractional oxygen saturation = [oxyhemoglobin/(oxyhemoglobin + deoxyhemoglobin + carboxyhemoglobin +

methemoglobin + sulfhemoglobin)]
• The mathematical formulae have been reformatted for clarity.
9. In paragraph 4, replace “The current generation of…” with “Dual wavelength…”
• Not all “current generation” devices are “dual wavelength”; therefore, the original wording is appropriate and has
been maintained.
10. Modify the last sentence of the fourth paragraph as follows: “Dual wavelength instruments that purport to measure fractional
in vivo saturation assume a fixed value for dyshemoglobins which may not be correct for a given patient.”
• This statement applies to pulse oximeters, not laboratory oximeters. The text has been modified for clarity.
11. Paragraph 5 states, “Clinical use of pulse oximeters is associated with minimal risk…” However, Section 4.5.2 mentions
skin erosion and tissue necrosis as possible effects of using the device. These comments are somewhat inconsistent. The
guideline should reference applicable data supporting claims of skin erosion and tissue damage.
• The committee firmly believes that the phrase “minimal risk” is appropriate. References have been added to Section
4.5.3.1 on Safety.
Section 3, Definitions
12. NCCLS document C25-A provides a more precise definition of dyshemoglobin.
• The definition of “dyshemoglobin,” supplied in HS3, is more comprehensive than the definition of the term provided
in the current edition of CLSI/NCCLS document C46—Blood Gas and pH Analysis and Related Measurements.
13. Delete NOTE b) from the definition of “dyshemoglobin.”
• NOTE b) has been deleted as recommended.
14. In the last line in the definition for “hemoglobin,” delete “…and related materials,” or change to “CO2.”
• The phrase “and related materials” has been deleted as suggested.
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15. Definition of “laboratory oximeter”: I would prefer to call this instrument “(multiwavelength) hemoglobin photometer.” In
the first line, change the term “content” to “concentration.” If a note is deemed necessary here, I think it should read, “SO2
measured in arterial blood samples should be used for comparison with pulse oximeter readings.”
• The committee has retained the broader term “laboratory oximeter.” The term “concentration” has replaced
“content.”
16. “Oxygen content” should be defined as, “the amount of oxygen contained in a given volume of blood, either bound as HbO2
or dissolved in the plasma.”
• The definition of “oxygen content” is consistent with CLSI/NCCLS document C46—Blood Gas and pH Analysis and
Related Measurements.
17. In the definition for “oxygen content,” although “concentration” would be the chemically correct term, “content” is
unambiguous in the context.
• See response to comment 16.
18. Modify the definition for “oxygen saturation” to read, “the amount of oxyhemoglobin in blood expressed as a percent
fraction of the amount of hemoglobin available to bind oxygen.”
19. Delete the parenthetical statement preceding “n” in the definition of “oxygen saturation.”
• The parenthetical statement has been deleted as suggested.
20. Modify the definition of “partial pressure” to read, “the pressure that a gas, G…”
• The definition of “partial pressure” is consistent with CLSI/NCCLS document C46—Blood Gas and pH Analysis and
Related Measurements.
21. Modify the definition of “pulse oximeter” to read, “a device that measures the modulation of two wavelengths of light
passing through pulsatile arterial blood and uses those signals to estimate the SaO2 and pulse rate.”
• The definition has been modified to read, “A noninvasive device that measures wavelengths of light passing through
pulsatile arterial blood to estimate the SaO2 and pulse rate.”
22. Modify the definition of “SpO2” to read, “an estimate of the arterial oxygen saturation arrived at by measuring the relative
absorption of red and infrared light by pulsating arterial blood.”
• The definition has been modified as suggested.
23. Definition of SpO2: I think this symbol should be abandoned, since it is the result, as well as the cause, of several
misunderstandings. First, it looks like a hybrid of SO2 and pO2, while it does not signify anything in relation to pO2. Second, it
suggests that the pulse oximeter does not measure arterial oxygen saturation, but some other quantity.
I understand that the reason for the different symbol and the definition given is a warning against the relative inaccuracy of
the method, which is indeed to a considerable extent the result of the absence of a suitable theory of light absorption and
scattering in living tissues. This is the old, basic problem of oximetry which has not been solved by the introduction of the
pulse principle. Yet, the instrument gives a signal that reflects changes in the oxygen saturation of the arterial blood, and it is
calibrated using arterial blood samples in which the oxygen saturation has been accurately measured in vitro (by the way,
usually also by calculation from light absorption measurements, though it could be gasometrically). Thus, the pulse oximeter
measures, or perhaps one should cautiously say estimates, SO2. There are sources of indirect methods in biology and
medicine that only have such an empirical basis. This demands a thorough error analysis, not renaming of the measured
quantity.
The argument that SpO2 is an established symbol is not valid; only the presently practicing generation is accustomed to it. It
should not confuse all future generations.
• Changing a term that has been universally accepted in clinical practice is not the prerogative of this committee.
The term is defined in and is consistent with ISO/FDIS 9919, Medical electrical equipment- Particular requirements for
the basic safety and essential performance of pulse oximeter equipment for medical use.
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Section 4.1, Indications for Use
24. There is a lot of interesting information in this section, but I cannot find any “indications for use.” This text would be more
appropriate in the introduction.
• The text has been modified to suggest “indications for use.”
25. In the first paragraph, various methodologies for assessing oxygenation using blood are described. While “capillary blood
gases (heelstick)” are mentioned, the committee might want to consider also including the earlobe. (See the following for
information: Pitkin AD, Roberts CM, Wedzicha JA. Arterialised earlobe blood gas analysis; an underused technique.
Thorax. 1994:49;364-366. Sauty A, Uldry C, Debetaz LF, Leuenberger P, Fitting JW. Differences in PO2 and PCO2
between arterial and arterialized earlobe samples. Eur Respir J. 1996;9:186-189.)
• This recommendation is not consistent with the current edition of CLSI/NCCLS document H11—Procedures for the
Collection of Arterial Blood Specimens; therefore, the original wording has been maintained.
26. Define “instantaneous results,” as the phrase is “relative.” (Note: Section 5.1 on Duration implies that instantaneous is
approximately equivalent to “a minimum of 60 seconds.”)
• The phrase “instantaneous results” has been deleted.
27. Change the first sentence of the second paragraph to read, “A pulse oximeter provides an estimate of the arterial oxygen
saturation.”
• The text has been modified to read, “A pulse oximeter minimally displays SpO2 in %, an estimate of the functional
arterial oxygen saturation (SaO2), and pulse rate (PR) in beats per minute (bpm).”
28. In the last sentence of the first paragraph, replace “SpO2” with “pulse oximeter.”
• The committee believes that, in the context of the sentence, SpO2 is more correct.
29. Consider adding a fourth statement to the second paragraph, i.e., “4) Continuous monitoring with a pulse oximeter is
indicated in patients at risk for hypoxemia. Such patients include those: on continuous supplementary oxygen therapy, being
supported by mechanical ventilator, receiving respiratory depressant medication, undergoing surgical procedures, etc.”
• The committee appreciates the commenter’s input. The recommendation has been incorporated into the text with
modified wording. It reads, “A trend of the SpO2 data can be helpful: 1) between periods of direct arterial blood
analysis, especially in those at risk for dynamic shifts in oxygenation (e.g., hypoxia, apnea); 2) when being supported
by mechanical ventilation or receiving a respiratory depressant; and 3) where sampling and analysis of blood would
be impractical (e.g., patient transport, exercise testing for titration of supplemental oxygen).”
Section 4.2, Environment of Use (Formerly Clinical Settings)
30. Consider changing the heading of this section from “Clinical Settings” to “Environment of Use.”
• The section heading has been modified as suggested.
31. This section states, “A pulse oximeter is used upon the prescription of a physician…” I wonder about this statement as I see
pulse oximetry used frequently for safety without such a prescription. Many hospitals have policies and procedures that
incorporate such a practice. Consider rewording this sentence, i.e., it may be more correct to state that pulse oximetry is used
when ordered by a physician or according to approved standard operating procedures. I am also aware of hospitals and
clinics that consider the use of pulse oximetry a vital sign, like blood pressure or temperature.
• Standard operating procedures (SOPs) and clinical practice guidelines (CPGs) require medical direction; therefore,
the committee believes the original wording is appropriate as stated.
Section 4.3, Patient Assessment
32. Add the following to the end of the first paragraph, “Therefore an important part of patient assessment is selecting a
monitoring site that is likely to yield good signals. It is also essential to select a sensor that is appropriate for the chosen
monitoring site.”
• The text has been modified to incorporate this recommendation. It reads, “The performance of a pulse oximeter can
be adversely affected by the patient/sensor interface (i.e., the site selected and type of sensor). It is essential to select a
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sensor that is appropriate for the chosen monitoring site and that the sensor is correctly aligned and securely fitted to
the site. The site should also be well perfused, and free of known artifact sources (e.g., deep skin pigmentation, nail
polish, tattoos, extraneous light, intravascular dyes, venous congestion, and motion).”
33. The sources of known artifact listed parenthetically are well known. Most of these are well understood without further
clarification (e.g., nail polish). However, deep skin pigmentation is less clear. At what level is skin pigmentation considered
“deep,” clinically? Consider the reference, Ries AL, Prewitt WM, Johnson JJ. Skin Color and Ear Oximetry, Chest. 96-
2:287-290, which uses the Munsell color system for classifying degrees of skin pigmentation.
• Section 6.2.10, Nail Polish, Skin Pigmentation, and Tattoos, has been added to address the commenter’s concerns.
34. In the second paragraph, “sources of interference (e.g., EMI, MRI)” should be added to the parenthetical list of “sources of
known artifact.”
• Magnetic resonance imaging (MRI) is not a source of artifact; it is a hazard which has been addressed in Section
4.5.3.1 on Safety.
35. Delete “venous congestion” as a source of interference.
• The phrase “venous congestion” has been maintained and a supporting reference has been cited.
Section 4.4, Instrument
36. This section lists commercial configurations. I question its value as it likely changes frequently and sounds a little too
commercial.
• Knowledge of available configurations may be useful to the reader; therefore, the list has been maintained.
Section 4.4.1, Calibration/Maintenance
37. We are aware of some sensor manufacturers that recommended immersion for cleaning. Consider rephrasing this sentence
as, “To prevent damage, soaking or immersing the sensor in any liquid solution should be avoided unless specifically
recommended by the sensor manufacturer.”
• The text has been modified as suggested.
38. In the fourth line, replace “SpO2” with “arterial SO2” or “aSO2.”
• SpO2 has been maintained as it is considered “standard terminology” in clinical practice.
39. Consider modifying the last sentence of the first paragraph as follows: “The basic relationship between patient-derived
optical signals and the displayed value of SpO2 is determined by the manufacturer for a given combination of oximeter and
sensor. This relationship is defined by coefficients stored permanently in firmware, and is never adjusted.”
• The text has been modified to read, “The basic relationship between optical signals and the displayed value of SpO2
and PR is determined by the manufacturer for a given combination of pulse oximeter and sensor, which is stored
permanently in the device.”
40. In the first sentence of the second paragraph, the suggestion that such simulators are commonly available for medical
instruments should be deleted. The sentence should be modified to read, “For pulse oximeters there are no simulators
available which have proven adequate for field calibration.”
41. Paragraph 2, last sentence: Replace the term “accuracy” with “reliability of a pulse oximeter reading.”
• The term “reliability” is not consistent with manufacturers’ specified requirements; therefore, the term “accuracy”
has been maintained.
Section 4.5, Sensor and Sensor Site Selection and Preparation (Formerly Sensor Site Selection/Preparation)
42. The first sentence should read, “… choosing a pulse oximeter sensor site.”
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• The sentence has been modified to read, “The points below should be considered when choosing a sensor application
site.”
43. The first sentence should read, “… choosing a sensor application site.”
44. Fourth bullet, last sentence: I am not aware of recommendations from manufacturers to place the sensors on sites positioned
at the level of the heart. This is not always practical and not the case during exercise when using a finger, ear, or reflectance
probe (e.g., forehead). Consider deleting the sentence.
• The text has been modified and a supporting reference has been added.
Section 4.5.2, Duration of Use
45. Recommendations for duration of use should align with ASTM F1415 (i.e., Does the standard distinguish between
“disposable” and “reusable” for duration of contact?).
• This section has been modified to be inclusive of all sensor types.
46. If there are references demonstrating damage to tissue when properly applied pulse oximetry sensors are used for periods
greater than four hours (reusable) and eight hours (disposable), they should be listed. Also, sensors applied too tightly with
tape or adhesive material may cause damage in less time than listed. It should be stressed that proper sensor application is at
least as, if not more, important than the frequency at which the sensor is repositioned. Additionally, these limits are very
appropriate for patients who are unconscious or otherwise unable to assess their own tissue damage. However, pulse
oximeters are used frequently on patients who are able to notice pain to the sensor area and longer duration may be
appropriate as long as the signs of damage and action to take are addressed with them. Pulse oximeters used for sleep
monitoring in the home or sleep lab are examples of this situation. The issue of skin sensitivity or allergic reaction to
adhesives or other materials is not addressed, and perhaps should be. Also, you may wish to speak to the problems
associated with application of adhesives, potentially abrasive materials (wraps), and pressure to friable skin.
• The text of this section has been modified to include a cautionary statement and a supporting reference.
47. The last sentence in this section is alarming. Are there data to support this statement? It conflicts with the wording in the
introduction stating that this is a safe procedure. What is the basis of changing or repositioning the sensor every four hours?
Is it the same amount of time for infants versus adults? Are these recommendations manufacturer (i.e., probe-type) specific?
• See response to comment 46. Users should refer to manufacturers’ instructions for use.
Section 4.5.3.1, Safety
48. Delete the first sentence.
• The committee firmly believes pulse oximetry is a safe procedure; therefore, the sentence has been maintained.
49. This section states, “Pulse oximetry use has not been associated with exacerbation of symptoms in patients who exhibit latex
allergies.” This should be referenced if data are available. If not, this sentence should be deleted.
• The sentence has been deleted as recommended.
Section 5, Monitoring/Testing Session
50. Replace “SpO2” with “SO2” throughout the section, and the remainder of the document.
Section 5.2.2, Alarm Management
51. Consider reducing/eliminating the technical jargon. For a clinicians’ guide, I would think there would be more specific,
activity-oriented information like: Always check the default alarm settings and make sure they are appropriate for the
patient. Also include recommendations of how to select appropriate alarm settings, like: It is recommended that the low
saturation alarm be set “n” sat points below the stabilized reading.
• This section has been modified to include practical recommendations for alarm management.
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52. Delete the first sentence of the paragraph.
Section 5.2.3, Signal Averaging and Data Storage
53. Clarify signal averaging, i.e., “summing = Σ” and “average = Σ/N.”
• Signal averaging has been defined as, “the process of averaging instantaneous values over a given interval (for pulse
oximetry, usually in seconds).”
54. Modify the first paragraph to read, “Signal averaging over a given interval (for pulse oximetry, usually seconds) reduces
fluctuations in SpO2 caused by artifact or by clinically insignificant transients. An unintended effect of such techniques is
that they may also attenuate real changes in SpO2, and can negate alarm thresholds (Figure 3). Furthermore, long averaging
times may be undesirable during assessment of nocturnal desaturation events and can lead to underestimating the number of
desaturation events by up to 60% when compared to a control.36 In some instruments, the signal-averaging interval may be
adjusted by the user to minimize nuisance alarms while maintaining the desired sensitivity to reductions in SpO2.
• The first paragraph has been modified to read, “Signal averaging is the process of averaging instantaneous values
over a given interval (for pulse oximetry, usually in seconds). The technique of signal averaging can reduce
artifactual fluctuations in SpO2 but an unintended effect is that the display of real changes in SpO2 is blunted (see
Figure 3). Particularly in apnea of prematurity but also found in adult sleep apnea, episodes of hyperventilation often
follow each apnea, leading to acute resaturation/desaturation epochs. The result is that long signal averaging times
during assessment of desaturation events can lead to underestimating the number of events by up to 60% when
compared to a control. The signal-averaging interval should be adjusted by the user to minimize nuisance alarms
while maintaining the desired sensitivity to changes in SpO2.”
55. The graph displaying SpO2 and time using various signal-averaging schemes shows a real-time change in SpO2 from
approximately 95% to 60% in four seconds, and then a quick rise back to 95% in another four seconds. I have never seen
this happen because of a physiologic event. Rather, it can happen if the sensor is removed or altered in some way. The point
of this section is to discuss the use of signal averaging during nocturnal monitoring. If this figure comes from actual data, it
should be referenced. If it was created to make a point, it should state that fact.
• Examples have been added for clarification. See response to comment 54.
56. Modify the second paragraph to read, “Many systems have the capability to store data for later retrieval. The memory
capacity of a pulse oximeter should be adequate to cover the desired study period. When the trend data function is being
used, the memory of the oximeter should be erased prior to a given monitoring session to avoid mixing data from different
patients. The user must also be aware of the sampling rate for data storage, since this affects the resolution of the data. The
sampling rate should be frequent enough to ensure that significant events are not missed.”
• The text has been modified to read, “Many systems have the capability to store and retrieve information from
memory. The data storage capacity of a pulse oximeter should be adequate to cover the desired study period. Note
that to eliminate the chance of mixing patient data, the resident memory of the oximeter must be erased prior to
placement on the subject. The user may need to be aware of the sampling rate for data storage, since this may affect
resolution of the data. The sampling rate should be frequent enough to ensure that significant events are not missed.
It is common for devices used for the study of pulse oximetry during sleep to capture the data at intervals of ≤4
seconds. Less frequent sampling could result in meaningful events being missed.”
Section 5.3.1, Indicators of Signal Quality
57. The first paragraph is equating signal strength with signal quality. Signal strength is a component of signal quality.
• The intent of this paragraph is to address shape of the waveform as an indicator of quality.
58. Paragraph 2, second sentence: Can visual inspection of the plethysmographic waveform detect motion or electrical artifact?
Please provide a reference.
• Text and a supporting reference have been added to address the commenter’s query.
59. Newer technology should be mentioned, i.e., oximeters that decouple O2 saturation from heart rate.
• Newer technologies are addressed in Section 6.2.6, Motion Artifact.
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60. Section 5.3.1 might benefit from an illustration of what an adequate blood pressure waveform on a properly functioning
pulse oximeter looks like.
• Pulse oximeters do not display blood pressure waveforms.
Section 6.1.1, Accuracy
61. Many manufacturers are reporting accuracy as Arms, which combines the effects of bias and scatter. A statement that at least
68% of readings will be within the Arms is accurate. However, the interaction of bias and scatter makes discussion more
complex. You may want to consider expanding this section to the discussion of Arms.
• This section has been expanded to address reporting accuracy as Arms.
Section 6.1.2, Reliability
62. The user should understand how to use the alarm management method features safely.
• The committee agrees. Users should familiarize themselves with the manufacturer’s instructions for use.
63. The first paragraph of this section is identical to the first five sentences of Section 5.2.2.
• This is a different step in the path of workflow. The test was reintroduced in this section, as the “interpreter” needs
to be aware of these processes.
Section 6.2, Sources of Error
64. Some additional sources of error to consider adding include:
Nail Polish: Some, but not all, nail polishes absorb light at the wavelengths used by the pulse oximeter. Black, blue, and
green, but not red or purple nail polish, produced significant decreases in SpO2 compared to unpolished controls.
Skin Pigmentation: The reliability of pulse oximetry in darkly pigmented subjects has been reported to be poor, and caution
should be used in interpretation of these data.
Section 6.2.2, Intravenous Dye Injection
65. Replace “RHb” with “deoxyhemoglobin (HHb).”
Section 6.2.3, Dyshemoglobins
66. In lines 5 through 9, the pulse oximeter does not interpret anything. I propose the following text for the remainder of this
exception, except the last line: “The error caused by COHb is insubstantial, but MetHb gives an underestimation at high and
an overestimation at low SO2, the turning point being near 70% SO2. (Reference 1: Ziljlstra WG, Buursma A, Meeuwsen-van
der Roest WP. Absorption spectra of human fetal and adult oxyhemoglobin, deoxyhemoglobin, caroxyhemoglobin, and
methemoglobin. Clin Chem. 1991:37;1633-1638.) The influence of the presence of fetal hemoglobin (HbF) is insubstantial
at SO2>70%, but at SO2-25%, a significant underestimation of some 5% SO2 can be found (Reference 2: Nijland R,
Jongsma HW, Nijhuis JG, Oeseburg B, Ziljlstra WG. Notes on the apparent discordance of pulse oximetry and multi-
wavelength haemoglobin photometry. Acta Anaesthesiol Scand. 1995:37(Suppl 107);49-52.)” This of course only matters in
fetal monitoring. (Note: This might be illustrated by reproducing either Table 4 from Reference 1 above, when fetal
monitoring is not mentioned, or Table 2 from Reference 2 above, when fetal monitoring is mentioned.)
• The text has been modified. A table describing the effects of dyshemoglobins on SpO2 values has been added.
Section 6.2.5, Low Peripheral Perfusion
67. Sections 6.2.5 and 6.2.6 should probably include a statement to the effect that application of pulse oximetry during exercise
testing may produce false-negative or false-positive results, presumably due to the effects of low perfusion and/or motion
artifact. This is important because of the widespread use of pulse oximetry in various types of exercise testing.
• See Section 4.2, Environment of Use, for information related to the use of pulse oximetry during exercise testing.
©
Number 5 HS3-A
Section 6.2.6, Motion Artifact
68. After the second sentence, add the following: “Some types of motion also degrade the integrity of the optical signal by
moving sensor components relative to one another or relative to the tissue.”
Section 6.2.7, Sensor Malpositioning
69. Modify the first sentence to read, “…signal-to-noise ratio may deteriorate.”
Section 6.2.8, Electrosurgical Unit (ESU)
70. In the fifth line, change “ESU” to “ESU interference.”
Section 6.3.1, The Oxyhemoglobin Dissociation Curve
71. In the first line, delete the phrase “arterial function.”
• The text has been modified to read, “Arterial hemoglobin oxygen saturation (SaO2)…”
72. In Figure 4, SulfHb does not replace the ODC to the left.
• The following text has been added to clarify the shift:
“The second important property of the dissociation curve is its variable shifting to the right or left by other factors in
the blood such as temperature, pH, PCO2, 2,3-DPG, fetal Hb, or dyshemoglobins (see Figure 5). This phenomenon
assists in the uptake of oxygen from the lungs and delivery to tissues. Because of these factors, the SpO2 reading
cannot be used to reliably calculate PaO2. The inverse is also the case (i.e., the calculated saturation derived from a
blood gas analyzer should not be used for a reference of SpO2 values). Only the functional oxygen saturation value
from a laboratory oximeter should be a qualified reference for SpO2. Moreover, CLSI/NCCLS document C46—
Blood Gas and pH Analysis and Related Measurements recommends that calculated SO2 values from a blood gas
analyzer not be used to assess oxygenation status because of potential error.”
73. In the ninth line of the second paragraph, is the more general “PO2” intended, or should it be “PaO2”?
• The term has been changed to PaO2 as recommended.
Section 6.3.2, Oxygen Transport
74. In the equation, numerical values are given for the oxygen-binding capacity of hemoglobin and for the solubility of oxygen
in blood. It should be added that the first quantity is expressed in mL/g, the second value in mL•dL-1•mmHg-1 and that,
consequently, the hemoglobin concentration should be in g/dL. Moreover, I would prefer to use the theoretical oxygen
binding capacity of 1.39 mL/g and substitute for [Hb]: ctHb-cdysHb, which can be fairly approximated by ctHb-cCOHb-CmetHb
(Reference: Zijlstra WG. Hϋfner memorial lecture: The oxygen-binding capacity of human blood. Lab Hematol.
1995:1;145-153.)
• The equation has been modified as follows: “CaO2 = (1.39 mL/g x [Hb] x SaO2) + (0.003 mL/dL/mmHg x PaO2),
where CaO2 is expressed in mL/dL, and the unit of measure for Hb in g/dL, and for PaO2 is mmHg.”
75. In the last sentence, it is true that numerically, a decrease in SO2 and a decrease in ctHB have the same effect on the oxygen
content of the blood, but physiologically there is an important difference. A decrease in SO2 is accompanied by a fall in pO2,
whereas a decrease in ctHb is not. The phrase “in the same manner” obscures this difference.
• The essence of this sentence is that oxygen content may be reduced by either a decrease in the amount of hemoglobin
or its saturation. For clarity, the text has been modified to read, “…will reduce the oxygen content just as decreased
saturation does.”
©
Volume 25 HS3-A
Section 6.4, Summary
76. Include a statement regarding usefulness of SpO2 and pulse oximeters to the summary.
• The following text has been added to Section 6.4: “The development of pulse oximeters has been an important
advance in monitoring patient oxygen status. Ease of use and relatively low cost have resulted in the widespread
clinical application of this technology for detecting oxygenation status.”
77. This section may need to be more specific regarding data stored in the memory of the pulse oximeter. Many of the devices
store data without adequate means of identifying the source of the data (i.e., the patient’s name or number). Some statement
regarding the problem of not clearing the device’s memory before beginning a new measurement is probably in order.
• The following text has been added to Section 7.2, Memory Capacity, to address the commenter’s concern:
“To reduce the chance of combining data from multiple patients into one patient’s record, it is prudent to erase the
data storage memory at the conclusion of each use.”
©
Number 5 HS3-A
Summary of Delegate Comments and Committee Responses

HS3-A: Pulse Oximetry; Approved Guideline
Section 3, Definitions
1. In the definition of Partial Pressure/Tension, rewrite the NOTE to read: “The pressure of oxygen that would exist in a
hypothetical ideal gas phase in equilibrium with arterial blood is symbolized by PaO2.”
• The NOTE has been modified to read, “In the human body, the pressure of oxygen that would exist in a
hypothetical ideal gas phase in equilibrium with arterial blood is symbolized as PaO2.”
Section 4.4.1, Calibration/Maintenance
2. What is the frequency of calibration? It seems likely that it is state/provincially controlled.
• Pulse oximeters cannot be calibrated by the end user. Calibration is fixed in the software by the manufacturer.
Section 5.1, Duration
3. Statement “It is the consensus...” is redundant, as the preamble indicates this is a consensus document.
• This sentence has been modified to read, "A minimum of 60 seconds is needed from the time the SpO2 and PR
display stabilizes to assess the quality of the detected signal in order to ensure the reliability of the measured
values."
Section 5.2.3, Signal Averaging and Data Storage
4. What is an epoch? Perhaps a respiratory therapist would know.
• The term “epoch” is specific to sleep studies and is commonly used terminology in the field of sleep diagnostics,
often staffed by respiratory therapists.
Section 6.1.1, Accuracy
5. I think it would be better to specify that COHb and metHb should be negligible (<2%) before using a laboratory oximeter as
a reference for SpO2; otherwise, the implicit assumption is that all pulse oximeters read COHb and metHb as
oxyhemoglobin.
• The wording has been maintained. SPO2 values can be adversely affected by the presence of COHb and metHb.
Whole blood co-oximetry remains the means of determining dyshemoglobins (COHb, metHb).
Section 6.2.9, Anemia
6. Edit the second sentence to read “...severe anemia (total hemoglobin <10 g/dL)...”
• The sentence has been modified as suggested.
Section 6.3.1, The Oxyhemoglobin Dissociation Curve
7. I suggest the sentence containing the phrase “…carbon dioxide poisoning” be deleted.
• The sentence has been modified to read, “This phenomenon assists in the uptake of oxygen from the lungs and
delivery to tissues.”
8. I suggest deleting the sentence beginning, “The inverse...” (Also, the operation described is not the inverse of the operation
in the previous sentence.)
• The sentence has been modified, and now reads, "Because of these factors, the SpO2 reading cannot be used to
reliably calculate PaO2. Therefore, the calculated saturation derived from a blood gas analyzer should not be
used for a reference of SpO2 values.”
©
Volume 25 HS3-A
NOTES
©
Number 5 HS3-A
The Quality System Approach

Clinical and Laboratory Standards Institute subscribes to a quality system approach in the development of standards
and guidelines, which facilitates project management; defines a document structure via a template; and provides a
process to identify needed documents. The approach is based on the model presented in the most current edition of
Clinical and Laboratory Standards Institute document HS1—A Quality Management System Model for Health Care.
The quality system approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to
all operations in any healthcare service’s path of workflow (i.e., operational aspects that define how a particular
product or service is provided). The QSEs provide the framework for delivery of any type of product or service,
serving as a manager’s guide. The quality system essentials (QSEs) are:
Documents & Records Equipment Information Management Process Improvement

Organization Purchasing & Inventory Occurrence Management Service & Satisfaction
Personnel Process Control Assessment Facilities & Safety
HS3-A addresses the quality system essentials (QSEs) indicated by an “X.” For a description of the other Clinical
and Laboratory Standards Institute documents listed in the grid, please refer to the Related Clinical and Laboratory
Standards Institute Publications section on the following page.
Purchasing &
Improvement
Organization
Management
Management
Information
Satisfaction
Assessment
Facilities &
Occurrence
Documents
Equipment
& Records
Service &
Personnel
Inventory
Control
Process
Process
Safety
X
Adapted from Clinical and Laboratory Standards Institute document HS1—A Quality Management System Model
for Health Care.
©
Volume 25 HS3-A
Related CLSI/NCCLS Publications*

C46-A Blood Gas and pH Analysis and Related Measurements; Approved Guideline (2001). This document
provides clear definitions of the several quantities in current use, and provides a single source of information
on appropriate specimen collection, preanalytical variables, calibration, and quality control for blood pH and
gas analysis and related measurements.
GP26-A3 Application of a Quality Management System Model for Laboratory Services; Approved Guideline—
Third Edition (2004). This guideline describes the clinical laboratory’s path of workflow and provides
information for laboratory operations that will assist the laboratory in improving its processes and meeting
government and accreditation requirements.
H11-A4 Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition
(2004). This standard describes principles for collecting, handling, and transporting arterial blood specimens
to assist with reducing collection hazards and ensuring the integrity of the arterial specimen.
HS4-A Application of a Quality System Model for Respiratory Services; Approved Guideline (2002). This
document provides a model for providers of respiratory services that will assist with implementation and
maintenance of an effective quality system.
*
Proposed- and tentative-level documents are being advanced through the Clinical and Laboratory Standards Institute consensus
process; therefore, readers should refer to the most recent editions.
©
Number 5 HS3-A
NOTES
©
Volume 25 HS3-A
NOTES
©
Number 5 HS3-A
NOTES
©
Volume 25 HS3-A
NOTES
©
Number 5 HS3-A
NOTES
©
Volume 25 HS3-A
NOTES
©
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HS3-A

Pulse Oximetry; Approved Guideline

Reproduced with permission, from CLSI publication HS3-A—Pulse Oximetry; Approved

Copyright ©2005. Clinical and Laboratory Standards Institute.

Area Committee on Healthcare Services

Philip S. Clifford, PhD – Medical College of Wisconsin, Milwaukee, WI

Committee Membership........................................................................................................................ iii

Foreword .............................................................................................................................................. vii

Summary of Comments and Subcommittee Responses........................................................................20

Summary of Delegate Comments and Committee Responses ..............................................................30

The Quality System Approach..............................................................................................................32

Related CLSI/NCCLS Publications ......................................................................................................33

Hemoglobin, oximetry, oxygen, oxygen saturation, oxyhemoglobin, oxyhemoglobin saturation

Pulse Oximetry; Approved Guideline

Figure 1. Absorption Spectra of Oxy- and Deoxyhemoglobin

Hemoglobin//Hb//Hgb – The iron-containing red pigment-protein of erythrocytes; NOTE: Hemoglobin

Perfusion – The presence of blood flow.

SaO2 – Oxygen saturation of arterial blood.

4.1 Indications for Use

4.2 Environment of Use

4.3 Patient Assessment

4.5 Sensor and Sensor Site Selection and Preparation

4.5.1 Sensor Application

4.5.2 Duration of Use

4.5.3 Patient Activity

5.2 Instrument Settings

5.2.1 Alarm Settings/Management

Table 1. Typical Default Alarm Limits

5.2.2 Alarm Management

5.2.3 Signal Averaging and Data Storage

5.3 Quality of Signal

5.3.1 Indicators of Signal Quality

• intense ambient light;

• electrical interference from nerve stimulators or electrocautery instrumentation42,43;

• malpositioning of the probe18,19; and

• placement over pulsating arteries.44

Table 2. Guidelines for Troubleshooting

6.1 Performance: Accuracy and Reliability

A pulse oximeter is approvable if it is on average accurate to within 3% of a CO-oximeter based upon

6.2 Sources of Error

6.2.1 Ambient Light Interference

6.2.2 Intravenous Dye Injection

Table 3. Effects of Dyshemoglobins on SpO2 Values

Figure 4. Absorption Spectra of Dys-, Oxy-, Deoxyhemoglobin Derivatives

6.2.4 Venous Pulsations

6.2.5 Low Peripheral Perfusion

6.2.6 Motion Artifact

6.2.7 Sensor Malpositioning

6.2.8 Electrosurgical Unit (ESU)

6.2.10 Nail Polish, Skin Pigmentation, and Tattoos

6.3 Interpretation of SpO2 Data

6.3.1 The Oxyhemoglobin Dissociation Curve

Figure 5. The Oxyhemoglobin Dissociation Curve

6.3.2 Oxygen Transport

7.1 Patient Records

• sensor site and comment about signal quality; and

7.2 Memory Capacity

7.3 Remote Use

Summary of Comments and Subcommittee Responses

Section 2, Introduction (Formerly Section 1)

• The suggested changes have been incorporated.

Functional oxygen saturation = [oxyhemoglobin/(oxyhemoglobin + deoxyhemoglobin)]

Fractional oxygen saturation = [oxyhemoglobin/(oxyhemoglobin + deoxyhemoglobin + carboxyhemoglobin +