May 1999

Oximeters, Pulse
the frequency of arterial puncture and laboratory
Scope of this Product Comparison blood gas analysis. Hypoxia is possible if hypoxic gas
mixtures are inadvertently administered during gen-
This Product Comparison covers pulse oximeters
eral anesthesia, if gas lines are occluded during sur-
that can be used alone, as well as modular units
gery, if oxygen delivery is discontinued postoperatively
that interface with anesthesia units or physi-
during transport to the recovery room, or if a procedure
ologic monitoring systems. Pulse oximetry capa-
or disease (e.g., spinal anesthesia, bronchoscopy, acute
bilities that are configured into physiologic
bronchospasm) blocks the air passages or hinders the
monitoring systems are not included. (See the
breathing process; prolonged hypoxia could result in
Product Comparison titled PHYSIOLOGIC MONI-
irreversible brain damage or death. Pulse oximetry
TORING SYSTEMS, ACUTE CARE; NEONATAL; ECG
can detect decreasing oxygen saturation levels before
MONITORS for information on patient monitors
damage occurs and, generally, before the appearance
that have built-in pulse oximetry.) For informa-
of physical signs.
tion on combination pulse oximetry/carbon diox-
ide (CO2) units (i.e., capnographs with CO2 Pulse oximetry is considered a standard of care for
monitoring as a standard feature), see the Product monitoring arterial oxygen saturation in the operating
Comparison titled CARBON DIOXIDE MONITORS, room during procedures requiring anesthesia and in
EXHALED GAS.
intensive care units, recovery areas, burn units, cardiac
catheterization laboratories, and ambulances. Its use
UMDNS information in general medical/surgical and outpatient areas for
This Product Comparison covers the following spot-checking is increasing rapidly. Other applications
device term and product code as listed in ECRIs include dentistry anesthesia, sleep studies, exercise
Universal Medical Device Nomenclature System
(UMDNS):
Oximeters, Pulse [17-148]

Purpose

Pulse oximeters noninvasively monitor the oxygen

saturation (expressed as a percentage or decimal) of
arterial hemoglobin by measuring light absorbance
changes resulting from arterial blood flow pulsations.
Their use allows continuous and instantaneous moni-
toring of oxygenation; can provide early detection of
hypoxia before other signs such as cyanosis, tachy-
cardia, or bradycardia are observed; and may reduce Pulse oximeter

217520 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

424-008 Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail hpcs@ecri.org
Healthcare Product Comparison System
testing, and home monitoring of certain patients, such
as infants at risk for sudden infant death syndrome
and patients requiring respiratory therapy. Battery-
powered units are particularly convenient because
they can also monitor the patient during transport.
Principles of operation
Pulse oximeters provide a spectrophotometric as-
sessment of hemoglobin oxygenation (SpO2) by meas-
uring light transmitted through a capillary bed,
synchronized with the pulse. The detection system
consists of single-wavelength light-emitting diodes
(LEDs) and microprocessors.
The pulse oximeter probe is applied to an area of the
body such as a finger, a toe, or an ear. Two wavelengths
of light (e.g., 660 nm [red] and 930 nm [infrared]) are
transmitted by the probe through the skin and are dif-
ferentially absorbed by oxyhemoglobin, which is red and
absorbs infrared light, and deoxyhemoglobin, which is
blue and absorbs red light. The ratio of red to infrared
light is used to derive oxygen saturation. The photo-
detector on the other side of the tissue converts the
transmitted light into electrical signals proportional to
the absorbance. The signal is then processed by the units
microprocessor, which displays a reading and, if the
reading is outside the alarm limits, sounds an alarm.
Each pulse of arterial blood causes the capillary bed
to expand and relax. The resultant cyclic variations in
the path length of the transmitted light allow the
device to distinguish arterial blood (pulsating) hemo-
globin saturation from venous blood and tissue compo-
nents because there is no pulse from the surrounding
tissue and the pulse of venous blood is insignificant.
The microprocessor compares the relationship of the
absorbance values of pulsatile arterial blood with
stored data derived from human invasive studies to
calculate and display the SpO2. Some units synchro-
nize the absorbance measurements with the R wave of
an electrocardiogram (ECG) to detect motion artifact
(this technique prevents extraneous signals from being
mistaken for pulse signals), and some have memory for
trending a patients SpO2 over time. To reduce small
variations in displayed oxygen saturation values and
to counter any false values from artifactual wave-
forms, pulse oximeters use algorithms for averaging
data and recognizing artifacts.
Most pulse oximeters also offer other display fea-
tures, including pulse rate, alarm limits on oxygen
saturation and pulse rate, plethysmograms, bar
graphs indicating pulse amplitude, and various sys-
tem-status and error messages. For modular units,
these displays are part of the main device to which the
unit is connected.
2 1999 ECRI. Duplication of this page by any means for any purpose is prohibited.
Handheld pulse oximeter
Audible alarms typically sound when SpO2 or pulse
rate alarm limits are violated. On some units, a tone
marking each pulse will vary in pitch as the SpO2 value
changes. Most audible alarms can be manually disabled,
either temporarily or permanently. Visual alarms can
include all audible alarm conditions, as well as low signal
strength or low perfusion, low battery, probe status,
silenced audible alarm, and system status.
Both disposable and reusable probes are available.
Reusable probes include spring clips applied to a finger
or ear, flexible wraps, and multisite probes. Disposable
probes are usually applied to the skin with adhesive.
Depending on the manufacturer, probes are available in
sizes suitable for adults, children, infants, and neonates.
Some pulse oximeters use flat reflectance photome-
try probes, which measure the intensity of light re-
flected (backscattered) from the skin. This method can
allow oxygen saturation measurements from more
central body locations such as the forehead and chest,
which are not used with most transmittance photome-
try probes. Reflectance probes are not yet as commonly
used as the transmittance probes because of the lat-
ters longer, well-established record of use. Depending
on the application, one probe type may be more desir-
able than the other (e.g., reflectance forehead probes
are advantageous for trauma patients who have dam-
aged or poorly perfused transmittance probe sites).
Most units are precalibrated by the manufacturer and
require only the daily performance of a self-diagnostic
test. They are considered to be relatively trouble-free,
and users require little training.
Several manufacturers have developed or are de-
veloping pulse oximeters that can be safely used dur-
ing magnetic resonance imaging (MRI) studies.
MRI-compatible units use nonconductive fiberoptic
cables that will not cause radio-frequency (RF) burns

and can reduce the occurrence of artifacts in magnetic
resonance images.
Several manufacturers have also introduced port-
able, battery-powered, handheld pulse oximeters for
short-term bedside monitoring of patients pulse and
oxygen saturation. A computer memory stores data
that can later be downloaded to a printer or computer
terminal. Because they usually do not have any
alarms, these handheld models should be used for
spot-checking at the patients bedside in noncritical
care areas. For this application, portable pulse oxime-
ters have been fairly reliable; however, their use may
result in errors in accuracy if measurements are not
double-checked or verified by, for example, checking
the patients pulse with the pulse rate displayed on the
pulse oximeter. In addition, spot-check measurements
should not be used as a basis for clinical guidance or
changes in treatment. Other applications of portable
pulse oximeters include outpatient assessment and
use during emergency transport.
Reported problems
The use of pulse oximeters can be limited by inter-
ference from the surrounding environment. For exam-
ple, electrosurgical units (ESUs) generate high-
frequency currents, which can radiate to an oximeter
probe and interfere with its operation. Most units have
isolation circuitry or some method of suspending meas-
urement when used during an ESU procedure; how-
ever, clinicians should be aware that some models
freeze the SpO2 display during such interference,
which may give the operator a false sense of security
when a monitor is not measuring.
High-intensity light (e.g., fluorescent light) in the
patient environment interferes with oximeters. Be-
cause they are designed to measure weak light signals
transmitted through the skin, the photodetectors in
the sensor can also be affected by other light sources
such as surgical lights, radiant warmers, bilirubin
lights, and sunlight. In addition, modulations in some
light sources can defeat ambient light protection cir-
cuitry by producing a pseudopulsatile signal that ac-
tually mimics physiological signals, creating the
potential for a missed or inappropriate diagnosis that
could result in serious patient injury or death. Placing
an opaque cover over the probe frequently eliminates
such interference, but clinicians must remain alert to
the potential problems. Reusable probes appear to be
less susceptible to ambient interference than dispos-
able probes (Blackwell 1989). Various types of interfer-
ence from light sources or high-frequency electrical
signals can also occur during home monitoring, and the
home user may not be well prepared to identify and
resolve them.
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Oximeters, Pulse
In oximeters using ear probes, changes in the oxy-
gen delivery system (especially variations in blood flow
distribution that may accompany physiologic stress or
shock) can cause large discrepancies between the oxy-
gen saturation levels in the capillary bed of the earlobe
and the partial pressure of oxygen in alveolar gas
(pAO2). Clinicians must be aware of this problem when
caring for critical or unstable patients who may re-
quire frequent invasive arterial blood gas monitoring.
ECRI has received reports of burns resulting from
the use of incompatible probes, even though the probe
initially appeared to be compatible with the oximeter.
Users should verify that probes and pulse oximeters
from different manufacturers are compatible.
ECRI has also received reports concerning potential
interference between pulse oximetry and MRI. The
MRI units magnetic field can affect pulse oximeter
circuitry and performance, while the pulse oximeters
electronic frequencies can produce artifacts on the
magnetic resonance image. In addition, burns have
been reported at the probe site during MRI, probably
resulting from electrical currents in the probes cable
induced by the RF magnetic field during imaging. The
MRI compatibility of a pulse oximeter should be veri-
fied with the manufacturer before use. For more infor-
mation about MRI, see the Product Comparison titled
MAGNETIC RESONANCE IMAGING (MRI) UNITS.
Pulse oximeters cannot detect carbon monoxide
(CO) poisoning because they cannot distinguish car-
boxyhemoglobin from oxyhemoglobin the value ob-
tained is generally the sum of the oxyhemoglobin and
carboxyhemoglobin saturations. In marked contrast to
other forms of hypoxia, CO poisoning causes the blood
and skin to become a brighter red rather than the blue
usually associated with lack of oxygen in the tissues;
patients may appear well oxygenated according to the
usual visual clues, yet they may still be deficient in
oxygen. Thus, when CO poisoning is suspected, as in
smoke inhalation victims, arterial blood gas analysis
should be performed using the arterial puncture tech-
nique and appropriate laboratory instruments such as
a co-oximeter (see the Product Comparison titled
OXIMETERS, IN VITRO, MULTIWAVELENGTH). Pulse
oximeters also cannot distinguish methemoglobin
from oxyhemoglobin and do not measure CO2 or pH,
which are important in pulmonary gas exchange and
assessment of acid-base status.
A number of other factors can affect pulse oximetry
measurements. Intravenous dyes such as methylene
blue, indigo carmine, or indocyanine green can cause
inaccurate readings. It is best to remove any polish or
false nails from the patients fingernails before apply-
ing the probe because certain nail polish colors and
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Healthcare Product Comparison System
cover materials can interfere with SpO2 measure-
ments. Extreme forms of anemia (a low number of red
blood cells or hemoglobin) and heavily pigmented skin
can prevent sufficient light from penetrating through
to the photodetectors to obtain accurate results. Gen-
erally, bilirubin does not interfere significantly with
pulse oximetry (it has minimal absorption at pulse
oximetry wavelengths) and may not be significant even
with bilirubin concentrations greater than 10 mg/dL
(Wukitsch et al. 1988; Beall and Moorthy 1989). Any
movement, clinical or otherwise, that causes slight
cyclic changes in the optical pathway is likely to be
detected and displayed by the oximeter as artifact (See
Stage of Development for a new technology regarding
motion artifact). Interference has been reduced by
digital signal processing and by averaging the dis-
played SpO2 over several seconds. Further, pulse
oximeters that display the arterial plethysmographic
waveform generally allow the operator to assess signal
quality and observe any motion artifacts that might
alter the units accuracy.
Because pulse oximeters base oxygen saturation
measurements on the pulsating vascular bed, condi-
tions that affect pulse detection also limit the measure-
ment capability of the oximeter. For example, if an
arteriole does not have a significantly stronger pulse
than the surrounding venous blood and tissue, the
oximeter cannot differentiate between nonpulsatile
and pulsatile absorbances. Low pulse signals result
from decreased circulation to the measurement area
(low perfusion), the causes of which include hypother-
mia, peripheral vascular disease, hypotension, vaso-
constrictive drug therapy, and low cardiac output. To
compensate, a probe can be applied to the bridge of the
nose, spanning the nasal septum. The vessels in this
area are supplied by a branch of the internal carotid
artery and may provide a stronger signal. Pulsations
at the nasal septum persist under greater extremes
than those in peripheral areas (e.g., fingertips, toes,
feet) because the body automatically protects circula-
tion to the brain under stressful conditions. This is also
an advantage of the forehead reflectance probe.
Other factors that may rule out pulse oximetry are
hemoglobin levels below 5 mg/dL and the use of tour-
niquets, blood pressure cuffs, or intravenous infusion
(which can cause vasoconstriction) in the same extrem-
ity as the oximeter. Most pulse oximeters detect low-
perfusion conditions, and some have an alarm circuit
that detects no-pulse conditions.
Purchase considerations
Because most pulse oximeters can be interfaced
with other printers/recorders, computers, or multi-
parameter monitoring systems, buyers should make
4 1999 ECRI. Duplication of this page by any means for any purpose is prohibited.
sure that the equipment to be purchased will be com-
patible with existing equipment. In addition, because
some governing bodies (e.g., state/federal government,
standards organizations) mandate the use of pulse
oximetry in certain situations, hospitals should deter-
mine the number of pulse oximeters and probes that
are necessary to meet the needs of the entire facility.
Display size and visibility (from a distance, from
various angles, and in various lighting situations) can
be important. Backlit liquid crystal displays (LCDs),
light-emitting diodes (LEDs), cathode ray tubes
(CRTs), vacuum fluorescent displays, and electrolumi-
nescent displays are currently available. Some dis-
plays are simple, with a minimum of information;
others, particularly the CRT displays, are able to pre-
sent graphic displays of trends and pulse waveforms.
Pulse oximeters normally operate on AC power, and
many have battery backup. Although proper battery
operation depends on use and user care, ECRI does
recommend audible low-battery alarms. ECRI also
recommends that pulse oximeters without audible
alarms be labeled with the following information: that
they do not have audible alarms and that users should
therefore minimize use on battery power, that the
power source should be verified with the battery-in-
use light or AC power indicator, and that users should
ensure that the AC power cord is properly connected.
Cost containment
Reusable probes are available with all pulse oxime-
ters, and disposable and semidisposable (flex) types
are available with some units. The useful lives of the
three types vary: generally, the reusable type can be
used on many patients over a period of six months to
one year, the flex type can be used for approximately
three months, and the disposable type is used once.
Disposable probes are advantageous for patients re-
quiring particular attention to infection control (espe-
cially adults in the intensive care unit and neonates)
and patients who cannot remain still (disposable
probes are applied with adhesive strips or wraps and
typically attach more securely than reusable probes).
However, they may cost more than reusable or
semidisposable probes over the long term. Some hos-
pitals are buying reusable probes because of signifi-
cant cost savings. Before purchasing a pulse oximeter,
the types of probes available and the associated costs
should be considered.
Some hospitals have implemented in-house recy-
cling programs; disposable probes are gas-sterilized
and inspected before reuse. Savings of over $100,000
annually have been reported. Before recycling probes
in-house, hospitals should set policies for sterilization

methods to eliminate cross-infection risk, for testing
the functioning of recycled probes, and for determining
the number of times a probe is recycled. One hospital
found that laminating disposable oximeter sensors
and inserting them into a disposable protective shield
allows reusability and does not alter sensor response
time or relative accuracy. Another attempt to reduce
expenses involves hospitals cleaning, sterilizing, and
returning disposable probes to the suppliers, who then
remanufacture, resterilize, and relabel the probes as
recycled disposable sensors.
Microprocessor-controlled equipment could be af-
fected by the change from 1999 to 2000 if it uses a
real-time clock and its design does not include provi-
sion for a change in century for instance, it does not
use a four-digit data field for the year. Furthermore,
any incompatibilities in the way different devices han-
dle the year 2000 might have adverse effects. Even if
a device is unaffected, it may affect or be affected by
other devices through device and information systems
interfaces.
Facilities purchasing new equipment should add a
specification to the request for proposal or other bid
documents stating that the device will not be affected
by the change to the year 2000 and that the supplier
will provide written certification of this fact. Such a
precaution will help prevent costly downtime or major
software changes after purchase.
Stage of development
Pulse oximeters have been commercially available
since the early 1980s. Since their endorsement in 1986
by the American Society of Anesthesiologists as a stan-
dard of care for use whenever anesthesia is used, pulse
oximeters have become the preferred method for meas-
uring arterial oxygen saturation. In the last 10 years, the
use of pulse oximeters has expanded to include most
areas of the hospital. Pulse oximetry is being increasingly
offered as part of multiparameter modular systems.
Reflectance pulse oximeters can be useful for assess-
ing status during labor and delivery by applying a
forehead probe (Izumi et al. 1997). One fetal oximeter
currently marketed places a single-patient-use sensor
against the babys cheek or temple and is held in place
through labor and delivery. This device can be used in
conjunction with fetal heart rate monitors.
One company has developed a technique for han-
dling low signal-to-noise ratios associated with low
perfusion and patient motion. This method identifies
and measures noise components, such as venous blood
movement, and removes these components by adaptive
digital filtering. A study found that this technology
1999 ECRI. Duplication of this page by any means for any purpose is prohibited.
Oximeters, Pulse
generates fewer alarms, suggesting improvement in
differentiation between signal and noise during oxy-
gen saturation measurements in frequently moving
patients, such as infants and children (Bohnhorst and
Poets 1998).
One manufacturer offers a self-contained finger
pulse oximeter that is ideal for spot checks and at-
tended patient monitoring and a pulse oximeter test-
ing system that evaluates the precision of oximeters
and sensors.
In 1992, the Joint Commission on Accreditation of
Healthcare Organizations confirmed the need for
pulse oximetry use outside the operating room. Be-
cause of this statement, as well as the development of
MRI-compatible and portable, handheld models, the
market for pulse oximeters to be used in other areas of
the hospital is expected to increase. Prices of bedside
models are expected to continue decreasing (Burney
1998).
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Berguis P, Cohen N, Decker M, et al. Respiration.
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Blackwell GR. The technology of pulse oximetry.
Biomed Instrum Technol 1989 May-Jun;23:188-93.
Bohnhorst B, Poets CF. Major reduction in alarm
frequency with a new pulse oximeter [letter]. Inten-
sive Care Med 1998 Mar;24(3):277-8.
Burney M. Pulse oximeters go mobile as prices con-
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