Masimo Pronto User manual
Operator's Manual
Pronto® Pulse CO-Oximeter®
These operating instructions provide the necessary information for proper operation of all
models of the Pronto. There may be information provided in this manual that is not relevant
for your system. General knowledge of pulse oximetry and an understanding of the features
and functions of Pronto are prerequisites for its proper use. Do not operate Pronto without
completely reading and understanding these instructions.
Notice: Purchase or possession of this device does not carry any express or implied license to
use with replacement parts which would, alone or in combination with this device, fall within
the scope of one of the relating patents.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be
used for any processes, procedures, experiments, or any other use for which the device is not
intended or cleared by the applicable regulatory authorities, or in any manner inconsistent
with the directions for use or labeling.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
Masimo Corporation
40 Parker
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Medical electrical equipment with respect to electric shock, fire, and mechanical
hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1
80fk
Patents: www.masimo.com/patents.htm
© 2016 Masimo Corporation
, Discrete Saturation Transform, DST, FST, Masimo, Pronto, Pulse CO-Oximeter, rainbow,
rainbow ReSposable, SET, Signal Extraction Technology, Signal I.Q., and SpHb are federally
registered trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
www.masimo.com 1 Masimo
Contents
About This Manual------------------------------------------------------------------------------------------ 5
Product Description, Features, and Indications for Use -----------------------------------------------7
Product Description and Features ---------------------------------------------------------------------7
Indications for Use ---------------------------------------------------------------------------------------7
Contraindications ----------------------------------------------------------------------------------------7
Safety Information, Warnings, and Cautions ----------------------------------------------------------- 9
Safety Warnings and Cautions ------------------------------------------------------------------------ 9
Performance Warnings and Cautions --------------------------------------------------------------- 10
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 13
Compliance Warnings and Cautions ---------------------------------------------------------------- 14
Chapter 1: Technology Overview ------------------------------------------------------------------------ 15
Masimo Signal Extraction Technology (Masimo SET®) ----------------------------------------- 15
rainbow Pulse CO-Oximetry Technology ----------------------------------------------------------- 17
Chapter 2: System Description -------------------------------------------------------------------------- 21
Front Panel ---------------------------------------------------------------------------------------------- 21
Rear Panel ----------------------------------------------------------------------------------------------- 23
Chapter 3: Setup ------------------------------------------------------------------------------------------- 25
Unpacking and Inspection --------------------------------------------------------------------------- 25
Power Requirements ----------------------------------------------------------------------------------- 25
Initial Setup --------------------------------------------------------------------------------------------- 25
Chapter 4: Operation -------------------------------------------------------------------------------------- 27
Basic Operation ---------------------------------------------------------------------------------------- 27
Default Settings ---------------------------------------------------------------------------------------- 29
Audible Alerts ------------------------------------------------------------------------------------------ 30
Battery Level Indicator ------------------------------------------------------------------------------- 30
Navigating the Menu ---------------------------------------------------------------------------------- 31
Trend Setup and Use --------------------------------------------------------------------------------- 33
Chapter 5: Messages ------------------------------------------------------------------------------------- 35
Messages ----------------------------------------------------------------------------------------------- 35
Chapter 6: Troubleshooting ----------------------------------------------------------------------------- 39
Troubleshooting --------------------------------------------------------------------------------------- 39
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Pronto Contents
Low Perfusion ------------------------------------------------------------------------------------------- 40
Low Signal I.Q. (Low SIQ) ---------------------------------------------------------------------------- 40
Low Battery Audible Alert ---------------------------------------------------------------------------- 41
Chapter 7: Specifications --------------------------------------------------------------------------------- 43
Performance Specifications -------------------------------------------------------------------------- 43
Display Ranges ----------------------------------------------------------------------------------------- 44
Resolution ----------------------------------------------------------------------------------------------- 44
Electrical------------------------------------------------------------------------------------------------- 44
Environmental ------------------------------------------------------------------------------------------ 45
Physical Characteristics ------------------------------------------------------------------------------ 45
Trend Memory ------------------------------------------------------------------------------------------ 45
Alerts ----------------------------------------------------------------------------------------------------- 45
Display Indicators -------------------------------------------------------------------------------------- 46
Compliance --------------------------------------------------------------------------------------------- 46
Citations ------------------------------------------------------------------------------------------------- 48
Symbols-------------------------------------------------------------------------------------------------- 49
Guidance and Manufacturer's Declaration - Electromagnetic Emissions -------------------- 51
Guidance and Manufacturer's Declaration - Electromagnetic Immunity -------------------- 52
Recommended Separation Distances -------------------------------------------------------------- 55
Chapter 8: Service and Maintenance ------------------------------------------------------------------ 57
Cleaning ------------------------------------------------------------------------------------------------- 57
Battery Replacement ---------------------------------------------------------------------------------- 57
Performance Verification ----------------------------------------------------------------------------- 58
Service and Repair ------------------------------------------------------------------------------------- 58
Limited Warranty ------------------------------------------------------------------------------------- 60
Exclusions ---------------------------------------------------------------------------------------------- 60
Limitation of Warranty ------------------------------------------------------------------------------- 60
Sales & End-User License Agreement -------------------------------------------------------------- 61
Restrictions --------------------------------------------------------------------------------------------- 61
Index --------------------------------------------------------------------------------------------------------- 63
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About This Manual
This manual explains how to set up and use Pronto® Pulse CO-Oximeter®. Important safety
information relating to general use of Pronto appears in this manual. Read and follow any
warnings, cautions, and notes presented throughout this manual. The following are
explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.
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Product Description, Features, and Indications for Use
Product Description and Features
Pronto® Pulse CO-Oximeter® is a noninvasive device intended to monitor functional oxygen
saturation of arterial hemoglobin (SpO2), pulse rate (PR), perfusion index (PI), and total
hemoglobin (SpHb®).
The following key features are available for Pronto:
• Masimo SET® and rainbow® SET technology performance.
• SpO2 and pulse rate monitoring in motion and low perfusion environments.
• Noninvasive spot-checking of total arterial hemoglobin concentration (SpHb).
• Download capabilities to transfer data from the device to a computer.
Indications for Use
The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for
noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2),
pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET® Pronto
Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and
pediatric individuals during both no motion and motion conditions, and for individuals who
are well or poorly perfused in clinical and nonclinical settings (e.g., hospitals, hospital-type
facilities, mobile environments, homes, clinics, physician offices, blood donation facilities,
and ambulatory surgery centers).
Contraindications
Pronto is contraindicated for use as an apnea monitor. Pronto is also contraindicated for use
as a continuous monitor.
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Safety Information, Warnings, and Cautions
Caution: Pronto is to be operated by, or under the supervision of, qualified personnel only.
The manual, accessories, directions for use, all precautionary information, and specifications
should be read before use.
Safety Warnings and Cautions
WARNING: Do not use the Pronto if it appears or is suspected to be damaged.
WARNING: Do not start or operate Pronto unless the setup was verified to be correct.
WARNING: Do not use Pronto during magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING: Explosion hazard: Do not use the Pronto in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
WARNING: Do not place the Pronto or accessories in any position that might cause it to fall
on the patient.
WARNING: To ensure safety, avoid stacking multiple devices or placing anything on the
device during operation.
WARNING: To protect against injury, follow the directions below:
• Avoid placing the device on surfaces with visible liquid spills.
• Do not soak or immerse the device in liquids.
• Do not attempt to sterilize the device.
• Use cleaning solutions only as instructed in this operator's manual.
• Do not attempt to clean Pronto while monitoring patient.
WARNING: To protect from electric shock, always remove the sensor and completely
disconnect Pronto before bathing the patient.
WARNING: As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
CAUTION: Do not place the Pronto where the controls can be changed by the patient.
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Pronto Safety Information, Warnings, and Cautions
Performance Warnings and Cautions
WARNING: Pronto should not be used as the sole basis for medical decisions. It must be used
in conjunction with clinical signs and symptoms.
WARNING: Variation in hemoglobin measurements may be profound and may be affected by
sampling technique as well as the patient's physiological conditions. Any results exhibiting
inconsistency with the patient’s clinical status should be repeated and/or supplemented with
additional test data. Blood samples should be analyzed by laboratory instruments prior to
clinical decision making to completely understand the patient’s condition.
WARNING: If any measurement seems questionable, first check the patient’s vital signs by
alternate means and then check Pronto for proper functioning.
WARNING: Do not use Pronto for continuous monitoring.
WARNING: Pronto is not an apnea monitor.
WARNING: Pronto should not be used for arrhythmia analysis.
WARNING: Do not use Pronto during defibrillation.
WARNING: Do not use Pronto during electrocautery.
WARNING: Do not place containers with liquids on or near Pronto. Liquids spilled on Pronto
may cause it to perform inaccurately or fail.
WARNING: Interfering Substances: Dyes, or any substance containing dyes, that change
usual blood pigmentation may cause erroneous readings.
WARNING: SpO2 and SpHb are empirically calibrated in healthy adult volunteers with
normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).
WARNING: Inaccurate SpO2 readings may be caused by:
• Improper sensor application and placement
• Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a
seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected,
laboratory analysis (CO-Oximetry) of a blood sample should be performed.
• Elevated levels of bilirubin
• Elevated levels of dyshemoglobin
• Vasospastic disease, such as Raynaud’s, and peripheral vascular disease
• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,
sickle cell, etc.
• Hypocapnic or hypercapnic conditions
• Severe anemia
• Very low arterial perfusion
• Extreme motion artifact
• Abnormal venous pulsation or venous constriction
• Severe vasoconstriction or hypothermia
• Arterial catheters and intra-aortic balloon
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Pronto Safety Information, Warnings, and Cautions
• Intravascular dyes, such as indocyanine green or methylene blue
• Externally applied coloring and texture, such as nail polish, acrylic nails, glitter,
etc.
• Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal
fingers. etc.
• Skin color disorders
Warning: Inaccurate SpHb readings may be caused by:
• Improper sensor application and placement
• Low arterial oxygen saturation levels
• Elevated carboxyhemoglobin levels
• Elevated methemoglobin levels
• Elevated levels of bilirubin
• Elevated levels of dyshemoglobin
• Elevated PaO2 levels
• Vasospastic disease, such as Raynaud’s, and peripheral vascular disease
• Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c,
sickle cell, etc.
• Hypocapnic or hypercapnic conditions
• Peripheral vascular disease
• Liver disease
• Severe anemia
• Low arterial perfusion
• Motion artifact
• Abnormal venous pulsation or venous constriction
• Severe vasoconstriction or hypothermia
• Arterial catheters and intra-aortic balloon
• Intravascular dyes, such as indocyanine green or methylene blue
• Externally applied coloring and texture, such as nail polish, acrylic nails, glitter,
etc.
• Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal
fingers. etc.
• Skin color disorders
• Elevated altitude
• EMI radiation interference
CAUTION: Do not place the Pronto on electrical equipment that may affect the device,
preventing it from working properly.
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Pronto Safety Information, Warnings, and Cautions
CAUTION: The device must be configured to match your local power line frequency to allow
for the cancelation of noise introduced by fluorescent lights and other sources.
CAUTION: If the Low SIQ Indicator illuminates frequently, find a better perfused monitoring
site. In the interim, assess the patient and, if indicated, verify oxygenation status through
other means.
CAUTION: If using pulse oximetry during full body irradiation, keep the sensor out of the
radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or
the device might read zero for the duration of the active irradiation period.
CAUTION: When patients are undergoing photodynamic therapy they may be sensitive to
light sources. Pulse oximetry may be used only under careful clinical supervision for short
time periods to minimize interference with photodynamic therapy.
CAUTION: If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition.
Note: A functional tester cannot be used to assess the accuracy of the Pronto.
Note: It is recommended that Pronto battery is fully charged prior to use.
Note: All batteries lose capacity with age, thus the amount of run time at Low Battery will
vary depending upon the age of the battery.
Note: Do not loop the patient cabling into a tight coil or wrap around the device, as this can
damage the patient cabling.
Note: Additional information specific to the Masimo sensors compatible with Pronto,
including information about parameter/measurement performance during motion and low
perfusion, may be found in the sensor's directions for use (DFU).
Note: High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor,
may not allow the Pronto to obtain vital sign readings.
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Pronto Safety Information, Warnings, and Cautions
Cleaning and Service Warnings and Cautions
WARNING: Do not adjust, repair, open, disassemble, or modify Pronto. Injury to personnel or
equipment damage could occur. Return Pronto for servicing.
WARNING: Electrical Shock Hazard: The battery should be installed and/or removed from the
Pronto by qualified personnel only.
WARNING: Do not incinerate battery.
WARNING: Do not use petroleum-based or acetone solutions, or other harsh solvents, to
clean the Pronto. These substances affect the device’s materials and device failure can result.
WARNING: Do not touch, press, or rub the display panels with abrasive cleaning compounds,
instruments, brushes, rough-surface materials, or bring them into contact with anything that
could scratch the display.
CAUTION: An operator may only perform maintenance procedures specifically described in
the manual. Refer servicing to qualified service personnel trained in the repair of this
equipment.
CAUTION: Do not submerge Pronto in any cleaning solution or attempt to sterilize by
autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously
damage Pronto.
CAUTION: Electric shock hazard: Do not open the Pronto cover except to replace the battery
or batteries.
CAUTION: Electrical shock and flammability hazard: Before cleaning, always turn off the
device and remove batteries.
CAUTION: Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of
patient-applied circuits and the system are within acceptable limits as specified by the
applicable safety standards. The summation of leakage currents must be checked and in
compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked
when connecting external equipment to the system. When an event such as a component
drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest
before further use. Injury to personnel could occur.
Note: Excessive cleaning solution can flow into the monitor and cause damage to internal
components.
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Pronto Safety Information, Warnings, and Cautions
Compliance Warnings and Cautions
WARNING: Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
CAUTION: Disposal of product - Comply with local laws in the disposal of the device and/or
its accessories.
CAUTION: Dispose of used batteries according to country or regional regulations.
CAUTION: To minimize radio interference, other electrical equipment that emits radio
frequency transmissions should not be in close proximity to Pronto.
Note: Use the Pronto in accordance with Environmental Specifications section in this
manual.
Note: This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause
undesired operation.
Note: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user
is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Note: This equipment has been tested and found to comply with the Class B limits for
medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful interference in a
typical medical installation.
Note: In order to maintain compliance with FCC regulations, shielded cables must be used
with this equipment. Operation with non-approved equipment or unshielded cables is likely
to result in interference to radio and TV reception. The user is cautioned that changes and
modifications made to the equipment without the approval of manufacturer could void the
user's authority to operate this equipment.
Note: To satisfy RF exposure requirements, this device and its antenna must operate with a
separation distance of at least 20 cm from all persons and must not be co-located or
operating in conjunction with any other antenna or transmitter.
Note: This Class B digital apparatus complies with Canadian ICES-003.
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Chapter 1: Technology Overview
The following chapter contains general descriptions for the parameters, measurements, and
technology used within Masimo products.
Masimo Signal Extraction Technology (Masimo SET®)
The signal processing in Masimo Signal Extraction Technology (Masimo SET®) differs from
that of conventional pulse oximeters. Conventional pulse oximeters assume that arterial
blood is the only blood moving (pulsating) in the measurement site. During patient motion,
however, the venous blood also moves, causing conventional pulse oximeters to read low
values, because they cannot distinguish between the arterial and venous blood movement
(sometimes referred to as noise).
Masimo SET® pulse oximetry utilizes parallel engines and adaptive filtering. Adaptive filters
are powerful because they are able to adapt to the varying physiologic signals and/or noise
and separate them by looking at the whole signal and breaking it down to its fundamental
components. The Masimo SET® signal processing algorithm, Discrete Saturation Transform®
(DST®), in parallel with Fast Saturation Transform (FST®), reliably identifies the noise,
isolates it and, using adaptive filters, cancels it. It then reports the true arterial oxygen
saturation for display on the monitor.
Masimo SET® Parallel Engines
This figure is for conceptual purposes only.
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Pronto Chapter 1: Technology Overview
Masimo SET® DST
This figure is for conceptual purposes only.
General Description for Oxygen Saturation (SpO2)
Pulse oximetry is governed by the following principles:
1. Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated
blood) differ in their absorption of red and infrared light (spectrophotometry).
2. The amount of arterial blood in tissue changes with your pulse
(photoplethysmography). Therefore, the amount of light absorbed by the varying
quantities of arterial blood changes as well.
Functional Oxygen Saturation (SpO2)
The Pronto is calibrated to measure and display functional oxygen saturation (SpO2): the
amount of oxyhemoglobin expressed as a percentage of the hemoglobin that is available to
transport oxygen.
Note: Dyshemoglobins are not capable of transporting oxygen, but are recognized as
oxygenated hemoglobins by conventional pulse oximetry.
General Description for Pulse Rate (PR)
Pulse rate (PR), measured in beats per minute (bpm), is based on the optical detection of
peripheral flow pulse.
General Description for Perfusion Index (PI)
The Perfusion Index (PI) is the ratio of the pulsatile blood flow to the non-pulsatile or static
blood in peripheral tissue. PI thus represents a noninvasive measure of peripheral perfusion
that can be continuously and noninvasively obtained from a pulse oximeter.
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Pronto Chapter 1: Technology Overview
rainbow Pulse CO-Oximetry Technology
rainbow Pulse CO-Oximetry technology is governed by the following principles:
1. Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood),
carboxyhemoglobin (blood with carbon monoxide content), methemoglobin
(blood with oxidized hemoglobin) and blood plasma constituents differ in their
absorption of visible and infrared light (using spectrophotometry).
2. The amount of arterial blood in tissue changes with pulse
(photoplethysmography). Therefore, the amount of light absorbed by the varying
quantities of arterial blood changes as well.
Pronto uses a multi-wavelength sensor to distinguish between oxygenated blood,
deoxygenated blood, blood with carbon monoxide, oxidized blood, and blood plasma.
Pronto utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the
site to a diode (detector). Signal data is obtained by passing various visible and infrared
lights (LEDs, 500 to 1400nm) through a capillary bed (for example, a fingertip, a hand, a foot)
and measuring changes in light absorption during the blood pulsatile cycle. This information
may be useful to clinicians. The maximum radiant power of the strongest light is rated at ≤ 25
mW. The detector receives the light, converts it into an electronic signal, and sends it to
Pronto for calculation.
1. Light Emitting Diodes (LEDs)
(7 + wavelengths)
2. Detector
Once the Pronto receives the signal from the sensor, it utilizes proprietary algorithms to
calculate the patient’s functional oxygen saturation (SpO2 [%]), total hemoglobin
concentration (SpHb [g/dL]), and pulse rate (PR). The SpHb measurement relies on a
multi-wavelength calibration equation to quantify the percentage of carbon monoxide and
methemoglobin and the concentration of total hemoglobin in arterial blood. Maximum
skin-sensor interface temperature was tested to be less than 41º C (106º F) in a minimum
ambient temperature of 35º C (95º F). The tests were conducted with sensors operating at
reasonable worst case power.
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Pronto Chapter 1: Technology Overview
Pulse CO-Oximetry vs. Drawn Whole Blood Measurements
When SpO2 and SpHb measurements obtained from Pronto (noninvasive) are compared to
drawn whole blood (invasive) measurements by blood gas and/or laboratory CO-Oximetry
methods, caution should be taken when evaluating and interpreting the results.
The blood gas and/or laboratory CO-Oximetry measurements may differ from the SpO2 and
SpHb measurements of Pronto. Any comparisons should be simultaneous, meaning the
measurement on the device should be noted at the exact time that blood is drawn.
In the case of SpO2, different results are usually obtained from the arterial blood gas sample
if the calculated measurement is not appropriately corrected for the effects of variables that
shift the relationship between the partial pressure of oxygen (pO2) and saturation, such as:
pH,temperature, the partial pressure of carbon dioxide (pCO2), 2,3-DPG, and fetal
hemoglobin.
In the case of SpHb, variation in hemoglobin measurements may be profound and may be
affected by sampling technique as well as the patient's physiological conditions. Any results
exhibiting inconsistency with the patient's clinical status should be repeated and/or
supplemented with additional test data. As with most hemoglobin tests, a laboratory blood
sample should be analyzed prior to clinical decision making.
High levels of bilirubin may cause erroneous SpO2 and SpHb readings. As blood samples are
usually taken over a period of 20 seconds (the time it takes to draw the blood), a meaningful
comparison can only be achieved if the oxygen saturation, carboxyhemoglobin, and
methemoglobin concentration of the patient are stable and not changing over the period of
time that the blood gas sample is taken. Subsequently, blood gas and laboratory CO-Oximetry
measurements of SpO2 and SpHb may vary with the rapid administration of fluids and in
procedures such as dialysis. Additionally, drawn whole blood testing can be affected by
sample handling methods and time elapsed between blood draw and sample testing.
Measurements with Low Signal IQ should not be compared to laboratory measurements.
General Description for Total Hemoglobin (SpHb)
Pulse CO-Oximetry is a continuous and noninvasive method of measuring the levels of total
hemoglobin (SpHb) in arterial blood. It relies on the same principles of pulse oximetry to
make its SpHb measurement. The measurement is taken by a sensor capable of measuring
SpHb, usually on the fingertip for adults and pediatric patients.
The sensor connects directly to the Pulse CO-Oximeter or with a patient cable. The sensor
collects signal data from the patient and sends it to the device. The device displays the
calculated data as measurement of total hemoglobin concentration.
Successful Monitoring for SpHb
A stable SpHb reading is associated with correct sensor placement, small physiological
changes during the measurement and acceptable levels of arterial perfusion at the
measurement site. Physiological changes at the measurement site are mainly caused by
fluctuations in the oxygen saturation, blood concentration, and perfusion. See Safety
Information, Warnings, and Cautions on page 9.
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Pronto Chapter 1: Technology Overview
SpO2 and SpHb Measurements During Patient Motion
Pronto displays measurements of SpO2 and may display SpHb during patient motion.
However, because of the changes in the physiological parameters such as blood volume,
arterial-venous coupling, etc. that occur during patient motion, the accuracy of such
measurements may not be reliable during excessive motion. In this case, the Low SIQ
indicator illuminates to alert the clinician that the device does not have confidence in the
value displayed due to poor signal strength caused by excessive motion or other signal
interference. For more information, see Low Signal I.Q. (Low SIQ) on page 40.
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