Masimo Pronto Pulse CO-Oximeter User manual

OPERATOR’S
MANUAL
Pulse CO-Oximeter™
Masimo Pronto
Pronto®

These operating Instructions intend to provide the necessary information for proper operation of the Masimo
Pronto®Pulse CO-Oximeter.
General knowledge of Pulse CO-Oximetry and an understanding of the features and functions of the Masimo
Pronto Pulse CO-Oximeter are prerequisites for proper use.
Do not operate the Masimo Pronto Pulse CO-Oximeter 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 LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
For further information contact:
Masimo Corporation
40 Parker
Irvine, CA 92618
USA
Tel.: [phone]
Fax.: [phone]
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
Covered by one or more of the following U.S. Patents: 5482036, 5490505, 5632272, 5685299, 5758644, 5769785,
5919134, 6002952, 6011986, 6067462, 6157850, 6229856, 6236872, 6263222, 6360114, 6388240, 6430525,
6463311, 6501975, 6515273, 6606511, 6643530, 6650917, 6654624, 6684090, 6699194, 6745060, 6816741,
6826419, 6850787, 6861639, 6979812, 7186966, 7215984, 7215986, 7221971, 7254433, 7295866, 7328053,
7373194, 7376453, 7377899, 7467002, 7469157, 7471969, 7489958, 7496393, 7499741, 7509154, 7530955,
RE38476, RE38492, international equivalents, or one or more of the patents referenced at www.masimo.com/
patents.htm. Other patents pending.
Masimo, , Discrete Saturation Transform, DST, DCI, Signal Extraction Technology, SET, Radical, Signal IQ,
FastSat, SpHb and Rainbow are federally registered trademarks of Masimo Corporation
SIQ, APOD, and Pulse CO-Oximeter are trademarks of Masimo Corporation
Printed in USA
© 2011 Masimo Corporation
80fk
EC REP
Title: Label, Radical, UL
LAB-2738
Revision: A
DRO-4230

Masimo Pronto Pulse CO-Oximeter Operator’s Manual
Non-Invasive Total Hemoglobin (SpHb) Accuracy
Compared to Invasive Laboratory Methods*
In 3519 comparisons of non-invasive total hemoglobin (SpHb) and invasive hemoglobin (tHb)
measurements from a laboratory CO-Oximeter, SpHb accuracy was as follows:
■0.91 correlation
■0.8 g/dL standard deviation
■Below 12 g/dL, 99% of SpHb readings were < 2 g/dL of the laboratory tHb value
■At or above 12 g/dL, 99% of SpHb readings were within 2 g/dL of the laboratory value
* Masimo FDA Submission Data
CONTRAINDICATIONS: The Pronto is contraindicated for use as an apnea monitor. The Pronto is
also contraindicated for use as a continuous monitor.
Safety Information, Warnings and Cautions
The Pronto is designed to minimize the possibility of hazards from errors in the software program
by following Sound Engineering Design Processes, Risk Analysis and Software Validation.
■The Pronto is to be operated by qualified personnel only. This manual, accessories, Directions
for Use, all precautionary information, and specifications should be read before use.
■Variation in hemoglobin measurements may be profound and may be affected by sample type, body
positioning, as well as other physiological conditions. As with most hemoglobin tests, Pronto test
results should be scrutinized in light of a specific patient’s condition. Any results exhibiting inconsistency
with the patient’s clinical status should be repeated and/or supplemented with additional test data.
■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.
■Electric shock hazard. Do not open the Pronto instrument. Only a qualified operator may
perform maintenance procedures specifically described in this manual. Refer servicing to
Masimo for repair of this equipment.
■High intensity extreme lights (including pulsating strobe lights and direct sunlight) directed on
the sensor, may not allow the Pronto to obtain readings.
■EMI radiation interference such as computer displays and/or LCD/plasma TVs can cause errors
or incorrect measurements on the Pronto.
■The Pronto should be considered an early warning device. For measurements of high or low
SpHb readings, blood samples should be analyzed by laboratory instruments to completely
understand the patient’s condition.
■If patient hypoxemia is indicated, blood samples should be analyzed by laboratory devices to
completely understand the patient’s condition.
■Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore
may not detect certain arrhythmias. The Pronto should not be used as a replacement or substitute
for ECG based arrhythmia analysis.
■As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
■Do not place the Pronto or accessories in any position that might cause it to fall on the patient.
Do not lift the Pronto by the cable or sensor.

Masimo Pronto Pulse CO-Oximeter Operator’s Manual
ii
■Patient Safety - If a sensor is damaged in any way, discontinue use immediately.
■Always remove the sensor from the patient and completely disconnect the patient from the
Pronto before bathing the patient.
■Interfering Substances: Dyes, or any substance containing dyes, that change usual blood
pigmentation may cause erroneous readings.
■Do not use the Pronto or sensors during magnetic resonance imaging (MRI) scanning. Induced
current could potentially cause burns.The Pronto may affect the MRI image and the MRI device
may affect the accuracy of the Pulse CO-Oximetry parameters and measurements.
■Do not use the Pronto during electrocautery.
■Do not use the Pronto or sensors during defibrillation.
■If using Pronto 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.
■Do not place the Pronto where the controls can be changed by the patient.
■Do not place the Pronto on electrical equipment that may affect the Pronto, preventing it from
working properly.
■Do not expose the Pronto to excessive moisture such as direct exposure to rain. Excessive
moisture can cause the device to perform inaccurately or fail.
■Do not place containers with liquids on or near the Pronto. Liquids spilled on the device may
cause it to perform inaccurately or fail.
■Changes or modifications not expressly approved by the party responsible for compliance could
void the user's authority to operate the equipment.
■SpO2is empirically calibrated to functional arterial oxygen saturation in healthy adult
volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). The
Pulse CO-Oximeter cannot measure elevated levels of COHb or MetHb. Increases in either
COHb or MetHb will affect the accuracy of the SpO2measurement.
■Inaccurate SpO2readings can be caused by:
❚Elevated levels of COHb and MetHb
❚For increased COHb: COHb levels above normal tend to increase the level of SpO2. The
level of increase is approximately equal to the amount of COHb that is present.
❚NOTE: High levels of COHb may occur with a seemingly normal SpO2. When elevated
levels of COHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample
should be performed.
❚For increased MetHb: the SpO2may be decreased by levels of MetHb of up to
approximately 10% to 15%. At higher levels of MetHb, the SpO2may tend to read
in the low to mid 80s. When elevated levels of MetHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.
❚Intravascular dyes such as indocyanine green or methylene blue
❚Externally applied coloring (such as nail polish)
Safety Information, Warnings and Cautions, continued

Masimo Pronto Pulse CO-Oximeter Operator’s Manual iii
❚Elevated levels of bilirubin
❚Severe anemia
❚Low arterial perfusion
❚Motion artifact
■Inaccurate SpHb readings can be caused by:
❚Intravascular dyes such as indocyanine green or methylene blue.
❚Externally applied coloring (such as nail polish)
❚Elevated levels of bilirubin
❚Low arterial perfusion
❚Motion artifact
❚Low arterial oxygen saturation levels including altitude induced hypoxemia
❚Hemoglobin synthesis disorders
❚Hemoglobinopathy
❚Thalassemias
❚Peripheral vascular disease
❚EMI radiation interference
■Do not place the Pronto face against a surface. This can cause the a system or battery (non-
clinical) alarm to be muffled.
■Additional information specific to Masimo sensors including information about parameter/measurement
performance during motion and low perfusion, may be found in the sensor's Directions For Use (DFU)..
■Always use the Pronto precisely in accordance with the directions in this manual.
■If the Pronto fails any part of the setup procedures or leakage spot check, remove the
instrument from operation until qualified service personnel have corrected the situation.
■Use the Pronto in accordance with Section 7, Specifications: Environmental in this manual.
■Do not incinerate battery.
■To protect against injury from electric shock, follow the directions below:
■Avoid placing the device on surfaces with visible liquid spills.
■Do not soak or immerse the device in liquids.
■Use cleaning solutions sparingly.
■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.
■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
Safety Information, Warnings and Cautions, continued

Masimo Pronto Pulse CO-Oximeter Operator’s Manual
iv
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.
■In accordance with international telecommunication requirements, the frequency band of 5,150
MHz to 5,250 MHz is only for indoor usage to reduce potential for harmful interference to
co-channel mobile satellite systems
■This equipment has been tested and found to comply with the limits for medical devices to
the EN 60601-1-2: 2002, Medical Device Directive 93/42/EEC and Class B. These limits are
designed to provide reasonable protection against harmful interference in a typical medical
installation.
■A functional tester cannot be utilized to assess the accuracy of the Pronto or any sensors.
■Cleared Use Only: The device and related accessories are cleared by the Food and Drug
Administration (FDA) 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 FDA, or in any manner inconsistent with the instructions for use or labeling. The
device and related accessories are not intended for use in combination with other medical
devices or in high-risk applications.
■Disposal of product - Comply with local laws in the disposal of the instrument and/or its
accessories.
■This Class B digital apparatus complies with Canadian ICES-003.

Masimo Pronto Pulse CO-Oximeter Operator’s Manual
Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive Laboratory Methods......... i
Safety Information, Warnings and Cautions ............................................................................................. i
Section 1 - Overview
About this Manual...........................................................................................................................1-1
Warnings, Cautions and Notes.......................................................................................................1-2
Product Description ........................................................................................................................1-3
Features and Benefits .........................................................................................................1-3
Indications for Use...............................................................................................................1-3
Pulse CO-Oximetry ........................................................................................................................1-4
SpO2General Description ..................................................................................................1-4
SpHb General Description ..................................................................................................1-4
Principle of Operation..........................................................................................................1-5
Functional Saturation ..........................................................................................................1-6
Pronto vs. Drawn Whole Blood Measurements...................................................................1-6
Signal Extraction Technology (SET) ....................................................................................1-6
SpHb Measurements During Patient Motion.......................................................................1-6
Masimo SET Parallel Engines.............................................................................................1-7
Masimo SET DST®.............................................................................................................1-7
Section 2 - System Description
Introduction ....................................................................................................................................2-1
Front Panel Controls ......................................................................................................................2-1
Rear Panel......................................................................................................................................2-3
Symbols...............................................................................................................................2-4
Section 3 - Setup
Introduction.....................................................................................................................................3-1
Unpacking and Inspection..............................................................................................................3-1
Preparation for Spot Checking .......................................................................................................3-1
Power Requirements ...........................................................................................................3-1
Device Setup ..................................................................................................................................3-2
Initial Setup..........................................................................................................................3-2
Section 4 - Operation
Introduction.....................................................................................................................................4-1
Basic Operation..............................................................................................................................4-1
General Setup and Use.......................................................................................................4-1
Default Settings ...................................................................................................................4-2
Successful SpHb Spot Check ........................................................................................................4-3
Masimo Sensors..................................................................................................................4-3
Numeric Display - SpHb......................................................................................................4-3
Numeric Display - SpO2.............................................................................................................................4-4
Numeric Display - Pulse Rate .............................................................................................4-4
Numeric Display - PI ...........................................................................................................4-4
Low Perfusion......................................................................................................................4-4
Low Signal IQ (Low SIQ) ...................................................................................................4-5
Troubleshooting Sensor Placement.....................................................................................4-5
Low Battery Audible Alarm..................................................................................................4-6
Table of Contents

Masimo Pronto Pulse CO-Oximeter Operator’s Manual
Alarm Identification..............................................................................................................4-6
Battery Level Indicator.........................................................................................................4-6
Setup Menu ....................................................................................................................................4-7
Menu Navigation .................................................................................................................4-7
Trend Setup and Use....................................................................................................................4-10
Introduction........................................................................................................................4-10
TrendCom Utility Operation ...............................................................................................4-10
Erasing Trend Memory ......................................................................................................4-11
Trend Data Format ............................................................................................................4-11
Sample Trend Output.........................................................................................................4-11
Section 5 - Messages
Messages .......................................................................................................................................5-1
Section 6 - Troubleshooting
Troubleshooting ..............................................................................................................................6-1
Section 7 - Specifications
Specifications .................................................................................................................................7-1
Section 8 - Sensor and Patient Cables
Introduction.....................................................................................................................................8-1
Selecting a Rainbow SpHb Sensor Only ............................................................................8-1
Masimo Rainbow® Sensors...........................................................................................................8-2
SpHb Rainbow Reusable and Adhesive Sensors...............................................................8-2
Sphb Rainbow Resposable Pulse Oximeter Sensor System..............................................8-3
Sensor Accuracy .................................................................................................................8-3
Cleaning and Reuse of Masimo Reusable Sensors and Cables ........................................8-3
Section 9 - Service and Maintenance
Introduction.....................................................................................................................................9-1
Cleaning .........................................................................................................................................9-1
Battery Replacement...........................................................................................................9-2
Performance Verification.................................................................................................................9-2
Power-On Self-Test..............................................................................................................9-2
Service and Repair.........................................................................................................................9-3
Repair Policy .......................................................................................................................9-3
Return Procedure................................................................................................................9-3
Sales & End-User License Agreement...........................................................................................9-4
Warranty .........................................................................................................................................9-4
Exclusions ......................................................................................................................................9-4
End-User License...........................................................................................................................9-5
Restrictions.....................................................................................................................................9-5
Section 10 - Accessories
Accessories ..................................................................................................................................10-1
Overview

Masimo Pronto Pulse CO-Oximeter Operator’s Manual 1-1
1
Overview
About this Manual
This manual explains how to set up and use the Masimo Pronto Pulse CO-Oximeter. Important safety
information relating to general use of the device appears before this introduction. Other important safety
information is located throughout the manual where appropriate.
Read the entire safety information section before you operate the device.
In addition to the safety section, this manual includes the following sections:
■Section 1 Overview
■Section 2 System Description
■Section 3 Setup
■Section 4 Operation
■Section 5 Messages
■Section 6 Troubleshooting.
■Section 7 Specifications
■Section 8 Sensors and Patient Cables
■Section 9 Service and Maintenance
■Section 10 Accessories
Section 1 - Overview

1-2 Masimo Pronto Pulse CO-Oximeter Operator’s Manual
1Overview
Warnings, Cautions and Notes
Please read and follow any warnings, cautions and notes presented throughout this
manual. An explanation of these labels are as follows:
A WARNING is provided when actions may result in a serious outcome (i.e., injury,
serious adverse affect, death) to the patient or user. Look for text in a gray shaded box.
Sample of Warning:
WARNING: THIS IS A SAMPLE 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.
Sample of Caution:
CAUTION: This is a sample of a caution statement.
A NOTE is provided when additional general information is applicable.
Sample of Note:
NOTE: This is a sample of a Note.

Masimo Pronto Pulse CO-Oximeter Operator’s Manual 1-3
1
Product Description
The Pronto Handheld Spot Check Pulse CO-Oximeter with Masimo Rainbow®SET®Technology
is developed to simultaneously and non-invasively measure total hemoglobin (SpHb), functional
arterial oxygen saturation (SpO2), pulse rate (PR) and perfusion index (PI).
Features and Benefits
Single-Button Operation
Simply connect the sensor to the device, properly align the sensor on the finger and press the
“SpHb” button.
Accurate and non-invasive functional arterial oxygen saturation (SpO2) and pulse rate (PR)
The Pronto uses multiple wavelengths of light and proprietary algorithms to obtain functional
arterial oxygen saturation (SpO2) and pulse rate (PR) readings.
Accurately and non-invasively measures and displays total hemoglobin (SpHb)
The Pronto measures total hemoglobin (SpHb) using similar principles as pulse oximetry with
additional wavelengths of light to obtain the measurements.
Clinically proven Masimo SET (Signal Extraction Technology) performance
Clinically proven accurate in excessive motion and low perfusion environments.
Additional Features:
■Signal I.Q.® (SIQ™) for signal identification and quality indication
■Lightweight, ergonomic handheld design
■Bright, multicolored lights and display
■Sensor life indicator shows approximate sensor uses remaining
■Progress indicator shows progress to completion of spot check
■Parameter/Measurement Select: “Up/Down”allows user to determine values to display
■Automatic shutdown power conservation
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 and in clinical and non-clinical settings (e.g., hospitals, hospital-type facilities, home,
clinics, physician offices, blood donation facilities and ambulatory surgery centers).
Overview

1-4 Masimo Pronto Pulse CO-Oximeter Operator’s Manual
1Overview
Pulse CO-Oximetry
SpO2General Description
Pulse oximetry is a noninvasive method of measuring the level of functional arterial oxygen
saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the
fingertip for adults and pediatric patients. The sensor connects to the pulse oximetry device
directly or with a patient cable. The sensor collects signal data from the patient and sends it to the
instrument. The instrument displays the calculated data as a percent value for functional arterial
oxygen saturation (SpO2).
SpHb General Description
Pulse CO-Oximetry instruments offer a noninvasive method of measuring the levels of total
hemoglobin (SpHb) in blood. It relies on the same principles as pulse oximetry to make the SpHb
measurement. The measurements are taken by placing a sensor (2) on a patient, usually on the
fingertip for adults as shown in the figure above. The sensor connects directly to the instrument
(1). The sensor collects signal data from the patient and sends it to the instrument. The instrument
displays the calculated data as measurement of total hemoglobin concentration.
2
1
1. Instrument
2. Sensor

Masimo Pronto Pulse CO-Oximeter Operator’s Manual 1-5
1
Overview
Principles of Operation
Pulse CO-Oximetry 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, see figure below).
2. The amount of arterial blood in tissue changes with a person’s pulse
(photoplethysmography). Therefore, the amount of light absorbed by the varying quantities
of blood changes as well.
The Pronto uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated
blood and blood plasma. The Pronto utilizes a sensor with various light-emitting diodes (LEDs) that
pass light through the site to multiple photodiodes (detectors) (see figure below).
Signal data is obtained by passing various visible and infrared lights (500nm to 1300nm) through
a capillary bed (for example, a fingertip) 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 ≤25mW. The detectors receive the light, convert it into an electronic
signal and sends it to the Pronto for calculation.
Once the Pronto receives the signal from the sensor, it utilizes Masimo Rainbow SET signal
extraction technology 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
multiwavelength calibration equation to quantify the percentage of total hemoglobin in blood. In an
ambient temperature of 95ºF (35º C) the maximum skin surface temperature has been measured
Carboxyhemoglobin
Oxyhemoglobin
Methemoglobin
Deoxyhemoglobin
Absorption Spectra
Plasma
Absorption (1/mm)
0
0.5
600 800
1.0
1.5
2.0
2.5
3.0
3.5
4.0
1000 1200 1400 1600
Wavelength (nm)
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1
1. Light Emitting Diodes (LEDs)
(7+ wavelengths)
2. Detectors

1-6 Masimo Pronto Pulse CO-Oximeter Operator’s Manual
1Overview
at less than 106º F (41º C), verified by Masimo sensor skin temperature test procedure.
Functional Oxygen Saturation
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. See the Safety information, Warnings and Cautions section in front of this manual for
details.
Pronto vs. Drawn Whole Blood Measurements
When SpO2and SpHb measurements obtained from the instrument (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 SpO2and SpHb measurements of
the Pronto Pulse CO-Oximeter.
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. High
levels of bilirubin may cause erroneous SpO2and 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 SpO2and 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.
Signal Extraction Technology (SET)
Masimo Signal Extraction Technology’s signal processing differs from 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 digital 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®) 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.
SpO2and SpHb Measurements During Patient Motion
SpO2and SpHb measurement accuracy may not be reliable during excessive motion because
of the changes in the physiological parameters such as blood volume, arterial-venous coupling,
etc. that occur during patient motion. When the Pronto does not have confidence in the value of a
parameter due to poor signal quality caused by excessive motion or other signal interference, the
Low SIQ LED will illuminate. See Section 4, Low Signal IQ (Low SIQ).

Masimo Pronto Pulse CO-Oximeter Operator’s Manual 1-7
1
Overview
Masimo SET Parallel Engines
Masimo SET DST®
�
�
SpOC
12
FST
MST

1-8 Masimo Pronto Pulse CO-Oximeter Operator’s Manual
1Overview

Masimo Pronto Pulse CO-Oximeter Operator’s Manual 2-1
2
Introduction
The Pronto is a spot check Pulse CO-Oximeter which includes non-invasive total hemoglobin
(SpHb) measurement. The device is designed for accuracy and ease of operation. All hemoglobin
pulse oximetry measurement information, as well as device status data, is displayed on the front
panel of the device. All user input is handled by control buttons on the front panel and the sensor
cable connection is located at the top edge of the device.
The Pronto is powered by 4 AA alkaline batteries to provide the capacity of up to 8 hours of
continuous use, when fully charged. Continous use is defined as consecutive spot check tests
with each consecutive spot check test initiated immediately upon the conclusion of the previous
spot check test.
A spot check sensor or patient cable attaches to the connector on the top of the Pronto.
2
System Description
Section 2 - System Description
Front Panel Controls
Pronto
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GRAPHIC DOCUMENTATION AND APPROVAL
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GRAPHIC DOCUMENTATION AND APPROVAL
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© 2001 Masimo Corporation
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GRAPHIC DOCUMENTATION AND APPROVAL
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GRAPHIC DOCUMENTATION AND APPROVAL
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© 2001 Masimo Corporation
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GRAPHIC DOCUMENTATION AND APPROVAL
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© 2001 Masimo Corporation
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2/4/04
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GRAPHIC DOCUMENTATION AND APPROVAL
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© 2001 Masimo Corporation
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GRAPHIC DOCUMENTATION AND APPROVAL
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© 2001 Masimo Corporation
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GRAPHIC DOCUMENTATION AND APPROVAL
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© 2001 Masimo Corporation
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GRAPHIC DOCUMENTATION AND APPROVAL GR-10887
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2-2 Masimo Pronto Pulse CO-Oximeter Operator’s Manual
2
CONTROL / INDICATOR DESCRIPTION
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Parameter/
Measurement
Numeric Display
Displays parameter/measurement numeric values once a spot
check test is complete.
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Pulse Indicator Flashes with patient's pulse reading (PR) during spot check test
period.
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Spot Check Progress
Indicator
Incrementally illuminates upward after a SpHb spot check has
been initiated. This indicates progress towards completion of a
SpHb spot check. A fully illuminated spot check progress indicator
indicates a competed spot check.
GRAPHIC DOCUMENTATION AND APPROVAL
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Parameter/
Measurement Label
Display
Displays parameter/measurement label once a spot check test is
complete.
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Power On / Off Powers the instrument on or off. Press the button once to power on.
Press and hold the button for 2 seconds to power off.
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Battery Level
Indicator
Battery charge level is indicated by four LED indicators. All four
indicators will be lit when the batteries are full, with fewer indicators
being lit as the batteries lose their charge.
GRAPHIC DOCUMENTATION AND APPROVAL
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Patient Cable /Sensor
Connector
The Patient Cable/Sensor connector is where a compatible sensor
is connected to the Pronto.
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Low SIQ Indicator SIQ is a signal identification and quality indicator. When this
indicator illuminates, re-checking the measurement is necessary.
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Sensor Use Indicator
This illuminates to display the approximate number of uses
remaining for the attached sensor. The bottom LED will turn red
when the remaining uses for the connected sensor are low. The
approximate number of sensor uses remaining is displayed upon
power up (if a sensor is attached) and when a sensor is connected.
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SpHb Button
Press to initiate total hemoglobin (SpHb) spot check information
on display or to display a Total Hemoglobin (SpHb) spot check test.
Oxygen saturation (SpO2), perfusion index (PI) and pulse rate
(PR) are automatically displayed. When in the configuration menu,
pressing this button will confirm a menu setting and navigate to the
next menu option. (See Section 4, Operation).
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Up/Down Arrow
Buttons
Use the Up and Down arrow buttons to scroll between parameter or
measurement spot check results. When in the configuration menu,
use the Up and Down arrow buttons to scroll through menu setting
options. (See Section 4, Operation.)
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Speaker Provides audible indication of alarm conditions, pulse tone, and
feedback for control button presses.
System Description
Front Panel Controls, continued

Masimo Pronto Pulse CO-Oximeter Operator’s Manual 2-3
2
System Description
Rear Panel
Pronto
CONTROL / INDICATOR
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Serial Number Label
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Certification Label
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Battery Cover
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Battery Cover Release
Masimo Corporation
Irvine, CA 92618
USA
RxOnly
Rad-57
80 FK
UL 60601-1
Masimo Corporation
Irvine, CA 92618
USA
RxOnly
Rad-57
80 FK
UL 60601-1
Masimo, SET, , and SIQ are registered trademarks of Masimo Corporation.
Rad-57 is a trademark of Masimo Corporation.Rainbow and SpCO are
registered trademarks of Masimo Laboratories. Signal Extraction Pulse
CO-Oximeter and SpMet are trademarks of Masimo Laboratories.