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.: 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

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

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.

■SpO2 is 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 SpO2 measurement.

■Inaccurate SpO2 readings 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 SpO2 may be decreased by levels of MetHb of up to

approximately 10% to 15%. At higher levels of MetHb, the SpO2 may 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

SpO2 General 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

SpO2 General 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. 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 SpO2 and 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 SpO2 and 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 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.

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.

SpO2 and SpHb Measurements During Patient Motion

SpO2 and 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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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.

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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.

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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

Rx Only

Rad-57

80 FK

UL 60601-1

Masimo Corporation

Irvine, CA 92618

USA

Rx Only

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.

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Masimo Pronto Pulse CO-Oximeter User manual

Masimo Pronto Pulse CO-Oximeter User manual

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