Masimo Pronto-7 Operator's Manual

DRAFT 02 17 14

Pronto-7

Operator's Manual

www.masimo.com 1 Masimo

Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter, also referred to as
Pronto-7, operating instructions provide the necessary information for proper
operation of Pronto-7. There may be information provided in this manual that
is not relevant for your system. Do not operate Pronto-7 without completely
reading and understanding the instructions in this manual.

Notice:
Purchase or possession of this instrument does not carry any express or
implied license to use this instrument with replacement parts which would,
alone or in combination with this instrument, 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 professional use. See instructions for use for full prescribing
information, including indications, contraindications, warnings,
precautions and adverse events.

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

3148433
Patents: www.masimo.com/patents.htm.

Masimo, , Signal Extraction Pulse CO-Oximeter, rainbow, Pronto-7, SET,
SpHb and Signal I.Q. are registered trademarks of Masimo Corporation.

All other trademarks and registered trademarks are property of their
respective owners.

Printed in U.S.A.

www.masimo.com 2 Masimo

© 2014 Masimo Corporation.

www.masimo.com 3 Masimo

Contents

About this Manual -------------------------------------------------------------------------- 55
Product Description ----------------------------------------------------------------------- 77

Indications for Use --------------------------------------------------------------------- 77
Contraindications ----------------------------------------------------------------------- 77

Safety Information, Warnings, and Cautions---------------------------------------- 99

Safety Information, Warnings, and Cautions --------------------------------- 1010
Compliance Information, Warnings and Cautions --------------------------- 1213
Sensor Information, Warnings and Cautions --------------------------------- 1414

Chapter 1: Technology Overview --------------------------------------------------- 1515

Signal Extraction Technology (SET) -------------------------------------------- 1515
rainbow Pulse CO-Oximetry Technology -------------------------------------- 1515
Functional Oxygen Saturation ---------------------------------------------------- 1616
Pronto-7 vs. Drawn Whole Blood Measurements --------------------------- 1616
Non-Invasive Total Hemoglobin (SpHb) Accuracy Compared to Invasive

Laboratory Methods* --------------------------------------------------------------- 1717

Chapter 2: Product Description------------------------------------------------------ 1919

Pronto-7 Description ---------------------------------------------------------------- 1919
Pronto-7 Front Panel and Touchscreen --------------------------------------- 2020
Pronto-7 Back Panel ---------------------------------------------------------------- 2222
Pronto-7 Bottom Panel ------------------------------------------------------------- 2323
Parameter and Measurement Descriptions ----------------------------------- 2323

Chapter 3: Setup ------------------------------------------------------------------------ 2525

Unpacking and Inspection the System ----------------------------------------- 2525
Preparation for Use ----------------------------------------------------------------- 2525

Chapter 4: Operation ------------------------------------------------------------------- 2727

Common Screens ------------------------------------------------------------------- 2828
Commonly Used Icons ------------------------------------------------------------- 2828
Recommended Initial Testing Procedure -------------------------------------- 3030

Pronto-7Pronto-7 Contents

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Patient Testing ----------------------------------------------------------------------- 3332
Completed Test ---------------------------------------------------------------------- 3534
Incomplete Test ---------------------------------------------------------------------- 3634
Key Features ------------------------------------------------------------------------- 3635
Main Menu Options ----------------------------------------------------------------- 5147
Battery ---------------------------------------------------------------------------------- 5854

Chapter 5: Alarms and Messages -------------------------------------------------- 6157

Messages------------------------------------------------------------------------------ 6157

Chapter 6: Troubleshooting ---------------------------------------------------------- 6359

Troubleshooting ---------------------------------------------------------------------- 6359

Chapter 7: Specifications ------------------------------------------------------------- 6561

Specifications ------------------------------------------------------------------------- 6561
Calibration Verification ------------------------------------------------------------- 6864
Symbols -------------------------------------------------------------------------------- 6864

Chapter 8: Service and Repair ------------------------------------------------------ 7167

Service and Repair ------------------------------------------------------------------ 7167

Index --------------------------------------------------------------------------------------- 7973

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About this Manual

This manual explains how to set up and use Pronto-7. Important safety
information relating to general use of the product 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 and, death) to the patient or user. The following
is an example of a warning:

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 Pronto-7 or damage to other
property. The following is an example of a caution:

CAUTION: This is an example of caution statement.
A note is given when additional general information is applicable. The

following is an example of a note:

Note: This is an example of a note.
Read the entire safety information section before you operate the

instrument.

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Product Description

Indications for Use

The Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter and
Accessories are indicated for noninvasive spot check testing of functional
saturation of arterial oxygen hemoglobin (SpO2), pulse rate (PR), and total
hemoglobin concentration (SpHb). The Masimo rainbow SET Pronto-7 Spot
Check CO-Oximeter and Accessories are indicated for use by trained
personnel, with adult and pediatric individuals, in clinical and non-clinical
settings (e.g., hospitals, hospital-type facilities, home, clinics, physician
offices, and ambulatory surgery centers).

The Masimo rainbow SET Pronto-7 Spot Check CO-Oximeter is designed to
simultaneously and noninvasively measure functional arterial oxygen
saturation (SpO2), pulse rate (PR), total hemoglobin (SpHb), perfusion index
(PI), and hematocrit (SpHct).

Advanced features available on the Pronto-7 include SpHct access, multi test
mode, low signal I.Q., measurement through motion of SpHb and SpO2,
wireless download of spot check tests, SpO2 only mode and EMR connectivity
for parameter and measurement download.

The instrument is voice automated, provides step by step instructions when
administering tests and is equipped with an interactive touchscreen for user
selectable options.

Contraindications

The Pronto-7 is contraindicated for use as an apnea monitor. The Pronto-7 is
also contraindicated for use as a continuous monitor.

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Safety Information, Warnings, and
Cautions

The following section lists warnings, cautions, notes, and safety information
for Pronto-7.

Pronto-7 is to be operated by qualified personnel only. The manual,
accessories, directions for use, all precautionary information, and
specifications should be read before use.

Pronto-7 Safety Information, Warnings, and Cautions

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Safety Information, Warnings, and Cautions

Always use the Pronto-7 precisely in accordance with the directions in
this manual, including finger selection, finger alignment in the sensor,
and subject behavior during testing. Failure to follow all of the
directions in this manual could lead to inaccurate measurements.

The Pronto-7 should be considered an early warning device. Blood
samples should be analyzed by laboratory instruments prior to clinical
decision making to completely understand the patient’s condition.

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-7 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.

Pulse rate measurement is based on the optical detection of a peripheral flow
pulse and therefore may not detect certain arrhythmias. The Pronto-7 should
not be used as a replacement or substitute for ECG based arrhythmia
analysis.

If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken
to confirm the patient’s condition.

SpO2 is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).

Inaccurate SpO2 readings may be caused by:

• 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.

• Intravascular dyes such as indocyanine green or methylene blue

• Externally applied coloring and texture such as nail polish, acrylic

nails, glitter, etc.

• Elevated levels of bilirubin

• Severe anemia

• Low arterial perfusion

• Motion artifact

Inaccurate SpHb readings may be caused by:

• Improper sensor application

• Intravascular dyes such as indocyanine green or methylene blue

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• Externally applied coloring and texture such as nail polish, acrylic

nails, glitter, etc.

• Elevated PaO2 levels

• Elevated levels of bilirubin

• Low arterial perfusion

• Motion artifact

• Low arterial oxygen saturation levels

• Elevated carboxyhemoglobin levels

• Elevated methemoglobin levels

• Hemoglobinopathies and synthesis disorders such as thalassemias,

Hb s, Hb c, sickle cell, etc.

• Vasospastic disease such as Raynaud's

• Peripheral vascular disease

• Liver disease

• EMI radiation interference

SpHct is NOT reliable in cases of abnormal blood composition and is not
indicative of disease states. Abnormal values of SpHct that are displayed
should warrant repeat testing by conventional laboratory methods.

High intensity extreme lights (including pulsating strobe lights and direct
sunlight) directed on the sensor, may not allow the Pronto-7 to obtain
readings.

As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.

Do not place the Pronto-7 or accessories in any position that might cause it to
fall on the patient. Do not lift the Pronto-7 by the cable or sensor.

Ensure the sensor is physically intact, with no broken or frayed wires or
damaged parts. Visually inspect the sensor and discard if cracks or
discoloration are found.

Interfering Substances: Dyes, or any substance containing dyes, that change
usual blood pigmentation may cause erroneous readings.

Do not use the Pronto-7 or sensor during magnetic resonance imaging (MRI)
scanning. Induced current could potentially cause burns. The Pronto-7 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-7 during electrocautery.
Do not use the Pronto-7 or sensor during defibrillation.
Do not place the Pronto-7 where the controls can be changed by the patient.

Pronto-7 Safety Information, Warnings, and Cautions

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Do not expose the Pronto-7 to excessive moisture such as direct exposure to
rain. Excessive moisture can cause the instrument to perform inaccurately or
fail.

Do not place containers with liquids on or near the Pronto-7. Liquids spilled on
the instrument 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.

Explosion hazard. Do not use the Pronto-7 in the presence of flammable
anesthetics or other flammable substances in combination with air,
oxygen-enriched environments, or nitrous oxide.

EMI radiation interference such as computer displays and / or LCD / plasma
TVs can cause errors or incorrect measurements on the Pronto-7.

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.

Always remove the sensor from the patient and completely disconnect the
patient from the Pronto-7 before bathing the patient.

A functional tester cannot be utilized to assess the accuracy of the Pronto-7 or
its rainbow 4D DC reusable sensors.

Do not place the Pronto-7 on electrical equipment; it may prevent it from
working properly. If Pronto-7 is used adjacent to other electrical equipment,
the device should be observed to verify normal operation.

Compliance Information, Warnings and Cautions

Use the Pronto-7 in accordance with the Environmental Specifications in this
manual.

Do not incinerate device and/or battery.
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

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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.

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 equipment has been tested and found to comply with Class B limits for
medical devices according to the EN 60601-1-2. These limits are designed to
provide reasonable protection against harmful interference in all
establishments, including domestic establishments.

This Class B digital apparatus complies with Canadian ICES-003.
Do not open the Pronto-7 instrument. Only a qualified operator may perform

maintenance procedures specifically described in this manual. Refer servicing
to Masimo for repair of this equipment.

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.

Pronto-7 is provided with RF wireless capabilities. When used outside the US,
consideration should be taken to account for local/ national regulations or
restrictions for RF wireless technologies prior to using the wireless feature.

RF Exposure: The Pronto-7 was tested for SAR compliance with a 0mm
separation distance. In order to maintain FR exposure compliance, the
device should not be used for any other body worn accessories.

Pronto-7 Safety Information, Warnings, and Cautions

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Sensor Information, Warnings and Cautions

If using the Pronto-7 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 instrument might read zero for the duration of the active
irradiation period.

Failure to apply the sensor properly may lead to incorrect measurements.
Do not loop the sensor cable into a tight coil or wrap around the device, as this

can damage the sensor cable.
Additional information specific to Masimo's rainbow 4D DC reusable sensor,

including information about parameter/measurement performance during
motion and low perfusion, may be found in the sensor's Directions For Use
(DFU).

Do not expose the rainbow 4D DC reusable sensor to moisture, liquids or a
humid environment, as this may make the sensor perform inaccurately or fail.

Do not use damaged sensors. Do not use a sensor with exposed optical or
electrical components. Do not immerse the sensor in water, solvents, or
cleaning solutions (the sensors and connectors are not waterproof). Do not
sterilize by irradiation, steam, autoclave or ethylene oxide unless otherwise
indicated in the sensor's directions for use. See the cleaning instructions in the
sensors' directions for use.

Do not attempt to reprocess, recondition or recycle any Masimo sensors or
patient cables as these processes may damage the electrical components,
potentially leading to patient harm.

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Chapter 1: Technology Overview

Signal Extraction Technology (SET)

Masimo Signal Extraction Technology's signal processing 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 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®), 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.

rainbow Pulse CO-Oximetry Technology

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).

Pronto-7 Chapter 1: Technology Overview

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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-7 uses a multi-wavelength sensor to distinguish between
oxygenated blood, deoxygenated blood and blood plasma. The Pronto-7
utilizes a sensor with various light-emitting diodes (LEDs) that pass light
through the site to multiple photodiodes (detectors). See the figure below.

Light-

Emitting Diodes (LEDs)

(7+ Wavelengths)
Detectors

Signal data is obtained by passing various visible and infrared lights (ranging
from 500nm up 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 send it to the Pronto-7 for calculation.

Once the Pronto-7 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 (BPM). The
SpHb measurement relies on a multiwavelength calibration equation to
estimate the percentage of total hemoglobin in blood. In an ambient
temperature of 95º F (35º C) the maximum skin surface temperature has been
measured at less than 106º F (41º C), verified by Masimo sensor skin
temperature test procedure.

Functional Oxygen Saturation

The Pronto-7 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. Refer to the Safety
information, Warnings and Cautions section in front of this manual for details.

Pronto-7 vs. Drawn Whole Blood Measurements

When SpO2 and SpHb measurements obtained from the instrument
(noninvasive) are compared to drawn whole blood measurements (invasive)

Pronto-7 Chapter 1: Technology Overview

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by blood gas and/or laboratory hematology, caution should be taken when
evaluating and interpreting the results. The blood gas and/or laboratory
hematology measurements may differ from the SpO2 and SpHb
measurements of the Pronto-7.

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 mehemoglobin 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 hematology
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.

Non-Invasive Total Hemoglobin (SpHb) Accuracy
Compared to Invasive Laboratory Methods*

The following is data of the sensor compatible with the Pronto-7: Rainbow 4D
DC Reusable Sensor.

rainbow 4D DC Reusable Sensor

For Normal Sensitivity Mode in 10,253 comparisons of SpHb® and invasive
hemoglobin (tHb) measurements from a laboratory reference device in the
range of 8-17 g/dL, SpHb accuracy was as follows:

• 0.90 correlation

• 1.05 g/dL A

RMS

accuracy

For Maximum (MAX) Sensitivity Mode in 13,205 comparisons of SpHb and
invasive hemoglobin (tHb) measurements from a laboratory reference device,
SpHb accuracy was as follows:

• 0.86 correlation

• 1.00 g/dL A

RMS

accuracy

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Chapter 2: Product Description

Pronto-7 Description

The Pronto-7 is designed to simultaneously and noninvasively measure
functional arterial oxygen saturation (SpO2), pulse rate (PR), total hemoglobin
(SpHb), perfusion index (PI) and hematocrit (SpHct ). The instrument is voice
automated, provides step by step instructions when administering tests, and is
equipped with an interactive touchscreen for user selectable options.

The Test Ready screen, as seen in the following image, indicates a
compatible sensor has been properly inserted into the Pronto-7 and the
instrument is ready for testing.

The Main Menu icon, also available on the Test Ready screen, provides
access to additional icons and user configurable options.

Parameters and measurements are displayed on the Test Results screen and
may include functional arterial oxygen saturation (SpO2), pulse rate (PR), total
hemoglobin (SpHb), perfusion index (PI), and hematocrit (SpHct).
Measurements are collected through the rainbow 4D DC sensor, connected
via the connector port.

Pronto-7 Chapter 2: Product Description

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Pronto-7 Front Panel and Touchscreen

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Ref. Feature Description

1

Power On/Off

Places instrument in Power
On and Power Off modes.

2

LCD Touchscreen

Provides an interface for
user interactions.

3

Test Ready Screen

Indicates Pronto-7 is ready
for testing.

4

Connector Port

Provides connectivity for
rainbow 4D DC sensors.

5 Time

Displays instrument's time.

6

Battery Status

Indicates the estimated
percentage of battery
power remaining.

7

Action Icons

Provides user selectable
icons for navigation.

8

Test Icon

Allows for commencement
of spot check test.

9

Main Menu Icon

Provides access to
additional icons and user
configurable options.

10

Radical Sign

Indicates the number of
spot check test credits
remaining on the attached
sensor.

11

Sensor Size

Specifies the size of the
attached sensor (small,
medium or large).

12

Connectivity

Indicates Wi-Fi and
Bluetooth status.

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Pronto-7 Back Panel

Ref. Feature Description

1 Certification

Label

Documents the instrument’s certification marks.

2 Serial Number Lists unique serial number associated with the

instrument.

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Pronto-7 Bottom Panel

Ref. Feature Description

1 Earphone Jack 3.5mm earphone jack.

2 Micro SD Card

Slot

Micro SD flash memory card slot.

3 Mini USB Port Input port for mini USB cable to computer

connection.

4 Power Port Power supply connector for the Pronto-7 specific

power cable.

Parameter and Measurement Descriptions

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 adult 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
instrument. The instrument displays the calculated data as measurement of
total hemoglobin concentration.

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Arterial Oxygen Saturation (SpO2)

Pulse oximetry is a noninvasive method of measuring the level of functional
arterial oxygen saturation in blood. The instrument displays the calculated
data as a percent value for functional arterial oxygen saturation (SpO2).

A SpO2 reading is associated with correct sensor placement, small
physiological changes during the measurement and acceptable levels of
arterial perfusion at the measurement site.

Pulse Rate (PR)

Pulse rate (PR), measured in beats per minute (BPM) is based on the optical
detection of peripheral flow pulse.

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.

Hematocrit (SpHct)

Hematocrit (SpHct) is the fraction of whole blood volume that consists of red
blood cells. In normal conditions, there is a linear relationship between
hematocrit and the concentration of hemoglobin. An estimated hematocrit as
a percentage may be derived by multiplying the hemoglobin concentration in
g/ dL times three and dropping the units 1,2. The hematocrit measurement is
determined mathematically in the instrument as*:

%SpHct = 3.0422 x SpHb – 0.8059

The measurement is taken by a sensor capable of measuring SpHct, usually
on the fingertip for adults or pediatric patients. The sensor collects signal data
from the patient and sends it to the instrument. The instrument displays the
calculated data as measurement of SpHct. The hematocrit estimation is NOT
reliable in cases of abnormal blood composition and is not indicative of
disease states. Abnormal values of hematocrit that are displayed should
warrant repeat testing by conventional laboratory methods.

*Note: This is the relationship found between tHb and SpHb for 3,226 blood
samples measured on a Coulter LH 500 Hematology Analyzer.

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Chapter 3: Setup

Unpacking and Inspection the System

To unpack and inspect the system

1. Remove Pronto-7 and the components from the shipping carton.

2. Examine them for signs of shipping damage.

3. Check all materials against the packing list.

4. Save all packing materials, invoice and bill of lading. These may be

required to process a claim with the carrier.

If anything is missing or damaged, contact the Masimo Technical Service
Department, see Return Procedure on page 7369.

Preparation for Use

Before the Pronto-7 can be used, it needs to be properly setup and fully
charged.

Note: The initial battery charge can take up to 6 hours.

1. Power the instrument on. The touchscreen will illuminate and a

series of audible tones will sound. To change the audible tone
settings, see Sound Icon on page 5249.

2. The time and date need to be set. Enter your region's correct date

and time.

3. Tap the green check mark icon to accept changes.

4. Fully charge the instrument using the included AC power cable.

5. Insert the rainbow 4D DC sensor to the connector port.

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Chapter 4: Operation

The information in this chapter assumes that Pronto-7 is set up and ready for
use. Do not operate the Pronto-7 without completely reading and
understanding these instructions.

The following sections describe how the Pronto-7 information is displayed,
including available parameters, icons, features and accessing user
configurable settings.

Pronto-7 may provide the following parameters and features:
Key Parameters:

• Total Hemoglobin (SpHb)

• Arterial Oxygen Saturation (SpO2)

• Pulse Rate (PR)

• Perfusion Index (PI)

• Hematocrit (SpHct)

Key Features:

• Viewing Select Parameters

• Viewing SpHct

• Low Signal I.Q. (Low SIQ)

• Sensitivity and Test MOdes

• Emailing Spot Check Test Results

• Download of Spot Check Tests

• EMR Connectivity

Pronto-7 Chapter 4: Operation

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Common Screens

Item Description

Connect Sensor screen indicates a compatible sensor
should be properly connected to the Pronto-7 in order to
begin testing.

Test Ready screen indicates the Pronto-7 is ready for
testing.

Test Results screen provides parameter and
measurement test results.

Commonly Used Icons

Icons Description

Turns the instrument on/off.

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Icons Description

Starts a test.

Provides access to additional icons and user configurable
settings.

Submits inputs and exits the Main Menu.

Moves back one screen. Pressing and holding returns to
Test Ready screen.

Exits pop-up windows.

Scrolls down the list or page.

Scrolls up the list or page.

Displays an interactive dialogue for user options: printing,
e-mailing, or deleting test results.

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Icons Description

Adds patient specific information.

Discontinues test.

Recommended Initial Testing Procedure

SpHb Spot Check Measurement

Note: Potentially inaccurate results can occur if the user does not properly
follow the testing procedure. As with any diagnostic test, clinicians should
always evaluate hemoglobin measurements in the perspective of the clinical
context of the patient.

Sensor Site Selection

1. Assess the patient’s arm of the selected site for any restrictions from
shoulder to fingertip.

2. Restrictive garments or accessories should be removed as it can
impede blood flow to the sensor site. (Example: purse, backpacks,
watches, jewelry and blood pressure cuff).

Do not use sites with any of the following conditions:

• An anatomically abnormal finger (e.g. damaged, clubbed,

deviated, etc.)

• A finger or arm that has experienced previous surgical

procedures

• A finger or arm that is currently receiving an IV infusion

3. Site should be cleaned of debris and dry prior to testing.

4. Select the patient’s testing finger in the following priority:

• Non-dominant ring or middle finger

• Dominant ring or middle finger

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Sensor Selection

Pronto-7 is compatible with rainbow 4D DC sensors, which has three sizes:
large, medium and small. Use the Finger Size Guide attached to the sensor to
ensure the correct sensor is being used.

1. Measure the patient’s finger size (diameter) at the cuticle to

determine the correct sensor size using the Finger Size Guide.

2. Gently close sides of Finger Size Guide until the edges touch the

outside of the finger. The arrow indicates which size of sensor should
be used on the patients.

3. If Finger Size Guide falls on the line select the smaller sensor for

testing.

Sensor Placement

1. Rest patient’s hand and arm with sensor on a horizontal surface. The

hand and arm should be securely resting on a flat surface to limit the
movement of the patient. The patient’s hand should be placed on the
table palm side down.

2. Ensure the test finger just touches the finger stopper at the end of the

sensor without going over it, and sits in line with the finger. This
allows the emitter and detector to be placed on the optimum location
for monitoring.

3. Examine the finger while placed in the sensors to ensure the emitter

and detector are directly aligned on top of each other.

4. Ensure the cable runs flat over the top of the hand directly in the

middle of the finger with no kinks or twists so the cable does not pull
on the sensor.

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Performing a Test

1. Ensure the patient has been in the sitting or supine position for 2-3
minutes.

2. With the sensor properly applied, ensure the patient’s hand and arm
are securely resting on a flat surface to limit movement of the patient
during the reading.

3. Tap the Test icon on the Test Ready screen to commence the test.

In instances of test incomplete messages, try the following to increase the
probability of a successful test:

• Remove Nail Polish/Acrylics as certain types of nail polish and
acrylics may affect the reading.

• Warm Finger to increase perfusion.

• Use a light shield to cover the sensor from ambient light interference.

Do not perform measurements in environments with high ambient light or in
front of monitors as incomplete tests may occur. In these environments, a
Masimo ambient light shield should be used to limit the effect on the
measurement

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Patient Testing

Note: The patient should be in a seated position for 2-3 minutes prior to, and
during testing. Do not allow the patient to talk, laugh, cough or move during
testing. If this occurs, stop and re-test.

Tap the Test icon on the instrument’s Test Ready screen. When the
test is running, there will be an indicator of progress as it relates to the
completion of a test, as seen in the following image.

Successful Testing Ongoing

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If motion is detected, a hand icon will appear at the bottom right side of the
screen. (If the motion is not stopped and Measure Through Low SIQ is not on,
the test may be incomplete, in some cases, a measurement can be displayed
despite low signal quality conditions). See Low Signal I.Q. (Low SIQ) on
page 3836.

Patient Motion Detected Patient Motion and

Low SIQ Detected

Low SIQ Detected

After a complete test there will be a series of audible tones and the Test
Results screen will display.

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Completed Test

After a successful spot check test, parameters may be seen on the Test
Results screen. Additional parameters may be seen by tapping the icon

when available. Detailed information about the patient can be entered by
pressing the icon. If the printer or email options are configured, they can
be accessed through the print/email icon at the bottom of the screen.

See Emailing Spot Check Test Results on page 4442 for further details.
Completed test results can be sent to a designated printer, email address or

exported as a .csv file, by following the on-screen instructions.
The test results will dim and turn gray after 5 minutes of inactivity to indicate to

the user that the numbers they are viewing are from the previous test. Tap the
green check mark icon to exit the Test Results screen and return to the Test
Ready screen.

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Incomplete Test

An incomplete test can occur due to excessive motion, interference to the
instrument or if the red stop icon was pressed. The examples below show
incomplete test message screens.

When a test is incomplete, error code text may display at the bottom left
corner of the screen.

See the recommended initial testing procedure SpHb Spot Check
Measurement on page 3030 on for proper sensor and site selection. For
troubleshooting, see Chapter 6: Troubleshooting on page 6359.

Key Features

The following section details some of the features available on the Pronto-7.
See Main Menu Options on page 5147 for additional features.

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Viewing Select Parameters

Upon successful completion of a spot check test, the default parameters
shown on the firs page of the Test Results screen are SpHb, SpO2, PR, and
PI.

If the user would like the Test Results screen to display specific parameters,
on page 2, perform the following:

1. Tap the Main Menu icon.

2. Tap the Display icon.

3. Toggle parameters accordingly to display the parameters preferred

on page 1. Parameters listed under Display Parameters in green are
those that may be displayed on the Test Results screen page 1,
those in gray will be displayed on page 2.

4. Tap the green check mark icon to accept changes.

Information about each parameter is available. Tap directly on the parameter
for access. A pop-up window appears for the selected parameter.

Viewing SpHct

There are two ways to access SpHct.

To access prior to conducting a test, perform the following:

1. Tap the Main Menu icon.

2. Tap the Display icon.

3. Toggle to SpHct under Units of Measure.

4. Tap the green check mark icon to accept changes.

To access upon completion of a test, perform the following:

1. Tap the SpHb text next to the SpHb numeric result.

2. The text will spin to show the resulting SpHct measurement. Tap on

the SpHct text next to the SpHct numeric result to return to SpHb.

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Low Signal I.Q. (Low SIQ)

The Pronto-7 provides a visual indication of low signal quality by displaying, as
seen in the following image, a Low SIQ icon at the bottom of the screen during
a measurement when the displayed waveforms are based on inadequate
signal quality. Additionally, a hand icon may be displayed as a warning when
there is motion during the measurement.

In both cases, the test may be canceled if low signal quality continues. In
some cases, a measurement can be displayed despite low signal quality
conditions.

If the Low SIQ icon is displayed, it indicates that the accuracy specifications
claimed have not been met. When the test is canceled due to low SIQ
conditions, proceed with caution and do the following:

1. Assess the patient.

2. Check the sensor and ensure proper sensor application. The sensor
should not be placed upside down or sideways on the finger and the
sensor must be well secured to the site to obtain accurate readings.

3. Determine if an extreme change in the patient’s physiology and
blood flow at the measurement site occurred, e.g. an inflated blood
pressure cuff, a squeezing motion, sampling of an arterial blood
specimen from the hand containing the pulse oximetry sensor,
severe hypotension, peripheral vasoconstriction in response to
hypothermia, medications, or an episode of Raynaud’s syndrome.

4. After performing the above, retest. An arterial blood specimen for
laboratory CO-Oximetry analysis may be considered to verify the
oxygen saturation and hemoglobin values.

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Modes

Pronto-7 is equipped with five modes; three sensitivity modes and two test
modes. The sensitivity modes include normal, max and multi. The test modes
include SpO2 only and Measure through Motion, identified on the Pronto-7
screen as measure under Low SIQ.

If any of the three sensitivity modes are toggled to On, the Pronto-7 will remain
in the test mode until the user manually configures the mode to Off, or if SpO2
only test mode is turned On, as this test mode overrides all sensitivity modes.

Measure through Motion test mode can be turned on and used simultaneously
with any of the four other modes. If either of the two test modes is toggled to
On, the Pronto-7 will remain in this test mode until the user manually
configures the mode to off.

All modes can be accessed from the Main Menu icon. Some modes can be
accessed in additional ways.

Sensitivity Modes Details

• Normal is the default sensitivity mode for the Pronto-7.

• Max sensitivity mode should provide fewer “Test Incomplete”

messages compared to normal sensitivity mode.

• Multi test mode provides an averaged result based upon three tests.

Pronto-7 will perform multiple individual tests until three quality
samples are obtained which will be averaged for the single test
result.

Test Modes Details

• SpO2 only test mode displays SpO2, PI and PR only. Using this mode

does not consume a spot check test. If SpHb is needed after the
SpO2 only mode test is complete the user can access SpHb, which
will deduct a spot check test. See Accessing SpHb in SpO2 Only
Test Mode on page 4341 for details.

• If SpO2 only test mode is on, the Pronto-7 will remain in this test

mode until the user manually configures the mode to off. See
Accessing Sensitivity and Test Modes on page 4139 for details.

• Measure through Motion mode allows for fewer incomplete tests and

can be enabled from the Test Mode icon.

• If Measure through Motion test mode is on, the Pronto-7 will remain

in this test mode until the user manually configures the mode to off.
See Accessing Sensitivity and Test Modes on page 4139 for
details.

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Mode

Accuracy
under no
motion
conditions

Accuracy
under

Measure
Through
Motion Test
Mode

Notes

Normal

A

RMS

accuracy
over 6-18
g/dL: ± 1.1
g/dL

A

RMS

accuracy
over 8-17
g/dL: ± 1.0
g/dL

A

RMS

accuracy
over any
range is ± 1.5
g/dl

Default mode for Pronto-7

MAX

A

RMS

accuracy
over 4.5-20
g/dL: ± 1.1
g/dL

A

RMS

accuracy
over any
range is ± 1.5
g/dl

MAX sensitivity mode
should provide less “Test
Incomplete” messages
compared to the Normal
Sensitivity Mode

Multi

A

RMS

accuracy
over 6-18
g/dL: ± 1.1
g/dL

A

RMS

accuracy
over 8-17
g/dL: ± 1.0
g/dL

A

RMS

accuracy
over any
range is ± 1.5
g/dl

- In multi test mode,
Pronto-7 will perform
multiple individual tests until
three quality samples are
obtained which will be
averaged for a single test
result.

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Mode

Accuracy
under no
motion
conditions

Accuracy
under

Measure
Through
Motion Test
Mode

Notes

SpO2
Only

A

RMS

accuracy
over 6-18
g/dL: ± 1.1
g/dL

A

RMS

accuracy
over 8-17
g/dL: ± 1.0
g/dL

A

RMS

accuracy
over any
range is ± 1.5
g/dl

When SpO2 Only mode is
On, Normal, Max and Multi
sensitivity modes will be
overridden. SpHb
measurements are only
accessible by pressing
SpHb measurement
following SpO2 Only
measurement.

Accessing Sensitivity and Test Modes

All modes can be accessed from the main menu. To access modes;

1. Tap the Main Menu icon.

2. Tap the Settings icon.

3. Tap the Test Mode icon.

4. Toggle the mode to the desired test mode

5. Tap the green check mark icon to accept changes

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Accessing Multi Sensitivity Mode

In addition to accessing multi sensitivity mode from the main menu, it can also
be accessed directly from a Test Results screen upon completion of a spot
check test. To test in multi sensitivity mode upon successful completion of a
spot check test:

1. Tap the Multi icon to transition into multi test mode.

2. The Pronto-7 will direct you to complete the following steps:

• Remove the sensor completely.

• Reattach the sensor to the same finger and verify correct

positioning.

• Tap Continue to conduct the second of three tests.

• Repeat steps 2-3 for the final third test.

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Accessing SpHb in SpO2 Only Test Mode

SpHb is needed after the SpO2 only mode test is complete the user can
access SpHb, which will deduct a test credit.

To access SpHb in this mode, the user can tap the SpHb icon on the left side
of the screen. This will provide the SpHb reading, and a spot check credit will
be deducted.

If

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Emailing Spot Check Test Results

In order to email spot check test results, the user must first have an online
account for the Pronto-7.

Setting up a Pronto-7.com account

1. On a computer, go to the following website: www.pronto7.com.

2. Click the New User link and enter required information.

3. In the Sponsor Key field, enter the word email.

4. If registration is successful, your user name and password
information is saved. Retain this information for your records.

Configuring Outgoing Email Settings

1. From the Main Menu on the Pronto-7, navigate to the Connections
icon.

2. From the Connections icon, navigate to the Outgoing Email screen.

3. Enter the user name and password for the Pronto7.com account.

4. In the Reply-To Address field, enter an appropriate email address for
receiving responses.

5. In the Attach Image field, choose Yes if the test results screen image
should be attached to an outgoing email.

6. In the Attach .CSV field, choose Yes if the test results spreadsheet
should be attached to an outgoing email.

Emailing Results
Test results can be emailed from the Test Results screen or Test Results icon,

which is accessible from the Main Menu. You can email all test results or
individual test results.

To send all test results to a single email address

1. Tap the icon.

2. Tap the Email All Tests icon.

3. Enter email address to which the test results will be sent.

4. Tap the Accept icon.

To send individual test results

Tap the icon.

1. Tap the Email Single Test icon.

2. Enter email address to which the test results will be sent.

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3. Tap the Accept icon.

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Download of Spot Check Tests

Purchased spot check tests can be wirelessly or non-wirelessly downloaded
to the Pronto-7 sensor. The number next to the radical sign indicates the

quantity of remaining tests left on the sensor.
To download spot check tests directly using the Pronto-7, the instrument must

be connected to a wireless network.
There are two ways to access wireless download of spot check tests, either

from the Main Menu icon or the radical sign.
Main Menu:

1. Connect Pronto-7 to a wireless network by accessing the
Connections icon from the Main Menu icon, see Main Menu Access
on page 5148.

2. Connect the sensor to the Pronto-7.

3. Tap the Main Menu icon.

4. Tap the Help icon.

5. Tap the Load Tests icon.

6. Tap the Download icon.

Radical Sign:

1. Connect Pronto-7 to a wireless network by accessing the
Connections icon from the Main Menu icon, see Main Menu Access
on page 5148.

2. Connect the sensor to the Pronto-7.

3. Tap the radical sign at the top left corner of the Test Ready screen.

4. Tap the Download icon.

The following image and table explains the various features and displays of
wireless spot check test download once the Download icon is accessed.

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Step

Features /
Display

Description

1

Tests
Remaining

Number of tests remaining on the connected sensor.

2 Tests Available

Number of tests purchased and available for
download.

3

Quickload
Tests

Selectable shortcuts to download preset quantities of
tests (10, 25, 50, 100, 250 or 500 tests).

4 Manual Load Download user-specified quantities of tests.

5

Automation
Settings

Auto downloads a minimum quantity of tests based
on a user-specified threshold.

To begin the download, using either Quickload or Manual Load:

1. Select one of the following:

• Quickload: Tap on one of the quantity icons to indicate the
quantity of tests to download.

• Manual Load: Tap the Manual Load icon, enter a specific
quantity of tests to download in the new screen and tap Accept.

2. When prompted to verify the number of tests to be downloaded, if the
number is correct, tap Yes.

3. When the tests are being downloaded, the message Please Wait
displays in the bottom-left corner of the screen. When the tests are

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downloaded, the message Download Complete appears. To close
this message, tap .

Using a Micro_SD Card:

1. Connect a compatible sensor to the Pronto-7.

2. Insert the micro SD card with spot check tests on it into the Pronto-7
micro SD card slot.

3. Tap the Main Menu icon on the Test Ready screen.

4. Tap the Help icon.

5. Tap the Load Tests icon, and finally tap the micro SD Load icon.
After pressing the Load icon a dialog will appear confirming the tests
have been successfully loaded.

Using a USB Cable:

1. Connect a compatible sensor to the Pronto-7.

2. Connect the Masimo supplied USB cable to a computer*. The
Pronto-7 should appear as a mass storage device (such as a USB
drive on a computer).

3. When the Pronto-7 is visible as a drive, drag the purchased spot
check tests file into the Pronto-7 drive.

4. Once the file has completed downloading to the Pronto-7 drive,
follow the computer's standard procedure to eject an external mass
storage device.

5. After the file has downloaded to the instrument successfully and the
Pronto-7 has been correctly ejected as a mass storage device, the
USB cable can be disconnected from the instrument and the
computer.

6. Tap the Main Menu icon on the Test Ready screen.

7. Tap the Help icon.

8. Tap the Load Tests icon, and then tap the Internal Mass Storage
Load icon. After pressing the Load icon a dialog will appear
confirming the tests have been successfully loaded.

*To protect the instrument, connect only to a medical grade computer to
ensure grounding is sufficient. Use only the included mini USB to USB cable.

Note: If multiple Spot Check test files have been purchased, it is important to
load the test files in sequential order (i.e. test files purchased April 3, 2010
prior to test files purchased April 15, 2010). Non-sequential loading of test files

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will obsolete any skipped test files. If test files are available in different
locations (one on the micro SD and one on the Internal Device Storage) the
Pronto-7 will only allow you to load the oldest files. After the oldest file is
loaded, then the next most recent spot check test file can be loaded.

To confirm that new tests have been downloaded to the sensor, the test count
in the upper-left corner of the screen should be automatically increased by the
number of tests downloaded.

EMR Connectivity

The Pronto-7 can wirelessly connect to compatible EMR systems, allowing
test results to be sent to onsite EMR systems automatically. EMR connectivity
is supported by Telcor and Apex. Contact your local Masimo sales
representative for available EMR system compatibility.

To enable this feature, Pronto-7 must be connected to a wireless network and
EMR Connectivity settings must be configured in the EMR Connectivity icon
as seen in the following image.

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Uploading of files to the EMR can be performed manually or automatically.
Manual Upload:

1. Tap the Main Menu icon.

2. Tap the Connections icon.

3. Tap the EMR Connectivity icon.

4. Populate the Server and Port settings depending on the specific
EMR setup on-site.

5. Tap Send Results.

6. Tap the green check mark icon to accept changes.

Automatic Upload:

1. Tap the Main Menu icon.

2. Tap the Connections icon.

3. Tap the EMR Connectivity icon.

4. Toggle the EMR Connection to On.

5. Populate the Server and Port settings depending on the specific
EMR setup on-site.

6. Tap the green check mark icon to accept changes.

After each complete spot check test the file will be uploaded to the EMR.

Consult Masimo Technical Services for EMR connectivity support and
maintenance.

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Main Menu Options

The following section outlines all Main Menu features available on the
Pronto-7 and user configurable options.

Main Menu Access

To access the Main Menu:

1. Tap from any screen where it is shown.

2. The Main Menu icon allows access to the following icons.

• Test Results

• Sounds

• Connections

• Device Diagnostics

• Display

• Settings

• Help

3. To access these icons, tap the needed icon.

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Test Results Icon

The test results icon provides the date of patient testing, the patient ID and the
results produced. Sortable by column, data can be rearranged by pressing the
column header to sort. The data cannot be sorted by Results.

Option Factory Default Configurable Settings

Date Descending Ascending or descending

Patient ID Patient ID Ascending or descending

Results Most recent tests N/A

To access the patient and test details:

1. Tap the row of the patient in which data is needed. The details will be
visible in a pop-up window.

2. Tap the Page 2 icon where available for remaining measurements or
tap the icon to return to the Test Results icon details.

From the test results icon a user can tap the icon to search all tests
(displays a keyboard), delete all tests, print or e-mail the test results, and
export results to the Micro SD card (if Micro SD card is inserted).

From an individual test result screen a user can tap the icon to print or
e-mail the test result (if those options are setup), export the test to the Micro
SD card, edit patient information, delete a single test and e-mail results.

Sound Icon

The sound icon provides volume, sound effect and voice controls.

Option Factory Default Configurable Settings

Volume 10 1 - 10

Sound Effects On On, Off

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Option Factory Default Configurable Settings

Voice On On, Off

Connections Icon

Connections should be created or modified by an administrator familiar with
wireless networking and it is recommended that the instrument be connected
to a secure wireless network.

With an appropriately setup network, completed test result screens can be
emailed or printed and spot check tests can be downloaded.

Printing can be done over an internet connection or through a Bluetooth
printer (Bluetooth barcodes can be included).

Option

Factory
Default

Configurable Settings

Wireless Network

Wireless
Connection

Off On, Off

LAN
Configuration

DHCP DHCP, Static

Available
Networks

Available
networks list

User selectable from list

New Network N/A

User selectable (SSID, Security On, Off,
encryption key WEP64, WEP-128,
WPA-TKIP, WPA2-AES, Network password
key)

Outgoing Email

User Name N/A Enter Masimo server name

Password N/A Enter Masimo server password

Reply to Address N/A User editable (About Owner screen)

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Option

Factory
Default

Configurable Settings

Attach Image
(test screen shot)

No Yes, No

Attach .CSV
(.csv data file)

Yes Yes, No

Bluetooth Pairing

Bluetooth (2.0) Off On, Off

Security (if
Bluetooth is On)

Off On, Off

Printer Configuration

Printer Address N/A User editable

Port Number N/A User editable

Print Style Color Color, B/W (Black and White)

Include Picture Yes Yes, No

Include
Barcodes

No Yes, No

EMR Connectivity

EMR Connection Off On, Off

Server N/A User editable

Port N/A User editable

Upload all test
results

N/A Tap to send all pending results to EMR.

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Device Diagnostics Icon

Option Factory Default Configurable Setting

Interference Scan N/A

Check Environment for Interference

Display Icon

Option Factory Default Configurable Settings

Brightness 10 1 - 10

SpHb Units of Measure g/dL g/dL, g/L, mmol/Ls, SpHct (%)

Display Parameters

SpHb, SpO2, PR, PI

SpHb, SpO2, PR, PI, SpHct

*Finger Temp. Off °C, °F, Off

*Note: The temperature displayed is the temperature of the finger where the
sensor is placed. This is not the patient’s core body temperature and should
not be used to make clinical decisions.

Settings Icon

Option Factory Default Configurable Settings
Test Mode

Measure under
Low SIQ

No Yes, No

Sensitivity Normal MAX, Normal, Multi

SpO2 Test Mode Off On, Off

User ID/Patient ID/PIN

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Option Factory Default Configurable Settings

User ID Off On, Off

Patient ID Off On, Off

Pin# Protection Off On, Off

Test Off On, Off

Menu Off On, Off

Create/Change
Pin#

N/A

Up to 15 digit numeric PIN, user
editable

If the PIN # is forgotten, tap the Forgot Pin icon along the upper right edge of
the Enter PIN keypad.

Language

Language English List available, user selectable

Date and Time

Clock Display On On, Off

Time Format 12 hour 12 hour, 24 hour

Time hh/mm/pm User editable

Date Format mm/dd/yy yy/mm/dd, mm/dd/yy, dd/mm/yy

Date N/A User editable

Power Save Mode

Power Save Mode On On, Off

About Pronto-7 /Owner

About Pronto-7

Masimo Contact

N/A

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Option Factory Default Configurable Settings

Information

About Owner

Registered to
information

Name, street address, cite, state,
country, phone number, email,
website

Restore Settings

Restore Default
Settings

N/A No, Yes

Help Icon

Option Description

Quick Start Presents short slide show of basic testing operation

Common
Questions

List of questions and answers about the instrument
features

Contact Tech
Support

Specifies Masimo Tech Support contact information

Equipment
Report

Documents device serial number, software version, total
device run time, last service/location, sensor serial #, total
sensor run time, spot checks administered and remaining

Software
Update

Provides access to upgrade or downgrade the software
version from one of four locations: micro SD, internal mass
storage, compatible sensor or wireless network

Load Tests

Provides access Load Tests - Select to view available spot
check test files and/or load them in to the a compatible
sensor

Clear Database

Supplies access to erase all measurements and
patient/user database

Device

Allows download of latest configurations of Pronto-7 that is
available, displays a list of features enabled based on

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Option Description

Configurations existing configuration of the instrument

Battery

Battery Level Indicator

The Pronto-7 is powered by a rechargeable lithium polymer battery. It can also
be powered by AC power, when used with the included AC power cable.
Battery charge level is indicated by the battery icon in the upper right hand
corner of the LCD touchscreen. Battery conditions are:

• When the battery is fully charged, the icon will be solid green:

• When the battery is fully charged and plugged into AC power, an

electrical plug symbol displays on the battery icon:

• As the battery discharges, the capacity will be equivalent to the
fraction of green filling the icon:

• When the battery is charging, a charging symbol will display on the
battery icon:

Low Battery Alarm

• If the battery power level is too low, the instrument will not allow a
test to be taken. There will be a visual display, indicating the AC
power cable must be used to continue.

WARNING: Failure to plug in the AC power cable promptly after a low battery
alarm may result in the instrument shutting down.

WARNING: Only use the included AC power cable. Using a different AC
power cable could cause damage to the Pronto-7.

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Checking Battery Status

Tap the battery icon at any time to see the current battery status.

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Chapter 5: Alarms and Messages

Messages

The Pronto-7 will indicate other data or system errors. Messages are:

Message Possible Indication Recommendation

Ready Ready for spot check test

Initiate spot check test by
pressing the green Test icon.

Connect
Sensor

No compatible sensor is
connected

Connect a compatible sensor to
the instrument.

Test
Incomplete

Sensor disconnect or
interference

Check sensor connection or
perform interference scan.

Low Battery
Warning

Pronto-7 battery is too low
at start of measurement

Plug in Pronto-7 AC power cord.

Test Stopped

Stop icon is pressed

during test

Initiate new spot check test by
pressing the green Test icon.

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Chapter 6: Troubleshooting

Troubleshooting

The following chart describes what to do if the Pronto-7 system does not
operate properly or fails.

Problem Possible

Sources

Recommendation(s)

Incomplete test or no
reading

Sensor
placement

Ensure sensor is placed on a well
perfused site.

Make sure the patient's finger is all
the way in the sensor and touching
the finger stop.

Route sensor cable along the back of
the patient's hand to ensure that the
sensor is on in the correct orientation
(see sensor DFU figure).

Excessive
motion

Minimize or eliminate patient
movement at the sensor site.

Signal quality

Make sure measurement site is well
perfused, free of debris and there is
no nail polish on the patient's nail.

Check the testing environment for
interference using the interference
scanner in the Main Menu (see
Device Diagnostics Icon on page

5551).

If interference is high, shield the
sensor from excessive light,
modulated light sources (such as
computer displays) or strobe lights.

Reflective and /
or metallic nail
polish or acrylic
nails

Remove all nail polish.
Remove acrylic nails.

Pronto-7 Chapter 6: Troubleshooting

www.masimo.com 64 Masimo

Problem Possible

Sources

Recommendation(s)

Device does not
power on

Low battery

Plug in included AC power cable,
then power on the instrument.

Compatible sensor
does not connect to
instrument

Sensor
orientation is
incorrect

The sensor can only connect one
way. Make sure the sensor plug is
oriented correctly, according to the
sensor DFU and on-screen
directions and diagrams.

A computer
connected with the
included USB cable
does not recognize
the Pronto-7

Connection
issue

Make sure the instrument is powered
on and plugged into AC power.

Check the available drives on your
computer.

If the Pronto-7 still does not appear,
search your computer's User Manual
for proper external drive mapping
and troubleshooting.

Touchscreen icons
do not respond when
pressed

System failure

Turn off the instrument and then
power it on. If the problem reoccurs
or persists return for service. See
Service and Repair on page 7167.

www.masimo.com 65 Masimo

Chapter 7: Specifications

Specifications

Measurement Range

SpHb (total hemoglobin) 2 - 25 g/dL

PR (pulse rate) 30 - 240 bpm

SpO2 (arterial oxygen saturation) 0 - 100%

PI (perfusion index) 0.02 - 20%

SpHct (hematocrit) 5 - 75%

Accuracy

Arterial Oxygen Saturation, 70%
to 100% [1]

± 2% (± 3% under motion)

Pulse Rate [2] ± 3 bpm (± 5 bpm under motion)

Total Hemoglobin Concentration
(SpHb g/dL) for 4D DC Sensor
[3]

Normal and Multi Sensitivity Modes
A

RMS

accuracy over 6-18 g/dL: ± 1.1 g/dL

A

RMS

accuracy over 8-17 g/dL: ± 1.0 g/dL

MAX Sensitivity Modes
A

RMS

accuracy over 4.5 - 20 g/dL: ± 1.1 g/dL

Note: For all sensitivity modes under
motion, A

RMS

accuracy over any range is ±

1.5 g/dL.

Resolution

SpHb (total hemoglobin) 0.1 g/dL

PR (pulse rate) 1 bpm

SpO2 (Arterial Oxygen
Saturation)

1 %

Formatted Table

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www.masimo.com 66 Masimo

PI (perfusion index) 0.01%

SpHct 1 %

Interfering Substances

Refer to Safety Information, Warnings, and Cautions on page 99.

Product

Test storage capacity 8000

Wireless connectivity 802.11 b/g, Bluetooth

Reporting modes Print, email, audible, micro SD

Report formats Single test, multiple test, device summary

Reporting devices

Optional Bluetooth thermal printer, USB

802.11 wireless (PCL5, 5e 6), or Bluetooth
printing to validated printers

Electrical

Battery Power Rechargeable lithium polymer

Capacity Approximately 2 hours after full charge

Number of spot checks on fully
charged battery

140

Battery charging time

5 hours when powered off
6 hours when powered on

Isolation Medical Grade AC/DC Adapter

AC Power 100-240V, 50-60 Hz, 15VA max.

Environmental

System Operating Temperature 41°F to 104°F (5°C to 40°C)

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www.masimo.com 67 Masimo

Storage Temperature -40°F to 158°F (-40°C to 70°C)

Operating Humidity 5% to 95%, non-condensing

Operating Altitude

500 mbar to 1060 mbar

-1000 ft to 18,000 ft (-304 m to 5,486 m)

Physical Characteristics

Dimensions

5.1" x 2.8" x 1"
(13 cm x 7.2cm x 2.5 cm)

Weight 10.5 oz (296.4 g)

Visual Alarm Low Battery, System Failure

Display / Indicators

Data display: SpO2%, PR beats per minute, SpHb g/dL, PI%, SpHct %, wifi
status, Bluetooth status, time, date, spot check tests remaining, sensor size,
battery level indicator, pulse plethysmograph waveform, action icons.

Type 3.7" Resistive Touchscreen

Compliance

EMC Compliance EN60601-1-2, Class B

Equipment Classification IEC 60601-1

Type of Protection (battery
power)

Internally Powered

Type of Protection (AC Power) Class 2

Degree of Protection-Sensor Type BF-Applied Part

Mode of Operation Spot Check

Pronto-7 Chapter 7: Specifications

www.masimo.com 68 Masimo

[1] The SpO2 accuracy has been validated in human blood studies on healthy
adult male and female volunteers with light to dark skin pigmentation in
induced hypoxia studies in the range of 70-100% SpO2 against a laboratory
CO-Oximeter and ECG monitor. This variation equals plus or minus one
standard deviation, which encompasses 68% of the population.

[2] Masimo sensors have been validated for pulse rate accuracy for the range
of 30-240 bpm in bench top testing against a Fluke Biotek Index 2 simulator.
This variation equals plus or minus one standard deviation which
encompasses 68% of the population.

[3] The SpHb accuracy has been validated with (arterial / venous) blood from
healthy adult male and female volunteers and on patients with light to dark
skin pigmentation in the range of 4.5 – 20 g/dL, - 6-18 g/dL and 8-17
g/dLSpHb against a laboratory CO-oximeter. This variation equals plus or
minus one standard deviation which encompasses 68% of the population.

Calibration Verification

Pronto-7 does not require calibration during clinical use. The calibration
coefficients are embedded in the software and validated during manufacturing
testing in compliance with Masimo’s ISO-certified quality system procedures.
Once the systems have been placed into clinical use, both monitors
automatically perform a system verification (self-check) every time the
monitors are powered up and at the beginning of every measurement cycle.
No other calibration or quality control verification is required.

If any component of the system is not operating within specification, the
monitor will not allow a test to be performed and will alarm and display an error
code message. In this case, contact your Masimo representative and return
the device for service.

Symbols

The following symbols may be found on the Pronto-7 or packaging and are
defined below:

Symbol Description

Caution, consult accompanying documents

Pronto-7 Chapter 7: Specifications

www.masimo.com 69 Masimo

Symbol Description

Follow Instructions for Use

Type BF applied part complying with IEC 60601-1

Separate collection for electrical and electronic equipment
(WEEE)

Mark of Conformity to European Medical Device Directive
93/42/EEC

Federal law restricts this device to sale by or on the order of a
physician (USA audiences only)

Date of manufacture

Storage humidity range: 5% to 95%

Storage temperature range: +70˚C to -40˚C
Storage altitude range: 500 mbar to 1060 mbar

Keep dry

Fragile/breakable, handle with care

Pronto-7 Chapter 7: Specifications

www.masimo.com 70 Masimo

Symbol Description

MDSS GmbH, Schiffgraben 41, D-30175 Hannover, Germany

Manufacturer

ETL

Wireless features can be used in member states with the
restriction of indoor use in France

Federal Communications Commission (FCC) licensing

Non-ionizing electromagnetic radiation

Protection against vertically falling water drops

No parameter alarms

www.masimo.com 71 Masimo

Chapter 8: Service and Repair

Service and Repair

Introduction

This chapter covers how to properly clean and obtain service for the Pronto-7.
Under normal operation, no internal adjustment or recalibration is required.

Safety tests and internal adjustments should be done by qualified personnel
only.

The Pronto-7 is a reusable instrument. The instrument is supplied non-sterile.

Cleaning

The outer surface of the Pronto-7 can be cleaned with a soft cloth dampened
with a mild detergent and warm water solution. Do not allow liquids to enter
the interior of the instrument. The outer surface of the instrument can also be
wiped down using the following solvents: Cidex Plus (3.4% Glutaraldehyde),

0.25% Ammonium Chloride, 10% Bleach, 70% Isopropyl Alcohol.

WARNING: Before cleaning the instrument, always turn it off.
CAUTIONS:

1. Do not sterilize the Pronto-7.

2. Do not soak or immerse the Pronto-7 in any liquid.

3. Use the cleaning solution sparingly. Excessive solution can flow into

the Pronto-7 and cause damage to internal components.

4. Do not touch, press, or rub the display panels with abrasive cleaning

compounds, devices, brushes, rough-surface materials, or bring
them into contact with anything that could scratch the panel.

5. Use the included LCD cleaning cloth to remove fingerprints from the

touchscreen.

6. Do not use petroleum-based, acetone solutions, or other harsh

solvents, to clean the Pronto-7.

7. These substances erode the instrument’s materials and instrument

failure can result.

For cleaning instructions of the sensor, refer to the appropriate sensor
Directions for Use.

www.masimo.com 73 Masimo

Repair Policy

Masimo or an authorized Service Department must perform warranty repair
and service. Do not use malfunctioning equipment. Have the instrument
repaired prior to use.

WARNING: An operator may only perform maintenance procedures
specifically described in this manual. Refer servicing to qualified service
personnel trained in the repair of this equipment.

To return the Pronto-7 for service, please follow the Return Procedure.

Return Procedure

Remove all saved patient identifying data by deleting all tests (For
configuration details, see Main Menu Options on page 5147 ). Please clean
contaminated/dirty equipment (See Cleaning on page 7167) before returning
and make sure it is fully dry before packing the equipment. Call Masimo
Technical Services to request return authorization (RMA), at the phone
number below.

Package the equipment securely – in the original shipping container if
possible – and enclose or include the following information and items:

1. A letter describing in detail any difficulties experienced with the

Pronto-7. Please include the RMA number in the letter.

2. Warranty information – a copy of the invoice or other applicable

documentation must be included.

3. Purchase order number to cover repair if the instrument is not under

warranty, or for tracking purposes if it is.

4. Ship-to and bill-to information.

5. Person (name, telephone / telex / fax number, and country) to

contact for any questions about the repairs.

6. A certificate stating the Pronto-7 has been decontaminated for

bloodborne pathogens.

Pronto-7 Chapter 8: Service and Repair

www.masimo.com 74 Masimo

Return the Pronto-7 to the following shipping address:

USA, Canada, Asia
Pacific (except Japan)

Japan Europe

All other
locations

Masimo Corporation
40 Parker
Irvine, California 92618
Tel: [phone], or
800-326-4890 (option

2)
Fax: [phone]

Masimo Japan
Corporation
Kojimachi Office
World Time Bldg.
4F
10-7,
Ichiban-cho,
Chiyoda-ku
Tokyo 102-0082
Japan
Tel: 03 3237
3057
Fax: 03 3238
1110

Masimo
International
Sàrl
Puits-Godet 10
2000 Neuchatel
Switzerland
Tel: [phone]
1111
Fax: [phone]
1448

Contact your
local Masimo
Representative

Sales & End-User License Agreement

This document is a legal agreement between you (“purchaser”) and Masimo
Corporation (“Masimo”) for the purchase of this Product (“Product”) and a
license in the included or embedded Software (“Software”) except as
otherwise expressly agreed in a separate contract for the acquisition of this
Product, the following terms are the entire agreement between the parties
regarding your purchase of this Product. If you do not agree to the terms of
this agreement, promptly return the entire Product, including all accessories,
in their original packages, with your sales receipt to Masimo for a full refund.

Pronto-7 Chapter 8: Service and Repair

www.masimo.com 75 Masimo

Warranty

Masimo warrants to the initial Purchaser for a period of one (1) year from the
date of purchase that: each new Product and the Software media as delivered
are free from defects in workmanship or materials.

Batteries are warranted for six (6) months.
To request a replacement under warranty, Purchaser must contact Masimo

for a returned goods authorization. If Masimo determines that a Product must
be replaced under warranty, it will be replaced and the cost of shipment
covered. All other shipping costs shall be the responsibility of Purchaser.

Masimo’s sole obligation under this warranty is to repair or replace any
Product or Software that is covered under warranty.

Pronto-7 Chapter 8: Service and Repair

www.masimo.com 76 Masimo

Exclusions

The warranty does not extend to, and Masimo is not responsible for, repair,
replacement, or maintenance needed because of: a) modification of the
Product or Software without Masimo’s written authorization; b) supplies,
instruments or electrical work external to the Product or not manufactured by
Masimo; c) disassembly or reassembly of the Product by anyone other than
an authorized Masimo agent; d) use of the Product with Sensors or other
accessories other than those manufactured and distributed by Masimo; e) use
of the Product and Software in ways or in environments for which they are not
labeled; and f) neglect, misuse, improper operation, accident, fire, water,
vandalism, weather, war, or any act of God. This warranty does not extend to
any product that has been used in violation of the operating instructions
supplied with the product. This warranty does not extend to any Product that
has been reprocessed, reconditioned or recycled.

This warranty also does not apply to any Products provided to Purchaser for
testing or demonstration purposes, any temporary Products Modules or any
Products for which Seller does not otherwise receive a usage or purchase fee;
all such Products are provided AS-IS without warranty.

This warranty, together with any other express written warranty that may be
issued by Masimo is the sole and exclusive warranty as to the Product and
Software. This warranty is expressly in lieu of any oral or implied warranties,
including without limitation any implied warranty of merchantability or fitness
for a particular purpose. Masimo shall not be liable for any incidental, special
or consequential loss, damage or expense directly or indirectly arising from
the use or loss of use of any Products or Software. In no event shall Masimo’s
liability arising from any Product and Software (under contract, warranty, tort,
strict liability or other claim) exceed the amount paid by purchaser for the
Products giving rise to such claim. The limitations in this section shall not be
deemed to preclude any liability that cannot legally be disclaimed by contract.

End User License

1. Grant of License: In consideration of payment of the Software license
fee, which is part of the price paid for the Product, Masimo grants to
Purchaser a nonexclusive, nontransferable (except as set forth
below) license (“License”), without right to sublicense, to use the
copy of the Software in connection with Purchaser’s use of the
Product for its labeled purpose as set forth in these directions for
use. Masimo reserves all rights not expressly granted to Purchaser.

2. Ownership of Software: The Software is licensed not sold; all rights
and interests in the Software and all copies thereof remain at all
times vested in Masimo, and do not pass to Purchaser. Any
references in this Agreement to the purchase or sale of the Software

Pronto-7 Chapter 8: Service and Repair

www.masimo.com 77 Masimo

shall be deemed the purchase or sale of a Software License as set
forth herein.

3. This Software is proprietary and owned by Masimo or its third party

suppliers and can be used solely in connection with the monitor
described herein.

Restrictions

1. Copyright Restrictions: The Software and the accompanying written

materials are copyrighted. Unauthorized copying of the Software,
including Software that has been modified, merged, or included with
other software, or the written materials is expressly forbidden.
Purchaser may be held legally responsible for any copyright
infringement that is caused or incurred by Purchaser’s failure to
abide by the terms of this Agreement. Nothing in this License
provides any rights beyond those provided by 17 U.S.C. §117.

2. Use Restrictions: Purchaser may physically transfer the Product

from one location to another provided that the Software is not copied.
Purchaser may not electronically transfer the Software from the
Product to any other instrument. Purchaser may not disclose,
publish, translate, release, distribute copies of, modify, adapt,
translate, reverse engineer, decompile, disassemble, or create
derivative works based on the Software or the written materials.

3. Transfer Restrictions: In no event may Purchaser transfer, assign,

rent, lease, sell, or otherwise dispose of the Product or the Software
on a temporary basis. Purchaser shall not assign or transfer this
License, in whole or in part, by operation of law or otherwise without
Masimo's prior written consent; except that the Software and all of
Purchaser’s rights hereunder shall transfer automatically to any party
that legally acquires title to the Product with which this Software is
included. Any attempt to assign any rights, duties or obligations
arising hereunder other than as set forth in this paragraph shall be
void.

4. U.S. Government Rights: If Purchaser is acquiring Software

(including the related documentation) on behalf of any part of the
United State Government, the following provisions apply: the
Software and documentation are deemed to be “commercial
software” and “commercial computer software documentation,”
respectively pursuant to DFAR Section 227.7202 FAR 12.212, as
applicable. Any use, modification, reproduction, release,
performance, display or disclosure of the Software (including the
related documentation) by the U.S. Government or any of its
agencies shall be governed solely by the terms of this Agreement
and shall be prohibited except to the extent expressly permitted by
the terms of this Agreement.

Pronto-7 Chapter 8: Service and Repair

www.masimo.com 78 Masimo

No Implied License

Possession or purchase of this device does not convey any express or implied
license to use the device with unauthorized sensors or cables that would,
alone, or in combination with the device, fall within the scope of one or more of
the patents relating thereto. BY ACCEPTANCE OR USE OF THIS DEVICE,
YOU ACKNOWLEDGE YOUR ACCEPTANCE OF THESE TERMS.

Sensors Licensed for Monitoring Use Only

Sensors designated for monitoring only are licensed to you under patents
owned by Masimo to be used for patient monitoring, in an unmodified form as
originally received from Masimo, and no license is granted to have Masimo’s
sensors reprocessed or otherwise modified, unless specifically authorized by
Masimo. There is no license, implied or otherwise, that would allow use of
licensed sensors beyond their intended duration. After use of sensors through
their designated duration, there is no further license granted by Masimo to use
the sensors and the sensors must be discarded or returned to Masimo for
reprocessing.

Additional typefaces for this product can be obtained at www.fonts.com

www.masimo.com 79 Masimo

Index

A

About this Manual • 5
Accessing Multi Sensitivity Mode •

40

Accessing Sensitivity and Test

Modes • 37, 39

Accessing SpHb in SpO2 Only

Test Mode • 37, 41

Arterial Oxygen Saturation

(SpO2) • 23

B

Battery • 54
Battery Level Indicator • 54

C

Calibration Verification • 64
Chapter 1

Technology Overview • 15

Chapter 2

Product Description • 19

Chapter 3

Setup • 25

Chapter 4

Operation • 27

Chapter 5

Alarms and Messages • 57

Chapter 6

Troubleshooting • 34, 59

Chapter 7

Specifications • 61

Chapter 8

Service and Repair • 67

Checking Battery Status • 55
Cleaning • 67, 69
Common Screens • 28
Commonly Used Icons • 28
Completed Test • 34
Compliance Information,

Warnings and Cautions • 13
Connections Icon • 50
Contraindications • 7

D

Device Diagnostics Icon • 51, 59
Display Icon • 51
Download of Spot Check Tests •

43

E

Emailing Spot Check Test Results

• 34, 42
EMR Connectivity • 46
End User License • 71
Exclusions • 70

F

Functional Oxygen Saturation • 16

H

Help Icon • 53
Hematocrit (SpHct) • 24

I

Incomplete Test • 34
Indications for Use • 7
Introduction • 67

Pronto-7Pronto-7 Index

www.masimo.com 80 Masimo

K

Key Features • 35

L

Low Battery Alarm • 55
Low Signal I.Q. (Low SIQ) • 33, 36

M

Main Menu Access • 43, 48
Main Menu Options • 35, 47, 69
Messages • 57
Modes • 37

N

No Implied License • 72
Non-Invasive Total Hemoglobin

(SpHb) Accuracy Compared to
Invasive Laboratory Methods* •
17

P

Parameter and Measurement

Descriptions • 23
Patient Testing • 32
Performing a Test • 31
Perfusion Index (PI) • 24
Preparation for Use • 25
Product Description • 7
Pronto-7 Back Panel • 22
Pronto-7 Bottom Panel • 23
Pronto-7 Description • 19
Pronto-7 Front Panel and

Touchscreen • 20

Pronto-7 vs. Drawn Whole Blood

Measurements • 16

Pulse Rate (PR) • 24

R

rainbow 4D DC Reusable Sensor

• 17

rainbow Pulse CO-Oximetry

Technology • 15

Recommended Initial Testing

Procedure • 30
Repair Policy • 69
Restrictions • 71
Return Procedure • 25, 69

S

Safety Information, Warnings, and

Cautions • 9, 10, 62
Sales & End-User License

Agreement • 70
Sensor Information, Warnings and

Cautions • 14
Sensor Placement • 31
Sensor Selection • 30
Sensor Site Selection • 30
Sensors Licensed for Monitoring

Use Only • 72
Service and Repair • 60, 67
Settings Icon • 52
Signal Extraction Technology

(SET) • 15
Sound Icon • 25, 49
Specifications • 61
SpHb Spot Check Measurement •

30, 34

Pronto-7Pronto-7 Index

www.masimo.com 81 Masimo

Symbols • 64

T

Test Results Icon • 48
Total Hemoglobin (SpHb) • 23
Troubleshooting • 59

U

Unpacking and Inspection the

System • 25
Using a Micro_SD Card: • 44
Using a USB Cable: • 45

V

Viewing Select Parameters • 35
Viewing SpHct • 35

W

Warranty • 70

www.masimo.com

33492/LAB-5621S 0214