Masimo PRONTO-7 User 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.

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© 2014 Masimo Corporation.

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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.
Awarning is given when actions may result ina 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 (SpO
2
), 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 (SpO
2
), 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 SpO
2
,
wireless download of spot check tests, SpO
2
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 SpO
2
values indicate hypoxemia, a laboratory blood sample should be taken
to confirm the patient’s condition.
SpO
2
is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
Inaccurate SpO
2
readings may be caused by:
•Elevated levels of COHb or MetHb: High levels of COHb or MetHb
may occur with a seemingly normal SpO
2
. 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

Pronto-7 Safety Information, Warnings, and Cautions
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•Externally applied coloring and texture such as nail polish, acrylic
nails, glitter, etc.
•Elevated PaO
2
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

Pronto-7 Safety Information, Warnings, and Cautions
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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 beused 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 (%SpO
2
),
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 (SpO
2
): 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 SpO
2
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 SpO
2
and SpHb
measurements of the Pronto-7.
In the case of SpO
2
, 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 (PO
2
) and saturation, such as: pH, temperature, the
partial pressure of carbon dioxide (PCO
2
), 2,3-DPG, and fetal hemoglobin.
High levels of bilirubin may cause erroneous SpO
2
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 SpO
2
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