The Root of Our Inspiration
Letter from the Chairman & CEO
Delivering on Our Mission and Guiding Principles
For this year’s annual report, we selected a cover image that perfectly symbolizes our core mission. The image
shows someone who cares, holding a patient who needs to be cared for. This interaction is the root of our
inspiration—the healing connection between patients and their caring caregivers. From the very beginning, we
have sought to revolutionize noninvasive monitoring so that patients can be better assessed and cared for by
those who care. From that vision, 24 years ago, came our mission—‘improving patient outcomes and reducing
cost of care by taking noninvasive monitoring to new sites and applications’. Along with our mission, we
established a strong and simple set of guiding principles that stay with us today:
> Remain faithful to your promises and responsibilities
> Thrive on fascination and accomplishment and not on greed and power
>
Strive to make each year better than the year before both personally and for the team
> Make each day as fun as possible
> Do what is best for patient care
At that same time, and with a gifted group of engineers, we also set on a bold course to innovate in ways that no one had done before. For
solving the measure-through motion and low perfusion pulse oximetry problem that had stumped the industry, we got great recognition
from the scientific, clinical, and business communities. And for finding a way to measure carbon monoxide, methemoglobin, hemoglobin
noninvasively, and acoustically measure respiration rate, we received more recognition and accolades. We have not stopped. We continue
to launch more breakthrough noninvasive measurements, monitors, and systems, but we also always strive to give our customers and
partners the most caring sales and service team. In the process, we have grown double-digits since our first year of sales and, in 2012, we
once again delivered record revenue despite a challenging global economy and rapidly evolving healthcare market.
Reinforcing Our Roots
In the process, we have cultivated an
many other things that happened along
Much has changed since I founded
Masimo in my home in 1989. But after
more than two decades of technical
innovation, broad clinical impact, and
solid growth, our roots remain the
same. They have just gotten stronger
and broader. From the outset, Masimo
resolved to be different from any other
company. We didn’t just set out to create
breakthrough technologies; we also
wanted to improve patient lives more
significantly than any other company.
And, by the way we conducted ourselves,
we hoped to improve the way business
is done. By standing and striving for
enterprise in which approximately 3,000
Masimo’s journey that also stand as
talented people deliver on their promises
proud examples of the promises we
in an environment where fascination,
accomplishment, and fun can thrive.
made to ourselves 24 years ago.
Proving We Mean It
When we discovered our Rad-9® product
(acquired in 2002 from one of our
The pages of this annual report are full
OEMs) could visually but not audibly
of innovations that are testaments
alarm if a sensor failed, we proactively
We didn’t just set out to create
breakthrough technologies; we also
wanted to improve patient lives more
significantly than any other company.
issued a recall for the device to ensure
the highest level of patient safety in
the midst of our IPO roadshow in 2007.
Months later, the FDA stated it didn’t
require a recall as the behavior met
industry standards. When no other
pulse oximetry company put a speaker
backup in their devices to ensure that
patient alarms would be heard, even in
truth, while relentlessly pursuing our
to everything we originally set out to
mission and adhering to our guiding
accomplish. It has been said that the true
principles, we have continued to focus on
test of character is what you do when no
the rarest cases of a speaker failing, we
solving “unsolvable” problems, protecting
one else is looking. While less noticeable
looked beyond product costs and did it
patients, and innovating for the future.
than our innovations, there have been
for all of our bedside monitors anyway.
2
Joe Kiani
Chairman & CEO
When other companies refused to provide
evaluated on their individual clinical
from preventable causes. The inaugural
overcame the technological limitations
for those who need it, and in multiple
for simultaneous measurement of
their pulse oximeters for use in home
and cost merits, that is what we do.
Summit attracted former President
of conventional pulse oximetry, making
cases has demonstrated its lifesaving
SpO2, SpCO®, SpMet®, and SpHb®.
care because of the potential liabilities
vis-à-vis high-risk patients and a litigious
environment, we decided to make our
products available because we knew
they provided the best and sometimes
only solution possible for patient care.
When we won the antitrust lawsuit
against one of our competitors, we
kept fighting for a final ruling so our case
could help other companies avoid what
we experienced—instead of focusing on a
possibly large settlement. And when the
final rulings were in, rather than banking
the legal proceeds, we used a significant
portion of those funds to set up the
Masimo Foundation for Ethics, Innovation,
Seeding a Patient
Safety Movement
The Masimo Foundation has now
extended its mission even further,
founding the first annual Patient Safety,
Science & Technology Summit, which
was held in January 2013. The Summit
The excitement generated at the
January 2013 Summit has quickly
become a “movement,” which is
now focused on connecting people,
connecting ideas, and connecting
Bill Clinton, 300 leading clinicians,
technologists, patient advocates, and
other healthcare stakeholders to focus
on specific patient safety challenges
that could eliminate needless deaths
and injuries due to failure to rescue,
medication errors, and transfusion
overuse, as well as neonatal care
advancements with congenital heart
disease screening and optimal oxygen
targeting. The inaugural Summit also,
for the first time in history, brought 8
medical technology companies together
with Masimo in pledging to make
medical device data open and available
to whomever needs it to improve patient
and Competition in Healthcare.
technologies so that patients don’t
safety. Cercacor, Cerner, Dräger, GE
In our quest for solutions to the
industry’s most vexing technical and
clinical problems, we are constantly
reminded that it takes more than
engineering prowess, clinical know-
how, and ingenuity to succeed. It
takes courage, strength, and an
die from preventable causes.
Healthcare Systems, Smiths Medical,
Sonosite, Surgicount, and ZOLL each
publicly announced commitments to
was created to confront large problems
share the data for which their products
with actionable ideas and innovations
are purchased, for the sake of patients.
that can transform the process of
In addition to these companies, clinicians
care and dramatically improve patient
and hospitals have also made public
safety—one solution, one hospital,
commitments to take decisive action
uncompromising commitment to our
and one patient at a time, to help us
core values—ethics, innovation, and
meet the inaugural Summit’s goal
fair play. If that means standing up
of ZERO preventable patient deaths
to improve patient safety and be held
accountable on those commitments.
for our rights and our beliefs so that
by 2020. The excitement generated
Continuing Innovation
others may benefit from our stand,
at the January 2013 Summit has
then that is what we do. And if it means
quickly become a “movement,” which
challenging unfair Group Purchasing
is now focused on connecting people,
Organization practices with entrenched
connecting ideas, and connecting
interests, so that medical products are
technologies so that patients don’t die
Masimo’s innovation engine has
fueled many industry firsts, which
have significantly improved patient
care and reduced costs. Masimo SET®
1,088,000
979,000
855,000
724,000
625,000
Installed Base
(estimated units)*
4,000
16,000
38,000
100,000
62,000
214,000
150,000
507,000
392,000
296,000
it more accurate during the challenging
potential to help clinicians detect occult
The new SpfO2 measurement allows
conditions of patient motion and
bleeding. Our rainbow® technology
more precise arterial oxygenation
low perfusion. This invention has
has also been shown to help clinicians
assessment in patients with elevated
made pulse oximetry a clinically
assess fluid responsiveness, improve
dyshemoglobins—common throughout
useful tool and, for the first time
fluid management, identify changes in
hospital and pre-hospital settings—
since pulse oximetry was introduced
breathing, and assess carbon monoxide
as compared to functional oxygen
in the 1970s, it has been shown in
levels for faster therapy for those with
saturation (SpO2). As a result, SpfO2
clinical studies to improve patient
CO poisoning. With growing clinical
should enable earlier interventions and
outcomes. Masimo SET® has now
been shown to help clinicians reduce
retinopathy of prematurity, detect
In 2013, we intend to re-write
congenital heart disease in newborns,
the rules for monitoring and
reduce medical errors in critical care,
wean patients from the ventilator
faster, and save lives and costs in the
care of post-surgical patients on the
general floor. Approximately 10 years
after the introduction of Masimo
SET®, our rainbow® platform has
ushered in noninvasive and continuous
measurements that previously required
invasive procedures, allowing clinicians
to make earlier and better decisions
to care for patients in ways they never
thought possible.
As one example, our noninvasive and
continuous total hemoglobin (SpHb®)
monitoring has been shown to help
clinicians reduce the number of risky
and costly blood transfusions in surgical
patients, speed up blood transfusion
connectivity with the launch
of Root™.
evidence and customer advocacy, more
and more OEM partners are including
rainbow® technology in their products,
including the leading multiparameter
monitoring companies throughout the
world. The list now includes 3F, Atom,
Dräger, Edwards Life Sciences, Fukuda
Denshi, GE, GS Corpuls, Hamilton
Medical, Philips, Physio-Control, Saadat,
Schiller, Welch Allyn, ZOLL, and Zondan.
In 2012, we introduced SpfO2™, the
first true fractional noninvasive oxygen
saturation monitor, along with the
rainbow SuperSensor™, which allows
more timely therapeutic decisions.
In 2012, we also revolutionized the
Radical-7® by making it rainbow-® and
clinician-centric with touchscreen
and embedded Wi-Fi technology.
While we are proud of our past
technological accomplishments, we
intend to continue to introduce new,
innovative products. In 2013, we intend
to re-write the rules for monitoring
and connectivity with the launch of
Root™. Root is a powerful new patient
monitoring and connectivity platform
that integrates our full suite of rainbow®
measurements with multiple additional
parameters in an integrated, clinician-
centric platform. Our approach is
designed to unleash innovation in patient
monitoring via third-party development
of new measurements. With a dock for
the Radical-7, an instantly interpretable
493.2
28.3
464.9
439.0
32.5
406.5
405.4
49.0
356.4
349.1
49.0
300.1
307.1
47.5
259.6
Revenues
(millions of dollars)
1.7
6.7
14.4
20.9
40.6
46.7
256.3
56.1
200.2
224.3
68.8
155.5
107.9
69.4
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
* Excludes Handheld Devices
4
Product Revenues
Royalty Revenues
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display, and a networking/connectivity
appreciative feedback that we received
including operating rooms, procedural
gateway, Root integrates multiple
when we introduced our solutions to
sedation, and intensive care units.
streams of data and simplifies patient
the “people care” community. We also
care workflows, empowering caregivers to
launched our first-ever monitoring device
make quicker patient assessments, earlier
for the promising consumer health and
interventions, and better clinical decisions
wellness market—iSpO2™. We expect
throughout the continuum of care.
both these new markets to grow in
Improving Care and Lowering Cost
Hospitals around the world continue to
2013 and beyond.
Expanding Our Technology Base
Performing in a
Challenging Climate
By helping clinicians improve the quality
and efficiency of patient care, we
delivered another year of record revenues
in a global economy that continues
to be challenged. Our total revenues
see significant advantages provided by
In 2012, we made two important strategic
grew to $493.2 million, while product
SET® Measure-through Motion and Low
acquisitions. Spire Semiconductor (now
revenues rose 14% to $464.9 million and
Perfusion™ pulse oximetry. We shipped
Masimo Semiconductor) makes advanced
rainbow® revenues rose to $40.3 million.
146,400 instruments and boards in 2012,
light emitting diode (LED) and other
Net income was $62.3 million or $1.07
increasing our estimated worldwide
installed base of SET® and rainbow®
instruments to 1,088,000. We
estimate that over 100 million people
around the world each year are better
cared for with our break-through, life-
saving, and life-improving technologies.
We believe we will see increased growth
in our installed base as more clinicians
component-level technologies—both
per diluted share, compared to $1.05 in
for Masimo’s own noninvasive sensors,
the prior year. Our 2012 earnings were
as well as for other applications in the
reduced by $0.06 per share due to the
biomedical, telecommunications, and
acquisitions of Spire Semiconductor
In total, we estimate that US
hospitals alone could save over
and Phasein. We anticipate that our
core business in Masimo SET® pulse
oximetry will continue to grow steadily
while our new products—especially
$5 billion when their clinicians
rainbow® Pulse CO-Oximetry™ and
choose the rainbow® platform. The
use Masimo technologies to
improvements in the process of care
have resulted in real cost savings to
hospitals using Masimo technologies.
their fullest potential.
rainbow Acoustic Monitoring™—will
increasingly contribute to our growth
as more OEM partners offer and more
hospitals adopt rainbow® technologies.
In total, we estimate that US hospitals
consumer products markets. We are very
alone could save over $5 billion when
excited about the potential for harnessing
their clinicians use Masimo technologies
and advancing Masimo Semiconductor’s
Looking to the Future,
Inspired by Our Roots
to their fullest potential.
Expanding to New Markets
Masimo SET® has allowed pulse
oximetry to succeed in markets where
conventional pulse oximetry had failed—
including home and long-term acute care
facilities. Our rainbow® measurements
have also allowed us to increase our
impact beyond the hospital, from helping
emergency personnel detect carbon
monoxide poisoning at the scene of a
fire to enabling noninvasive hemoglobin
spot-check testing in the physician’s
office. And as more caregivers gain
access to our products, we know that
more lives will be improved and saved.
myriad optoelectronic technologies as
part of Masimo’s product, technology, and
market expansion strategy.
Our second 2012 acquisition, Phasein,
was an innovative developer and
marketer of ultra-compact mainstream
and sidestream capnography, multigas
analyzers, and handheld capnometry
solutions. The acquisition of Phasein’s
multigas technologies complements
From the launch of SET® in 1996 to the
launch of rainbow® technology in 2005 to
our 2007 IPO—one of the most successful
healthcare IPOs of the year—we have
always pushed ourselves to perform
better while remaining committed to
the root of our inspiration—the healing
interaction between caring caregivers and
their patients. Today, we renew our pledge
made in 1989—to impact patient lives in a
way that no company has done before and
Masimo’s breakthrough innovations for
to continue to improve the way business
patient monitoring with a portfolio of
is practiced in our industry.
products ranging from OEM solutions
for external “plug-in-and-measure” gas
analyzers and integrated modules to
handheld capnometers. With multiple
measurements delivered through either
This year, we also entered the animal
mainstream or sidestream options,
health market, offering a variety of
Masimo customers can now benefit from
differentiated solutions to domestic and
end-tidal CO2, N2O, O2, and anesthetic
large animal veterinarians, with the same
agent monitoring in a variety of care areas,
Joe Kiani
Chairman & CEO
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Root™: At the Root of
Transforming Care
From the company’s inception, the root
of our inspiration has been unwavering—
patients, their families, and their caregivers.
This inspiration is evident every time we have set out
to solve a previously “unsolvable” problem, in every
new measurement we have created, and in every new
software, hardware, or systems innovation we have
developed. We have done all of these things for one
overriding reason—to enable clinicians to get to the root
of better care for their patients. In honor of this ongoing
quest, we are proud to introduce the newest addition to
Masimo’s product portfolio—Root™.
Breakthrough Measurements.
Breakout Connectivity. Brilliant Display.
Root is a powerful new patient monitoring
and connectivity platform that integrates our
breakthrough rainbow® and SET® measurements
with multiple additional parameters—including
SedLine® brain function monitoring and Phasein™
capnography and gas monitoring*—in an
integrated, clinician-centric platform.
Root includes a dock for the Radical-7 handheld
monitor, an instantly interpretable display, and
multiple networking/connectivity options. Root
integrates multiple streams of data and simplifies
patient care workflows, empowering caregivers to
help make quicker patient assessments, earlier
interventions, and better clinical decisions
throughout the continuum of care.
* Root is CE Marked.
“ Root integrates rainbow®
measurements so at any
moment I can see what I
want to see and how I want
to see it—a great advantage
to the anesthesiologist in a
data-rich operating room.
Root makes it easy to use
SpHb and PVI together to
optimize transfusions and
fluid management.”
Dr. Keith Ruskin
Professor of Anesthesiology at Yale-New
Haven Hospital in New Haven, CT
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The Root of Root™
Instantly Interpretable, High-visibility Display
With the Radical-7 handheld in its dock, Root enables
instant interpretation of Masimo’s breakthrough
noninvasive measurements. The brilliant, high-resolution,
adaptive display is designed to aid clinicians rapid
assessment of patient status in three distinct ways:
> “Trend” view in which each measurement
value is displayed alongside its graphical trend
> “Analog” view for quick assessment
through gauges showing measurement
values in relation to alarm ranges
> When docked with Root, the Radical-7’s screen
can transform into an alarm status visualizer,
with a three-dimensional, anatomical image that
associates device measurements with alarm status.
Intuitive Touchscreen Navigation for Easy and
Adaptable Use in Any Hospital Environment
With a simple tap, swipe, or drag-and-drop, screen
views and parameter sizing can be customized to
suit any hospital environment, workflow, clinician
preference, or patient-specific need. This allows
Root to be adaptively used across a wide variety of
care areas with disparate clinical and operational
requirements—from the operating room to the
intensive care unit to the general floor.
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The alarm visualizer associates device
measurements with alarm status and is
color coded to indicate no alarms (green),
approaching alarm (yellow), and alarm
state (red). (Color emphasis added).
Flexible Measurement Expansion in
Root with Masimo Open Connect
With Root, Masimo is providing an open invitation to other companies, from small to large,
to develop and commercialize their innovations and deliver them via the Root platform.
Expanding Masimo Measurements
Alarm Indicator
Iris™ Connectors
Hi-Fi Speaker
Root offers expanded measurement
capability through software upgrades
and Masimo Open Connect (MOC-9™)
modules. SedLine® brain function
monitoring is the first measurement
to utilize MOC-9, offering the exclusive
ability to measure 4 simultaneous EEG
channels to help clinicians assess the
hypnotic state or depth of sedation.
Additional MOC-9 measurements are
planned with Phasein sidestream and
mainstream capnography and gas
analyzers. And that is just the start. We
anticipate a whole new ecosystem of
third-party measurements to grow from
Root—expanding its capability into new
areas of patient monitoring.
Designed to Stimulate
Third-party Innovation
MOC-9 is designed to enable third-
party development of additional
measurements. Market barriers and
development costs often keep small,
innovative companies from delivering
products to the clinicians and patients
who need them most. With Root,
Masimo is providing an open invitation
to other companies, from small to large,
to develop and commercialize their
innovations and deliver them to market
via the Root platform.
Nurse Call
Connector
Ethernet Port
MOC-9™
Power Entry Module
USB Ports
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Root™ with Brain Function Monitoring
Featuring 4 simultaneous channels of high-quality EEG data, SedLine® provides continuous
information about both sides of the brain and provides information about a patient’s response
to anesthesia.
The Root of Better Data
Facilitating Individualized Titration
Patients respond differently to anesthetics, which can mean
SedLine enables individualized titration of sedation and
over- or under-administration during surgery and conscious
faster emergence, while offering reliable monitoring during
sedation procedures. SedLine technology measures brain
challenging conditions such as electrocautery. Use of SedLine
function on a continuous basis and provides information
and its Patient State Index (PSI™) has been shown to help
about a patient’s response to anesthesia. SedLine enables
clinicians manage patients to significantly faster emergence
monitoring of both sides of the brain simultaneously. The
from anesthesia and recovery.1
Density Spectral Array (DSA™) provides immediate detection
of asymmetrical activity.
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“ SedLine gives me a better idea of where I stand at each phase of
anesthesia. The PSI number helps guide me to make subtle
changes in my anesthetic appropriate for the patient’s heart rate
and blood pressure, and thus arrive at the end where I want to be.”
David Drover, MD
Stanford University Hospital
Stanford, CA
1 Drover DR et al. Anesthesiology. 2002;97:82-89.
Root with SedLine Brain Function Monitoring is CE Marked.
Capnography and Gas Monitoring Adds Even
More to the Patient Safety Equation
Changes in expired respiratory gas can be an early indicator of an
adverse respiratory event. Hypoventilation, hyperventilation, airway
obstruction, and other potentially life-threatening conditions can be rapidly
detected with capnography—enabling clinicians to intervene as early as
possible. Capnography and gas monitoring also provide insight into the
effectiveness of the anesthesia breathing circuit, aiding clinicians in
maintaining proper gas concentrations and ventilation levels.
Our new Phasein™ capnography and gas monitoring solutions complement our breakthrough noninvasive
portfolio with innovative, multispectral technologies for measuring respiratory gases. The solutions range
from integrated OEM solutions to external “plug-in and measure” gas analyzers to handheld devices. With
multiple measurements delivered through either mainstream or sidestream options, Masimo customers
can now benefit from end-tidal CO2, FiCO2, RR, N2O, O2, and anesthetic agent monitoring in a range of
hospital environments—from the operating room to intensive care to the general floor.
IRMA™—A Complete Monitor in a Probe
Designed with the latest advancements in miniaturized components
and microprocessor technology, the IRMA mainstream analyzer weighs
less than 1 ounce and fits in the palm of your hand. This versatile,
complete mainstream capnography and gas monitoring system
can be utilized with adult, pediatric, or infant patients.
ISA™—Ultimate Performance in a Sidestream Analyzer
Enabled by state-of-the-art Phasein spectrometer technology that utilizes nine different
wavelengths of light and powerful signal processing algorithms, ISA provides the clinician with
precise capnography and gas measurements with crisp waveforms that help depict the clinical
situation for adults and neonates, from the operating room to the general floor. ISA sidestream
analyzers are available as standalone or easy-to-integrate OEM modules.
Nomoline™—No Moisture Sampling Line
Nomoline fluid protection technology eliminates
common problems associated with conventional
sidestream gas analysis. Incorporating a special
polymer and a hydrophobic bacterial filter, the
Nomoline allows water in the sampling line to
evaporate into the surrounding air, while leaving
oxygen, carbon dioxide, and anesthetic gases
unaffected. Specially designed for low-flow
applications and functional in any orientation,
Nomoline technology can be used in any clinical
application for all types of patients from neonates to
adults. Nomoline is designed to extend the product
life in single-use applications, such as high humidity
environments. Nomoline’s innovative design also
allows multi-patient use as a resposable solution.
Single-patient-use cannula
and Nomoline adapter.
Single-patient-use cannula
and multi-patient-use
Nomoline adapter.
ISA OR+
ISA AX+
> EtCO2
> RR
> N2O
> O2
> Anesthetic Agent
Identification
> EtCO2
> RR
> N2O
> Anesthetic Agent
Identification
ISA CO2
> EtCO2
> FiCO2
> RR
Root with Capnography is CE Marked.
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Integrating Measurements to
Enable Meaningful Use of Health
Information Technology
Today’s challenging hospital environment subjects clinicians to
increasing mountains of information with expanding documentation
requirements. Masimo’s innovation simplifies and automates this
process, streamlining workflow and improving patient safety by
empowering clinicians to focus on patients rather than technology.
Keeping Clinicians and Patients Connected
New standards for hospitals require meaningful use of the electronic health record (EHR)
by charting changes in vital signs as well as documentation of interventions. Masimo
enables automatic recording and transmission of key data into the EHR so clinicians spend
their time caring for patients, not recording data. Masimo’s pulse oximeters also feature
a built-in wireless radio for communication through a hospital’s wireless network—with
seamless integration to the EHR. Patient SafetyNet* incorporates the Masimo Adaptive
Connectivity Engine™ (ACE), which enables two-way, HL7-based connectivity to the EHR.
ACE significantly reduces the time and complexity to integrate and validate custom HL7
implementations, and demonstrates Masimo’s commitment to innovation that automates
patient care with open, scalable, and standards-based connectivity architecture.
Iris™ Integration Platform
Despite huge advances in medical technology, the lack of device communication and
integration creates risks to patient safety in hospitals around the world. Existing
approaches for device interoperability require separate hardware, software, and/or
network infrastructure, which can clutter the patient room, burden IT management,
and increase the complexity and cost of care.
Root with Iris offers a built-in connectivity gateway that can integrate
multiple standalone devices such as IV pumps, ventilators, beds,
and other patient monitors. Iris allows device information to
be remotely viewed with Patient SafetyNet™, transmitted
through notification systems or to electronic health
record (EHR) systems to facilitate better patient care
and meaningful use, and eventually displayed on Root
at the point of care to facilitate decision support. Device
connectivity with Iris is designed to leverage existing
network infrastructures and reduce costs while enhancing
workflows and decision support to improve patient safety,
whether the clinician is at the bedside, down the hall, or
across the globe.
*The use of the trademarks PATIENT SAFETYNET and PSN is
under license from University Health System Consortium.
Through Iris™, Root is designed
to provide built-in integration
to multiple standalone devices.
Examples include:
> IV pumps
> Ventilators
> Beds
> Other patient monitors
Third-party
Device
Iris Icon
Wireless 802.11
or Wired
Connection
Root
Patient SafetyNet
Appliance
Connectivity to Electronic
Health Record & Central
Monitoring Stations
Notifications
Patient SafetyNet
View
Device Icons
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A Radical Departure from Traditional Monitoring
Breakthrough flexibility to meet clinician and patient needs.
Over 100 Different Sensor and Cable Combinations
for Either Single- or Multi-patient Use
Masimo rainbow® sensors measure SpO2, PR, PI, PVI, RRp*, SpfO2*, SpHb, SpOC, SpMet, SpCO.
The Radical-7 leverages Masimo’s breakthrough noninvasive
The intuitive touchscren operation allows for exceptionally
measurements with a radical departure from traditional
easy operation to change displayed parameters, waveforms,
monitoring for breakthrough functionality designed to
or trends on the fly never losing track of vital signs. In
automate the process of care and enable clinicians to
addition, easy customization allows clinicians quick access
instantly adapt to changing monitoring needs in individual
to alarms and system settings enabling instant changes in
patients and care areas.
alarm settings with a simple gesture.
> Breakthrough measurements
> Instantly adaptable functionality
> Intuitive touchscreen operation
> Easy customization
> Flexible clinical applications
> Integrated wireless connectivity
Instantly Adaptable Functionality
Three-in-one capability allows the Radical-7 to be used as:
rainbow® R25-L
rainbow® ReSposable R2-25
sensor system
rainbow® R25
Masimo SET® sensors measure SpO2, PR, PI, PVI, RRp.
M-LNCS Blue®
M-LNCS E1™
M-LNCS Trauma
M-LNCS Adtx
M-LNCS Neo
M-LNCS DBI
M-LNCS DCI
M-LNCS ReSposable S-ROS 3U
ReSposable S-DOS 25
M-LNCS TF-1
M-LNCS TC-1
Standalone device for bedside monitoring
Multiparameter monitoring interface via SatShare®, allowing hospitals
to seamlessly implement rainbow® measurement capabilities
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* RRp and SpfO2 are CE Marked
Detachable, battery-operated,
wireless handheld or wearable
device to facilitate untethered
monitoring during transport
and ambulation
The Radical-7 handheld
monitor docks comfortably
in Root providing an instantly
interpretable display, and
multiple networking/
connectivity options
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Supporting Clinicians in Reducing
Blood Transfusions with SpHb®
With the rainbow® measurement platform including
noninvasive total hemoglobin (SpHb), Masimo
technologies aid some of the most common, costly,
and critical decisions made in healthcare.
Risks and Costs of Red Blood Cell Transfusions
Red blood cell (RBC) transfusion is one of the most frequent procedures
performed in US hospitals, with one in ten inpatients receiving one
or more blood units.1 While blood loss during surgery is a known risk
factor, RBC transfusion overuse can increase patient risk and cost of
care. Meta-analysis of pooled results from multiple observational studies,
each of which adjusts for risks between patients, shows that patients
receiving RBC transfusions have an 88% higher mortality, 69% higher
infection rate, and 250% higher rate of acute respiratory distress
syndrome (ARDS).2 Multiple randomized controlled trials indicate that
restrictive transfusion practices—those in which significantly lower
hemoglobin triggers are used to determine need for transfusion—are
safe.3 In addition, the cost of each RBC unit is estimated between
$522 and $1,183 per unit, without including morbidity-associated
costs.4 Beyond the cost of transfusion, each RBC unit transfused
is associated with increased cost of care and transfusions that
occur at higher hemoglobin levels increase the cost of care more
than those given at lower hemoglobin levels.5
With the growing recognition of the need to reduce transfusions,
noninvasive and continuous hemoglobin (SpHb) can be a key tool
to help overcome the limitations of existing approaches.
Risk-adjusted analysis of multiple observational
studies has shown that RBC transfusions are
associated with 88% higher mortality, 69% higher
infection rate, and 250% higher rate of ARDS.2
1 AHRQ. Inpatient Sample. 1997-2007. 2 Marik PE et al. Crit Care Med.
2008;36(9):2667-74. 3 Carson et al. Cochrane Database Syst Rev. 2012
Apr 18;4:CD002042. 4 Shander A et al. Transfusion. 2010;50(4):753-765.
5 Murphy GJ et al. Circulation. 2007;116:2544-2552.
23
“
Deciding to transfuse based
on a single static measurement
more often results in patients
receiving unnecessary
transfusions with increased
risks, costs, and the depletion of
an already scarce blood supply.
New medical technologies
and devices that continuously
monitor hemoglobin, oxygen,
and perfusion will become
essential for transfusions.”
Dr. Aryeh Shander
Chief, Department of Anesthesiology,
Pain Management and Hyperbaric Medicine,
Icahn School of Medicine at Mount Sinai,
Mount Sinai Hospital, New York
22
The Overuse of RBC Transfusions
The Growing Recognition of the
Need to Reduce Transfusions
American Medical Association and
be delayed in the period between blood
The Joint Commission also recently
draw and laboratory analysis. This time
Many transfusions are unnecessary. A
systematic, expert review of 494 studies
for positive impact on health outcome
showed that 59% of RBC transfusions
are “inappropriate.”1 Given the risks
and costs of RBC transfusions, there
is a growing recognition of the need to
implement strategies to reduce RBC
transfusions. The Joint Commission has
introduced Patient Blood Management
Measures that encourage hospitals to
identified RBC transfusions as one
gap of information can lead to sub-
of the top five overused procedures
optimal transfusion decisions.4
in medicine, defining overuse as
“circumstances where the likelihood
of benefit is negligible or zero, and the
patient is exposed to the risk of harm.”3
Limitations with Existing
Approaches to Assess
Transfusion Need
The most universally available
information about whether a
transfusion is needed during surgery
is estimated blood loss, which is often
overstated. Visible blood and fluid loss
appears to tell one how much blood has
been lost, but in a recent study at Duke
University, anesthesiologists estimated
Hemoglobin levels are used as a primary
blood loss at 40% more than it actually
evaluate appropriateness of transfusions
indicator for RBC transfusion, but
was.5 The implication is that the need
as a continuous quality indicator.2 The
laboratory measurements are only
for transfusion may appear to exist,
available intermittently and results can
when in fact it does not.
Appropriate Use of Transfusion
12%
59%
29%
Inappropriate Uncertain Appropriate
494 studies were evaluated by an expert panel in a systematic method
to assess appropriateness of RBC transfusion, revealing a significant
opportunity to reduce unnecessary transfusions.1
24
The American Medical Association
and The Joint Commission also
recently identified RBC transfusions
as one of the top five overused
procedures in medicine, defining
overuse as “circumstances
where the likelihood of benefit is
negligible or zero, and the patient
is exposed to the risk of harm.”3
Stable
Dropping
Rising
b
H
p
S
SpHb
Lab Hemoglobin
Continuous hemoglobin trending between invasive blood sampling provides a real-time indication of whether hemoglobin is stable
when it may appear to be dropping, rising when it may not appear to be rising, or dropping when it appears to be stable.
Time
How SpHb Monitoring Helps
with Transfusion Decisions
Masimo’s solution provides hemoglobin
both noninvasively and continuously.
The noninvasive aspect makes the
technology easy to apply to the patient,
and the continuous aspect assists in
better decision making. While SpHb
monitoring is not intended to replace
blood draws, it identifies significant
when the SpHb trend is stable and
changes in hemoglobin and lack of
the clinician may otherwise perceive
significant changes in hemoglobin
hemoglobin is dropping, or when the
between invasive blood sampling and
SpHb trend is rising and the clinician
laboratory analysis.6
Continuous hemoglobin means
clinicians can determine the directional
trend of hemoglobin—whether it
is stable, rising, or falling. This can
help avoid unnecessary transfusions
may otherwise perceive it is not
rising fast enough. Inside and outside
the operating room, a dropping SpHb
trend may also allow clinicians to
identify internal bleeding and permit
earlier interventions.
1 Shander et al. TransMed Rev. 2011. 232-246. 2 Joint Commission Perspectives. The Joint Commission Continues to Study Overuse Issues. Volume 32, Number 5,
2012: 4-8(5). 3 http://www.jointcommission.org/patient_blood_management_performance_measures_project/ 4 Friedman MT et al. Arch Pathol Lab Med. 2006
Apr;130(4):474-9. 5 Hill SJ et al. ASA. 2011 (abstract). 6 Frasca D et al. Crit Care Med. 39(10); 2011; 2277-2282.
25
SpHb helps clinicians reduce transfusion
frequency in lower blood loss surgery1
4.5%
87%
Reduction in Blood
Transfusion Frequency
0.6%*
s
n
o
i
s
u
f
s
n
a
r
T
d
o
o
B
e
v
i
t
a
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e
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o
a
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t
n
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o
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c
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e
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q
e
r
F
5%
4%
3%
2%
1%
0%
Standard Care Group
SpHb Group
Randomized controlled trial in 327 orthopedic patients.
* p=0.03 vs Standard Care Group
SpHb helps clinicians reduce the amount
of blood transfused in higher blood loss surgery2
1.9
0.9
Average RBC Units
Reduced Per Patient
1.0**
t
n
e
i
t
a
P
r
e
P
d
e
s
u
f
s
n
a
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T
s
t
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C
B
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e
g
a
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v
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2.5
2
1.5
1
0.5
0
Standard Care Group
SpHb Group
Prospective cohort study in 106 neurosurgery patients.
**p<0.001 vs Standard Care Group
SpHb also helps clinicians decrease the time to
transfusion, when a transfusion is truly indicated2
)
n
m
i
(
d
e
h
s
i
l
b
a
t
s
E
d
e
e
N
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e
t
f
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a
t
S
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T
o
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T
i
50
40
30
20
10
0
50.2
41
Minute
Reduction in Time
to Transfuse
9.2**
Standard Care Group
SpHb Group
Prospective cohort study in 106 neurosurgery patients.
** p<0.001 vs Standard Care Group
Reducing Blood
Transfusions and Costs
Clinical Evidence that SpHb Monitoring
Helps Reduce Transfusions
There are now two studies showing that
SpHb monitoring helps clinicians reduce
RBC transfusions.
SpHb monitoring has been shown in a
randomized controlled trial in lower blood loss
surgery (orthopedic surgery) to reduce the
frequency of intraoperative blood transfusions
by 87% (from 4.5% to 0.6%) and the average
number of RBC units transfused by 90%
(from 0.1 to 0.01 units per patient).1
SpHb monitoring has also been shown in a
prospective cohort study in higher blood loss
surgery (neurosurgery) to reduce the percent
of patients receiving three or more RBC units
from 73% to 32% and reduce the average
number of RBC units transfused by 47% (from
1.9 to 1.0 units per patient).2 In this study, the
researchers also showed that patients who
needed RBC units received them sooner by
41 minutes on average.
Projected Cost Savings from SpHb
Monitoring to Reduce Transfusions
To project the potential savings from SpHb monitoring, the
range of published cost estimates for RBC transfusions ($522
to $1,183) can be multiplied by the expected reduction in RBC
transfusions per patient.3 In lower blood loss surgery, the 0.09
lower RBC units per patient with SpHb monitoring is projected
to reduce RBC costs by $47 to $106 per patient monitored.1 In
higher blood loss surgery, the 0.90 lower RBC units per patient
with SpHb monitoring is projected to reduce RBC costs by $470
to $1,065 per patient monitored.2 These estimates do not take
into account the expense of SpHb monitors or sensors, or the
other costs associated with over transfusion or delayed care.
Potential Blood Cost
Savings Per Patient
with SpHb Monitoring3
Range of RBC
Transfusion
Cost Estimates
Lower Blood
Loss Surgery1
Higher Blood
Loss Surgery2
$522
$47
$470
$1,183
$106
$1,065
1 Ehrenfeld JM et al. ASA. 2010. LB05. (abstract) 2 Awada W.F.N., Maher F. Proceeding of the
Society for Technology in Anesthesia Annual Meeting, 2013: p 51. 3 Shander et al. Transfusion.
2010;50(4):753-765.
27
Risk and Cost of
Undetected Bleeding
In addition to assisting with transfusion management,
continuous SpHb can also help clinicians inside and outside
the operating room monitor and detect internal bleeding.
Bleeding affects up to 35% of patients in surgery, intensive
care, and obstetric care areas.1 Bleeding is considered
a significant risk factor for patients, and late detection
further increases risk and cost.2 Surveys show that the
majority of US hospitals have multiple patients per
year with serious injury or death due to late detection
of bleeding.3
Post-partum Hemorrhage
Every 90 seconds around the world, a woman dies
from complications related to pregnancy or childbirth.4
For every woman who dies, 30 more suffer injuries or
disabilities.5 Bleeding in obstetric patients, known
as post-partum hemorrhage, affects 3% of mothers
giving birth in the US.6 Worldwide, it is the #1
cause of maternal mortality.7 The Joint Commission
has issued a sentinel event alert on post-partum
hemorrhage, calling on hospitals to develop specific
protocols to systematically detect bleeding to
allow earlier intervention.8 Unfortunately, previous
efforts have failed to make significant progress.
Limitations of Current Approaches
to Detect Bleeding
A significant number of injuries or deaths due to
bleeding are preventable. Prevention requires
identifying that a patient has experienced
significant bleeding and then intervening to
stop the bleeding and improve the patient’s
condition. Identifying bleeding is challenging
because even during surgery and childbirth,
clinical estimation of blood loss is inaccurate
and changes in standard vital signs can
occur long after the bleeding has begun. Low
hemoglobin identifies bleeding over 90% of
the time, but is only assessed intermittently
and requires a blood draw and laboratory
analysis.9 In some parts of the world,
laboratory testing is simply not available.
“ Masimo SpHb helped prevent
a potentially life-threatening
event. I am now using it for all
my major craniofacial procedures
and can’t see doing a surgery
without it.”
Jeffrey Fearon, MD
Physician for 8-year-old girl who had just completed
craniofacial surgery in which SpHb signaled undetected
bleeding through a dramatic drop in hemoglobin over a
5-minute period.
28
Potential for Earlier Identification of Falling Hemoglobin Values
8.0
7.0
6.0
Standing
lab order
tHB Lab Test
Masimo SpHb (Unblinded)
Blood Transfusion Initiated
Lab tHb ordered early
due to declining
SpHb values
Patient transported to
OR for splenectomy
10
11
12
13
14
15
16
17
18
19
Hours
Noninvasive and Continuous Hemoglobin
Monitoring to Detect Bleeding
By measuring hemoglobin continuously, clinicians can become
aware of real-time drops in hemoglobin that are indicative of
bleeding. Identification of low or falling hemoglobin levels allows
interventions that may prevent preventable death and disability.
“ In cases of severe hemorrhaging during and after childbirth,
SpHb has enabled us to immediately identify and continuously
assess blood loss severity to better manage internal bleeding,
prevent overloading of fluid, and decrease maternal death.”
Madhava Karunarathna, MD
OB/GYN, Balangoda Hospital, Sri Lanka
1 Hebert PC. Crit Care. 1999: 3(2):57-63. 2 Herwaldt LA. Infect Control Hosp Epidemiol. 2003; 24(1):44-50. 3 HRA Research of Hospital Executive. 2012. 4 Maternal Mortality
in 2005: WHO, UNICEF, UNFPA and the World Bank. 5 UNICEF Statistic, 2003. 6 Bateman BT et al. Anesth Analg May 2010 110:1368-1373. 7 Khan KS et al. WHO. 2006.
367:1066-1074. 8 The Joint Commission, “Sentinel Event Alert: Preventing Maternal Death” Issue 44, January 26, 2010. 9 Bruns B et al. J Trauma. 2007; 63(2):312-5.
29
Accuracy of Noninvasive and Continuous Hemoglobin
Monitoring Compared to Common Invasive Methodologies
While hemoglobin is one of the most
expected between hemoglobin device
analyzer, both in single measurement
common laboratory tests performed,
methods. A total of 471 hemoglobin
comparisons as well as trended
most clinicians are unaware of variation
measurements were evaluated from 62
measurement comparisons. Only SpHb
that should be expected when comparing
patients. Noninvasive and continuous
provides hemoglobin noninvasively and
hemoglobin measurements–both within
hemoglobin (SpHb), a satellite laboratory
continuously—ideal for indicating real-
and between various device models.
CO-Oximeter (Siemens RapidPoint 405),
time visibility to hemoglobin changes,
This is because clinicians do not typically
and a point-of-care device (HemoCue
or lack of changes, in between invasive
measure hemoglobin more than once
301) were all compared to reference
blood sampling and laboratory analysis.
in the same patient at the same time.
hemoglobin from the central laboratory
Variation is induced by physiology, blood
hematology analyzer (Sysmex XT2000i).
sampling technique, device methodology,
and individual device calibration.1
In this study, the absolute accuracy and
trending accuracy of SpHb was similar to
The results of an independent study
the two widely used invasive methods
conducted in a surgical intensive care
when all three methods were compared
unit illustrate the variation that can be
to the central laboratory hemoglobin
The Radical-7 enabled with rainbow® technology allows noninvasive and continuous monitoring of blood constituents.
Single Hemoglobin Measurement Comparison Between Three
Devices and the Central Laboratory Hematology Analyzer2
Trended Hemoglobin Measurement Comparison Between Three
Devices and the Central Laboratory Hematology Analyzer2
SpHb
CO-Oximeter
HemoCue
SpHb
CO-Oximeter
HemoCue
)
L
d
/
g
(
b
H
p
S
18
16
14
12
10
8
6
4
30
)
L
d
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g
(
b
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e
t
e
m
i
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O
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18
16
14
12
10
8
6
4
)
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g
(
b
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e
u
C
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m
e
H
18
16
14
12
10
8
6
4
Bias + Standard Deviation = 0.9 + 0.6 g/dL
Bias + Standard Deviation = 0.0 + 1.0 g/dL
l
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b
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o
m
e
H
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Bias + Standard Deviation = 0.3 + 1.3 g/dL
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4
6
8
10
12
14
16
18
4
6
8
10
12
14
16
18
4
6
8
10
12
14
16
18
Hematology Analyzer tHb (g/dL)
Hematology Analyzer tHb (g/dL)
Hematology Analyzer tHb (g/dL)
)
L
d
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g
(
)
b
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S
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4
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Difference in Consecutive Hemoglobin
Values (tHb) (g/dL)
Difference in Consecutive Hemoglobin
Values (tHb) (g/dL)
Difference in Consecutive Hemoglobin
Values (tHb) (g/dL)
1.0 g/dL (ARMS)
1.1 g/dL (ARMS)
1.3 g/dL (ARMS)
R=0.64
R=0.60
R=0.39
1 Berkow L. J Clin Monit Comput. 2013 Mar 26. 2 Frasca D et al. Crit Care Med. 2011 Oct;39(10):2277-82.
31
Quick and Painless Hemoglobin Assessment
The Pronto-7® is designed specifically for noninvasive total hemoglobin (SpHb)
spot-check testing, along with SpO2, pulse rate, and perfusion index.
A Revolutionary Device for a Variety of Clinical Settings
almost any environment, including hospitals, clinics, blood
Hemoglobin is one of the most commonly ordered tests in
both hospital and non-hospital settings because it is critical
to assessing anemia. However, traditional lab testing involves
delayed results.
The Pronto-7 represents a breakthrough solution for measuring
hemoglobin quickly in under a minute—without needles,
time-consuming laboratory analysis, or the risk of blood
contamination or hazardous medical waste.
The palm-sized Pronto-7—approximately 5” x 3” x 1” and
weighing just 11 ounces—puts the power of noninvasive
hemoglobin spot-check testing into any clinician’s hands in
donation centers,* and emergency medical services.
Operation is easy and intuitive with the Pronto-7’s touchscreen
interface. Embedded 802.11 b/g and Bluetooth capability
enable wireless printing or emailing of test results, as well as
transmission to EHR systems. In addition, new tests can be
downloaded directly to the device via WiFi.
The newest features are designed to improve calibration and
motion support for measuring SpO2 and SpHb. New parameters
include hematocrit (SpHct) and Pleth Variability Index (PVI).
In addition, the new Active Pulse Sensor** generates a pulsatile
signal for more robust measurements—especially in patients
with low perfusion.
The Active Pulse Sensor vibrates to
induce a pulsatile signal for more
robust measurements.**
* Use in blood donation settings is CE Marked. ** Pronto-7 with Active Pulse and other features are under development.
33
Operating Room2
Pleth Variability Index (PVI)
Aiding Clinician Assessment
of Fluid Responsiveness
and Fluid Management
with PVI®
Arterial Pulse Pressure Variation (PVV)
Cardiac Index (CI)
Pulmonary Capillary Wedge Pressure (PCWP)
Central Venous Pressure (CVP)
Fluid administration is one of the most
common hospital interventions. Although
it is critical to improving patient status
and enabling end organ preservation,
unnecessary fluid administration is
associated with increased morbidity
and mortality.1
Pleth Variability Index (PVI)
Arterial Pulse Pressure Variation (PPV)
Cardiac Index (CI)
Pulmonary Capillary Wedge Pressure (PCWP)
Central Venous Pressure (CVP)
10
20
30
40
50
60
70
80
90
100
100 - Specificity (%)
Fluid Non-Responders Detection
This observational study evaluated 25 surgical patients before and
after volume expansion, with fluid responders (sensitivity) defined as
a cardiac index increase of >15% and fluid non-responders (specificity)
defined as a cardiac index increase of <15%.
Intensive Care Unit4
Pleth Variability Index (PVI)
Central Venous Pressure (CVP)
Stroke Volume Variation (SVV)
0.0
0.2
0.4
0.6
0.8
1.0
1-Specificity
This study has shown PVI to be an effective alternative indicator
for accurate, noninvasive, and continuous fluid responsiveness in
mechanically ventilated patients undergoing major surgery.
Assessing Fluid Responsiveness
Masimo continuous and noninvasive Pleth Variability
Index (PVI) has been shown in multiple studies to
help clinicians assess fluid responsiveness in adult
and pediatric surgical and intensive care patients
under mechanical ventilation.2-6 PVI has also been
shown to help assess which patients will become
hemodynamically unstable with the addition of
Positive End Expiratory Pressure (PEEP), which may
allow clinicians to more carefully select ventilator
settings and monitor effects more closely.7
“
With Masimo PVI, I
can predict when my patients
will benefit from fluid
administration—and when
it might harm them.”
Maxime Cannesson, MD
University of California,
Irvine, CA
100
90
80
70
60
50
40
30
20
10
n
o
i
t
c
e
t
e
D
r
e
d
n
o
p
s
e
R
d
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l
F
i
)
%
(
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t
i
v
i
t
i
s
n
e
S
y
t
i
v
i
t
i
s
n
e
S
1.0
0.8
0.6
0.4
0.2
0.0
34
Aiding Clinicians in Reducing Patient Risk
A recent randomized controlled trial showed that compared to
standard care without PVI, clinicians using PVI PEEP were able
to improve fluid management and as a result, reduce patient risk—
as evidenced by lower lactate levels.8 By helping clinicians maintain
appropriate fluid and oxygen levels in the blood, important organs
may be protected.
2.5
2
1.5
1
0.5
0
)
1
-
L
l
o
M
m
(
s
l
e
v
e
L
e
t
a
t
c
a
L
*
*
*
PVI Group
Control Group
Start of the
Intraoperative Surgery
At 24 h
At 48 h
This randomized study of 82 abdominal surgery patients found
that PVI-based, goal-directed fluid management reduced the
volume of intraoperative fluid infused and reduced intraoperative
and postoperative lactate levels.8
Inclusion in Fluid Management Guidelines
The positive and expanding evidence for PVI has led to its
inclusion in guidelines and best practices for fluid management.
In 2012, the United Kingdom’s National Health Service (NHS)
included PVI in its Intra Operative Fluid Management Pack,
which serves as a guide for hospitals implementing fluid
responsiveness monitoring to improve patient outcomes.9 In
2013, the French Society for Anaesthesia and Intensive Care
(SFAR) added PVI to its guidelines for optimal hemodynamic
management of surgical patients.10
The other dynamic monitoring technologies that have been
shown to help clinicians assess fluid responsiveness and
improve fluid management are invasive, complex, and/or costly. In
contrast, PVI is noninvasive, easy to use, and has no incremental
procedural cost because pulse oximetry monitoring is already
performed on all surgical and intensive care patients. PVI
monitoring should be considered in all mechanically ventilated
patients in which an invasive arterial line or more complex or
costly monitoring technologies may not be justified.
1 Bundgaard-Nielsen M et al. Acta Anaesthesiol Scand. 2007; 51(3):331-40 2 Cannesson M et al. Br J Anaesth. 2008;101(2):200-6. 3 Loupec T et al. Crit Care Med.
2011;39(2). 4 Zimmermann M et al. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. 5 Fu Q et al. Biosci Trends. 2012 Feb;6(1):38-43. 6 Byon HJ et al. J Anaesth. 2013
Apr;110(4):586-91. 7 Desebbe O et al. Anesth Analg 2010;110:792–798. 8 Forget P et al. Anesth Analg. 2010;111(4):910-4. 9 http://www.ntac.nhs.uk/NewsAndEvents/
IOFM_Technology_Adoption_Pack_Published.aspx 10 Vallet B et al. Strategy for perioperative vascular filling - Guidelines for perioperative haemodynamic
optimization. French Society of Anaesthesia and Intensive Care (SFAR). 2013.
35
Masimo PVI has been shown to help clinicians assess fluid responsiveness as reliably as new invasive parameters, and better than traditional invasive parameters.2
Signal Extraction Technology®:
Where “Solving the
Unsolvable” Started
Twenty-four years ago, two young engineers asked
themselves why pulse oximetry wouldn’t work during
patient motion and low perfusion—and by doing
so, set a new course that created a revolution in
patient monitoring.
Overcoming the Limitations of Conventional Pulse Oximetry
Since its inception, pulse oximetry was plagued by unreliability when
it was needed most—during patient motion and low perfusion. The
industry had given up and considered the problem “unsolvable.”
Clinicians were forced to live with the results —excessive false alarms,
delayed notification due to long averaging times, inaccurate data, and
an inability to obtain data on the most critical patients.
Conventional pulse oximetry works under the assumption that by
looking at only the pulse and normalizing the pulsating signal over
the non-pulsating signal, oxygen saturation (SpO2) can be measured
without calibration. Although this was a big step forward in the
evolution of pulse oximetry, it has one major flaw—it assumes
the only pulsating component is arterial blood. Unfortunately for
conventional pulse oximetry, venous blood moves every time
the patient moves or breathes. This causes conventional pulse
oximeters to display false low or high SpO2 and pulse rates—
resulting in false alarms as high as 90% in ICUs and recovery rooms.
Validated by Independent and Objective Research
To date, more than 100 independent and objective studies have
shown that Masimo SET® outperforms all other pulse oximetry
technologies, providing clinicians with unmatched sensitivity
and specificity to make critical patient care decisions.
37
Unleashing Breakthrough Performance
When Joe Kiani and Mohamed Diab
After six years of dedicated and focused
signal processing of Masimo SET®
looked at the same pulse oximetry
research and development, Masimo
consistently resulted in significantly
signal differently than anyone had
SET® debuted in 1995 at the Society for
fewer false alarms and improved
before, they created new possibilities. By
Technology in Anesthesia and won the
true alarm detection.
employing advanced signal processing
prestigious Excellence in Technology
techniques—including parallel engines
Innovation Award. Thereafter, skeptical
and adaptive filters—they believed
clinicians around the world sought
they could find the true arterial signal
actively to compare Masimo SET® to
that would allow accurate monitoring
the best pulse oximetry technologies
of arterial oxygen saturation and pulse
other companies had to offer. But in
With Masimo SET®, clincical studies
have shown false alarms can be reduced
by over 95%, while true alarm detection
was shown to be over 97%—even during
the challenging conditions of motion and
rate, even during the most challenging
study after study, the breakthrough
low perfusion.1
conditions. Signal Extraction Technology,
or Masimo SET®, assumes that both the
arterial and venous blood can move
and uses parallel signal processing
engines—DST®, FST®, SST™, and MST™
—to separate the arterial signal from
sources of noise (including the venous
signal) to measure SpO2 and pulse rate
accurately, even during motion.
“ Conventional pulse oximeters are
a fair-weather friend. Masimo SET®
is a foul-weather friend.”
Jeremy Swan, MD
Former Chairman of Masimo’s Scientific Advisory Board and Chairman
Emeritus Cedars-Sinai Medical Center’s Division of Cardiology
True Alarm Performance During Motion and Low Perfusion*
43%
Nellcor N-600
3%
Masimo SET®
Missed True Alarms
SenSitivity
97%
* In this hospital-based study, investigators measured SpO2 in 10 subjects during motion and low perfusion conditions and calculated the
false alarm rate during 120 full oxygenation events (specificity) and true alarm rate during 40 de-oxygenated events (sensitivity).1
R/IR
DIGITIZED, FILTERED, AND NORMALIZED
R/IR
DST®
FST®
(Conventional Pulse Oximetry)
Adaptive Filter
SST™
Adaptive Filter
MST™
EVALUATION AND ANALYSIS
POST PROCESSOR
Masimo SET DST 97%
0
50%
66%
SpO2%
97%
100%
Conventional pulse oximetry uses the standard red over infrared
algorithm to provide SpO2, while Masimo SET® uses that
conventional algorithm but has added four other algorithms
that all run in parallel. These algorithms allow the distinction
between arterial and venous signal during motion and low
perfusion by identifying and isolating the non-arterial and
venous noise SpO2s (left peak shown in blue) from the true
arterial SpO2 components (right peak shown in red) in the
signal. The plot peak on the right is then chosen as the SpO2
value, since the physiologically higher SpO2 value within the
measuring site will be arterial signal.
False Alarm Performance During Motion and Low Perfusion*
28%
Nellcor N-600
5%
Masimo SET®
False Alarms
SpeCiFiCity
95%
1 Shah N., Ragaswamy H.B., Govindugari K., Estanol L. J Clin Anesth. 2012 Aug;24(5):385-91.
38
39
Industry-leading Pulse
Oximetry Solution
Masimo SET® is the world’s leading pulse
oximetry technology, proven by both
independent and objective research and
the real-world success of our customers
and partners.
The Choice of Clinicians in the World’s
Leading Hospitals
Because of its unmatched reliability during challenging
conditions of motion and low perfusion, clinicians at
thousands of hospitals around the world count on
Masimo SET® every day to help them care for patients.
And while many leading hospitals have already
integrated Masimo SET® pulse oximetry technology,
more are converting every day.
These hospitals and clinicians trust Masimo SET®
to help them deliver the most effective and
efficient patient care possible. With fewer false
alarms,1 clinicians can focus on the patients who
need the most attention. With more trustworthy
measurements, clinicians can more tightly
control oxygenation levels. And with more
timely detection of true events, clinicians can
intervene earlier for better patient outcomes
and improved patient safety.
Performance During Motion
and Low Perfusion1
100
90
80
70
60
50
40
30
20
10
n
o
i
t
c
e
t
e
D
m
r
a
l
A
e
u
r
T
)
%
(
y
t
i
v
i
t
i
s
n
e
S
10
20
30
40
50
60
70
80
90
100
False Alarm Rate
100 - Specificity (%)
Philips 24C
Philips CMS-B
Datex-Ohmeda 3740
Nellcor N-395
Datex-Ohmeda AS-3
Datex-Ohmeda 3800
Datex-Ohmeda 3900
Nellcor N-200
Philips CMS
Nellcor N-295
GE 8000
Novametrix MARS
Nellcor NPB-190
Nellcor NPB-180
Novametrix 520A
Spacelabs 90308
Nonin 8600
BCI 3304
Criticare 5040
A total of 70 volunteers were
tested with motorized hand
motions. Each motion was
studied during both room air
breathing and hypoxemia.
Pulse oximeters on the
stationary hand were used to
provide control measurements
for comparison. Sensitivity was
defined as ability to detect a
true SpO2 <90%. Specificity was
defined as the ability to detect
a true SpO2 >90%.
Integrated in More Industry-leading Products Than Any
Other Pulse Oximetry Technology
Each company manufacturing multiparameter patient monitors
chooses which pulse oximetry solution to offer in its products.
Today, Masimo SET® is integrated in more industry-leading products
than any other pulse oximetry technology—available in more than
100 OEM monitors from 50 leading brands. In many of these monitors,
Masimo SET® is the only pulse oximetry technology provided.
In addition, more and more of our OEM partners are enhancing
the capabilities of their monitoring solutions by integrating our
rainbow® technology.
Dräger® with rainbow®
Welch Allyn® with rainbow®
Physio-Contro®
with rainbow®
ZOLL® with rainbow®
GE® with Masimo SET®
Philips® with Masimo SET®
MS-2040™
Very low power SET®
OEM Board
MS-2013™
Low power SET®
OEM Board
MX-5™
Low power rainbow®
OEM Board
1 Barker SJ. Anesth Analg. 2002 Oct;95(4):967-72.
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41
Helping Improve Outcomes on the General
Floor with Masimo Patient SafetyNet™
In August 2012, The Joint Commission Sentinel Event Alert on the safe use of opioids in
hospitals recommended implementation of better dosing along with continuous oxygenation
and ventilation monitoring (instead of spot checks) in post-surgical patients.1 Patient
SafetyNet™*—combined with Masimo SET® pulse oximetry and rainbow Acoustic Monitoring™
or standard capnography—offers a clinically proven, cost-effective approach to continuous post-
operative monitoring with high nursing satisfaction and patient compliance.
Reducing Rescues and ICU Transfers
in a post-surgical floor where only
be assured their loved ones are receiving
intermittent spot-checking was used
maximum protection.
before, Dartmouth-Hitchcock Medical
Center reduced rapid response activations
Proven Cost-effectiveness
For many years, clinicians have
understood the risks of not continuously
monitoring patients on the general floor.
However, excessive false alarms due
to patient motion made improving the
safety of these patients an elusive goal.
In the last decade, Masimo SET® has been
shown in multiple studies to improve
the process of care in neonates and
by 65% and ICU transfers by 48%,2 and
saved $1.48 million annually. In addition,
there were zero brain-damaged patients
over a 5-year period.3
Just as pulse oximetry has become
a standard of care in the OR, PACU,
pediatric patients due to its Measure-
and ICU, we now believe that Measure-
through Motion and Low Perfusion
through Motion and Low Perfusion
performance. However, a landmark study
pulse oximetry will become a standard
in 2010 showed that Masimo SET® also
of care on the general floor. With Masimo
improves clinical outcomes in adults.
technologies on the general floor,
After implementing Masimo SET® and
clinicians can be confident their patients
Patient SafetyNet remote monitoring
are being watched even when they
and wireless notification system
aren’t at the bedside, while families can
When translated into financial impact,
the Dartmouth-Hitchcock study showed
that implementing Masimo SET® and
Patient SafetyNet to more safely monitor
post-surgical patients could also have
a significant impact on the hospital’s
bottom line by increasing ICU bed
availability and reducing costs associated
with emergency rescue events.3 With
both the clinical and financial rationale
now in place, hospitals are increasingly
implementing general floor monitoring
with Masimo technologies.
Halo Index™* Enables Assessment of Patient Status
to include additional information from the patient data
Halo Index is a new indicator for cumulative trending
assessment of the global patient status. Physiologic
deterioration often occurs long before a patient crisis and
manifests through subtle and often undetected changes in
multiple physiologic parameters. Masimo designed Halo Index
to mimic the systematic approach that expert clinicians use
in assessing patient physiologic deterioration—analyzing
the patient history and extracting key vital sign parameter
characteristics to assess global patient status. Halo Index
currently uses available Masimo parameters but is scalable
repository. Each parameter’s significance is weighted and
combined into the Halo Index, a single displayed number with
a range from 0 to 100 that provides a cumulative trending
assessment of global patient status. Increases in Halo Index
suggest physiologic deterioration and may indicate a need for
clinicians to more closely assess the patient.
Patient SafetyNet can
display actual parameter
values (below) or color-
coded alarm states
(left), which allows more
patients to be viewed
simultaneously on screen.
0
Patients Suffered Brain Damage
or Died Over a 5-year Period†
48%
Reduction in ICU Transfers
65%
Reduction in Rapid
Response Team Activations
$1.48
Million in Annual Cost Savings
Significant reductions in rapid response team activations and ICU transfers were observed in an 11-month evaluation of Patient SafetyNet on a post-surgical unit.
Rescue events decreased 65%, from 3.4 to 1.2 per 1,000 patient discharges, and ICU transfers decreased 48%, from 5.6 to 2.9 per 1,000 patient days after implementation.
The financial impact resulted in annual opportunity cost savings of $1.48 million. Results drove expansion of the use of Patient SafetyNet to other care areas.2, 3
† Since expansion, no patients suffered irreversible, severe brain damage or died as a result of respiratory depression from opioids over a 5-year period.
* The use of the trademarks PATIENT SAFETYNET and PSN is under license from University Health System Consortium.
In this example, Halo Index indicates a declining patient condition while displaying parameter
trends and their contribution (the size of the bubbles below the parameter) to the Halo Index.*
* Halo Index is CE Marked. Not available in the US.
1 The Joint Commission Sentinel Event Alert. 2012;49. 2 Taenzer AH et al. Anesthesiology. 2010;112(2):282-287.
3 Taenzer AH et al. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
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Clinician-centric Monitoring with MyView™
Empowering Clinicians to See What They Want, When They Want to See It.
MyView in Patient SafetyNet automatically senses when the physician
approaches and highlights his or her patients for easy viewing.
The level of information required can change dramatically by
clinician and care area, but medical devices historically function
in a static manner with the same parameters, waveforms, and
trends displayed the same way. While Masimo measurements
and display flexibility continue to expand, this doesn’t mean
that all clinicians need to see all of the information in the
same way. MyView* technology—featured in Masimo Patient
SafetyNet—is being expanded to allow wireless sensing of
the device, clinician, patient, and care area to provide the
parameters, waveforms, and trends that clinicians want to see
and what their patients and family see. While a physician may
want to see all parameters and waveforms, a medical assistant
may only want to see Halo Index* or a few parameters and
no waveforms. If no clinician is in the room, the patient and
family may be best served with no specific device information,
but rather a visual indicator with a green, yellow, or red color
indicating device alarm status.
* CE Marked.
** This feature is under development.
When the clinician
re-enters the room,
MyView recognizes the
clinician and displays the
measurements that interest
the particular clinician.**
When no clinicians are in
the room, the clinician may
select a device display that
is entirely green, yellow,
or red—depending on the
alarm status. This eliminates
a common distraction for
the patient and family while
limiting unnecessary concerns
or questions for caregivers.
With the use of a presence
tag, upon approach, the
information displayed on
Root will change based on
clinician-set preferences.
Clinician-centric view with the use of
a presence tag or smart phone allows
caregivers to see the customized
information most important to them
upon approach to a patient.*
45
Protect More Patients by Monitoring Every
Breath with rainbow Acoustic Monitoring™
To expand the rainbow® platform’s promise of breakthrough noninvasive measurements,
we have grown beyond our optically based technologies to include clinical measurements
derived from sound.
Protecting More Patients by Monitoring Every Breath
patient distress—offering a breakthrough in patient safety for
Continuous monitoring of respiration rate is especially
important for post-surgical patients receiving patient-
controlled analgesia for pain management. Conscious
sedation can induce respiratory depression and place
patients at considerable risk of serious injury or death. The
post-surgical patients on the general floor and for procedures
requiring conscious sedation.
Allowing More Patients to Be Monitored,
More Safely than Ever Before
Anesthesia Patient Safety Foundation (APSF) and The Joint
When rainbow Acoustic Monitoring™ is used in conjunction
Commission recommend continuous oxygenation and
with rainbow® Pulse CO-Oximetry and the Patient SafetyNet
ventilation monitoring in all patients receiving opioid-based
system, clinicians can follow key indicators of oxygenation
pain medications.1 However, current methods for respiration
with industry-leading Masimo SpO2; ventilation with
rate monitoring are limited by patient tolerance. While we
breakthrough acoustic respiration rate (RRa); circulation
offer the best-in-class capnography solution, we believe
with Masimo Measure-through Motion pulse
rainbow Acoustic Monitoring™ is better suited for
post-surgical monitoring and conscious sedation.
rate (PR); and hemoglobin levels
with Masimo’s continuous and
Masimo’s rainbow Acoustic Monitoring™ now provides
noninvasive and continuous respiration rate that has been
shown to be accurate, easy to use, and enhances patient
compliance.2 Acoustic Respiration Rate (RRa™) may help
clinicians reliably and continuously assess breathing—
facilitating earlier detection of respiratory compromise and
noninvasive hemoglobin
(SpHb)—enabling clinicians
to monitor more patients,
more safely than
ever before.
rainbow Acoustic Monitoring™ noninvasively and continuously measures respiration rate using
an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably
applied to the patient’s neck.
Ability to Detect Respiratory Pause3
RESPIRATION RATE METHOD
Oridion Capnostream SARA v4.5
Masimo rainbow Acoustic Monitoring™ v7804
Sensitivity
(respiratory pause detected when
actual respiratory pause occurs)
62%
81%
Retrospective analysis of 34 PACU subjects. Reference respiration rate determined by expert observer.
A total of 21 episodes of respiratory pause were identified, defined as 30 seconds with no breathing activity.
“ Our research shows RRa has greater accuracy, precision,
and sensitivity to pauses in ventilation than capnometry.”
Michael Ramsay, MD
Chief of the Department of Anesthesiology and Pain Management,
Baylor University Medical Center, Dallas, TX
46
1 Stoelting RK et al. APSF Newsletter. 2011. (www.apsf.org) 2 Macknet MR et al. Anesthesiology. 2007;
107:A84. (abstract) 3 Ramsay M.A. et al. Anesth Analg. 2013;DOI: 10.1213/ANE.0b013e318290c798.
47
Helping Screen for Congenital Heart Disease
and Reduce Eye Damage and Blindness
From the very beginning, infants and children have been the focus of our research
development. As a result, Masimo leads the industry in solutions designed exclusively
for these most vulnerable patients.
Enabling Critical Congenital Heart Disease Screening
oxygen can cause severe eye damage from retinopathy of
The breakthrough performance of Masimo SET® is often most
appreciated by the clinicians caring for fragile newborns. Up
to 30% of all congenital heart disease (CHD) deaths occurring
in the first year of life are unrecognized at the time of hospital
prematurity (ROP). Masimo SET® is the only pulse oximetry
proven to help clinicians dramatically reduce ROP.4
Empowering Care for Cyanotic Patients
discharge after birth. Masimo SET® pulse oximetry has been
In cyanotic infants, Masimo SET® with the Blue® Sensor is the
shown to reliably assist clinicians in the screening for critical
only pulse oximeter proven accurate—enabling accurate
congenital heart disease (CCHD),1, 2 spurring the US Secretary
maintenance of targeted oxygen saturation levels.5 And for
of Health and Human Services to add Measure-through
very low birth weight babies, only the Masimo NeoPt-500™
Motion and Low Perfusion pulse oximetry to the recommended
Sensors are designed for both size and performance in infants
Uniform Screening Panel for newborns.3 Masimo SET® pulse
as small as 500 grams.
oximeters and sensors meet the recommended criteria
for newborn screening, were exclusively used in the two
studies that were the basis for the CCHD workgroup decision to
recommend newborn screening, and were the first to receive
FDA 510(k) clearance with labeling for CCHD screening.
Helping Clinicians Reduce Retinopathy of Prematurity
Real-time Newborn Monitoring and Assessment
When each second matters during newborn resuscitation, the
Masimo Newborn Sensor ensures the fastest response time at
the highest sensitivity—allowing clinicians to focus on real-time
patient management instead of the device. In addition, Masimo
SET® is increasingly being used to supplement the standard
Premature infants requiring neonatal intensive care need
APGAR score to more reliably assess general newborn health.
enough oxygen to preserve vital organ function, but too much
CCHD Detection Screening with Masimo SET®2
N = 39,821 babies
Physical Exam Alone
Physical Exam + Masimo SET® Pulse Oximetry Screening2
Sensitivity for CCHD Detection
Specificity for CCHD Detection
63%
98%
83%
99.8%
SpO2 screening was conducted on 39,821 newborn babies, preductally (palm of right hand) and postductally (either foot) before routine physical
examination. The baby was considered to be screening positive if: 1) either preductal or postductal SpO2 measurement was <90%; 2) if in three repeat
measurements, both preductal and postductal SpO2 were <95%, or the difference between the two measurements was >3%.
Reduction of ROP with Masimo SET®4
Severe Retinopathy of Prematurity (ROP) Rate
Center
A
B
Period 1 (pre-policy change)
Period 2 (post-policy change)
Period 3 (post-policy change)
12% with Nellcor
5% with Masimo
4% with Masimo
13% with Nellcor
13% with Nellcor
6% with Masimo
In period one, the baseline rate for severe ROP in two centers, both using Nellcor pulse oximetry, is established. In period two, the oxygen targeting policies,
caregivers, and patient characteristics were the same at both centers, but only Center A switched to Masimo SET®, which led to a significant reduction in
ROP (from 12% to 5%). In period three, Center B switched to Masimo SET® and experienced a reduction in ROP from period two (from 13% to 6%).
1 Ewer AK et al. Lancet. 2011 Aug 27;378(9793):785-94. 2 de-Wahl Granelli AD et al. BMJ. 2009;338.
3 Secretary of Health & Human Services letter to the Secretary’s Advisory Committee on Heritable
Disorders in Newborns and Children (SACHDNC); dated September 21, 2011. 4 Castillo A et al. Acta
Paediatr. 2011 Feb;100(2):188-92. 5 Cox PN et al. Anesthesiology. 2007;107:A1540. (abstract)
48
49
Helping Protect Patients from Hidden Dangers with SpMet®
Monitoring for unintended consequences of drugs commonly
given in hospitals and during certain procedures.
Addressing the Risk of Dangerous Drug Reactions
Many drugs commonly used in hospitals—such as lidocaine,
benzocaine, dapsone, and nitrates—cause a dangerous
reaction known as acquired methemoglobinemia that
reduces the delivery of oxygen to the tissues. While
methemoglobinemia can occur in all care areas and patients,
it is often unrecognized and undiagnosed. If not detected and
treated immediately, it can result in avoidable injury or death.
Medications Known to Cause Methemoglobinemia: Benzocaine,
Cetacaine, Chloroquine, Dapsone, EMLA topical, Flutamide, Lidocaine,
Metoclopramide, Nitrates, Nitric oxide, Nitroglycerin, Nitroprusside,
Nitrous oxide, Phenazopyridine (Pyridium), Prilocaine, Primaquine,
Riluzole, Silver nitrate, Sodium nitrate, Sulfonamides.
“ Acquired methemoglobinemia is
fairly common and causes morbidity
and mortality in both the inpatient
and outpatient settings. Acquired
methemoglobinemia is often
unrecognized and thus untreated.”
Rachel Ash-Bernal, MD
and other researchers at Johns-Hopkins Hospital
Baltimore, MD
Enabling Quick Treatment with SpMet
Masimo noninvasive methemoglobin (SpMet) helps clinicians
assess for methemoglobinemia, facilitating earlier detection
and immediate treatment to reduce patient risk—especially
in care areas where drugs that cause methemoglobinemia are
used most often, such as procedure labs and the operating
room. This enables them to quickly adjust exposure to the
dangerous drug and initiate potentially life-saving treatment.
Prevalence of Methemoglobinemia
Number of
Methemoglobinemia Cases
Patient Age
Care Areas
Fatalities
138
(2.5 cases per hospital per month)
4 days
to 86 years
Surgery, intensive care, outpatient clinics, pediatrics,
emergency department, cardiac cath lab
1 fatality
3 near fatalities
Results from a retrospective study at two Johns Hopkins Hospitals over a 28-month period,
using laboratory CO-Oximeter results, and patient electronic medical records.1
“ Masimo SpMet helps
detect methemoglobinemia,
allowing clinicians to
accurately diagnose and treat
this life-threatening condition.”
Mark Macknet, MD
Assistant Professor of Anesthesiology,
Loma Linda University
Loma Linda, CA
1 Ash-Bernal RA et al. Medicine. 2004;83:265-273.
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Helping Detect Carbon Monoxide
Poisoning with SpCO®
A Deadly Poison Revealed with SpCO
Carbon monoxide (CO) poisoning is the most common cause of poisoning
in industrialized countries, but is often misdiagnosed because its
symptoms are similar to the flu, and moderate poisoning is possible with
no symptoms at all. Our first rainbow® measurement was noninvasive
carboxyhemoglobin (SpCO), helping clinicians assess CO levels in the
blood, facilitating earlier detection and treatment of CO poisoning.
A recent study examined data from the Undersea Hyperbaric Medicine
Society’s CO poisoning surveillance system (supported by the Centers
for Disease Control) and found that patients who were initially measured
using Pulse CO-Oximetry had an almost one-hour reduction in time from
the end of CO exposure to treatment.1
Saving Lives Every Day
In emergency medical services, SpCO is helping protect both victims
and first responders from the dangers of CO poisoning. SpCO helps
paramedics and emergency medical technicians to detect CO
poisoning—enabling prompt treatment and removal of those exposed
to deadly CO in homes, hotels, and places of work.
SpCO is also helping firefighters reduce the risk of CO poisoning that
they face every day. Just one severe CO poisoning nearly doubles
the risk of premature death, and consistent CO exposure may cause
long-term heart and brain damage.2,3 When even mild levels of CO
are circulating in the blood, the heart and brain are robbed of critical
oxygen. This can cause mental confusion that leads to poor decision
making and also increases the risk of heart disease or stroke—two
conditions already accounting for nearly 50% of on-duty firefighter
deaths.4 These factors are why industry-leading organizations
have lined up to support CO education, and the National Fire
Protection Association (NFPA) introduced a new fire rehabilitation
standard—NFPA 1584—that supports on-scene CO assessment
of firefighters.
“
We believe that all 50-plus people in
the hotel would have been dead at
dawn if it were not for this lifesaving
intervention from Masimo.”
Skip Kirkwood, MS, JD, eMt-p
Chief, EMS Division, Wake County Dept. of Emergency Services
Raleigh, NC
1 Hampson NB. J Emerg Med. 2012 May 23. 2 Hampson NB et al. Crit Care Med.
2009; 37(6): 1941-47. 3 Bledsoe BE. JEMS. 32:54-59, 2007. 4 Bledsoe BE.
FireRescue Magazine. September 2005.
53
“
Any firefighter exposed to
CO poisoning or presenting
with... symptoms at an
incident where CO is
present should be assessed
for CO poisoning.”
national Fire protection Association
1584 Fire Rehab Standards
Immediate Capnography at Your Fingertips
EMMA™ (Emergency Mainstream Analyzer)
Capnographs measure carbon dioxide (CO2) concentrations in
expired gases. They are used during anesthesia, emergency
care, and intensive care—where capnography is often used as
a substitute for blood gas measurement or to monitor the
performance of assisted ventilation. EMMA is a compact,
portable, lightweight mainstream capnograph that requires
virtually no warm-up time with full accuracy in 15 seconds.
The continuous capnogram allows for confirmation and
continuous monitoring of endotracheal tube placement,
enables clinicians to assess the depth and effectiveness
of compressions, and allows clinicians to recognize return of
spontaneous circulation (ROSC).1 Its primary use is short-term
monitoring of end-tidal CO2 and respiration rate in adults,
pediatric, and infant patients.
“ Monitoring respiratory rate and end-tidal
carbon dioxide in the positive-pressure
ventilated patient represents the greatest
opportunity to avoid harm and improve
clinical outcomes in all of resuscitation.”
Daniel Davis, MD
Professor of Clinical Emergency Medicine
Director, Center for Resuscitation Science
UCSD Emergency Medicine
San Diego, CA
EMMA fits onto a breathing circuit, facilitating CPR.
1 Neumar RW et al. Circulation. 2010;122:S729-S767.
54
55
“ Masimo technology has raised
the bar in the quality of care
that can be delivered in a post-
acute setting—the right thing
to do for patient safety.”
Gene Gantt, RRt
Linde Respiratory Support Services
Expanding Impact Outside
of the Hospital
Industry-leading Masimo SET® is increasingly
being used to enhance the quality of patient
care outside of the hospital.
A New Level of Care in the Home
For pediatric patients requiring continuous monitoring at home,
Masimo SET® offers the best pulse oximetry monitoring for parents
caring for special needs children—dramatically reducing false
alarms during motion and low perfusion that can complicate an
already difficult situation.
Adding a Safety Net in Post-acute Care
As hospital costs rise, more patients are receiving care in long-
term acute care and skilled nursing facilities. A major challenge
in these facilities is weaning patients off ventilator care, which
can put patients at increased risk of adverse events. Post-acute
care facilities integrating Masimo SET® bedside pulse oximeters
and Patient SafetyNet remote monitoring and notification
systems have experienced considerable reduction in rapid
response activations as well as emergency “transfer outs.”
Reliable Sleep Lab Monitoring
During sleep lab monitoring, conventional pulse oximetry fails
to provide the fidelity and accuracy required to help clinicians
detect clinically relevant physiologic events. Masimo SET®
technology is integrated in leading sleep lab monitoring
systems, enabling clinicians and patients to benefit from its
unmatched reliability in this challenging environment.
“
The sensitivity and motion artifact
rejection characteristics of the
non-Masimo SET® pulse oximeters
we tested were not adequate for a
pediatric sleep laboratory setting.”
Bob Brouillette, MD
Montreal Children’s Hospital
Montreal, Canada
56
The Future of Healthcare Is at Hand
We are witnessing an exciting convergence of
medical device and mobile device technology that
promises to transform healthcare positively.
Our iSpO2™ device is the world’s first pulse oximeter for iOS and
Android mobile platforms.
iSpO2 combines a Masimo “board-in-cable”, reusable or
disposable sensor, and an application running on a smart
phone or tablet device. It features Masimo’s proven Measure-
through Motion and Low Perfusion pulse oximetry—SpO2,
pulse rate, and perfusion index. Masimo iSpO2 also allows
both consumers* and healthcare providers** to trend
measurements and email trend data.
* For sports and aviation use only in the US.
** CE Marked.
“ Just tried this new
mobile iSpO2 app
for blood oxygenation
saturation. Love it!”
Dr. eric topol
Director of the Scripps Translational
Science Institute
La Jolla, California
“ This pulse oximeter is without a
doubt the best one available for
the consumer market. Masimo
uses impressive digital signal
processing combined with
proprietary LED technology.
If you need a serious pulse
oximeter, this is the one to get.”
Kirk Shelley MD, phD
Professor of Anesthesiology
Yale University
New Haven, CT
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59
Advancing Pulse Oximetry
Masimo’s newest innovations demonstrate that
our commitment to pulse oximetry technology
has never been stronger.
First Ever Noninvasive Fractional SpO2 Measurement
Until now, pulse oximeters could only measure and display
functional oxygen saturation (SpO2). So, when patients had
elevated carboxyhemoglobin (from carbon monoxide poisoning)
and/or elevated methemoglobin (negative reaction to more
than 30 common drugs used in hospitals, like caines, nitrates,
and Dapsone), the displayed functional oxygen saturation
overestimated the actual oxygen saturation value.
In 2012, we introduced SpfO2™*—the first truly fractional,
noninvasive oxygen saturation monitor—along with the
rainbow® SuperSensor™* which allows for simultaneous
measurement of SpO2, SpCO, SpMet, and SpHb. The
new SpfO2 measurement allows more precise arterial
oxygenation assessment in patients with elevated
dyshemoglobins—common throughout the hospital
and pre-hospital settings—as compared to functional
oxygen saturation (SpO2). As a result, SpfO2 should
enable earlier interventions and more timely therapeutic
decisions. For example, in a patient who is a smoker with
an SpO2 of 97%, carboxyhemoglobin level of 12%, and
methemoglobin of 1%, if SpfO2 were available, it would be
displayed at 84%. It is well accepted that clinicians would
frequently make different diagnostic and therapeutic
decisions at an oxygenation of 84% versus 97%.
The rainbow® SuperSensor also elevates the utility
of noninvasive and continuous oxygen content
(SpOC™) monitoring. Since we introduced rainbow®
Pulse CO-Oximetry, clinicians have been leveraging
noninvasive and continuous hemoglobin (SpHb) and
functional oxygen saturation (SpO2) for real-time
oxygen content monitoring (SpOC). Now, with the
advent of fractional, noninvasive oxygen saturation
(SpfO2), SpOC becomes an even more accurate
indicator of patient oxygenation—especially in
rapidly changing clinical situations.
* CE Marked.
The new SpfO2 measurement
allows more precise arterial
oxygenation assessment
in patients with elevated
dyshemoglobins, as
compared to functional
oxygen saturation (SpO2).
Utilizing more than seven wavelengths of light and breakthrough signal processing, Masimo rainbow® Pulse
CO-Oximeters can measure and display oxygen content (SpOC), along with its components, hemoglobin and
fractional arterial oxygen saturation (SpfO2).
60
61
Addressing the Number One Technology
Hazard in Hospitals Today—Alarms
Providing Earlier Notification of
Potential Risk with Advanced Alarms
Core Technology Advantages
The Joint Commission, the ECRI Institute, the Anesthesia Patient Safety Foundation
and numerous other leading industry bodies have repeatedly cited alarm fatigue among
the most pressing patient safety hazards.1-3 Conventional approaches to alarm
management were developed mainly to address the problems of conventional
pulse oximetry’s inability to measure through motion. Fixed alarm thresholds
and delays sometimes reduce non-actionable alarms, but with potentially delayed
notification of significant events. Masimo SET® broke through past barriers and
reduced false alarms by over 95%. In an area like the ICU where up to 90% of all alarms
used to be false, Masimo has helped reduce the false alarm incidence to just 5%.4
Automated, Patient-centric Approach with Adaptive Threshold Alarm™*
With false alarm problems largely solved with Masimo SET®, Masimo’s Adaptive
Threshold Alarm was designed to help clinicians manage the frequency of alarms,
improving on the limited alarm paradigms of the past to notify clinicians when
significant changes in physiology have occurred. Adaptive Threshold Alarm helps
clinicians reduce alarms and reduces the time required to set patient-specific alarms
by automatically adjusting the audible alarm to the patient’s baseline (Figure 1).
* CE Marked.
100
98
96
94
92
90
88
86
84
82
2
O
p
S
• •
100
• •
150
200
250
Time in Minutes
••••
300
Baseline
SpO2
•
Fixed Threshold Alarm Event
Adaptive Threshold
Adaptive Threshold Alarm Event
Fixed Threshold
Figure 1. Alarm frequency of fixed threshold alarm and Adaptive Threshold Alarm, both with 10-second delay.
While standard SpO2 and pulse rate alarms can sometimes
• Low SpO2 alarm limits are typically set too low to spot multiple
provide a signal of deteriorating patient conditions, Masimo’s
transient desats that could indicate increased patient risk. 3D
advanced 3D alarms give you another dimension of advanced
desat index alarm signals after five desaturations below 93%
notification of parameter conditions that may precede clinically
over a period of 60 minutes or less (Figure 2).
significant events.
> 3D Desat Index Alarm™ helps clinicians detect multiple
> 3D Perfusion Index Alarm™ helps clinicians quickly detect
critical changes in peripheral perfusion.6, 7
transient desaturation events that may identify patients
• Changes in peripheral perfusion can reflect significant
at risk for respiratory failure.5
100%
Desat Index
Alarm Limit 93%
1
2
O
p
S
Low SpO2
Alarm Limit 90%
2
underlying cardiovascular changes. 3D Perfusion Index Alarm
notifies clinicians when there is a 25% change in Perfusion
Index (PI) within a period of 60 minutes or less (Figure 3).
4
3
5
Alarm sounds after five desaturations below
93% over a period of 60 minutes or fewer
Time (in minutes)
20
40
60
80
Figure 2. 3D Desat Index Alarm Example
1.0
0.9
0.8
0.7
0.6
x
e
d
n
I
n
o
i
s
u
f
r
e
P
PI Baseline determined by the Radical-7
PI Delta % Change = 25
(within a 1 hour period)
Alarm triggered
Time (1 Hour)
Figure 3. 3D PI Delta Alarm Example
1
1 The Joint Commission Sentinel Event Alert. 2012;49. 2 ECRI Institute. 2012. 3 Stoelting RK et al. APSF. 2011. 4 Shah N et al. J Clin Anesthesiology. 2012. 5 Wong MW et al.
J Trauma Inj Infect Crit Care. 2004; 56(2):356-362. 6 De Felice et al. Pediatr Crit Care Med. 2008;(9)2:203-208 7 Ginasar et al. Acta Anaesthesiol Scand. 2009; 53:1018-1026.
* CE Marked.
62
63
X-Cal™ Technology for Enhanced Patient Safety
and Improved Clinician Efficiency
Masimo has implemented a new technology called X-Cal in
its sensors, cables, and monitors to enhance patient safety
and improve clinician efficiency. All Masimo components
work together as an integrated system to measure through
challenging conditions including motion and low perfusion.
When all components are fully functioning, the system works
as intended. In contrast, when any of these system components
is compromised, erroneous measurements can occur.
X-Cal is designed to address three common factors that can
impact measurement accuracy and patient safety due to
reliability risks associated with:
1) Imitation Masimo sensors and cables
2) Cables and sensors used far beyond their expected life
3) Third-party reprocessed pulse oximetry sensors
X-Cal Components
Masimo SET® Measure-through Motion and Low Perfusion
pulse oximetry has three system components:
1) The sensor that connects to the patient
Poor Quality and Performance of Imitation
Masimo Sensors and Cables
Multiple third-party manufacturers have attempted to copy
or imitate Masimo sensors and cables. Imitation cables
and sensors (also known as “knockoffs”, “copy-cat”, “pirated”
products, etc.) use components without the same design,
manufacturing process, or quality controls as Masimo
and as such, do not meet Masimo quality or performance
specifications. This becomes particularly problematic in
challenging conditions. With X-cal, when an imitation sensor
or cable connects to an X-Cal enabled monitor, a message is
displayed to replace the sensor or cable.
Reliability Risks Associated with Cables and Sensors
When Used Beyond Their Expected Life
Eventually, all cables and sensors wear out and fail, and it is
widely accepted that the longer any brand of cable or sensor
is in service, the more likely that it will reach that point of
failure. Masimo is aware of situations in which the monitor
has displayed false saturation values because of cable or
sensor malfunction or failure. Often, hospital personnel are
not aware of the age of a particular cable and the failure is
2) The patient cable that connects the sensor to the Masimo
only discovered during active patient monitoring. To avoid
circuit board in the monitor
3) The Masimo circuit board (SET® SpO2 or rainbow® Pulse
CO-Oximetry) installed in a multiparameter patient
monitor or Masimo Pulse Oximeter®
these situations and as a matter of policy, some hospitals
replace their cables before their expected life is exhausted.
It is also important to note that as cables and sensors
become worn, they may also cause intermittent problems
with measurement accuracy which lead to false alarms or
1 Sensor
2 Cable
mask true alarming events such as hypoxemia. Damaged
components that lead to intermittent performance issues
can cause care inefficiencies and frustration such as repeated
returns of the patient cable with intermittent faults to
Biomedical Engineering, or repeated, inconclusive biomedical
testing and investigation.
X-Cal provides an automatic method to detect when cables
and sensors have been used far beyond their expected life,
allowing the aging inventory to be replaced. With X-Cal,
biomedical engineers are expected to spend less time
troubleshooting faulty/nuisance alarms and even less time
investigating, testing, and replacing faulty patient cables.
3
Monitor
Patient Monitor
or
Masimo Oximeter
64
Poor Quality and Performance of Third-Party
Reprocessed Pulse Oximetry Sensors
Customers often assume third-party reprocessed sensors
function to the same specification as Masimo sensors. This
is not the case. Masimo testing of third-party reprocessed
sensors identified a variety of performance issues including
biological debris, functional defects, risk of component failure,
and adhesive properties that are likely to cause discomfort
with infants and neonates.
Third-party reprocessing alters single-patient-use sensors from
their original form and function, which may have an adverse
effect on the consistency and accuracy of oxygen saturation and
pulse rate measurements. Because third party reprocessors do
not understand the intricacies of Masimo products, they do not
have controls to evaluate the extent of sensor use or condition
of components prior to reprocessing previously used sensors.
Consequently, third-party reprocessed sensors often have
damage to both optical and electrical components.
X-Cal does not prevent the use of reprocessed sensors but
does provide an automatic method to detect when reprocessed
sensors have been used far beyond their expected life.
Poor Performance of Third-party Reprocessed Sensors
How X-Cal Works
X-Cal is seamlessly integrated into Masimo sensors, cables
and circuit boards and is provided at no additional cost
to end users. X-Cal can detect imitation cables and
sensors and measures the active patient monitoring
time of each cable and sensor. Monitors equipped with
X-Cal enabled circuit boards will not function with
imitation cables and sensors and will display a message
to replace cables and sensors that have been used
beyond their useful life.
Furthermore, the indication to change a sensor or
cable only occurs outside of active patient monitoring
to avoid disruption to clinical practice. For example, if
the end of a single-patient-use sensor’s expected life
is reached while actively monitoring a patient, the
sensor will continue to operate until monitoring with
that sensor is stopped. At the next reapplication of
the same sensor, the monitor will display a message
to advise the clinician to replace the sensor.
91%
Light Transmission
Failed to meet Masimo specifications
for light transmission.
3x
Sensor Adhesion Pull Force
9%
Electrical Noise Immunity
Failed to meet Masimo specifications
for electrical noise immunity testing.
79%
Visible Defects
Testing of Infant and Neonatal versions of third-
party reprocessed sensors showed that almost
three times the pull force was required to remove
the sensor compared to Masimo Infant and
Neonatal sensors.
Visual quality inspection revealed that 79% of third-
party sensors had visible defects, which would not
meet Masimo’s acceptance criteria. Six percent had
some form of biological debris including hair, skin,
and red and yellow stains from bodily fluids.
Masimo ran multiple tests on sensors produced by a third-party reprocessor to evaluate the performance
on three important sensor characteristics: light transmission, electrical noise immunity, and sensor adhesion.
65
Green Designed In™
34%
90%
Masimo offers products to help hospitals meet environmental objectives while reducing costs.
Sustainability Without Sacrificing Safety
and Performance
Hospitals are facing more pressure than ever to reduce costs
and implement green initiatives while maintaining infection
control practices that protect patients and staff from the risks
of cross-contamination. Disposable pulse oximetry sensors
have historically offered the best performance, greatest
ease of use, and most comfort—but they do generate more
addition, our reprocessed sensors are the only reprocessed
sensors guaranteed to provide new sensor performance
because we replace every emitter and detector. For hospitals
seeking the best in performance, waste and carbon footprint
reduction, and cost-effectiveness, our new ReSposable™
Sensor line offers a revolutionary combination of benefits—
equivalent to 100% recycling at the point of care with a real
reduction in the carbon footprint.
waste. Reprocessing sensors may appear to reduce waste
Reusable + Disposable = ReSposable™
and the per-sensor price, but third-party reprocessed sensors
do not offer the same performance or quality as new sensors
and are labor-intensive. In addition, reprocessing itself
requires additional manufacturing and transportation,
which negatively impacts the environment. Reusable sensors
may offer low environmental impact, but do not offer the same
performance, comfort, or reduction of cross-contamination risk
as disposable sensors.
Multiple Options to Reduce Waste and Cost
Our ReSposable Sensor system was created after more than
ten years of research and development, incorporating feedback
from hundreds of clinicians on what they wanted most in a
sensor—less waste, more value, and superior performance. The
ReSposable system combines the best features of our LNOP,
LNCS®, M-LNCS™, and rainbow® sensors into an innovative
design that features a reusable optical sensor (ROS™) for
use over multiple patients and a disposable optical sensor
(DOS™) for single-patient use. The revolutionary ReSposable
sensor system offers the performance and comfort of a
Masimo LNOP® Sensors were the first green single-use sensors
single-use disposable sensor with the cost-effectiveness
to work accurately through motion and low perfusion. In
and environmental advantages of a reusable sensor.
Universal ReSposable™ SpO2 Sensor System
Two-piece design includes a reusable sensor and a disposable sensor
14 Pin Connector
20 Pin Connector
Custom Style Connector
New Disposable
Sensors
Mix of New + Reprocessed
Sensors
ReSposable™
Sensors
Up to 90% Less Waste than New
Disposable Sensors and 34% Less than
a Mix of New and Reprocessed Sensors*
43%
41%
Up to 41% Lower Carbon Footprint
than New Disposable Sensors vs 43%
Higher Carbon Footprint with a Mix of
New and Reprocessed Sensors**
New Disposable
Sensors
Mix of New + Reprocessed
Sensors
ReSposable
Sensors
* Waste calculated by sensor weight for 40% reprocessed sensors with a mix of 80% Adult and Pediatric sensors, 20% Neo and Infant sensors. Carbon footprint
comparisons calculated by lbs. CO2 emissions with same reprocess mix as waste. ** Carbon footprint calculations validated by Carbonfund.org in November, 2011.
“Butterfly-style
sensor” in two sizes
“L-style sensor” in
three sizes with
adhesive or SofTouch
replaceable wraps
67
Choose Your Reusable Optical Sensor (S-ROS™) Based on Your Device
Choose Your Single-Patient-Use Disposable Optical Sensor (S-DOS™) Based on Your Patient
66
Innovations for Increased Patient
Comfort and Expanded Applications
Enhancing Comfort During Long-term Monitoring
with Cabled Sensors
Smaller Boards that Consume Less Power for
Expanded Applications
In the past, single-use pulse oximeter sensors with integrated
Masimo’s technology board innovation has continued with
wiring have been limited in their comfort and flexibility by the
reduced size (as small as 1.8” x 1.2” x 0.5”) and power consumption
size of the emitter and detector. After an intense development
(less than 45 mW), allowing Masimo SET® performance to be
effort, Masimo’s new SpO2 sensor components are much thinner
integrated where it was not previously feasible, inside multiple
than ever before—increasing patient comfort by increasing
new OEM products with the MS-2040 board or externally as part
sensor flexibility and reducing bulk while maintaining the
of the patient cable with uSpO2® and iSpO2™.
Masimo SET® performance that clinicians expect.
Internal integration with
MS-2040 and MS-2040ds
or external integration with
iSpO2™ or uSpO2®
Select OeM partners
Relative size of new detector (left) and emitter (right)
iSpO2™
MS-2040ds
MS-2040
uSpO2®
68
69
Technologies and Products
Technologies and Parameters
Monitors
Sensors
Circuit Boards
Measure-through Motion and
Low Perfusion pulse oximetry and
fluid responsiveness monitoring
> Functional Oxygen Saturation (SpO2)
> Pulse Rate (PR)
> Perfusion Index (PI)
> Pleth Variability Index (PVI®)
> Respiration Rate from Pleth (RRp)*
rainbow® Pulse
CO-Oximetry
Noninvasive blood constituent monitoring
> Total Hemoglobin (SpHb®)
> Carboxyhemoglobin (SpCO®)
> Methemoglobin (SpMet®)
> Oxygen Content (SpOC®)
> Fractional Oxygen Saturation (SpfO2™)*
> Plus all Masimo SET® measurements
rainbow Acoustic
Monitoring™
Noninvasive respiratory
monitoring
> Acoustic Respiration Rate (RRa™)
SedLine® Brain
Function Monitoring
Noninvasive depth
of sedation monitoring
> Patient State Index (PSI™)
Phasein™ Capnography
and Gas Monitoring
> End-tidal Carbon Dioxide (EtCO2)
> Fractional Concentration of
Inspired Carbon Dioxide (FiCO2)
> Respiration Rate (RR)
> Nitrous Oxide (N2O)
> Oxygen (O2)
> Anesthetic Agent Identification (Agent ID)
70
Root™
Complete rainbow® Pulse CO-Oximetry and
rainbow Acoustic Monitoring™, upgradeable,
Radical-7®
Complete rainbow® Pulse CO-
Oximetry and rainbow Acoustic
Radical®
Masimo SET®,
Monochrome
color touchscreen display, standard wireless
Monitoring™, upgradeable, color
LCD display
radio, MyView™, expandable measurements
touchscreen display, standard
with MOC-9™, and connectivity with Iris™
wireless radio, MyView™
Rad-8®
Masimo SET®, LED display
Rad-87™
Complete rainbow® Pulse CO-Oximetry and
rainbow Acoustic Monitoring™, upgradeable,
LED display, optional wireless radio
Pronto-7®
rainbow® 4D with SpHb spot-check
with wireless communication
EMMA™ Capnometer
Portable mainstream
EMMA™ Capnograph
Portable mainstream
capnometer
capnograph
Masimo SET® Sensors
SpO2, PR, PI, PVI®, RRp
rainbow® Acoustic Sensor
RRa™
MS-2011
MS-2013
MS-2040
MX-5
External Measurement Technologies
IRMA™
Capnography and
ISA™
Capnography and
Gas Monitoring
Gas Monitoring
SedLine®
Brain Function
Monitoring
Cannulas and Adapters
rainbow® SET Sensors
SpHb®, SpOC®, SpCO®, SpOC™, SpfO2™,
SpMet®, SpO2, PR, PI, PVI®, RRp
Patient SafetyNet™ System
Cannula
Nomoline™
Adapter
Pronto®
rainbow® with
SpHb spot-check
Rad-57™
rainbow®
Pulse CO-Oximetry
Rad-5v™
Masimo SET®
iSpO2™
Masimo SET®
SedLine® Sensor
PSI®
The sensors above are just some of the over 100
different sensors that Masimo offers. * CE marked
Remote monitoring and notification system
> Direct alarms to nurse via pager
> HL7 interface to hospital EHR
> MyView for clinician-centric monitoring
> Monitor up to 200 patients on a single server
71
National and International Awards for Excellence
Financial Performance
Consolidated Balance Sheets (in thousands)
1995 STA Excellence in Technology Innovation
for Measure-through Motion and Low
Perfusion Pulse Oximetry
2008 Outstanding Growth
2000 SCCM Technology Excellence
2008 Outstanding Medical Device Company
2000 Outstanding Medical Device Company
2008 Best in Class
2001 Innovative Product and Technology
2008 AARC Zenith Award
American Association for Respiratory Care
2001 Distinguished Leadership
2009 Best in Class
2001 Excellence in Leadership
2009 AARC Zenith Award
American Association for Respiratory Care
2001 Medical Design Excellence
2009 Patient Monitoring CEO of the Year
2003 New Standard of Care
2003 Technology of the Year in
Patient Monitoring
2009 Masimo SET and the Patient SafetyNet
System help Dartmouth-Hitchcock Medical
Center win the 4th Annual Health Devices
Achievement Award
2003 Platform ABBY for Innovations
2010 GHX Respiratory Product Best-in-
in Healthcare
Class Award
2005 Innovative Product and Technology
2010 AARC Zenith Award
American Association for Respiratory Care
2006 STA Application of Technology for
Noninvasive Methemoglobin and
Carboxyhemoglobin Monitoring
2006 Medical Design Excellence
2011 iF Product Design Award for the Pronto-7
2011 Medical Design Excellence —
2011 WINNER
Gold for the Pronto-7
2007 STA Excellence in Technology Innovation for
2011 TechAmerica High-Tech Innovation
Noninvasive Total Hemoglobin Monitoring
for the Pronto-7
2007 Groundbreaking Innovation of
rainbow® SET Technology
2007 Patient Monitoring Technology
Leadership of the Year
2007 Brand Development Strategy Leadership
2008 Excellence in Medical Technology
2012 Gold “Stevie” Award for Best New
Health Product for the Pronto-7
2012 Ernst & Young National Entrepreneur of the
Year—2012 Life Sciences Award Winner
2013 STA Best Clinical Application of
Technology Award for SpHb
2013 JEMS Hot Product Award for
EMMA and iSpO2
December 29, 2012
December 31, 2011
ASSETS
Current assets
Cash and cash equivalents
$71,554
$129,882
Accounts receivable, net of allowance for doubtful accounts
Royalties receivable
Inventories
Prepaid expenses
Prepaid income taxes
Deferred tax assets
Other current assets
67,911
7,130
47,358
6,507
2,080
12,911
3,896
57,013
7,102
45,944
6,424
2,986
11,576
2,008
Total current assets
219,347
262,935
Deferred cost of goods sold
Property and equipment, net
Intangible assets, net
Goodwill
Deferred tax assets
Other assets
52,103
23,924
27,363
22,824
22,363
8,022
51,679
15,239
11,393
448
16,766
7,644
Total assets
$375,946
$366,104
LIABILITIES AND EQUITY
Current liabilities
Accounts payable
$27,033
$27,302
Accrued compensation
Accrued liabilities
Income taxes payable
Deferred revenue
Current portion of capital lease obligations
Total current liabilities
Deferred revenue
Capital lease obligations, less current portion
25,021
16,648
1,504
19,278
55
89,539
576
60
Other liabilities
10,103
Total liabilities
100,278
Equity
Masimo Corporation stockholders’ equity:
Common stock
Treasury stock
Additional paid-in capital
Accumulated other comprehensive income
Retained earnings
57
(63,664)
258,783
3,542
74,361
Total Masimo Corporation stockholders’ equity
273,079
Noncontrolling interest
2,589
Total equity
275,668
Total liabilities and equity
$375,946
19,717
12,297
570
16,019
48
75,953
984
74
9,427
86,438
58
(37,396)
243,528
1,274
69,364
276,828
2,838
279,666
$366,104
72
73
Financial Performance
Consolidated Statements of Income (in thousands, except per share information)
Consolidated Statements of Cash Flows (in thousands)
Year ended:
December 29, 2012
December 31, 2011
Year ended:
December 29, 2012
December 31, 2011
Revenue:
CASH FLOWS FROM OPERATING ACTIVITIES:
Product
$464,928
Royalty
28,305
Total revenue
493,233
Cost of goods sold
Gross profit
166,982
326,251
Operating expenses:
Selling, general and administrative
193,948
Research and development
Total operating expenses
Operating income
Non-operating income (expense)
Income before provision for income taxes
Provision for income taxes
Net income including noncontrolling interest
Net (income) loss attributable to noncontrolling interest
47,077
241,025
85,226
(1,405)
83,821
21,883
61,938
334
Net income attributable to Masimo Corporation stockholders
$62,272
Net income per share attributable to Masimo Corporation stockholders:
Basic
Diluted
Weighted average shares used in per share calculations:
Basic
Diluted
Cash dividend declared per share
$1 08
$1 07
57,445
58,374
$1 00
$406,487
32,501
438,988
144,854
294,134
169,205
38,412
207,617
86,517
14
86,531
22,478
64,053
(353)
$63,700
$1 07
$1 05
59,659
60,845
–––
Note: The Consolidated Balance Sheets,
Consolidated Statements of Income, and
Consolidated Statements of Cash Flows
are derived from our Audited Consolidated
Financial Statements as published in our
Form 10-K filed with the Securities and
Exchange Commission on February 15, 2013.
Net income including noncontrolling interest
$61,938
$64,053
Adjustments to reconcile net income including noncontrolling interest to net cash provided by operating activities:
Depreciation and amortization
Share-based compensation
Provision for doubtful accounts
Provision for obsolete inventory
Provision for warranty costs
Benefit from deferred income taxes
Income tax benefit from exercise of stock options granted prior to January 1, 2006
Excess tax deficit (benefit) from share-based compensation arrangements
Realized foreign exchange gain on forward contracts
Changes in operating assets and liabilities:
9,369
14,097
231
1,063
2,489
(6,806)
338
748
(586)
Increase in accounts receivable
(10,130)
(Increase) decrease in royalties receivable
Increase in inventories
Increase in deferred cost of goods sold
(Increase) decrease in prepaid expenses
Decrease in prepaid income taxes
Increase in other assets
Increase (decrease) in accounts payable
Increase (decrease) in accrued compensation
Increase (decrease) in accrued liabilities
Increase (decrease) in income taxes payable
Increase (decrease) in deferred revenue
Increase (decrease) in other liabilities
Net cash provided by operating activities
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment
Increase in intangible assets
Cash paid for acquisitions, net of cash acquired
Net cash used in investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayments on capital lease obligations
Proceeds from issuance of common stock
Excess tax (deficit) benefit from share-based compensation arrangements
Dividends paid
Repurchases of common stock
Short swing profit recovery
Net proceeds from settlement of forward contracts
Net cash used in financing activities
Effect of foreign currency exchange rates on cash
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
(28)
(524)
(409)
186
1,255
(2,193)
(1,726)
4,827
450
198
2,850
(2,203)
75,434
(10,828)
(3,664)
(37,399)
(51,891)
(26)
1,642
(748)
(57,275)
(26,268)
–––
586
(82,089)
218
(58,328)
129,882
$71,554
7,342
13,676
231
2,130
2,592
(3,217)
1,650
(67)
–––
(7,549)
4,898
(3,046)
(4,526)
(1,874)
366
(1,502)
5,159
(1,333)
(77)
(89)
(921)
1,061
78,957
(5,057)
(2,451)
–––
(7,508)
(50)
5,943
67
–––
(36,187)
73
–––
(30,154)
282
41,577
88,305
$129,882
74
75
HeADquARteRS
MASiMO CORpORAte HeADquARteRS
40 Parker
Irvine, CA 92618
USA
Tel: 949 297 7000
inteRnAtiOnAl OpeRAtiOnS CenteR
MASIMO INTERNATIONAL SARL
Puits-Godet 10
2000 Neuchâtel
Switzerland
Tel: +41 327201111
COuntRy OFFiCeS
MASIMO ASIA PACIFIC
572A Serangoon Rd
Singapore 218187
Singapore
Tel: +65 63924085
MASIMO AUSTRIA
Meldemannstr 18
1200 Wien
Austria
Tel: +43 (0) 1 533 73 61
MASIMO CHINA
Room 502, Suite E
Triumph Tower Bldg 6
170 Beiyuan Road,
Beijing 100101
China
Tel: +86 1058236155
MASIMO INDIA
70/2 Miller’s Road
Miller’s Boulevard, 2nd Floor
Bangalore 560052
Karnataka State,
India
Tel: + 1 800 425 MASIMO
MASIMO LATIN AMERICA/
MASIMO MEXICO
Florencia 57 Piso 3
Col Juárez
06600 México, D F
México
Tel: +5255 5242 5807
MASIMO AUSTRALIA
ABN 71 124 372 701
Suite 3, Bldg 7
49 Frenchs Forest Rd
Frenchs Forest, NSW 2086
Australia
Tel: +61 294523763
MASIMO CANADA
4901 Levy St
Saint-Laurent,
QC H4R 2P9
Canada
Tel: 888 336 0043
MASIMO FRANCE
Espace Européen d’Ecully
BAT G
15 Chemin du Saquin
69130 Ecully
France
Tel: +33 0472 179370
MASIMO ITALY
Via Filzi 33
20124 Milano
Italy
Tel: +39 0245076308
MASIMO MIDDLE EAST
Offices 505-508,
Manhal Center
Manhal Square, Jubaiha
Amman, Jordan
Tel: +962 7 9701 1135
Masimo’s Global Reach
Masimo is committed to improving patient
care globally, with approximately 3,000
talented people worldwide and operations
in North America, Europe, Latin America,
the Middle East, Asia, and Australia.
MASIMO GERMANY
Niederlassung
Deutschland
Lindberghstr 11
82178 Puchheim
Germany
Tel: +49 89800658990
MASIMO JAPAN
Sumitomo Fudosan
Korakuen Bldg 17F
1-4-1, Koishikawa, Bunkyo-ku
Tokyo 112-0002
Japan
Tel: +81 338685201
MASIMO NETHERLANDS
Hart van Brabantlaan
12-14-16
5038 JL Tilburg
Netherlands
Tel: +31 135832479
MASIMO SPAIN
Ronda de Poniente
12 2F
28760 Tres Cantos
Madrid
Spain
Tel: +34 918049734
MASIMO TURKEY
Mustafa Kemal Mah 2125 Sok
Kolbay Is Mrk C Blok No:6/10
Sogutozu
Ankara
Turkey
Tel: +90 312 219 54 38
MASIMO UK
Unit Q, Loddon
Business Centre Roentgen Rd
Basingstoke Hants
RG24 8NG
United Kingdom
Tel: +44 01256479988
MASIMO SEMICONDUCTOR
25 Sagamore Park Road
Hudson, NH 03051
USA
Tel: 603 595 8900
MASIMO SWEDEN AB
Svärdvägen 15,
182 33 Danderyd
Sweden
Tel: +46 8 544 98 150
Headquarters
International
Operational
Center
Regional
Offices
Manufacturing
Center
OEM
Partners
Distributors
Masimo
Semiconductor
Masimo
Sweden AB
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77
Forward-looking Statements
Regulatory Notice
All statements other than statements of historical facts included in this
Some of the products featured in this Annual Report are currently or planned to
document that address activities, events or developments that we expect,
be marketed worldwide by Masimo. Not all products or features profiled in this
believe or anticipate will or may occur in the future are forward-looking
report have US FDA 510(k) or other regulatory agencies’ clearances (such as EU,
statements. These statements include but are not limited to statements
Canada, Japan, etc.) at the time of printing. As of July 2013, products/features
about: our business generally; expectations regarding our ability to design and
that have not been FDA 510(k) cleared for sales and marketing in the US include
deliver innovative new noninvasive technologies; demand for our technologies;
SpfO2, SpvO2, RRp, iSpO2 Rx, Active Pulse, the SuperSensor, MyView, Halo
estimates regarding potential cost savings through using our technologies;
Index, Root with all of the described functions, and Adaptive Threshold Alarm.
and expectations regarding the growth of our installed base of drivers. These
Submissions for some of these products or features either have been filed or are
forward-looking statements are based on management’s current expectations
planned to be filed in other regulated markets.
and beliefs and are subject to uncertainties and factors, all of which are
difficult to predict and many of which are beyond our control and could cause
actual results to differ materially and adversely from those described in the
forward-looking statements. These risks include, but are not limited to, those
related to: our dependence on Masimo SET and Masimo rainbow SET products
and technologies for substantially all of our revenue; any failure in protecting
our intellectual property exposure to competitors’ assertions of intellectual
property claims; the highly competitive nature of the markets in which we sell
our products and technologies; any failure to continue developing innovative
products and technologies; the lack of acceptance of any of our current or
future products and technologies; obtaining regulatory approval of our current
and future products and technologies; the risk that the implementation of our
international realignment will not continue to produce anticipated operational
and financial benefits, including a continued lower effective tax rate; the loss
of our customers; the failure to retain and recruit senior management; product
liability claims exposure; a failure to obtain expected returns from the amount of
intangible assets we have recorded; the maintenance of our brand; the impact
of the decline in the worldwide credit markets on us and our customers; the
amount and type of equity awards that we may grant to employees and service
providers in the future; and other factors discussed in the “Risk Factors” section
of our most recent periodic reports filed with the Securities and Exchange
Commission (“SEC”), including our most recent Annual Report on Form 10-K and
Quarterly Report Form 10-Q, all of which you may obtain for free on the SEC’s
website at www.sec.gov. Although we believe that the expectations reflected
in our forward-looking statements are reasonable, we do not know whether our
expectations will prove correct. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date hereof,
even if subsequently made available by us on our website or otherwise. We do
Senior Management Team
Yongsam Lee
Executive Vice President,
Operations and Chief
Information Officer
Tetsuro Maniwa
President,
Masimo Japan
Tom McClenahan
Executive Vice President,
General Counsel
Anand Sampath
Executive Vice President,
Engineering
Stacey Taggart
President, Europe,
Middle East & Africa
Robert Zyzanski
President,
Masimo Sweden
Joe Kiani
Chief Executive Officer
Matthew Anacone
Vice President, US Acute
Care Sales
Jon Coleman
President, Worldwide Sales,
Professional Services and
Medical Affairs
Mark de Raad
Executive Vice President
& Chief Financial Officer
Rick Fishel
President, Worldwide
OEM Business &
Corporate Development
Paul Jansen
Executive Vice President,
Marketing & Clinical
Development
Board of Directors
not undertake any obligation to update, amend or clarify these forward-looking
statements, whether as a result of new information, future events or otherwise,
Joe Kiani
Chairman of the Board of Directors
except as may be required under applicable securities laws.
NOTE REGARDING THIS ANNUAL REPORT: Please note that this annual report
does not constitute the Company’s “annual report to security holders” for
purposes of the requirements of the SEC. For a copy of the Company’s annual
Edward Cahill
Director
report to security holders required under Rule 14a-3 of Regulation 14A of the
Securities Exchange Act of 1934, as amended, please refer to the Company’s
Robert Coleman, PhD
Director
Steven Barker, MD, PhD
Director
Annual Report on Form 10-K for the fiscal year ended December 31, 2012, which
you may obtain for free on the SEC’s website at www.sec.gov.
Sanford Fitch
Director
Jack Lasersohn
Director
78
Masimo • 40 Parker • Irvine, CA 92618 • Tel: 949 297 7000 • www.masimo.com
© 2013 Masimo Corporation Masimo, SET, rainbow, rainbow Acoustic Monitoring, RRa, RAM, SpHb, SpCO, SpMet, SpOC, PVI, Adaptive Connectivity Engine, Adaptive Threshold Alarm, Adaptive Probe
Off Detection, APOD, Green Designed In, Measure-through Motion and Low Perfusion Pulse Oximetry, Pulse CO-Oximetry, Signal Extraction Technology, Signal IQ, Masimo Patient SafetyNet, Root,
Radical, Radical-7, Rad-87, Rad-57, Pronto, Pronto-7, Rad-8, Rad-5, Rad-5v, Rad-9, Blue, M-LNCS, LNCS, LNOP, Max, NeoPT-500, Newborn, MS-1, MX-1, MX-3, DST, SST, FST, MST, RAS, DOS, ROS, rainbow
4D, ReSposable, SatShare, SmarTone, FastSat, FastStart, SofTouch, Halo Index, SedLine, MyView, X-Cal, uSpO2, PSI, Phasein, IRMA, ISA, Nomoline, Improve patient outcomes and reduce the cost of care by
taking noninvasive monitoring to new sites and new applications, and Closer to the Heart are trademarks, registered trademarks, or service marks of Masimo Corporation All rights reserved Apple, iPhone,
iPad, iPod, and iPod touch are registered trademarks of Apple Inc registered in the U S and other countries IOS is a trademark or registered trademark of Cisco in the U S and other countries and is used
under license Android is a trademark of Google Inc All other products, logos, or company names mentioned herein may be trademarks and/or registered trademarks of their respective companies
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