Masimo Annual Report 2016

FY2016 Annual Report · Masimo

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Through M o v e m e n t

L e t t e r f r o m t h e C h a i r m a n & C E O

We Are Always
in Motion

As we mark the 10-year anniversary of our Initial Public Offering,
I am happy to report that, as a public company, we have done what few
companies ever do—build a 10-year plan and not let quarterly earnings
reports impede the sustainable and meaningful progress that is only
possible with a long-term view, strategy, and execution.

We thank the patient shareholders who

have stuck by us, who are now being

rewarded with sustainable revenue and

earnings growth fueled by revolutionary

noninvasive monitoring technologies that

are saving peoples' lives, sold and serviced

by a professional and dedicated clinical

MISSION STATEMENT

Improve patient outcomes and reduce the

cost of care by taking noninvasive monitoring

to new sites and applications.®

sales team in 21 countries directly.

GUIDING PRINCIPLES

• 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

Joe Kiani
Chairman & CEO,
Masimo

EARNINGS PER SHARE

$5.65

$2.22

$1.21

$0.88

$1.05

$1.07

$1.02

$1.55

$1.30

$0.60

$0.53

2007

2008

2009

2010

2011

2012

2013

2014

2015

20161

The first phase of our 10-year plan was to invest

while building a sustainable growing business.

in R&D and key functional areas, allowing

At 28 years old, Masimo remains as idealistic and

the company to gain a worldwide presence

fascinated by new possibilities as ever. While

sufficient to facilitate long-term growth.

we hope to continue to deliver product revenue

Phase two leveraged these investments with a

growth at multiple times the market’s rate, we

growing base of breakthrough technologies and

know that shareholders will be rewarded reliably

products, resulting not only in solid growth, but

when management plans and executes a long-

due to value engineering that started in the last

term strategy.

trimester, bottom-line financial growth. While

we didn’t think investors would have to wait

Our bodies and our world depend and thrive on

this long, a few unexpected events, including

movement. Masimo thrived by making products

a dramatic hospital census drop and foreign

that dealt with movement. Progress is only

exchange headwinds in 2013 and 2014, delayed

possible through collective movement. And, like

the emergence of such results even though we

ripples on a pond, our success moves us away

continued to grow product revenue at multiple

from the safety of where we were, in an outward

times the market’s rate. Long-term planning

direction, seeking answers, seeking solutions to

is necessary to push forward the life-saving

patient safety problems. So, that collectively we

innovations that others deemed impossible

can solve broader problems facing us.

This Annual Report is dedicated to all of those
who move the world forward and who help
preserve our hope by continuing
to improve lives.

1 Included in the FY2016 Historical GAAP Earning Per Share was $3.43 per
diluted share related to a $300.0 million settlement agreement, of which $270.0 million
was recognized as a gain on the Statement of Operations at December 31, 2016.

REVENUES

IN MIL L IONS OF D OLLARS | P RO DUCT REVENUES

| ROYA LTY REVENUES

586.6

29.8

556.8

547.2

29.8

517.4

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

256.3

56.1

200.2

694.6

30.8

663.8

630.1

30.8

599.3

INSTALLED BASE

ESTIMAT ED UNITS EXCLUDES HANDHE LD S

1,088,000

979,000

855,000

640,000

567,000

470,000

1,504,000

1,414,000

1,313,000

1,205,000

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

This Annual Report is dedicated to all of those

sick, rescuing accident victims, and engineering

who move the world forward, who help preserve

the amazing, life-saving, life-enhancing

our hope by continuing to improve lives: doctors,

technologies that help so many in distress.

PVi®, and other technologies such as Root®, we

who have trusted us to advance the business of

help those who help us all stay in motion.

patient care with a long-term view. I hope we can

continue rewarding our employees, customers, and

nurses, respiratory therapists, engineers, and

Their relentless movement helps to keep us all

In this Annual Report, we not only reflect on our

shareholders through our long view on humanity

first responders —among countless others. Every

in motion that much longer. At Masimo, we are

financial performance but on the technologies and

and the advancement of medicine.

day, all over the world, medical professionals

proud to play a part in their heroic endeavors,

products we have created to help our heroes sustain

and other amazing individuals are, through their

to develop and provide the tools that help save

thoughtful movement, saving lives, healing the

countless lives and the eyesight of newborns.

and accelerate their miracles of healing. We thank

Joe Kiani

them for the opportunity to be part of our ever-

Chairman & CEO

From solving the “unsolvable” problem of motion

artifact in pulse oximetry—to measure through the

motion that is the hallmark of life—to inventing the

noninvasive measurements of total hemoglobin,
carboxyhemoglobin, methemoglobin, ORi™ and

improving healthcare system. We also thank our

innovative engineers, dedicated sales and clinical

teams, and the manufacturing, finance, quality, and

regulatory affairs teams who keep our innovation

engine moving. Finally, we thank our shareholders,

Solving Motion
Artifact with SET®:
The Movement that Rippled Through
Healthcare, Helping Clinicians Save Babies’
Eyesight, Save Lives, and Reduce Hospital and
Payer Costs, While Challenging an Industry

Solving the
“Unsolvable” with SET

Our first breakthrough, Signal Extraction Technology®, was invented to overcome the limitations of

conventional pulse oximetry, which is unreliable when patients are moving or poorly perfused.

Pulse oximetry is an important patient monitoring
tool. However, conventional pulse oximeters made
it difficult to determine the true arterial blood signal
during patient motion because moving venous
blood appears to pulsate like arterial blood.1

Masimo SET® works by recognizing that both
arterial and venous blood can move, using parallel
signal processing engines—DST®, FST®, SST™, and
MST™—to separate the true arterial signal from

sources of noise, including the venous signal.2
By measuring through patient motion and low
perfusion, Masimo SET® has helped pulse oximetry
become a clinically reliable tool in operating
rooms, intensive care units, general wards, and
other healthcare settings all over the world.3

Conventional pulse oximetry uses the

standard red over infrared algorithm
to provide SpO2, while Masimo SET®

includes four additional algorithms,

running in parallel. These algorithms

distinguish between arterial signal and

venous noise during motion and low

perfusion by identifying and isolating

the non-arterial and venous noise SpO2

(left peak, shown in blue) from the true

arterial SpO2 components (right peak,

shown in red) in the signal.

1 Mardirossian G et al. Anesth Prog. 1992;39(6):194-196.
2 Szocik J et al. Published in Miller’s Anesthesia, 8th edn. Phila, PA:
Elsevier; 1315-1344 (1334). 3 Ortega R et al. N Engl J Med. 2011; 364 16:e33-36.

Advancing
Patient Safety

Before Masimo SET®, approximately 70%-90%
of alarms that occurred outside the OR were
false alarms.1,2,3 In a study of twenty-thousand
surgical patients, not only did pulse oximeters
fail to monitor 7% of the time on ASA IV patients
in the OR, but the study showed no evidence to
indicate a reduction in the overall rate of post-
operative complications using pulse oximetry.
After the introduction of Masimo SET®, false
alarms dropped by over 90% and true alarm
detection increased to 97% during motion and
low perfusion.4 Significantly, outcome studies
have shown that Masimo SET®, in conjunction
with clinician assessment, helps clinicians reduce
severe retinopathy of prematurity in neonates5
and improve CCHD screening in newborns.6

Validated by Independent and
Objective Research
Over 100 independent and objective studies7 have
shown that Masimo SET® outperforms other pulse
oximetry technologies, providing clinicians with
the sensitivity and specificity required to make
critical patient care decisions.

Masimo SET®: Comparative Studies

s
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120

100

102

Postive

Neutral

Negative

1 Lawless ST et al. Crit Care Med 1994;22:981-5. 2 Wiklund L et al. J Clin Anesth 1994;67:182-8. 3 Dumas C et al. Anesth Analg 1996;83:269-72. 4 Shah N et al. J Clin Anesth.
2012 Aug;24(5):385-91. Published clinical studies can be found on our website at: http://www.masimo.com/cpub/clinical-evidence.htm 5 Castillo A et al. Acta Paediatr. 2011
Feb;100(2):188-92. 6 de-Wahl Granelli A et al. BMJ. 2009;338. 7 Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at
http://www.masimo.com/home/clinical-evidence/clinical-evidence/ 8 Barker SJ. Anesth Analg. 2002;95(4):967-72. 9 Shah N et al. J Clin Anesth. 2012;24(5):385-91.

Pulse Oximeter ROC Curves
During Motion—Including Drop-outs

100

)

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A
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T

100

False Alarm Rate—Specificity (%)

A total of 70 volunteers were tested using a
motorized table that produced different 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 the ability to detect a
true SpO2 value <90%. Specificity was defined
as the ability to detect a true SpO2 value >90%.8

Masimo SET®
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

Performance During Motion and Low Perfusion

95%

97%

72%
Nellcor N-600

y
t
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c
fi
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p
S

100

57%
Nellcor N-600

y
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100

False Alarm Reduction

True Alarm Detection

In this 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). Results shown
are calculated by combining sensitivity and specificity outcomes of machine-generated and volunteer-generated motion.9

Industry-leading
Pulse Oximetry

Clinicians all around the world count on
Masimo SET® to help them care for patients.
With significantly fewer false alarms, clinicians
can focus on the patient, not the monitor.

With more accurate measurements, clinicians
can more tightly control oxygenation levels.1
And with timely detection of true events,
clinicians can intervene earlier.

OEM Technology Boards

MX-7™
Low power rainbow®
OEM board

MSX™
Very low power SET®
OEM board

The Pulse Oximetry Technology of Choice

Over 100 multi-parameter monitors from 50 leading brands have

integrated Masimo SET® pulse oximetry. In addition, more and more of our

partners are enhancing their monitoring solutions by integrating rainbow®

noninvasive blood constituent monitoring technology.

Dräger® Infinity M540
with rainbow SET™ technology

GE® CARESCAPE VC150
with rainbow SET™ technology

Philips® MX800
with rainbow SET™ technology

1 Durbin et al. Crit Care Med. 2002;30(8):1735-1740.

Physio-Control® LIFEPAK 15
with rainbow SET™ technology

Welch Allyn® Connex 6300 Series
with rainbow SET™ technology

ZOLL® X Series
with rainbow SET™ technology

Advancing
Newborn Care

Masimo offers a unique portfolio of core technologies and specialty sensors that enable clinicians

to care for newborns requiring resuscitation, cyanotic infants requiring accurate saturation

measurements, and premature infants at risk for retinopathy of prematurity.

Newborn Resuscitation
Every second matters during newborn resuscitation.
The Masimo Newborn Sensor together with Masimo
SET® technology ensures the fastest response time
with maximum sensitivity—allowing clinicians to
focus on the patient, not the device.

Better Care for Cyanotic Patients
In a clinical study on cyanotic infants, Masimo SET®
pulse oximetry with the Blue® sensor has been
shown to enable accurate maintenance of targeted
oxygen saturation levels.1 Researchers have
demonstrated improved accuracy at saturations

Cedars-Sinai Medical Center (CSMC)

Vermont Oxford Network (VON)

Rates of Retinopathy of Prematurity in Very Low Birth Weight Infants2

V
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—
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14%

12%

10%

1997

1998

1999
Year

2000

2001

Incidence in ROP stages 3 to 4 for infants with birthweight of 500 to 1500 g at CSMC and VON for the years 1997 to 2001.

1 Cox PN et al. Anesthesiology. 2007;107:A1540. (abstract). 2 Sola et al. Pediatrics. 2003 Feb;111(2):339-45. 3 Harris BU et al. Pediatr Care Med. 2016 Apr;17(4):315-20. 4
Cannesson M et al. Anesthesiology 2007; 107: A204. 5 Castillo A et al. Acta Paediatr. 2011 Feb;100(2):188-92. 6 Sola et al. Pediatrics. 2003 Feb;111(2):339-45.

75-85% in cyanotic infants and children with the
Blue sensor versus the Nellcor and standard
Masimo sensors.3 Additionally, researchers
have found that, following cardiac surgery, the
combination of Masimo SET® and the Blue sensor
provided more accurate and reliable information
compared to old generation pulse oximeters.4

Retinopathy of Prematurity
Premature infants requiring neonatal intensive
care need enough oxygen to preserve vital organ
function. However, too much oxygen can cause
severe eye damage from retinopathy of prematurity
(ROP). With changes in clinical practice and the

addition of Masimo SET® pulse oximetry, clinicians
have shown a reduction in ROP.5

In another study, following the implementation of
Masimo SET® with a new protocol in a single tertiary
neonatal center at Cedars-Sinai Medical Center
(CSMC), the incidence in severe ROP decreased
over a five year period from 12.5% to 2.5% in very
low birth weight infants. The changes are compared
to the data reported by the Vermont Oxford
Network (VON), a nonprofit voluntary collaboration
of >400 NICUs that maintains a database including
>25,000 infants.6

Severe Retinopathy of Prematurity Rate

13%
Nellcor N-395

12%
Nellcor N-395

13%
Nellcor N-395

)
P
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14%

12%

10%

Center A

Center B

Center A

Center B

Center A

Center B

Period I
Pre-policy Change

Period II
Post-policy Change
(With Implementation of
Masimo SET® in Center B)

Period III
Post-policy Change
(With Implementation of Masimo SET®
in Center A and Center B)

In period one, the baseline rate for severe ROP in two centers, both using Nellcor pulse oximetry, was established. In period two,
new practice guidelines were implemented at both centers, however, only Center B switched to Masimo SET®, which led to a significant
reduction in ROP (from 12% to 5%). In period three, Center A also switched to Masimo SET® and experienced a reduction in ROP from
period two (from 13% to 6%).5

Improving Screening for
Critical Congenital Heart Disease

In the United States, CCHD screening with motion-tolerant pulse oximetry has been added to

the Department of Health and Human Services’ Recommended Uniform Screening Panel and is

further advocated by several healthcare authorities. With the proven measure through motion
low perfusion performance of Masimo SET® as an effective CCHD screening tool, we look

forward to helping more clinicians care for newborns as awareness in CCHD screening spreads

to other parts of the world.

According to the National Institutes of Health
(NIH), “Critical congenital heart disease (CCHD) is a
term that refers to a group of serious heart defects
that are present from birth. These abnormalities
result from problems with the formation of one
or more parts of the heart during the early stages
of embryonic development. CCHD prevents the

heart from pumping blood effectively or reduces
the amount of oxygen in the blood. As a result,
organs and tissues throughout the body do not
receive enough oxygen, which can lead to organ
damage and life-threatening complications.”2 While
congenital heart disease affects approximately
eight per 1,000 newborns, critical congenital heart

CCHD Screening with Masimo SET®

N = 39,821 BABIES

Sensitivity for
CCHD Detection

Specificity for
CCHD Detection

Physical
Exam Alone

Physical Exam + Masimo SET®
Pulse Oximetry Screening1

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%.1

disease has an incidence of approximately 2.5 to 3
per 1,000 live births.3 CCHD requires intervention
soon after birth to prevent significant morbidity
or mortality. Some babies with CCHD can appear
healthy at first and may be discharged from the
hospital before their heart defect is detected, which
may lead to cardiogenic shock or death. Later
detection of CCHD in infants also increases the risk
of brain damage.4

Screening for CCHD with Masimo SET®
In one of the earlier CCHD detection studies with
pulse oximetry, Masimo SET® and a conventional
pulse oximeter were used, but due to a lack of
measurements and a high false positive rate the
conventional pulse oximeter was abandoned by
researchers mid-study.

In a study of 39,821 infants, researchers observed
an increase in CCHD detection from 63% with

physical exam alone to 83% with physical exam and
the utilization of Masimo SET® pulse oximetry.1

Similarly, in the largest CCHD screening study
to date—including over 122,738 subjects—the
combined use of Masimo SET® pulse oximetry and
clinical assessment increased screening sensitivity
from 77% to 93%.6

Masimo SET® pulse oximeters and sensors were
exclusively used in the two studies1,6,7 (59,876
subjects) that were the basis for the CCHD
workgroup recommendation for CCHD screening
protocols.8 Furthermore, investigators observed
that the incorporation of cut-off values for perfusion
index with routine pulse oximetry may further
increase sensitivity in CCHD screening in infants
with pathologically low (<0.70) perfusion.9

Eve™* is an intuitive application that transforms Radical-7® into
a simple yet powerful screening tool that allows clinicians to
quickly and reliably screen newborn babies for CCHD

1 de-Wahl Granelli et al. BMJ. 2009 Jan 8;338:a3037. 2 NIH US National Library of Medicine, Genetics Home Reference (https://ghr.nlm.nih.gov/condition/critical-congenital-
heart-disease) 3 Hoffman JL et al. J Am Coll Cardiol. 2002;39(12):1890-1900 4 2011 Legislative Report; State of Maryland, Department of Health and Mental Hygiene, State Advisory
Council on Hereditary and Congenital Disorders. Recommendations on Implementation of Screening for Critical Congenital Heart Disease in Newborns. Page 7. 5 Granelli et al.
Acta Paediatrica 2005;94:1590-1596. 6 Zhao QM et al. Lancet. 2014 Aug 30;384(9945):747-54. 7 Ewer AK et al. Lancet. 2011 Aug 27;378(9793):785-94. 8 Kemper et al. Pediatrics,
2011, October,e4. 9 de-Wahl Granelli et al. Acta Paediatr. 2007;96(2):1455-1459. * Radical-7 with Eve is not available in the U.S.

Always Moving
Noninvasive Blood Oxygen
Monitoring Forward

ORi Monitoring Detected Impending Desaturation1

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1.0

0.8

0.6

0.4

0.2

0.0

100

)

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2
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12
Elapsed Time Since Start of Induction (min)

Median alarm occurs 31.5 sec before desaturation.1

Extending Noninvasive Blood Oxygen
Monitoring to Moderate Hyperoxia with ORi™
With the creation of rainbow® Pulse CO-Oximetry
in 2005, we were able to leverage more light
wavelengths to noninvasively measure additional
blood constituents that previously required
invasive techniques. For example, prior to the
introduction of Masimo Oxygen Reserve Index™
(ORi), there was not a noninvasive method of
assessing moderate hyperoxia. When a patient is
on supplemental oxygen, SpO2 provides a late
indication of oxygenation level. Between invasive
samplings, changes in the partial pressure of
oxygen (PaO2) can often go unnoticed, leading
to unexpected hypoxia or unintended hyperoxia.
By providing insight into a patient’s oxygen
status in the moderate hyperoxic range of 100 to
200 mmHg, ORi represents a fundamental step
forward in the visibility of a physiologic trait that
was until now difficult to measure.

Masimo SpfO2™ Fractional
Measurement with rainbow®
Masimo SpfO2* is the first truly fractional
noninvasive oxygen saturation measurement,
and is made possible, like ORi, through the
use of rainbow® technology. SpfO2 allows truer
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 may enable earlier interventions and more
timely therapeutic decisions.

Enhancing Comfort and Simplifying
Use with RD SET™ Sensors
As part of our commitment to improving the core
Masimo SET® pulse oximetry experience, in 2016
we introduced the RD SET™ sensor system. In
addition to other benefits, RD SET™ sensors feature
small, thin optical components that lie comfortably
on and better conform to the patient’s hand or foot.
Significantly, RD SET sensors have higher accuracy
than previous-generation sensors. RD rainbow SET
and RD rainbow Lite SET™ sensors will make similar
benefits available to rainbow® Pulse
CO-Oximetry monitoring.

Enhancing Patient Safety with X-Cal™
Imitation cables and sensors using components
and manufacturing processes that do not meet
Masimo quality and performance specifications—
specifications required to provide consistently
high SET® and rainbow® performance during

challenging monitoring conditions—can lead to
measurement inaccuracy and patient safety risks.
To overcome this, we developed X-Cal technology,
which enhances clinical performance, patient
safety, and clinician efficiency by allowing the
sensor, patient cable, and Masimo technology
board, installed in a host multi-parameter patient
monitor or Masimo pulse oximeter, to operate as
an integrated system. X-Cal alerts users when an
imitation or defective cable or sensor, or a sensor
or cable that has been used beyond its expected
life, needs to be replaced.

TFA-1™ Disposable Forehead Sensor
Masimo now offers the TFA-1 transflectance
forehead adhesive sensor as an alternative to
traditional digit sensors. The forehead provides
rapid detection of saturation changes compared to
digit sites during low perfusion and also offers easy
access during surgery, resuscitation, and in patients
with finger deformities or inaccessible digits.

1 Szmuk P et al. Anesthesiology. 4 2016,
Vol.124, 779-784. doi:10.1097/ALN.0000000000001009
* SpfO2, ORi, and RD rainbow Lite SET are not available in the U.S.

ORi™: First Noninvasive and
Continuous Parameter to
Provide Early Indication
of Impending Hypoxia

Pulse oximetry provides noninvasive and
continuous visibility to arterial blood oxygenation
in hypoxia (less than normal oxygenation)
and normoxia (normal oxygenation). During
supplemental oxygen administration, clinicians
often use the partial pressure of oxygen (PaO2),
which is invasive and intermittent, to monitor levels
of hyperoxia (higher than normal oxygenation).
Between invasive samplings, changes in PaO2 can
go unnoticed and lead to unexpected hypoxia or
unintended hyperoxia.

Oxygen Reserve Index (ORi)* is a relative indicator of
the partial pressure of oxygen in arterial blood (PaO2)
in the range of 100 to 200 mmHg. ORi is intended
to supplement, not replace, SpO2 monitoring and
PaO2 measurements. As an “index” parameter with
a unit-less scale between 0.00 and 1.00, ORi can be
trended and has optional alarms to notify clinicians
of changes in a patient’s oxygen reserve.

PaO2 Range and Available Monitoring Methods

600+

≈200

)
g
H
m
m

(

100

Oxygenation State (in PaO2 mmHg)

Hyperoxia

Moderate
Hyperoxia

Normoxia

Hypoxia

Oxygen
Reserve

PaO2

SaO2/SpO2

In patients receiving supplemental oxygen,
such as those in surgery, under conscious
sedation, or in the intensive care unit, ORi
may provide an advance warning of an
impending hypoxic event. In addition, ORi

may provide an indication of a hyperoxic
state. In this way, ORi may enable proactive
interventions during preoxygenation
before intubating and extubating to avoid
hypoxia and unintended hyperoxia.

* ORi is not available in the U.S.

Clinical Evidence for
the Utility of Masimo ORi

In a prospective study published in Anesthesiology,
Dr. Peter Szmuk and colleagues concluded that
ORi could provide clinicians with a median of
31.5 seconds advanced warning of impending
desaturation in pediatric patients with induced
apnea after pre-oxygenation.

The investigators enrolled 33 patients in this study.
Eight of these resumed spontaneous ventilation

during the study period, leaving 25 apneic
patients to evaluate, with an average age of 7.6
years. Data were recorded continuously with a
Masimo Radical-7 Pulse CO-Oximeter®. ORi was
retrospectively calculated and was not visible to
investigators. The amount of early warning time, per
patient, observed by the researchers is summarized
in the following histogram.

Early Warning Time Distribution (Seconds)

“In this pilot study, we found that during
prolonged apnea in healthy anesthetized
children, the ORi detected impending
desaturation in median of 31.5 seconds
(IQR, 19 to 34.3 seconds) before noticeable
changes in SpO2 occurred. Knowing even
roughly how much time remains before the
rapid desaturation phase begins seems
likely to guide proper decisions.”

Szmuk et al.

0-10

11-20

21-30

31-40

41-50

51-60

Seconds

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ORi Pediatric Surgical Case Study

Room Air

100% FiO2

30% FiO2

Intubation

Reoxygenation (100% FiO2)

1.00

0.90

0.80

0.70

0.60

0.50

0.40

0.30

0.20

0.10

R
O

0.00

Oxygen reserve starts to deplete

ORi alarm
sounds

Patient is given
extra oxygen prior
to intubation

SpO2 Drops

SpO2 Alarms

100

)

(
2
O
p
S

Additional FiO2 provided
and airway is established

ORi

SpO2

Event

9
8
Time (minutes)

ORi levels drop prior to “30% FiO2” period and “intubation” period, and minutes before the SpO2 drop. ORi then rises
during re-oxygenation. ORi was retrospectively determined using offline data analysis.

1 Szmuk P et al. Anesthesiology. 4 2016, Vol.124, 779-784. doi:10.1097/
ALN.0000000000001009

RD Sensor System

The RD Sensor System was designed to enhance sensor comfort.

The family includes RD SET, RD rainbow Lite SET, and RD rainbow SET.

Orientation of optical components positions
sensor cable comfortably on top of hand

Available in wrap-around L-style, for
patients with long fingernails or finger
deformities, and in fold-over butterfly
style, which offers more secure digit
application and intuitive sensor
alignment. RD sensors will also be
available for multiple weight ranges
to suit a variety of patient needs.

Small, Thin Optical Components

• Lightweight, flat sensor with smooth edges lies

comfortably on a patient’s hand or foot

• Low profile internal components allow the

sensor to better conform to the shape
of a finger and were designed
to put less pressure on the
measurement site

RD SET

RD rainbow Lite SET

RD rainbow SET

• SpO2, PR, Pi, PVi®

• SpO2, PR, Pi, PVi, ORi,

RPVi™

• SpO2, PR, Pi, PVi, ORi,
RPVi, SpHb®, SpCO®,
SpMet®, SpfO2,
SpOC™

* RD rainbow Lite SET and ORi are currently available in the Japan market, not available in the U.S. SpfO2 and RPVi are not available in the U.S.

RD SET™
Sensors

RD SET sensors provide higher accuracy than previous-generation sensors,

simplify use, and reduce waste.

Designed to Improve Accuracy

RD SET sensors have higher accuracy than previous
generation sensors. The adjacent table shows bias,
precision, and ARMS (Accuracy Root Mean Square)
values measured using the RD SET Adt sensor with
Masimo SET® Oximetry technology in a Masimo
study of healthy volunteers.1

Bias

0.47

Precision

ARMS2

1.36

1.44

Designed for Intuitive Clinician Use

• Sensor labels and graphics immediately communicate emitter and

detector locations and guide proper application for optimal performance
and easier removal and re-application

• Quick and intuitive sensor-to-cable connection with tactile and audible

feedback ensures proper connection

Designed to Help Hospitals Meet Green Initiatives

• Lightweight sensor results in

less material waste

• Sleek, recyclable packaging reduces storage space by half

• Up to 84% less waste with Adult RD SET sensors versus

traditional cable-based sensors*

Up to 84%
less waste

1 Masimo SET technology has been validated for no motion accuracy in a human blood study on healthy adult male and female volunteers with light to
dark pigmented skin in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter. 2 ARMS accuracy is a statistical
calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements
fell within +/- ARMS of the reference measurements in a controlled study. * Waste calculated by comparing the sensor and packaging weight of
traditional cable based sensors versus Adult RD adhesive sensors. Internal data on file.

X-Cal™ for Enhanced
Patient Safety

A Systems Approach to Safety
X-Cal technology is designed to enhance
clinical performance, patient safety, and
clinician efficiency by allowing the sensor,
patient cable, and Masimo technology board,
installed in a host multi-parameter patient
monitor or Masimo pulse oximeter, to operate
as an integrated system.

When all three components are genuine and
within their useful life, the system works as
intended. However, when any one component
is compromised, erroneous measurements
may occur which can impact patient safety.

How X-Cal Works
This system design helps prevent the
measurement inaccuracy and patient safety
risks that may be caused by violations of the
above principles, such as imitation cables and
sensors using components and manufacturing
processes that do not meet Masimo quality

and performance specifications—specifications
required to provide consistent high
performance during challenging monitoring
conditions. When an unreliable or imitation
sensor or cable is connected to an X-Cal-
enabled monitor, a message alerts the user
that the cable or sensor should be replaced.

To address the reliability risks associated with
failures that can occur in cables and sensors used
beyond their expected lives, X-Cal technology
automatically tracks the aggregate time that
individual cables and sensors are used for
active patient monitoring. X-Cal detects when a
specific cable or sensor has been used beyond
its expected life and notifies the user, reducing
the likelihood of a sensor failure that could affect
patient safety. X-Cal also includes Site ID, which
encodes the sensor with a unique identifier
upon use. Site ID is designed to help ensure that
reprocessed sensors are sourced from hospitals’
own supply of genuine Masimo sensors.

Sensor

Cable

Monitor

Settin g Our Sights Higher with
ra i nb ow ® Pulse CO-Oxim etry:

Noninvasive
Patient Monitoring
Movement

Building Momentum with
rainbow® Pulse CO-Oximetry

After solving the “unsolvable” problems of motion and low perfusion in pulse oximetry,

we set our sights even higher.

By leveraging more wavelengths of light,
we created rainbow® technology—a suite
of noninvasive measurements for total
hemoglobin, dyshemoglobins, and other
physiologic parameters that previously could
only be measured invasively. Our rainbow®
technologies now help clinicians keep critical
care patients safe; help nurses monitor

postoperative patients’ respiration rates; help
EMS first responders care for accident victims;
and help doctors screen for anemia.

rainbow® uses more than seven wavelengths
of light to acquire blood constituent data
based on light absorption. Advanced signal
processing algorithms and unique adaptive
filters work together to isolate, identify,
and quantify various types of hemoglobin.
Measurement results are then displayed
numerically and graphically as a trend line
on select instruments.

rainbow SET measurements include:

SpO2

Oxygen
Saturation

Pulse
Rate

PVi®

RRp™

Perfusion
Index

Pleth Variability
Index

Respiration Rate
from the Pleth

SpHb®

SpCO®

SpMet®

™

SpfO2

SpOC®

ORi®

RPVi™

RRa®

Total
Hemoglobin

Carboxyhemoglobin

Methemoglobin

Fractional
Arterial Oxygen

Oxygen Content

Oxygen Reserve
Index

rainbow Pleth
Variability Index

Acoustic
Respiration Rate

* RRp, SpfO2, ORi, and RPVi are not available in the U.S.

Utilizing more than seven wavelengths of light and breakthrough signal processing, Masimo’s rainbow®
Pulse CO-Oximeters can measure and display oxygen content (SpOC), along with total hemoglobin
concentration (SpHb) and fractional arterial oxygen saturation (SpfO2)

Real-time Visibility of
Hemoglobin Status Between
Invasive Blood Samples

Limitations of Traditional Blood Sampling Methods

• Without SpHb, clinicians are only limited to invasive blood

samples, which provide intermittent and delayed laboratory
hemoglobin results

Helping Clinicians Make More Informed And Timely Transfusion Decisions

Continuous hemoglobin monitoring provides real-time visibility to changes—or lack of changes—
in hemoglobin between invasive blood samples.

SpHb trend monitoring may provide additional insight between invasive blood samples when:

• The SpHb trend is stable and the clinician may otherwise think hemoglobin is dropping

• The SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising

• The SpHb trend is dropping and the clinician may otherwise think hemoglobin is stable

Without SpHb Monitoring

With SpHb Monitoring

n
b
o
g
o
m
e
H

Draw blood

Wait...

Time

SpHb

Lab Hemoglobin

Wait...

Multiple steps in laboratory
hemoglobin determination

Perform lab analysis

Label vial and
send to lab

Get results

Accuracy of Masimo SpHb
Compared to Common
Invasive Methodologies

While hemoglobin is one of the most common laboratory tests performed, most

clinicians are unaware of the variation that should be expected when comparing

hemoglobin measurements—from various devices. This is because clinicians do not

typically measure hemoglobin more than once in the same patient at the same time.

Variation is caused by physiology, blood sampling technique, device methodology,
and individual device calibration.1

The results of a study conducted in a surgical
intensive care unit illustrate the variation
that can be expected between hemoglobin
devices. A total of 471 hemoglobin
measurements were evaluated from 62
patients. Noninvasive and continuous
hemoglobin (SpHb), a satellite laboratory
CO-Oximeter (Siemens RapidPoint 405), and
a point-of-care device (HemoCue 301) were
all compared to reference hemoglobin from
the central laboratory hematology analyzer
(Sysmex XT2000i).

In this study, the absolute accuracy and
trending accuracy of SpHb was similar to the
two widely used invasive methods2 when all
three methods were compared to the central
laboratory hemoglobin analyzer, both in
single-measurement comparisons as well as
trended-measurement comparisons. Some
independent researchers have conducted their
own testing and obtained similar results to
the presented cases, while other researchers
have reported larger, or in some cases
smaller, differences when comparing SpHb
measurements to laboratory measurements.

Single Hemoglobin Measurement Comparison Between
Three Devices and the Central Laboratory Hematology Analyzer2,3

SpHb

CO-Oximeter

HemoCue

)
L
d
/
g
(
b
H
p
S

1.0g/dL (ARMS)

Bias + Standard Deviation = 0.0 + 1.0 g/dL

10 12
Hematology Analyzer tHb (g/dL)

14 16 18

)
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/
g
(
b
H

r
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m
i
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O
O
C

1.1g/dL (ARMS)

Bias + Standard Deviation = 0.9 + 0.6 g/dL

10 12
Hematology Analyzer tHb (g/dL)

14 16 18

)
L
d
/
g
(
b
H
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C
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H

1.3g/dL (ARMS)

Bias + Standard Deviation = 0.3 + 1.3 g/dL

10 12
Hematology Analyzer tHb (g/dL)

14 16

Trended Hemoglobin Measurement Comparison Between
Three Devices and the Central Laboratory Hematology Analyzer2,3

SpHb

CO-Oximeter

HemoCue

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R=0.64

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10 12
Difference in Consecutive Hemoglobin Values
(tHb) (g/dL)

14 16 18

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10 12
Difference in Consecutive Hemoglobin Values
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14 16 18

1 Berkow L. J Clin Monit Comput. 2013 Mar 26. PMID: 23529342. 2 Frasca D et al. Critical Care 2012, 16 (Suppl 1):P433 (doi: 10.1186/cc11040). 3 ARMS was calculated as defined by the ISO
80601-2-61. Published clinical studies on the accuracy of Masimo SpHb can be found on our website at: http://www.masimo.com/cpub/clinical-evidence.htm

Risk and Costs of
Red Blood Cell Transfusions

With noninvasive and continuous total hemoglobin (SpHb), Masimo may help

clinician decision-making regarding one of the most common, costly, and critical
problems in healthcare.1-3

Blood transfusions are one of the more
common procedures in hospitals today.2
The Joint Commission has noted that,
“while blood transfusions can be life-
saving, they also carry risks that range from
mild complications to death.”4 The Joint
Commission and the American Medical
Association have listed transfusions among
their top five “overuse intervention targets.”4

Several clinical studies and meta-analyses also
have suggested clinical risk associated with
inappropriate transfusions, and some suggest
that restrictive blood transfusion practices may
improve clinical outcomes.5-7 Also, given the
costs associated with acquiring, storing, and
administering blood, a reduction in unneeded
transfusions may have an economic benefit.3
For these reasons, and others, many institutions
are adopting patient blood management
protocols and programs.8

1 Ehrenfeld JM et al. J Blood Disorders Transf. 2014.
5:237. doi:10.4172/2155-9864.1000237. 2 ACMS data pull: ICD
99 3 Shander A et al. Transfusion. 2010;50(4):753-765. 4 Proceedings from
the National Summit on Overuse September 24, 2012 5 Rohdes et al. JAMA, 5/2014
6 Salpeter et al. American Journal of Medicine 2014 7 Villanueva et al. N Engl J Med
2013;368:11-21.8 SABM PBM Directory http://www.sabm.org/programsbystate

SpHb May Help Clinicians Reduce
Blood Transfusions in Both Low
and High Blood Loss Surgery

A randomized trial of 327 patients undergoing
elective orthopedic surgery conducted at
Massachusetts General Hospital (MGH) found that
the use of continuous noninvasive hemoglobin
monitoring reduced the rate of transfusions when
compared to standard care without continuous
noninvasive hemoglobin monitoring. Patients
undergoing elective orthopedic surgery were
randomized to receive standard care alone or

standard care with SpHb monitoring. The researchers
concluded, “We believe that the availability of SpHb
decreases inappropriate transfusion.”1

A prospective cohort study of 106 neurosurgical
patients found that adding SpHb monitoring to
standard of care blood management resulted in
decreased blood utilization in high blood loss neu-
rosurgery, while also facilitating earlier transfusions.2

In Two Studies, SpHb was Shown to Help Clinicians Reduce
Blood Transfusions in Both Low & High Blood Loss Surgery

SpHb Helped Clinicians Reduce Transfusion
Frequency in Lower Blood Loss Surgery1

SpHb Helped Clinicians Reduce the Amount of
Blood Transfused in Higher Blood Loss Surgery2

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4.5%

87%

reduction in blood
transfusion frequency

0.6%*

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2.5

2.0

1.5

1.0

0.5

0.0

1.9

0.9average RBC units

reduced per patient

1.0**

Standard Care Group

SpHb Group

Standard Care Group

SpHb Group

Randomized controlled trial in 327 orthopedic patients
* p=0.03 vs Standard Care Group1

Prospective cohort study in 106 neurosurgery patients
** p<0.001 vs Standard Care Group2

1 Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:237. doi:10.4172/2155-9864.1000237. 2 Awada WN et al. J Clin Monit Comput. 2015 Feb 4. SpHb is not intended to
replace lab testing but it can provide immediate and additional information to aid patient assessment.

Patients were enrolled into either a Control Group
or an intervention group (SpHb Group) where the
Control Group received intraoperative hemoglobin
monitoring by intermittent blood sampling. In
each group, if researchers noted SpHb trended
downward, below 10g/dL, a red blood cell
transfusion was started and continued until SpHb
trended upward, above 10g/dL. The blood sampling
technique was the same for patients in both the
control and the test group. Arterial blood was drawn
from a 20 gauge radial artery cannula into 2mL
ethylenediaminetetraacetic acid collection tubes,
thoroughly mixed, then sent immediately to the
central lab for analysis by a hematology analyzer. The
reference laboratory device used for hemoglobin
measurements in the study was a Coulter GEN-S
Hematology Analyzer. The transfusion threshold of
10g/dL was predetermined by the study protocol
and may not be appropriate for all patients. Clinical
decisions regarding red blood cell transfusions
should be based on the clinician’s judgment
considering among other factors: patient condition,
continuous SpHb monitoring, and laboratory
diagnostic tests using blood samples.

Compared to the Control Group, the SpHb
Group demonstrated:2

• Fewer units of blood transfused

– 1.0 (SpHb) vs 1.9 (Control) units for all patients
– 2.3 (SpHb) vs 3.9 (Control) units in patients

receiving transfusion

• Fewer patients receiving more than 3 units

– 32% (SpHb) vs 73% (Control)

• A shorter time to transfusion after the need

was established
– 9.2 (SpHb) vs 50.2 (Control) min

SpHb Helped Clinicians Decrease the Time to
Transfusion, When Transfusion was Truly Indicated2

)
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i
T

50.2

41minutes 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 Group2

The investigators concluded, “Adding
SpHb monitoring to standard of
care blood management resulted
in decreased blood utilization in
high blood loss neurosurgery, while
facilitating earlier transfusions.”

Risk and Cost of
Internal Bleeding

In addition to assisting with transfusion management, Masimo SpHb may help clinicians

inside and outside the operating room identify changes in hemoglobin continuously.

Bleeding is considered a significant risk
factor for patients, and late detection further
increases risk and cost.1

Low hemoglobin is usually a reliable indicator
that the patient is bleeding. However, current

invasive blood monitoring methods are often
intermittent and delayed.2 A declining SpHb
trend may allow clinicians to identify falling
hemoglobin levels and allow clinicians to
intervene sooner.

Example of How SpHb Monitoring Can Help Identify Internal Bleeding3

9.0

8.5

8.0

7.5

7.0

6.5

)
L
d
/
g
(
e
u
l
a
V
b
H

6.0

tHb lab test

Masimo SpHb (unblinded)

Blood transfusion initiated

Lab tHb ordered early
due to declining
SpHb values

Patient
transported to OR
for splenectomy

Standing
lab order

Hours

1 Herwaldt LA. Infect Control Hosp Epidemiol. 2003; 24(1):44-50. 2 Bruns B et al. J
Trauma. 2007; 63(2):312-5. 3 McEvoy M et al. Am J Crit Care. November 2013 vol.
22 no. 6 eS1-eS13. doi:10.4037/ajcc2013729.

Recent Study Investigates
the Impact of SpHb & PVi on
Anesthesia-Related Mortality

In a recent study conducted at Hospital Dupuytren (part of the Centre Hospitalier Universitaire

of Limoges, France), Professor Nathalie Nathan and colleagues concluded that monitoring

with SpHb and PVi, as part of a vascular filling protocol in surgical patients, “allowed earlier

transfusion and reduces mortality at a scale of a whole hospital with different clinical practices
(and practitioners) and unselected patients.”1

The study included 18,867 patients, of whom
3,450 underwent SpHb and PVi monitoring via
Masimo Radical-7 Pulse CO-Oximeters, which were
installed in all operating rooms, recovery rooms,
and intensive care units, along with Masimo Patient
SafetyNet™*. Patients in the monitoring group
received vascular filling with crystalloids or blood,
according to the clinical algorithm. Demographic,
anesthesia, surgical, and transfusion data were
collected in electronic medical records using

Patient SafetyNet. The researchers compared the
percentage of patients in the monitored group who
received transfusions within the first postoperative
48 hours to the percentage in the non-monitored
group. They also compared mortality rates for each
group at 30 days following surgery.

The researchers found that the patients in the group
monitored with SpHb and PVi had a 30% reduction
in mortality at 30 days in comparison to the control

group. While the proportion of patients receiving
transfusions and the number of units transfused
within 48 hours were not significantly different
between the two groups, non-cardiac surgical
patients in the monitored group were transfused
sooner in the operative or recovery room.

Reduction in Mortality

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y
a
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0
3
o
i
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s
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0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0.0

30%

Reduction

Control Group

SpHb/PVi Group

1 Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract
#A1103. * The use of the trademark SafetyNet is under license from
University HealthSystem Consortium.

Quick and Noninvasive
Hemoglobin and Oxygen
Saturation Measurements

Rad-67™ Pulse CO-Oximeter features rainbow SET technology for noninvasive spot-checking of

total hemoglobin (SpHb), oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi).

A Remarkable Device for a
Variety of Clinical Settings
The Rad-67 Pulse CO-Oximeter offers noninvasive
hemoglobin and oxygen saturation measurements.
The portable Rad-67—approximately 9” x 4” x 1”
and weighing just 20 ounces—puts the power of
noninvasive hemoglobin spot-check in clinicians’
hands in a variety of care environments including
hospitals, clinics, and emergency medical services.

Next Generation SpHb Spot-check*
New software in Rad-67 offers several
enhancements when used in conjunction with

the new reusable rainbow® DCI-mini sensor. Next
Generation SpHb technology offers improved
motion tolerance, SpHb results display in as few
as 30 seconds, enhanced field performance in the
range of 6 to 11 g/dL, and is comparable to certain
portable invasive point-of-care devices.

SpHb is not intended to replace lab testing, but it
can provide immediate and additional information
to aid patient assessment.

Next Generation SpHb Accuracy
Compared to Invasive Methods
The data in this section describes the accuracy of
SpHb measurements in the range of 8-17 g/dL by
a Rad-67 and a HemoCue analyzer each compared
to a laboratory reference device.

Performance Summary**

Device

Subjects Samples Std Dev Bias ARMS1

Invasive Point-of-care
Device vs Laboratory
Hematology Analyzers

SpHb vs Laboratory
Hematology Analyzers

330

1.1

-0.1

1.1

290

544

1.0

0.4

1.1

The table represents the accuracy of SpHb measurements obtained using
Rad-67 with Next Generation SpHb Technology and tHb measurements
using an invasive point-of-care device, each compared to a laboratory
reference device.

1 ARMS accuracy is a statistical calculation of the difference between
device measurements and reference measurements. Approximately
two-thirds of the device measurements fell within ± ARMS of the
reference measurements in a controlled study. * Next generation
SpHb, Rad-67, and rainbow DCI mini Sensor are not available in
the U.S. ** Data on file. Masimo SpHb and HemoCue accuracy
was determined by testing on healthy adult, pediatric, and
patient volunteers with light to dark skin pigmentation
at clinical sites against an automated Beckman
Coulter laboratory hematology analyzer. Masimo
study. Data collected at six different centers on
healthy and sick subjects.

Reusable rainbow®
DCI-mini sensor for patients ≥3 kg

Limitations of Existing
Methods to Support
Fluid Management

Fluid administration is one of the most common hospital interventions. Although it is critical for

improving patient status and enabling end organ preservation, unnecessary fluid administration
is associated with increased morbidity and mortality.1

Clinicians commonly use intravenous fluid
administration in the operating room and
intensive care unit to attempt to improve blood
flow, or cardiac output. However, administering
either too little or too much fluid can increase
patient risk. Therefore, experts recommend
the use of “dynamic” parameters that measure
physiologic variation over the respiratory
cycle.2 A meta-analysis of 31 randomized
controlled trials showed that goal-directed fluid
management, using parameters such as stroke
volume variation (SVV) and pulse pressure
variation (PPV), reduced surgical complications
by 32%.3 While studies have shown these
dynamic parameters to be beneficial, most are
invasive, difficult to use, and costly.

A Noninvasive Fluid Monitoring Option
Masimo SET® pulse oximetry technology has
the unique ability to also provide a dynamic
variable, called Pleth Variability Index (PVi). PVi is
a measure of the dynamic changes in Perfusion
Index (Pi) that occur during the respiratory cycle.
The calculation is made by measuring changes
in Pi over a time interval during which one or
more complete respiratory cycles have occurred.
Pleth Variability Index (PVi) may show changes
that reflect physiologic factors such as vascular
tone, circulating blood volume, and intrathoracic
pressure excursions. PVi is displayed on the same
monitor and obtained with the same sensors as
are used for Masimo SET® pulse oximetry and
rainbow® monitoring.

1 Bundgaard-Nielsen M et al. Acta Anaesthesiol Scand. 2007; 51(3):331-40.
2 Vallet B et al. SFAR. 2013. 3 Grocott et al. Br J Anaesth. 2013.

Inclusion of PVi in
Intraoperative Clinical
Guidelines and Pathways

The positive and expanding evidence for PVi has led to its inclusion in guidelines and best

practices for fluid management.

In a study of colorectal surgery patients managed
with the Enhanced Recovery After Surgery (ERAS)
protocol, PVi was integrated into the fluid therapy
bundle to reduce lactate levels, while the median
length of stay was reduced by 2.1 days.1

The Power of PVi and SpHb Together
While PVi and SpHb can help improve the quality of
care when used individually, the integrative power
of these parameters, brought together by Radical-7
and Root, can provide additional clinical insight.

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.2

In 2013, the French Society for Anaesthesia and
Intensive Care (SFAR ) added PVi to its guidelines
for optimal hemodynamic management of
surgical patients.3

Research suggests that the titration of excess
fluid could lead to hemodilution which could
subsequently increase the risk of complications,
such as tissue edema and cardiopulmonary
complications.4 Additionally, the administration
of excess blood could lead to high hematocrit
or hemoconcentration, which increases risks for
morbidities such as venous thrombosis.5

By using SpHb and PVi together, it is possible to
monitor both total hemoglobin and a patient’s fluid
responsiveness on a single monitor. This visibility can
help clinicians view the changes of these parameters
in response to changing patient condition, or in
response to an intervention such as a transfusion,
in real time. In a clinical study in which investigators
monitored patients with Masimo’s SpHb and PVi, the
result was a decrease in mortality of 25%.6

Operating Room

Intensive Care Unit

100

)

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0.8

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0.4

0.2

Pleth Variability Index (PVi)

Arterial Pulse Pressure Variation (PPV)

Cardiac Index (CI)

Pulmonary Capillary Wedge Pressure (PCWP)

Central Venous Pressure (CVP)

PVi, AUC = 0.97

SVV, AUC = 0.99

CVP, AUC = 0.56

100

Fluid Non-Responders Detection – 100-Specificity (%)

0.0

0.2

0.4
1-Specificity

0.6

0.8

1.0

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%.7

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.8

Intraoperative Surgery

2.5

2.0

)
1
L
I
o
M
m

(

s
l
e
v
e
L
e
t
a
t
c
a
L

1.5

1.0

0.5

0.0

Financial Benefits of Using Enhanced Recovery
After Surgery (ERAS) Protocol Including PVi for
Goal-Directed Therapy

Outcome

Conventional
Approach
without PVi

ERAS
Approach
with PVi

30-day hospital
costs

Median length
of stay

$18,017

$15,150

5 days

3 days

Most recently, and as part of a multi-modal perioperative management approach
called ERAS, PVi was shown to help reduce 30-day hospital costs by $2,867 per
patient and reduce median length of stay by 2 days.1

PVi Group

Control Group

Start

At 24 Hr
Intraoperative Surgery

At 48 Hr

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.9

1 Thiele RH et al. Journal of the American College of Surgeons (2015), doi:
10.1016/j.jamcollsurg.2014.12.042. 2 http://www.ntac.nhs.uk/NewsAndEvents/
IOFM_Technology_Adoption_Pack_Published.aspx. 3 Vallet B et al. SFAR. 2013. 4
Chappell et al. Crit Care, 2014, 18:538. 5 Schreijer et al. Haematologica. 2010 Feb, 95(2).
6 Ponsonnard et al. Proceedings of the European Society of Anaesthesiology Annual
Congress (Euroaneasthesia), 2015, Poster Abstract. 7 Cannesson M et al. Br J Anaesth.
2008;101(2):200-6. 8 Zimmermann M et al. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. 9
Forget P et al. Anesth Analg 2010; 111(4):910-4.

Helping First Responders
Monitor CO Levels and Screen
for Elevated CO Levels

Deadly Exposure Revealed with SpCO
Our original rainbow® measurement, SpCO,
measures carboxyhemoglobin, which forms in red
blood cells upon contact with carbon monoxide
(CO). This is particularly useful for patients who
show no symptoms, but may have been exposed
to dangerously high levels of CO. Evidence has
indicated that noninvasive SpCO monitoring may
lead to the identification of elevated CO levels
that might otherwise go undetected in front-line
settings. SpCO is intended to be used to monitor
CO levels in the blood. SpCO monitoring is not
intended to replace laboratory blood testing
and not to be used as the sole basis for making
diagnosis or treatment decisions related to carbon

monoxide poisoning. Blood samples should be
analyzed by laboratory instruments prior to clinical
decision making.

Results from several clinical studies conducted on
emergency room patients demonstrate that SpCO
technology may be a valuable tool in screening a
large number of patients for possible CO exposure,1,2
supporting the possible use of SpCO as an efficient
and rapid tool in first-line screening.3 A recent study
at the Medical University of Vienna assessed 32,396
emergency room patients with noninvasive SpCO.
Of the 32 patients with a diagnosis of CO poisoning,
22 (69%) would not have been identified without
obtaining an SpCO measurement.4

Saving Lives Every Day
SpCO helps paramedics and emergency medical
technicians identify and assess CO levels in
the blood. Just one severe CO exposure event
nearly doubles the risk of premature death, and
consistent CO exposure may cause long-term
heart and brain damage.5,6

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,
leading to poor decision making and increasing

the risk of heart disease or stroke—two conditions
that account for nearly 50% of on-duty firefighter
deaths.7,8 As a result of factors such as these,
industry-leading organizations have lined up to
support CO education. The National Fire Protection
Association (NFPA) released an updated Fire
Rehabilitation Standard (NFPA 1584) which requires
that firefighters exposed to smoke at incident
scenes and during training be assessed for elevated
carbon monoxide (CO) levels on the scene.

1 Suner S. et al. J Emerg Med. 2008 May;34(4):441-50. 2 Roth D et al. Ann Emerg Med. 2011 Jul;58 (1): 74-9.
3 Sebbane M et al. Respir Care. 19 March 2013. 4 Roth Det al. Int J Clin Pract. 2014 Apr 2. 5 Hampson NB et
al. Crit Care Med. 2009; 37(6):1941-47. 6 Bledsoe BE. J Emerg Med Svcs. 2007l 32:54-59. 7 Jakubowski G.
FireRescue Magazine. 22(11):52-55, 2004. 8 Bledsoe BE. FireRescue Magazine. September 2005.

Immediate Capnography at
the Point of Patient Contact

EMMA™ (Emergency Mainstream Analyzer)
EMMA is a compact, portable, lightweight
mainstream capnograph that requires minimal
warm-up time, with full accuracy in 15 seconds.
Capnographs measure carbon dioxide (CO2)
concentration in expired gases. Their primary
use is short-term monitoring of end-tidal CO2
levels and respiration rate in adults, pediatric, and

infant patients. They are used during anesthesia,
emergency care, and intensive care, where
capnography is often used to confirm endotracheal
intubation and to monitor assisted ventilation
performance. The continuous capnograph allows
clinicians to confirm effective resuscitation, to assess
the depth and effectiveness of compressions, and to
recognize the return of spontaneous circulation.1,2

1 Neumar RW et al. Circulation. 2010;122:S729-S767. 2 2010 American Heart Association.

Helping Clinicians Monitor
Methemoglobin Levels

Acquired Methemoglobinemia
Many drugs commonly used in hospitals—such as
lidocaine, benzocaine, dapsone, and nitrates—may
cause a dangerous reaction known as acquired
methemoglobinemia. Methemoglobinemia is
a blood disorder in which an abnormal amount
of methemoglobin, a form of hemoglobin,

is produced. With methemoglobinemia, the
hemoglobin can carry oxygen but is unable
to release it effectively to body tissues. While
methemoglobinemia can occur in all care areas and
patients, it is often unrecognized and undiagnosed.1
If not identified and treated, it may result in
avoidable injury or death.

Masimo SpMet May Be Valuable in
Methemoglobinemia Assessment
Masimo noninvasive methemoglobin (SpMet) helps
clinicians monitor for methemoglobin in care areas
where the drugs that cause methemoglobinemia
are most common, such as procedure labs and the
operating room. This enables them to quickly adjust

drug regimens and initiate potentially life-saving
treatment.2 SpMet monitoring is not intended to
replace laboratory blood testing and not to be
used as the sole basis for making diagnosis or
treatment decisions related to methemoglobinemia.
Blood samples should be analyzed by laboratory
instruments prior to clinical decision making.

Prevalence of Methemoglobinemia

Number of
Methemoglobinemia
Cases

Patient Ages

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
catheterization 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

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

1 Ash-Bernal R et al. Medicine (Baltimore). 2004 Sep. 83(5):265-73.
2 Annabi EH et al. Anesth Analg. 2009 Mar;108(3):898-9.

Protecting More Patients by
Monitoring Every Breath

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.

rainbow Acoustic Monitoring®
Continuous monitoring of respiration rate is
especially important for post-surgical patients
receiving patient-controlled analgesia for pain
management. The Anesthesia Patient Safety
Foundation (APSF) and The Joint Commission
recommend continuous oxygenation and ventilation
monitoring for all patients receiving opioid-based

pain medications.1,2 Conscious sedation can
induce respiratory depression and place patients
at considerable risk of serious injury or death.3
However, current methods for respiration rate
monitoring may be limited by patient tolerance.3,4
While Masimo offers capnography solutions, rainbow
Acoustic Monitoring may be better suited for post-
surgical monitoring and conscious sedation.

Ability to Detect Respiratory Pause

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 33 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.3

rainbow Acoustic Monitoring provides
noninvasive and continuous respiration rate,
Acoustic Respiration Rate (RRa), an accurate,
easy-to-use, and reliable monitoring solution
that also enjoys higher patient compliance.5,6
RRa may facilitate earlier detection of
respiratory compromise and patient distress,
offering a breakthrough in patient safety for
post-surgical patients and for procedures
requiring conscious sedation.6

Monitoring More Patients More
Safely than Ever Before
When rainbow Acoustic Monitoring is used in
conjunction with rainbow® Pulse CO-Oximetry
and the Patient SafetyNet system, clinicians
can track key oxygenation indicators with
industry-leading Masimo SpO2; ventilation with
breakthrough acoustic respiration rate (RRa);
circulation with Masimo Measure-through
Motion pulse rate (PR); and hemoglobin levels
with Masimo’s continuous and noninvasive
hemoglobin (SpHb).

Patient Tolerance

97.5%

62.5%

100

Capnography
(Oridion Capnostream 20)

rainbow Acoustic
Monitoring

15 out of 40 pediatric patients removed the nasal cannula while
only one removed the rainbow® acoustic sensor.7

RAS-45
Respiratory
Acoustic Sensor

1 Stoelting RK et al. APSF Newsletter. 2011.
(www.apsf.org). 2 The Joint Commission Sentinel
Event Alert. Issue 49, August 8, 2012. http://www.
jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_
final.pdf 3 Ramsay M et al. Anesth Analg. 2013. 4 Applegate
RA et al. Anesth Analg. 2016;122(4):1070-8. 5 Macknet MR et al.
Anesthesiology. 2007;107:A84. (abstract) 6 Goudra BG et al. Open J
Anesthesiol. 2013; 3:74-79. 7 Patino M et al. Paediatr Anaesth. 2013 Sep 3.

Rad-97™ and Rad-67: Our Next
Generation of Compact Portable
Patient Monitors

The new family of monitors will include
Rad-67, a compact handheld device

Rad-97 is our newest patient monitoring and
connectivity device.* Highly configurable
and adaptable for use in a wide variety of
care areas, Rad-97 utilizes our breakthrough
rainbow SET measurement platform with
future options to add capnography or
noninvasive blood pressure and temperature,
or even a camera module to enhance the way
the device works for you.

The touchscreen interface is sleek,
responsive, and highly intuitive. Rad-97’s
customizable display provides clinicians
with pertinent data at a glance, offering
a more complete picture of the patient’s
physiological status. Additionally, the device
settings can be configured to suit a variety
of clinical environments, workflows, clinician
preferences, and patient-specific needs.

*Rad-97 and Rad-67 are
not available in the U.S.

I nno v ating Patient Monitoring
a nd Connectivity Solution s

Moving Hospital
Rooms to the Future

The Root of Patient Care

All of our innovations are designed for one purpose—to enable clinicians to get to the root of

better care for their patients

Root is a powerful patient monitoring and
connectivity platform that augments our
breakthrough rainbow® and SET® measurements
with multiple additional parameters—including
SedLine® brain function monitoring, O3® regional
oximetry, and capnography and gas monitoring.

Root includes a dock for the Radical-7 or Radius-7®,
an intuitive display, and Iris® connectivity ports
for third-party devices such as infusion pumps,
ventilators, and anesthesia machines. Root integrates
multiple streams of data and simplifies patient care
workflows, helping caregivers make quicker patient
assessments, earlier intervention, and better clinical
decisions throughout the continuum of care.

Intuitive Multi-touch Navigation
Root is as easy to use and configure as the
smartphone in your pocket. With a simple tap,
swipe, or drag-and-drop, screen views and
parameter sizing can be customized to suit a
given care area, workflow, clinician preference,
or patient-specific need. This allows Root to be
used across a wide variety of environments with
disparate clinical and operational requirements—
from the operating room, to the intensive care
unit, to medical-surgical units.

Screen views and parameter
sizing are easily customized
with a simple tap, swipe,
pinch, or drag-and-drop

Trend view

Analog view

Alarm Status Visualizer

Versatile, High-visibility Display
Root displays Masimo’s breakthrough noninvasive
measurements with a docked Radical-7 handheld or
paired Radius-7 patient-worn monitor. The brilliant,
high-resolution, adaptive display is designed to
aid clinicians’ rapid assessment of patient status in
three distinct ways:

1. Trend view in which each measurement value
is displayed alongside its graphical trend
2. Analog view in which virtual gauges show

measurement values in relation to alarm ranges

3. Alarm status visualizer in which a three-dimensional,
anatomical image associates device measurements
with alarm status

No alarm

Approaching
alarm

Alarm state

customizable display of data from ventilators,
IV pumps, pulse oximeters, lab and radiology
results, and myriad other sources. In high acuity
departments, such as the ED, where comprehensive,

clearly organized, and timely data are key to making
the best clinical decisions and providing the best
patient care, UniView may make all the difference.

Kite®: Flexible, Versatile,
Clinician-centric

Expanding the Visibility of
Patient Data with Masimo Kite®
Kite provides a supplemental display of the
patient data from Masimo devices and connected
MOC-9™ modules, including SedLine brain function
monitoring, O3 regional oximetry, and NomoLine
capnography, through connection to a compatible
smart device, such as an LCD television. How
the patient data is displayed can be configured
differently than on the monitoring device itself. By
customizing what can be displayed, Kite allows
clinicians to focus on the most pertinent data
for each stage of a patient’s care, empowering
clinicians to make more informed decisions. In
addition, Kite also visually projects patient alarms

from the monitoring device, providing quick
notification of changes in a patient’s physiological
status. With its ability to project the most needed
data, with powerful customization possibilities,
Kite allows all clinicians in a busy operating room,
cardiac theater, or other venue to have better
visibility of the patient data they need.

Next Generation Data Aggregation
and Display with Masimo UniView™*
Building on the projection and customization
capabilities of Kite, UniView will take the
aggregation and customizable display of patient
data to a new level. Through a wired or wireless
connection to Masimo Iris Gateway™, which gathers
data from multiple Masimo and 3rd party devices
and sources, UniView will be able to project
integrated, near real-time information about the
patient from all connected systems in the hospital.
UniView will provide a central, convenient, and

*Masimo UniView is currently
not available.

MyView™: Clinician-centric
Monitoring

MyView empowers clinicians to see things their way.

The level and types 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 at all times. 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 every time. MyView
technology—a feature of 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,
patients, and their families each want to see. While
a physician may want to see all parameters and
waveforms, a medical assistant may only want to see
a few parameters and no waveforms. If no clinician is
in the room, the patient and family members 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.

MyView in Patient
SafetyNet automatically
senses when a clinician
approaches and
highlights their patients
for easy viewing

Clinician-centric view with the use of a presence
tag or smartphone allows caregivers to see the
customized information most important to them
as they approach a patient

When no clinician is present, 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 members while
limiting unnecessary concerns and questions. When
a clinician enters the room, MyView recognizes
them and displays that clinician’s preferred view

Root with Iris®: Keeping
Clinicians, Patients,
and Data Connected

Iris Connectivity
Despite advances in medical technology, the lack
of device interoperability is a serious patient safety
risk. Existing approaches for device interoperability
require separate hardware, software, and network
infrastructure which can clutter the patient room,
burden IT management, and increase the complexity
and cost of care. Root with Iris is an important part of
Masimo’s goal of bridging medical device data silos,
acting as a built-in connectivity hub that can integrate

multiple standalone devices. Device connectivity
with Iris is designed to leverage existing network
infrastructure and reduce costs, while enhancing
workflows and decision support. Via Iris Gateway
and Patient SafetyNet, Root with Iris can be used to
connect isolated devices to hospital EMR systems in
high-acuity settings like the OR and the ICU or in low-
acuity settings like the general ward.

Iris Gateway and Patient SafetyNet
Data generated from medical devices typically
remain captive within each device and may not be
captured in patient records. Iris Gateway provides
a timely and cost-effective solution by connecting
to existing medical devices, such as Root with
Iris, and performing the required translations
to move data from devices into the EMR. When
medical device data is readily available in the
EMR, clinicians have a more complete, more timely

picture of the patient. In addition to automated
documentation of patient data from multiple
devices in the EMR, Patient SafetyNet further
enhances connectivity by allowing patient data to
be remotely viewed at central stations and alarms
and alerts to be remotely transmitted to clinicians.
Together, Root with Iris, Iris Gateway, and Patient
SafetyNet are helping to connect clinicians,
patients, and their data more closely than ever.

Automatic data transfer from
medical devices to the EMR could
improve productivity and reduce the
likelihood of transcription errors1

EMR
Patient SafetyNet automates data
transfer from multiple devices
to the EMR

Root + 3rd Party Standalone Devices
Root’s built-in Iris ports act as a
connectivity hub for 3rd party
standalone devices

Patient SafetyNet
Patient SafetyNet converts all Masimo
and 3rd party standalone device
data into HL7

1 The Value of Medical Device Interoperability.
West Health Institute. 2013.

Root with Radius-7™: The Power
of Masimo Measurements in
a Patient-worn Monitor

Designed for Monitoring Mobile Patients
Studies have shown that patient mobility is a key
factor in more rapid patient recovery.1 Radius-7
allows clinicians to continuously monitor their
patients while they are mobile.

Root with Radius-7 can alert clinicians to critical
changes in a patient’s oxygen saturation, pulse rate,

respiration rate, and other key measurements at the
bedside or remotely, through Patient SafetyNet.
Radius-7’s wireless communication functionality—
either short range via Bluetooth® to Root
or with upgradeable WiFi for longer-range
communication—ensures patients can
be continuously monitored and connected
to caregivers while they are ambulating.

Each Radius-7 comes
with two rechargeable,
“hot-swappable” modules

First and Only Wearable rainbow® Monitor
Radius-7 is the only wearable wireless device to
enable continuous noninvasive monitoring of 10
rainbow SET parameters:

• Oxygen saturation (SpO2), pulse rate and perfusion
index (Pi) via Masimo SET® pulse oximetry, shown to
reduce false alarms and increase detection of true
alarms during patient motion and low perfusion

• Respiration rate with either rainbow Acoustic
Monitoring (for increased patient tolerance
versus capnography) or respiration rate from
the pleth (RRp)*

• Noninvasive and continuous monitoring of
a patient’s hemoglobin concentration with
SpHb, carboxyhemoglobin with SpCO;
methemoglobin concentration with
SpMet; oxygen content with SpOC; and
Pleth Variability Index (PVi).

1 Needham D et al. Archives of Physical Medicine and Rehabilitation Vol 91, Issue 4, PP 536-542, April 2010. * Radius-7 with RRp is not available in the U.S.

Root with Noninvasive Blood
Pressure and Temperature

With the addition of blood pressure and temperature monitoring capabilities,

Root is now available as a powerful and versatile vital signs monitor.

Root with integrated noninvasive blood pressure
and temperature (NIBPT) can enhance nursing
workflows and help ensure correct patient data
management. When used in conjunction with
Patient SafetyNet or Iris Gateway, Root with NIBPT
can be interfaced directly to hospital admit,
discharge, transfer (ADT), and charting systems.
This allows nurses to use a USB barcode scanner
attached to Root to scan patient wristbands for
simple, easy patient association, directly at the
point of care.

Once the patient association is complete, all
measurements are sent directly to the patient’s
chart with no additional steps required by the
clinician. In addition to transmitting and charting
data measured by Root NIBPT, the system is
also able to intake information from third-party
devices via its Iris ports, enabling information from
these devices to be charted as well. The system

comes with user-configured software that
prompts clinicians to associate patients so
that data can be charted and stored when
measured, and disassociate patients when
measurements are complete, ensuring that
correct patient data goes to each chart.

Early Warning Score
A recent Root software upgrade adds
the capability to automatically calculate
an Early Warning Score (EWS), based
on existing device measurements and
additional clinician input, that represents the
potential degree of patient deterioration.
As with other patient data, the EWS, which
must be clinician-initiated, can be pushed to
the Electronic Medical Record (EMR) directly
when Root is connected to Patient SafetyNet
or Iris Gateway.

MOC-9™: Flexible
Measurement Expansion With
Masimo Open Connect™

Masimo offers other companies the opportunity to develop and commercialize their

innovations and deliver them to market via the Root platform.

Expanding Masimo Measurements
Root offers expanded measurement capability
through software upgrades and Masimo Open
Connect (MOC-9) modules. SedLine brain
function monitoring, Masimo capnography and
gas monitoring, and O3 regional oximetry are all
provided as MOC-9 modules.

Designed to Stimulate Third-party Innovation
MOC-9 is designed to spur 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
provides an open invitation to other companies,
large and small, to develop and commercialize
their innovations and deliver them to market
via the Root platform. We anticipate a new
ecosystem of third-party measurements
springing from Root, seeding whole new fields
of innovation in patient monitoring.

MOC-9 modules expand
Root’s capability via third-party
development of additional
measurements

SedLine brain function monitoring is a
”plug and play” MOC-9 module

O3 regional oximetry is a ”plug and play”
MOC-9 module

Root with SedLine™ 2.0
Brain Function Monitoring

Four simultaneous channels of EEG data provide continuous information about a patient’s

response to anesthesia.

Patients respond differently to anesthetics,
which can mean over- or under-administration
during surgery and conscious sedation
procedures. SedLine brain function monitoring
provides continuous information about a
patient’s response to anesthesia. With four
channels of high-fidelity EEG data, SedLine
enables monitoring of both sides of the
brain simultaneously. The Density Spectral
Array (DSA) enables immediate recognition
of asymmetrical activity, identification of the
specific frequency in which most EEG activity is
occurring, and an easy-to-see display of burst
suppression events.

Use of SedLine with its Patient State Index (PSi)
has been shown to help clinicians manage
patients to significantly faster emergence from
anesthesia and recovery.1

SedLine 2.0
Our latest brain function monitoring innovation
was developed to display a PSi value that reflects
the patient’s anesthetic state during challenging
brain function monitoring situations. SedLine
2.0 utilizes Masimo’s Parallel Signal Processing
Engines to compute an EEG-derived parameter
(PSi) that is less influenced by electromyography
(EMG). SedLine 2.0 also utilizes Masimo’s
Adaptive Signal Processing with band-
independent features to search across many EEG
frequency bands and thus offer improved PSi
performance in cases of low power EEG.

Case Presentation—EMG

100

i
S
P

EMG

PSi—SedLine 2.0

PSi—SedLine 1.0

100

120

140

160

180

The above case demonstrates the improvement to PSi in SedLine 2.0 in reducing EMG bias in comparison to a legacy algorithm.

SedLine brain
function monitoring
is a ”plug and play”
MOC-9 module

1 Drover DR et al. Acta Anesthesiology. 2002; 97:82-89. SedLine 2.0 is not available in the U.S.

Root with
O3 Regional Oximetry

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to monitor oxygen saturation

(rSO2) in the brain.

The Root of Better Brain Oxygenation Monitoring
Regional oximetry, also referred to as tissue or
cerebral oximetry, may help clinicians monitor
cerebral oxygenation in situations in which pulse
oximetry alone may not be fully indicative of the
oxygen in the brain.

study did not require that end tidal carbon dioxide
(EtCO2) levels be fixed in the study protocol, allowing
the O3 measurement to be responsive to changes
in tissue oxygen saturation due to changes in CO2 in
the blood. Follow-up studies with O3 extended the
subject pool to 74 subjects and demonstrated that
O3 maintained its absolute and relative accuracy.2

In a study on 27 subjects published in Anesthesia and
Analgesia, researchers compared cerebral oxygen
saturation measurements obtained from O3 with
saturations obtained from blood samples (SavO2)
through induced hypoxia.1 O3 regional oximetry
provided absolute root-mean-squared error of 4%
and relative root-mean-squared error of 2.1%.1 This

A Powerful Combination
The combination of O3’s accurate regional
oximetry measurements and SedLine brain
function monitoring provides clinicians with even
more information about the brain’s response to
anesthesia on the same monitoring platform.

O3 Regional Oximetry Specifications

Body Weight

Trending Regional Oxygen Saturation (rSO2) Accuracy

Absolute Regional Oxygen Saturation (rSO2) Accuracy

Adult

Pediatric

> 40 kgs

< 40 kgs

—

1 Redford D et al. Anesth Analg. 2014 Dec;119(6):1315-9. 2 Masimo FDA submission data on file.

O3 regional oximetry
is a ”plug and play”
MOC-9 module

Root with Capnography
and Gas Monitoring

Changes in expired respiratory gas can be an early indicator of an adverse respiratory event.

Capnography can help clinicians quickly spot hypoventilation, hyperventilation, airway
obstruction, and other potentially life-threatening conditions.1

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.
Root with capnography and gas monitoring
complements our breakthrough noninvasive
portfolio with innovative, multispectral
technologies for measuring respiratory gases and
inhaled anesthetic agents. The solutions range

from integrated OEM solutions to an external
“plug in and measure” gas analyzer, to handheld
devices. With multiple measurements delivered
through either mainstream or sidestream options,
clinicians can now benefit from end-tidal CO2,
FiCO2, RR, N2O, O2, and inhalation anesthetic
agent monitoring in a range of hospital
environments—from the operating room, to
intensive care, to the general wards.

Capnography and Gas Monitoring are “plug and play” MOC-9 modules

ISA™ CO2 with NomoLine™ attached to
the back of Root enables capnography
and gas monitoring to be quickly
disconnected from and re-deployed to
any available Root

1 Nagler J et al. Emerg Med Clin North Am. 2008 Nov;26(4):881-97.

Solutions for a Variety of
Capnography Applications

Traditional capnography solutions utilize
compounds such as Nafion® to attract and trap
water which enters the sampling line due to
condensation of the expired patient gas. The
Nafion portion of the sampling line absorbs water
before it enters the gas analyzer and is the most
costly per-patient component of the sampling line.
These components, however, continuously absorb
water, which can occlude the patient sampling
line, causing readings to degrade over time or
potentially result in no readings at all.

NomoLine No Moisture Sampling Line
NomoLine technology eliminates common
problems associated with conventional sidestream
gas analysis. Incorporating a special polymer
and a hydrophobic bacterial filter, NomoLine
technology allows water in the sampling line to
evaporate into the surrounding air. This enables

a single NomoLine to last much longer than
conventional capnography sampling line solutions,
without affecting functionality of the ISA module.
NomoLine’s innovative design also allows multi-
patient use as a “resposable” solution, along with
the use of generic cannulas.

ISA—A High Performance Sidestream Analyzer
Using state-of-the-art spectrometer technology
that utilizes nine different wavelengths of light
and powerful signal processing algorithms, the
ISA sidestream analyzer provides clinicians with
capnography and gas measurements. Crisp
waveforms help depict the clinical situation
from the operating room to the general wards.
Additionally, with virtually no warm-up time and
full accuracy performance in ten seconds, ISA
saves time in critical situations. ISA is factory-
calibrated and does not require field calibration,
minimizing hospital-level maintenance. ISA
sidestream analyzers are available as standalone or
easy-to-integrate OEM modules.

IRMA™—A Complete Monitor in a Probe
With its compact size and microprocessor
technology, the versatile IRMA mainstream analyzer
weighs less than one ounce and fits in the palm of
your hand.

Single-patient-use cannula
and NomoLine adapter

IRMA AX+

EtCO2, RR, N2O,
Inhalation Anesthetic
Agent Identification

IRMA CO2

EtCO2, FiCO2, RR

ISA OR+

EtCO2, RR, N2O, O2,
Inhalation Anesthetic
Agent Identification

ISA AX+

EtCO2, RR, N2O,
Inhalation Anesthetic
Agent Identification

ISA CO2

EtCO2, FiCO2, RR

Reducing the Cost of Care
with Masimo Technologies

At Masimo, we focus not only on improving outcomes but on reducing the cost of care—

which benefits hospitals, clinicians, and patients.

Use of Masimo noninvasive technologies and monitoring systems, including SET pulse oximetry,
Patient SafetyNet, PVi, and SpHb, has been shown to reduce costs in a variety of healthcare settings.

SET Pulse Oximetry and Patient SafetyNet

Estimated Potential Cost Savings
with SET Pulse Oximetry and Patient SafetyNet

With Masimo SET®

Reduction in Arterial Blood Gas Testing1,2
(Masimo SET® compared to conventional pulse oximetry)

Reduction in Ventilator Time1-4
(Masimo SET® compared to conventional pulse oximetry)

False Alarm Distraction Productivity Savings5
(Masimo SET® compared to conventional pulse oximetry)

Reductions in ICU Transfers in 36-Bed Step-down
Unit Due To Continuous Surveillance Monitoring with
Patient SafetyNet, Including SET Pulse Oximetry6,7

$77,520*

$266,450*

$180,180*

$1,479,012

Total Annual Projected Cost Savings

$2,003,162

* Study results were applied to a 250-bed hospital model.

“Implementation of surveillance

with pulse oximetry was

associated with a reduced need

for patient rescue and intensive
care unit transfer.”6

Andreas Taenzer, MD
Dartmouth-Hitchcock
Medical Center, United States

PVi and SpHb

Estimated Potential Cost Savings
with an ERAS Protocol

With Masimo PVi
Cost savings when using PVi as part of Perioperative Enhanced Recovery Protocol8

Cost Savings per patient
in Enhanced Recovery Group

$7,129

Total Annual Projected Cost Savings
in ERAS Group**

$777,061

Estimated Potential Cost Savings
with SpHb During High Blood Loss Surgery

With Masimo SpHb
Cost savings when using SpHb during high blood loss surgery
in a 250-bed hospital with 2,500 surgeries

Estimated Potential Reduction in RBC units9†

473

Total Annual Projected Cost Savings‡

$384,667

Total Potential Annualized Cost Savings

SET Pulse Oximetry + Patient SafetyNet + PVi + SpHb =
$3,164,890¥

“Using a multidisciplinary

approach, we successfully

implemented an ER [Enhanced

Recovery] pathway that led to

substantial reduction in LOS,

complications and costs, while
improving patient satisfaction.”8

Robert H. Thiele, MD
The University of Virginia,
United States

“Total annual blood costs are

largely driven by transfusion

rate, which includes such

factors as the proportion of

surgical patients transfused

and number of RBC units per

patient transfused. Reducing

either or both factors has

the potential to reduce costs
dramatically.”10

Aryeh Shander, MD
Englewood Hospital, United States

1 Durbin CG Jr et al. Crit Care Med. 2002 Aug;30(8):1735-40. 2 Patel DS et al. Advance for Resp Care Managers.
2000: 9(9):86. 3 Dasta JF et al. Crit Care Med. 2005 Jun;33(6):1266-71. 4 Wunsch H et al. Crit Care Med. 2013
Dec;41(12):2712-9. 5 Shah N et al. J Clin Anesth. 2012;24(5):385-91. 6 Taenzer AH et al. Anesthesiology.
2010:112(2):282-287. 7 Taenzer AH et al. APSF Newsletter 2012. 8 Thiele RH, et al. J Am
Coll Surg. 2015 Apr;220(4):430-43. 9 Awada WN et al. J Clin Monit Comput. 2015
Dec;29(6):733-40. 10 Shander A et al. Transfusion. 2010;50(4):753-765.

** Direct costs associated with enhanced
recovery protocol included. † Cost Savings at
$853 per unit RBC10 with a 21% prevalence rate
for high blood loss surgeries. ‡ Includes sensor
costs. ¥ Not all savings may be realized.

Helping Improve
Outcomes on the Wards
With 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—built on Masimo SET® pulse
oximetry with rainbow Acoustic Monitoring
or standard capnography—offers a clinically
proven, cost-effective solution for continuous
post-operative monitoring with high nursing
satisfaction and patient compliance.

Reducing Rescues and ICU Transfers
Clinicians understand the risks of not
continuously monitoring patients on the
general wards. However, excessive false
alarms due to patient motion often preclude
continuous monitoring in these care areas.

In the last decade, Masimo SET® has been
shown in multiple studies to improve the
process of care in neonates and pediatric
patients due to its Measure-through
Motion and Low Perfusion™ performance.
However, in a landmark study published in

Anesthesiology in 2010, researchers found
that continuously monitoring patients on a
post-surgical floor at Dartmouth-Hitchcock
Medical Center using Patient SafetyNet with
Masimo bedside devices resulted in a 65%
reduction of rapid response team activations
and a 48% reduction in transfers back to
the ICU. In addition, the reduction in ICU
transfers over the initial 11-month period led
to a cost savings of $1.48 million.2

Following the initial implementation and
positive results in one post-surgical ward,
Patient SafetyNet with Masimo bedside
devices was expanded to cover more than 200
inpatient beds in all medical and surgical units.
In subsequent articles published in Anesthesia
Patient Safety Foundation Newsletter in
2012 and The Joint Commission Journal on
Quality and Patient Safety in 2016, researchers

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. The financial
impact resulted in annual opportunity cost
savings of $1.48 million.2 Results drove
expansion of the use of Patient SafetyNet
to other care areas; after 10 years, the
hospital had maintained a 50% reduction
in unplanned transfers and 60% reduction
in rescue events, despite increases in
patient acuity and occupancy.3,4

0Patients suffered

preventable brain damage
or died over a 5-year
period3

50%

reduction in unplanned
transfers over a 10-year period4

60%

reduction in rescue events
over a 10-year period4

$1.48M I L L I O N

in annual cost savings2

showed that Patient SafetyNet enabled the facility,
over a five-year period, to achieve their goal of
zero preventable deaths or brain damage due to
opioids,3 and, over a ten-year period, maintain a
50% reduction in unplanned transfers and 60%
reduction in rescue events, despite increases in
patient acuity and occupancy.4

Just as pulse oximetry has become a standard of care
in the OR, PACU, and ICU, we believe that Measure-
through Motion and Low Perfusion pulse oximetry will
become a standard of care on general wards.

Proven Cost-effectiveness
As a result of the study, Dartmouth-Hitchcock
Medical Center saved $1.48 million annually,
showing that implementing Masimo SET® and
Patient SafetyNet to more safely monitor post-
surgical patients can also have a significant impact
on a hospital’s bottom line, by increasing ICU bed
availability and reducing the costs associated
with emergency rescue events. With both clinical
and financial rationales now in place, hospitals
are increasingly implementing general ward
monitoring with Masimo technologies.

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. 4 McGrath SP et al. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

Halo Index™: Better View
of Overall Patient
Physiological Status

Halo Index™* Mimics an Expert Clinician
Halo Index is a new indicator for cumulative
trending assessment of global patient status.
Physiologic deterioration often occurs long
before a crisis event and manifests through
subtle and often undetected changes across
multiple physiologic parameters. Masimo
designed Halo Index to mimic the systematic
approach that expert clinicians use in assessing
patient physiologic deterioration: analyzing
patient history and extracting key vital sign
parameter characteristics to assess global

patient status. Halo Index currently uses
available Masimo parameters but is scalable
to include additional information from the
patient data 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.
An increase in a patient’s Halo Index would
suggest physiologic deterioration and might
indicate the need for clinicians to more closely
assess the patient.

Patient SafetyNet can display actual parameter
values (below) or color-coded alarm states
(right), which allows more patients to be
viewed simultaneously on screen

The relative contribution of each parameter to a patient's
Halo Index is indicated visually by a white dot, as shown to
the right. Whenever a particular parameter is being used in
the Halo Index calculation, the dot appears beneath it. The
size of each dot increases and decreases to reflect changes
in the current weighting of each parameter, which adjusts
dynamically based upon available clinical data.

In this example, a rising Halo Index indicates a declining patient
condition while displaying parameter trends and their relative
contributions to the Halo Index

* Halo Index is not available in the U.S.

Ta kin g Noninvasive Monitoring to
New S ites and Applications ™

Through Our
Movements, We Are
Doing What is Best
for Patient Care

Impact Beyond
the Hospital

Masimo technologies are increasingly being used to enhance the quality of patient care outside

the hospital.

A New Level of Care in the Home
The new Rad-9™* bedside pulse oximeter will be
easily customizable to suit the needs of the home
user. With an intuitive touchscreen interface, device
settings can be quickly and easily managed. To
ensure safety, the “Home” mode setting will lock
out non-clinicians from inadvertently changing
alarm settings. Rad-9 will be able to trend and store
parametric data for up to 96 hours at a two-second
sampling rate and offer the ability to transfer
data wirelessly via Bluetooth or WiFi, supporting
burgeoning telehealth initiatives.

Rad-9’s wireless connectivity options allow the
device to communicate with connected devices,
such as glucometers and weight scales, and can
allow the data from the connected device to be

transmitted remotely. Rad-9 will be available for
use on home and enterprise networks to connect
to remote monitoring systems, including Patient
SafetyNet. Additional devices can be simultaneously
attached to Rad-9 using the Iris hub.

Adding a Safety Net to 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
expose patients to increased risk of adverse
events.1 When ventilated patients are moved to
long-term care or assisted-living environments,
Rad-9 will provide continuous monitoring during
transportation to help clinicians manage adverse

respiratory events. The integration of Masimo SET®
bedside pulse oximeters and Patient SafetyNet
remote monitoring and notification systems has
enabled a considerable reduction in rapid response
activations as well as emergency “transfer-outs.”2

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
reliability in this challenging environment.3

Outpatient Clinical Procedures
There are many clinical procedures that require
light or conscious sedation. Under conscious
sedation, patients may have an unexpected
reaction to a drug or may inadvertently be over-
sedated. Both conditions may not be detected
without a monitoring system. For dentistry,
clinicians can monitor a patient’s SpO2 to ensure
adequate breathing throughout the procedure.4
Masimo SET® has also been shown to be useful
during other outpatient procedures such as
colonoscopies and bronchoscopies.5,6

Both Rad-9 and Rad-97 will be available with an optional camera, which can be used in

conjunction with Masimo Patient SafetyNet. The camera will provide a high resolution,
high-frame rate video feed, as well as audio, to the Patient SafetyNet view-station.
When used at home, camera-equipped Rad-9 and Rad-97 will allow patients
and clinicians to interact remotely, making it well-suited as a point-of-care

device for potential telehealth applications.

1 Bouadma L et al. Crit Care Med. 2015
Sep;43(9):1798-806. 2 Taenzer et al. Anesth.
2010;112(2):282-287. 3 Brouillette et al. Anesth
Analg. 2002;94:S47-S53. 4 Coulthard P. Evid Based Dent.
2006;7(4):90-1. 5 Kim YH et al. Dig Endosc. 2014 May;26(3):417-
23. 6 Liao W et al. J Int Med Res. 2012;40(4):1371-80. Rad-9 is
currently not available and the Rad-97 is not available in the U.S.

Rad-9 includes built-in wireless connectivity, via WiFi and
Bluetooth®. Using Bluetooth or a wired USB connection,
Rad-9 can connect to nearby devices, such as glucometers
and weight scales, and can allow the data from the
connected device to be transmitted remotely.

Gearing Up for the
mHealth Revolution

Masimo is well positioned for a future when mobile and medical device

technologies converge.

iSpO2® Rx*—The World’s First Pulse
Oximeter for iOS and Android
Mobile Platforms
Combining a Masimo board-in-cable,
reusable or disposable sensor, and an
app running on a smartphone or tablet

device, iSpO2 Rx features Masimo’s
proven Measure-through Motion and
Low Perfusion pulse oximetry—oxygen
saturation (SpO2), pulse rate (PR), and
perfusion index (Pi).

MightySat™ Rx is the First Fingertip
Pulse Oximeter with Masimo SET®
MightySat Rx* measures SpO2, PR, and Pi in a
compact, battery-powered unit with a large
color screen that can be rotated for real-time
display of the pleth waveform and other
measurements. Optional Bluetooth® wireless
functionality enables measurement display
via a free, downloadable app on iOS® and
Android™ mobile devices.

trended graphical display on a compatible
smart device. The app also interfaces with
the Apple Health Kit for iOS users, further
expanding its utility. The app empowers
clinicians and patients by allowing the
captured data to be shared via email.

MightySat Rx is also available with optional
Pleth Variability Index (PVi), a measure of the
dynamic changes in Pi that occur during the
respiratory cycle.

The Masimo Professional Health App includes
a high resolution plethysmographic waveform,
pulse beep audible feature, and trending
functionality. The app enables users to view
their measurements in real time or over a

Now with Respiration Rate from the Pleth
MightySat Rx now features RRp, a measurement
of respiration rate based on changes in the
plethysmographic waveform.

* iSpO2 Rx and MightySat Rx with RRp are not available in the U.S.

Better Data =
Better Performance™

Throughout our history, Masimo devices have mainly been designed to help patients in

healthcare settings. Now, we’re also helping healthy people live better lives.

We’ve made medical-grade pulse oximetry
technology available in the MightySat™ fingertip
pulse oximeter and iSpO2® pulse oximeter for
smart devices.

and recovery regimens. In addition, private pilots
are increasingly using our pulse oximeters to
accurately measure their oxygen levels, which
can fluctuate to very low levels at higher altitudes
without supplemental oxygen.

These devices are increasingly being used for
general wellness and health applications including
sports, fitness, and relaxation management.* Elite
athletes such as Olympic cycling medalist Dotsie
Bausch, Ironman® champion Heather Jackson, and
tennis stars Coco Vandeweghe and Taylor Fritz are
using our technologies to enhance their training

The “Quantified Self”
The “quantified self” movement is based on the
practice of self-knowledge through self-tracking
diet, sleep, activity, and—increasingly—health and
wellness. By tracking and comparing data over time,
one gains a more comprehensive and objective
understanding of one’s health and how to actively
manage oneself toward an optimal state. Such

self-tracking can be motivated by a simple desire
to improve daily function, or for amateur and
professional athletes to up their game.

you’re going to quantify yourself, you should have
the best, most reliable data available to you. That’s
what we mean by Better Data = Better Performance
and Better Data = Better Health.

The Masimo Advantage
Multiple companies have introduced low-priced
health tracking devices, including pulse oximeters,
to the consumer market. In some circumstances,
these products may provide inaccurate
measurements or no measurements at all. With
blood oxygen levels, this often occurs when
there is low blood flow to the finger (such as
when the fingers are cold) or during hand
movement (even with minimal motion, such
as shaking). In addition, many of the products
on the market are of low quality and do
not interface with smart devices to store,
manage, and share data. With MightySat and
iSpO2, the same high-performing Measure-
through Motion and Low Perfusion Masimo
SET® technology used by leading hospitals
is now available for general wellness and
health applications. We believe that if

“ Masimo MightySat tracks key

biometric data that allows me

to measure and improve my

athletic performance and

gauge my recovery.”

~ Dotsie Bausch

100

101

*For personal use.

Taking Noninvasive Monitoring
to the Animal Kingdom

Masimo Animal Health offers veterinarians the same industry-leading monitoring solutions that

have helped so many human patients.

Masimo SET® monitors and sensors enhance the
accuracy of arterial oxygen saturation (SpO2) and
pulse rate (PR) monitoring, particularly during the
most challenging conditions of motion and low
perfusion. Masimo SET® helps veterinarians provide
exceptional care—especially when patients are
most at risk, during anesthesia-induced operating
procedures and post-operative recovery.

Innovative Capnography Protects Animals
from the Operating Room to Recovery
Over 60% of all post-surgical animal deaths occur
in the post-operative setting. More than 70% of
these deaths are related to cardiovascular or
respiratory problems.1

The EMMA capnograph is Masimo’s most cost-
effective method for monitoring end-tidal CO2
and can help identify animals needing intervention
during CPR/resuscitation, surgical procedures,
and postoperative recovery.2 This water-resistant,
durable capnograph also meets American Animal
Hospital Association (AAHA) guidelines for end-
tidal CO2 monitoring.3

Cable
Rugged, durable design
with reliable connectors
for better performance

Sensor
Masimo provides a full line
of reusable sensors for
various clinical applications

Rad-9**

Technology
Look for Masimo SET®—the market leader in pulse
oximetry —for accurate measurements during
challenging conditions

102

1 Hall et al. Veterinary Anaesthesia. 10th ed. London, England: W.B.
Saunders;2001:51-53. 2 Brodbelt D et al. Vet Ane and Anal. 2008; 35: 365-373.
3 Bednarski et al. J Am Anim Hosp Assoc 2011; 47:377-385.

* All accuracy specifications and claims are based on human volunteer studies with sensors
placed on specifically determined sites for a given sensor type. Accuracy may vary for SpO2 depending
upon species, sensor type, and monitoring site. Refer to operator’s manual for complete description, instructions,
warnings, cautions, and specifications. ** Rad-9 is not currently available.

103

A Revolutionary
Patient Safety Movement

We live in turbulent times. Disruption and upheaval are the hallmarks of our age.

Some changes are positive—like medical advancements and the drive to empower patients.

However, some of the global geopolitical changes are wreaking havoc and suffering on an

unprecedented scale—for instance, the Syrian refugee crisis. Masimo is proud to be right in

the thick of things, helping out wherever we can.

ZERO Preventable Deaths by 2020
In January 2017, the Patient Safety Movement
(which the Masimo Foundation founded in 2012
and continues to sponsor) hosted the fifth annual
World Patient Safety, Science & Technology
Summit in Dana Point, California. President Bill
Clinton and Vice President Joe Biden keynoted the
event at which hundreds of diverse stakeholders
from all parts of the global healthcare ecosystem
came together to advance a vital mission—to
eliminate preventable patient deaths.

The Patient Safety Movement believes that “ZERO
preventable deaths by 2020” is not only a worthy
goal, but an attainable goal. By fostering and
facilitating mass collaboration; by breaking down
information silos that exist between hospitals,
medical technology companies, the government,
and other stakeholders; by promoting the data
sharing that can identify at-risk patients before
they’re in danger; and by providing specific,
actionable patient safety solutions (APSS) that
healthcare professionals can implement today,
we can eliminate preventable patient deaths.
It is simply a matter of connecting all the dots.

Helping Our Neighbors
All Over the World

Through our partnerships with the Clinton Global Initiative, the World Health Organization (WHO),

Partners in Health, and other organizations, Masimo is proud to contribute to worldwide healthcare

improvements, including donating $5 million in medical equipment to assist Jordan in providing

healthcare to over 1 million Syrian and Iraqi refugees.

The wars in Syria and Iraq constitute one of the
largest ongoing humanitarian crises in the world.
Over a million displaced people are now living
within Jordan’s borders, more than 600,000 of
whom are registered with the United Nations High
Commissioner for Refugees (UNHCR). Managing
healthcare is a critical requirement for stability
during crises and, while new hospitals are being
built near refugee camps, the vast majority of
refugees in Jordan reside in existing communities,
heightening the demand for health services
throughout the country. Masimo was determined
to help ease the burden of providing healthcare
by donating pulse oximeters and other medical
equipment and supplies, along with a long-term

commitment to train and provide continued
technical support for the Jordanian clinicians who
are delivering the front-line care.

Patients in many parts of the developing world
lack access to even basic medical screenings.
Working with WHO, Masimo donated pulse
oximeters for use by front-line health workers in a
study in Bangladesh, Ethiopia, India, and Malawi
which focused on improving access to essential
treatments for children. Masimo also donated pulse
oximeters to hospitals in Liberia and Sierra Leone
as part of a joint effort with Partners in Health to
rebuild the West African healthcare system.

104

105

The A ppendix

The Movement
Continues

Technologies and Products

PATIENT SAFETYNET™ SYSTEM

MONITORS

TECHNOLOGIES AND PARAMETERS

Masimo SET® Pulse Oximetry
Measure-through Motion and Low Perfusion™ pulse oximetry

• Functional Oxygen Saturation (SpO2)
• Pulse Rate (PR)
• Perfusion Index (Pi)
• Pleth Variability Index (PVi®)
• Respiration Rate from the Pleth (RRp™)

rainbow® Pulse CO-Oximetry and Acoustic Monitoring
Noninvasive blood constituent and fluid responsiveness monitoring
• Oxygen Content (SpOC®)
• Oxygen Reserve Index™ (ORi™)
• rainbow Pleth Variability Index (RPVi™)
• Acoustic Respiration Rate® (RRa®)
• Plus all Masimo SET® measurements

• Total Hemoglobin (SpHb®)
• Carboxyhemoglobin (SpCO®)
• Methemoglobin (SpMet®)
• Fractional Arterial Oxygen

Saturation (SpfO2™)

O3 Regional Oximetry

• Tissue Oxygen Saturation (rSO2)

Brain Function Monitoring
Noninvasive depth of sedation monitoring

• Patient State Index (PSi)

Capnography and Gas Monitoring

• End-tidal Carbon Dioxide (EtCO2)
• Fractional Concentration of Inspired Carbon Dioxide (FiCO2)
• Respiration Rate (RR)
• Nitrous Oxide (N2O)
• Oxygen (O2)
• Inhalation Anesthetic Agent Identification (Agent ID)

Patient SafetyNet Remote Monitoring and Notification System

• Direct alarms to nurse via pager
• Open architecture with HL7 interface to hospital EHR
• MyView™ for clinician-centric monitoring

Rad-5®
Masimo SET®
Pulse Oximeter

Rad-57®
rainbow SET™
Pulse
CO-Oximeter®

Pronto®
rainbow SET™ Pulse
CO-Oximeter® with
SpHb spot-check

Rad-67™
rainbow SET™
Pulse CO-Oximeter®
with SpHb spot-check

Rad-9™
Masimo SET®
Pulse Oximeter

Rad-97™
rainbow SET™
Pulse CO-Oximeter®
with rainbow
Acoustic and blood
pressure monitoring

Radical-7®
rainbow SET™
Pulse CO-Oximeter®
with rainbow
Acoustic Monitoring

Root® with NIBPT
rainbow SET™ with rainbow Acoustic and blood
pressure monitoring, temperature, MOC-9™, Iris™

Root®
rainbow SET™ with rainbow Acoustic Monitoring, MOC-9, Iris

Root with Radius-7®
rainbow SET™ with rainbow Acoustic Monitoring, MOC-9, Iris

CIRCUIT BOARDS

SENSORS

MX-7™
Low power rainbow®
OEM board

MSX™
Very low power
SET® OEM board

RD SET™
SpO2, PR, Pi, PVi

SAMPLING
LINE

EXTERNAL MEASUREMENT
TECHNOLOGIES

RD rainbow SET™
SpO2, PR, Pi, PVi, SpHb,
SpCO, SpMet, SpfO2, SpOC,
ORi, RPVi

RD rainbow Lite SET™
SpO2, PR, Pi, PVi, ORi, RPVi

Specialty Sensors
(Ear, Forehead, Blue, Newborn)
SpO2, PR, Pi, PVi

rainbow® Sensors
SpO2, PR, Pi, PVi, SpHb, SpCO,
SpMet, SpOC, ORi, RPVi

rainbow®
Acoustic Sensor
RRa

RD SedLine®
Sensor
PSi

O3™ Sensor
rSO2, SpO2*

NomoLine™
Sampling line and
NomoLine adapter

EMMA™
Portable
mainstream
capnograph

EMMA™
Portable
mainstream
capnometer

ISA™
Sidestream
Capnography and
Gas Monitoring

IRMA™
Mainstream
Capnography and
Gas Monitoring

SedLine®
Brain Function
Monitoring

O3™
Regional
Oximetry

iSpO2®** and
iSpO2®** Rx
SpO2, PR, Pi

MightySat™ and
MightySat™ Rx
SpO2, PR, Pi, PVi, RRp

See Regulatory Notice. * For informational use only. ** Smart device not included.

Improving Patient Outcomes and
Reducing Cost of Care by Taking
Noninvasive Monitoring to New
Sites and Applications®

111

Senior
Management
Team

From left to right: Matthew Anacone, Senior Vice President,
North America Sales; Tetsuro Maniwa, President, Masimo
Japan; Rick Fishel, President, Worldwide OEM Business
& Strategic Development; Jon Coleman, President,
Worldwide Sales, Professional Services & Medical Affairs;
Anand Sampath, Chief Operating Officer; Joe Kiani, Chief
Executive Officer; Mark de Raad, Executive Vice President,
Chief Financial Officer; Tom McClenahan, Executive Vice
President, General Counsel; Yongsam Lee, Executive
Vice President, Chief Information Officer; Bilal Muhsin,
Executive Vice President, Engineering; Stacey Orsat,
President, Europe, Middle East & Africa

Board of Directors (not pictured): Joe Kiani, Chairman
of the Board of Directors; Steven J. Barker, MD, PhD;
Sanford Fitch; Senator Tom Harkin; Adam Mikkelson;
Craig Reynolds

National and International
Awards for Excellence

2015 Life Sciences IP Champion Award

2012 Gold “Stevie” Award for Best New
Health Product for the Pronto-7®

2015 SafeCare Person of the Year

2012 National Entrepreneur of the Year
Life Sciences Award Winner

BECKER’S

Hospital Review

2015 Becker’s Hospital Review
Top 50 Leaders in Patient Safety

American Association for Respiratory Care

2011 Zenith Award at the American
Association of Respiratory Care Congress

American Association for Respiratory Care

2008 Zenith Award

2008 Best in Class

2005 Innovative Product
and Technology

2003 Platform ABBY for Innovations
in Healthcare

2015 GOLD Medical Design
Excellence Award for Root

2011 High-Tech Innovation for the Pronto-7

2008 Outstanding Medical
Device Company

2003 Technology of the Year in
Patient Monitoring

American Association for Respiratory Care

2014 Zenith Award

2011 WINNER

2011 Medical Design Excellence Gold
for the Pronto-7

2008 Outstanding Growth

2003 New Standard of Care

2014 Hubert H. Humphrey
“Dawn of Life” Award

2011 Product Design Award
for the Pronto-7

2008 Excellence in Medical Technology

2001 Medical Design Excellence

BECKER’S

Hospital Review

2014 Becker’s Hospital Review
Top 50 Leaders in Patient Safety

2010 Respiratory Product
Best-in-Class Award

2007 Patient Monitoring Technology
Leadership of the Year

2001 Distinguished Leadership

2013 Zenith Award at the American
Association of Respiratory Care Congress

2009 Masimo SET® and Patient SafetyNet help
Dartmouth-Hitchcock Medical Center win the
4th Annual Health Devices Achievement Award

2013 Best Clinical Application of
Technology Award for SpHb

2009 Patient Monitoring CEO of the Year

2013 EMS World Top Innovation Award
for EMMA

American Association for Respiratory Care

2009 Zenith Award

2013 Hot Product Award
for EMMA and iSpO2

2009 Best in Class

114

2007 Groundbreaking Innovation
of rainbow® SET

2007 Excellence in Technology
Innovation for Noninvasive
Total Hemoglobin Monitoring

2001 Innovative Product and Technology

2000 Technology Excellence

2006 Medical Design Excellence

2000 Outstanding Medical Device Company

2006 Application of Technology for
Noninvasive Methemoglobin and
Carboxyhemoglobin Monitoring

1995 Excellence in Technology Innovation
for Measure-through Motion and
Low Perfusion™ Pulse Oximetry

115

Select
OEM Partners

s e l e c t p a r t n e r s

Masimo SET® is integrated in more than 100 OEM monitors from 50 leading brands—more than

any other pulse oximetry technology. In addition, more and more of our OEM partners are
enhancing the capabilities of their monitoring solutions by integrating rainbow® technology.

s e l e c t p a r t n e r s

116

117

Global
Reach

Masimo is committed to

improving patient care

globally, with over 4,000

talented people worldwide

and operations in North

America, Europe,

Latin America, the Middle

East, Asia, and Australia.

HEADQUARTERS
Corporate Headquarters
52 Discovery, Irvine CA 92618
USA
Tel: 949 297 7000

INTERNATIONAL OPERATIONS
International Headquarters
Puits-Godet 10, 2000 Neuchâtel
Switzerland
Tel: +41 32 720 1111

MANUFACTURING CENTERS
U.S. Manufacturing
40 Parker
Irvine, CA 92618, USA

25 Sagamore Park Rd
Hudson, NH 03051, USA

Mexico Manufacturing
Calzada Del Oro No. 2001
Modulo-6, Mexicali, 21395
Mexico

Industrial Vallera de Mexicali S.A. de C.V.
Calle José López Portillo, 104-A, Parque
Industrial, Código Postal 83455,
San Luis Rio Colorado, Sonora, Mexico

118

Sweden Manufacturing
Svärdvägen 15,
SE-182 33 Danderyd, Sweden

Headquarters

Manufacturing Centers

Country Offices

Subsidiaries

Masimo Distributors

Masimo OEMs

Masimo Capnography OEMs

COUNTRY OFFICES
Asia Pacific
31 Ubi Road 1, #04-05
Singapore 408694
Tel: +65-6521-6700

Australia
Suite 3, Bldg. 7
49 Frenchs Forest Rd
Frenchs Forest, NSW 2086
Australia
Tel: 1-300-MASIMO

Austria
Meldemannstr. 18
1200 Wien
Austria
Tel: +43 (0)1 533 7361

Canada
4878 Rue Levy Street, Suite 200
Saint-Laurent, Québec H4R 2P1
Canada
Tel: 888 336 0043

China
#1004, Hopson Building
13 Deshengmen Wai Street
Xicheng District, Beijing 100088
China
Tel: +86 (10) 8201-0588

France
Espace Europeen Ecully
15 Chemin du Saquin, Bat G
69130 Ecully
France
Tel: +33 (0) 4 72 17 93 70

Germany
Niederlassung, Deutschland
Lindberghstr 11, 82178 Puchheim
Germany
Tel: +49 89 800 65 899-0

Hong Kong
22/F Unit 6, Tower 1, Millennium City 1
No. 388 Kwun Tong Road
Kwun Tong, Kowloon
Hong Kong
Tel: +852-2326-3011

India
70/2 Miller’s Rd
Miller’s Boulevard, 2nd Floor
Bangalore 560052
Karnataka State
India
Tel: + 1 800 425 MASIMO

Italy
Via Domenico Scarlatti 30
20124 Milano
Italy
Tel: +39 02 4507 6308

Japan
Shinjuku Front Tower, 24F2-21-1 Kitashinjuku,
Shinjuku-ku, Tokyo, 169-0074
Japan
Tel: +(81) 3-3868-5201

Korea
Platinum Tower 2F
Seochodae-ro 398, Seochu-gu
Seoul, South Korea
Tel: +82 2 597 4900

Latin America/Mexico
Paseo de la Reforma 404, Piso 6-602
Edificio Moncayo, Col. Juárez
México, D.F. 06600
Delegación Cuauhtémoc
Tel: +52 5511-2799

Middle East
Offices 505-508, Manhal Center
Manhal Square, Jubaiha, Amman
Jordan
Tel: +962 7 9701 1135

Netherlands
Hart van Brabantlaan 12-14-16
5038 JL Tilburg
Netherlands
Tel: +31 135 832 479

Saudi Arabia
360 Sulaimaniya Offices
Prince Sultan bin abdulaziz St.
Al Sulaimaniya District
Tel: +966 11 4721113

Spain
Ronda de Poniente, 12 2F
28760 Tres Cantos, Madrid
Spain
Tel: +34 91 8049734

United Kingdom
Matrix House, Basing View
Basingstoke-Hampshire RG21 4DZ
Tel: +44 (0)1256 479988

SUBSIDIARIES
Masimo Semiconductor
25 Sagamore Park Rd
Hudson, NH 03051, USA
Tel: 603 595 8900

Masimo Sweden AB
Svärdvägen 15,
182 33 Danderyd, Sweden
Tel: +46 8 544 98 150

Turkey
Mustafa Kemal Mah. 2125. Sok
Kolbay Is Merkezi C Blok No. 6/10
Ugur Apt. No. 15/8, Cankaya / Ankara
Tel: +90 312 219 54 38

THIRD PARTIES
Masimo Distributors
Masimo OEMS
Masimo Capnography OEMS

119

Financial
Performance

Condensed Consolidated Statements of Operations
(unaudited, in thousands, except per share amounts)

Revenue:

Product
Royalty

Total revenue
Cost of goods sold
Gross profit
Operating expenses:

Selling, general and administrative
Research and development
Litigation settlement, award and/or defense costs

Total operating expenses
Operating income
Non-operating expense
Income before provision for income taxes
Provision for income taxes
Net income including noncontrolling interest
Net loss attributable to noncontrolling interest
Net income attributable to Masimo Corporation stockholders
Net income per share attributable to Masimo Corporation stockholders:

Basic
Diluted

Weighted-average shares used in per share calculations:

Basic
Diluted

TWELVE MONTHS ENDED

December 31, 2016

January 2, 2016

$663,846
30,779
694,625
230,826
463,799

253,667
59,362
(270,000)
43,029
420,770
2,429
418,341
117,675
300,666
---
$300,666

$6.07
$5.65

49,530
53,195

$599,334
30,777
630,111
220,128
409,983

252,725
56,617
(19,609)
289,733
120,250
3,905
116,345
34,845
81,500
(1,800)
$83,300

$1.62
$1.55

51,311
53,707

120

Condensed Consolidated Balance Sheets
(unaudited, in thousands)

Assets:

Current assets:

Cash and cash equivalents
Accounts receivable, net of allowance for doubtful accounts
Inventories
Prepaid income taxes
Other current assets

Total current assets
Deferred cost of goods sold
Property and equipment, net
Intangible assets, net
Goodwill
Deferred income taxes
Other assets

Total assets

Liabilities and Equity:

Current liabilities:

Accounts payable
Accrued compensation
Accrued liabilities
Income taxes payable
Deferred revenue
Current portion of capital lease obligations

Total current liabilities

Deferred revenue
Long-term debt
Other liabilities

Total liabilities
Commitments and contingencies
Equity:

Masimo Corporation stockholders’ equity:

Preferred stock
Common stock
Treasury stock
Additional paid-in capital
Accumulated other comprehensive loss

Retained earnings

Total Masimo Corporation stockholders’ equity

Noncontrolling interest
Total equity
Total liabilities and equity

December 31, 2016

January 2, 2016

$305,970
101,720
72,542
981
26,014
507,227
79,948
135,996
29,376
19,780
38,975
9,223
$820,525

$132,317
80,960
62,038
2,404
21,423
299,142
66,844
132,466
27,556
20,394
44,320
11,013
$601,735

December 31, 2016

January 2, 2016

$31,125
43,180
31,476
76,316
38,198
71
220,366
25,336
---
14,587
260,289

---
50
(404,276)
382,263
(7,027)
589,226
560,236
---
560,236
$820,525

$25,865
38,415
44,222
2,777
21,280
74
132,633
298
185,071
8,021
326,023

---
50
(340,873)
332,417
(4,739)
288,560
275,415
297
275,712
$601,735

121

Financial
Performance

Condensed Consolidated Statements of Cash Flows
(unaudited, in thousands)

Cash Flows from Operating Activities:

Net income including noncontrolling interest
Adjustments to reconcile net income including noncontrolling
interest to net cash provided by operating activities:

Depreciation and amortization
Share-based compensation
Loss on disposal of property, equipment and intangibles
Provision for doubtful accounts
Gain on deconsolidation of variable interest entity
Benefit from deferred income taxes
Changes in operating assets and liabilities:
Increase in accounts receivable
(Increase) decrease in inventories
Increase in deferred cost of goods sold
Decrease (increase) in prepaid income taxes
Increase in other assets
Increase (decrease) in accounts payable
Decrease in accounts payable to related party
Increase in accrued compensation
(Decrease) increase in accrued liabilities
Increase in income taxes payable
Increase in deferred revenue
Increase (decrease) in other liabilities

Net cash provided by operating activities

TWELVE MONTHS ENDED

December 31, 2016

January 2, 2016

$300,666

$81,500

16,817
12,503
658
259
(273)
5,405

(21,243)
(10,831)
(8,251)
1,355
(7,314)
7,816
(1,092)
5,675
(7,605)
73,755
41,900
6,642
$416,842

15,684
10,825
608
342
---
(1,974)

(9,900)
7,505
(78)
(1,992)
(3,012)
(4,319)
---
5,334
19,902
1,316
58
(4,587)
$117,212

Condensed Consolidated Statements of Cash Flows
(unaudited, in thousands)

Cash Flows from Investing Activities:

December 31, 2016

January 2, 2016

Purchases of property and equipment
Increase in intangible assets
Reduction in cash resulting from deconsolidation
of variable interest entity
Net cash used in investing activities

($19,707)
(4,644)
(763)

($50,393)
(4,201)
---

(25,114)

(54,594)

TWELVE MONTHS ENDED

Cash Flows from Financing Activities:

Borrowings under revolving line of credit
Repayments under revolving line of credit
Debt issuance costs
Repayments on capital lease obligations
Proceeds from issuance of common stock

Payroll tax withholdings on behalf of employee for stock options
Repurchases of common stock
Net equity issuances (repurchases) by noncontrolling interest
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

45,000
(230,000)
(621)
(75)
37,290

---
(68,218)
---
(216,624)
(1,451)
173,653
132,317
$305,970

130,000
(70,000)
---
(80)
28,285

(472)
(150,152)
346
(62,073)
(2,681)
(2,136)
134,453
$132,317

122

123

Forward-looking
Statements

All statements other than statements of
historical facts included in this annual report
that address activities, events or developments
that we expect, believe, or anticipate will or
may occur in the future are forward-looking
statements. Forward-looking statements
include statements which are predictive
in nature, which depend upon or refer to
future events or conditions, or which include
words such as “expects,” “anticipates,”
“intends,” “plans,” “believes,” “estimates”
or the negative of these words or other
similar terms or expressions that concern our
expectations, strategy, plans or intentions.

These forward-looking statements are based
on management’s current expectations 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: actual foreign currency exchange rates;
our dependence on Masimo SET® and Masimo
rainbow SET™ products and technologies for
substantially all of our revenue; our ability to
protect and enforce our intellectual property

rights; potential exposure to competitors’
assertions of intellectual property claims; the
highly competitive nature of the markets in
which we sell our products and technologies;
our ability 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; our ability to retain
and recruit senior management; product
liability claims exposure; our ability to obtain
expected returns from the amount of intangible
assets we have recorded; the maintenance
of our brand; the amount and type of equity
awards that we may grant to employees and
service providers in the future; our ongoing
litigation and related matters; 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, Quarterly Reports on Form 10-Q

and Current Reports on Form 8-K, 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 not undertake
any obligation to update, amend or clarify
these forward-looking statements, whether as
a result of new information, future events or

otherwise, except as may be required under
applicable securities laws.

NOTE REGARDING THIS ANNUAL REPORT
Please note that this annual report does not
constitute our “annual report to security
holders” for purposes of the requirements of
the SEC. For a copy of our annual report to
security holders required under Rule 14a-3 of
Regulation 14A of the Securities Exchange Act
of 1934, as amended, please refer to our Annual
Report on Form 10-K for the fiscal year ended
December 31, 2016, which you may obtain for
free on the SEC ‘s website at www.sec.gov.

124

125

Masimo • 52 Discovery • Irvine, CA 92618 • Tel: 949 297 7000

© 2017 Masimo. Masimo, SET, rainbow, rainbow Acoustic Monitoring, rainbow 4D, rainbow ReSposable, rainbow SET, RD rainbow SET, RD rainbow Lite SET, RD SET, 3D Desat
Index Alarm, Adaptive Probe Off Detection, APOD, Blue, DCI, DOS, DST, EMMA, Eve, FastSat, FST, Halo Index, Iris, Iris Gateway, IRMA, ISA, iSpO2, Kite, LNCS, LNOP, Masimo
Animal Health, Masimo Open Connect, Masimo Patient SafetyNet, Measure-through Motion and Low Perfusion, MightySat, M-LNCS, MOC-9, MS-1, MS-2011, MS-2013, MS-2040,
MST, MX-1, MX-3, MX-5, MyView, NomoLine, O3, Oxygen Reserve Index, ORi, Pronto, Pronto-7, Pulse CO-Oximeter, PVi, Rad-57, Rad-67, Rad-9, Rad-97, Radical-7, Radius-7, RAM,
Root, ROS, RRa, RRp, SatShare, SedLine, Signal Extraction Technology, Signal I.Q., SpCO, SpfO2, SpHb, SpMet, SpOC, SST, TFA-1, TF-1, UniView, uSpO2, X-Cal, and Improve
patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and new applications, 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.

REGULATORY NOTICE
This “Annual Report, International Edition” presents Masimo features and/or products that have obtained CE Mark—unless otherwise noted. Not all features and/or products have
U.S. FDA 510(k) clearance. See the “Annual Report, U.S. Edition” for Masimo features and/or products that are cleared for the United States market. Outside the United States,
please consult local Masimo representatives for the commercially available products in specific regions/countries with the appropriate regulatory approvals/clearances.

60073/PLM-10610B-0617