Masimo Annual Report 2017

FY2017 Annual Report · Masimo

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Automating Care

Letter from the Chairman and CEO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Solutions: Automating Patient Management Across the Continuum of Care . . . . . . . . . . . . . . . . . . . . 182

Automating Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Company Info and Philanthropy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

Measurements: Automating Assessment of Patient Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Financial Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Products: Automating Clinician and Patient Interactions in the Care Environment . . . . . . . . . . . . . . . 98

This International Version of Masimo's Annual Report is intended for investors and also for health care providers outside the United States.

Table of Contents

Letter from the Chairman and CEO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2017 Financial Highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2017 New Product Highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Automating Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Measurements: Automating Assessment of Patient Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Solving the Unsolvable with SET®
Unleashing Breakthrough Performance with SET®
Reducing Retinopathy of Prematurity with SET®

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Challenges to Identifying a Life-Threatening Disorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Improving Screening for Critical Congenital Heart Disease with SET®

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Limitations of Existing Methods to Support Fluid Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Enabling Noninvasive Fluid Responsiveness Monitoring with PVi®

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Comparing PVi to Other Methods for Fluid Responsiveness Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Advancing Goal-Directed Fluid Therapy with PVi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Monitoring Breath Rate with RRp®
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Shining Light on Physiology with rainbow® Pulse CO-Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Risks and Costs of Red Blood Cell Transfusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Adding to Traditional Blood Sampling for Hemoglobin Measurement with SpHb®

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Validating SpHb Compared to Common Invasive Methodologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Helping Manage Blood Transfusion Decisions with SpHb Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Identifying Changes in Hemoglobin Associated with Bleeding with SpHb Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Differentiating Causes of Hemoglobin Drops Using SpHb and PVi Together . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Improving Outcomes in Surgical Patients with SpHb and PVi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Simplifying Fluid Responsiveness Monitoring with RPVi™

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Going Beyond Pulse Oximetry in Monitoring Oxygenation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Indicating Impending Hypoxia Earlier with ORi™
Helping Emergency Personnel Monitor Carbon Monoxide in the Blood with SpCO®
Revealing Elevated Methemoglobin in the Blood with SpMet®
Overcoming a Limitation of Conventional Pulse Oximetry with SpfO2™
Monitoring Capnography and Gas with NomoLine™
Protecting More Patients by Monitoring Every Breath with rainbow Acoustic Monitoring®

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Evaluating Respiration Rate Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 84
Estimating Depth of Sedation with SedLine® Brain Function Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Improving Anesthetic Drug Response with Next Generation SedLine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Enhancing Low Power EEG Performance with Next Generation SedLine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Indicating Brain Oxygenation with O3® Regional Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Combining O3 and SedLine for Simultaneous Brain Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Products: Automating Clinician and Patient Interactions in the Care Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Delivering Multiple Advancements with the RD Sensor System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Advancing Two-LED Monitoring with RD SET™ Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Customizing Applications with Masimo SET® Specialty Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Accessing Advanced Parameters with RD rainbow Lite SET™ Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Advancing Multi-wavelength Monitoring with RD rainbow SET™ Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Enhancing Patient Safety with X-Cal®

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Adapting to Changing Monitoring Needs with Radical-7®
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Getting to the Root® of Patient Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 116
Mobilizing Measurements with Radius-7®
Personalizing Monitoring with MyView™
Expanding Measurements with Masimo Open Connect®

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Offering Solutions for a Variety of NomoLine Capnography and Gas Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

Overcoming the Challenges of Traditional Gas Sampling with NomoLine Cannulas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Fueling Innovation with Masimo Open Connect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Addressing Safety Challenges on the General Ward with Patient SafetyNet™

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Improving Outcomes on the General Ward with Patient SafetyNet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Simplifying and Integrating Multiple Measurements with Halo Index™

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Deploying Root with Noninvasive Blood Pressure and Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Computing an Early Warning Score with Root . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Keeping Patients and Clinicians Connected to the EMR through Adaptive Connectivity Engine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Automating Workflows for Data Collection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Connecting and Controlling Third-Party Devices with Iris®
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Seeing Your Patient No Matter Where You Are with Replica™ and Built-in Camera . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
Extending Visibility with Kite®
Bringing Next Generation Data Aggregation and Display with UniView™

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Virtualizing Monitoring with AirGlass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . 158
Taking Flexibility to the Next Level with Rad-97™
Redefining Handheld Monitoring with the Revolutionary Rad-67™
Accessing Immediate Capnography at the Point of Patient Contact with EMMA™
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Carrying the Most Powerful Pulse Oximeter in Your Pocket with MightySat™ Rx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Providing Better Data for Better Performance with MightySat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Analyzing Patient Data with Trace™

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . 172

Integrating Technology into Leading Multi-parameter Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Select OEM Partners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Technologies and Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

Solutions: Automating Patient Management Across the Continuum of Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182

Physician Office . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Pharmacy Clinics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

Emergency Medical Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

Emergency Department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190

Newborn Care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Operating Room and Post-Anesthesia Care Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

Neonatal Intensive Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

Intensive Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

General Ward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

Post-Acute Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Home Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Developing World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214

Company Info and Philanthropy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

Financial Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Letter from the Chairman and CEO

Reflecting on the Past
and Defining the Future

Looking Back

I founded Masimo in 1989, nine years later we
launched Masimo SET® worldwide, and nine years

bookings. While this alone is great news for you,

our shareholders, you will be delighted to hear

after that, in August 2007, we took Masimo public.

the feedback I received from one of our largest

From the beginning, we took a long-term view,

customers, who in 2017 renewed their system-

developing products and only launching them

wide pulse oximetry agreement with us. When I

when we believed they would make a clinical

called to thank their chief medical stakeholder, she

difference. With a clear and consistent strategy,

said “We are happy to renew our agreement with

we remained relentlessly focused on execution,

Masimo because Masimo is advancing medicine

no matter what obstacles and hurdles were thrown

at an unprecedented rate, and we are just trying to

in front of us. Today, Masimo’s technologies help

keep up with it.” She added, “Your service is also the

clinicians take better care of over 100 million

best, bar none, and your prices are competitive.”

patients a year, and the exceptional impact our

Perhaps I could end my letter with this because it

revolutionary technologies have had on patient

truly says it all, but I want you to know this feedback

care throughout the world has created significant

did what our customer may have intended — drive

shareholder value.

us to double down on innovation that will advance

medicine, double down on the level of service

2017 marked the end of our ten-year, post-IPO

we provide, and double down on treating our

plan. One of our many 2017 accomplishments

customers fairly, helping them to improve patient

was record hospital-wide pulse oximetry contract

outcomes and reduce cost of care.

Today, Masimo technologies save countless
lives as they touch over 100 million patients
every year, or about 3 patients every second1

Joe Kiani
Chairman and CEO, Masimo

1 Estimate: Masimo data on file.

Looking Forward

In the coming years, we will remain committed

healthcare budgets around the world cannot

to the same guiding principles that have served

keep up with these additional demands, but in

us well for 29 years, while expanding our mission

these challenges we see opportunities to help. We

to focus on improving patient outcomes and

can reduce the cost of care by helping clinicians

reducing the cost of care through any possible

improve patient safety and dismantle many of the

means. We will continue to advance technology

barriers — such as disconnection between devices

and products in our core business of noninvasive

and increased documentation requirements — that

monitoring while also expanding our portfolio

hinder patient-clinician interaction. We believe

into new markets. Our growth will be driven

there is a tremendous opportunity for automating

by internal R&D, and we will look for unique

care by leveraging technology that lessens clinician

opportunities to supplement those efforts with

cognitive overload, providing clinicians the extra

external licensing and acquisitions. In doing

time and decision-support tools required to

so, we will leverage our strengths in signal

improve patient outcomes and patient satisfaction.

processing, systems theory, clinical research,

and manufacturing. With steadfast adherence

Our focus on how our products can help automate

to our guiding principles, we will expand our

opportunities, deepen our impact on global

care has expanded over time. When we invented
SET® Measure-through Motion and Low Perfusion™

health, and increase long-term shareholder value.

pulse oximetry, we saw how more accurate and

reliable monitoring helped facilitate care by

We know that healthcare systems are intensely

reducing the time clinicians spent walking to the

focused on improving quality and decreasing

bedside to investigate false alarms, by reducing

costs, but we also see that clinicians are faced with

the number of invasive blood samples they took

growing workloads as the number of patients and

to confirm measurements, and by reducing the

the severity of their illnesses increase. The available

need to use multiple sensors per patient just to

MISSION STATEMENT

Improve patient outcomes and

reduce the cost of care

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

obtain a reliable measurement. Next, we saw how
more accurate SET® pulse oximetry measurements

Over the next several years, we believe we can help

automate care even more with the Root patient

helped clinicians make better clinical decisions

monitoring and connectivity platform by reducing

for children, such as premature babies, helping

complexity through the integration of data from

to reduce the rate of retinopathy of prematurity

multiple disparate monitors and therapeutic

and helping to identify newborns at risk of critical

devices, by deploying decision support algorithms,

congenital heart disease. Then, we saw how our
accurate SET® pulse oximetry measurements

by saving time through semi-automated and

automated bedside vital signs measurement and

allowed, for the first time, reliable monitoring

documentation, and by improving data interpretation

of patients on the general ward — resulting

through adaptable and intuitive displays.

in decreased rapid response activations, ICU

transfers, and mortality in post-surgical patients.

We envision a future where patients are more

When we introduced noninvasive blood constituent
monitoring with rainbow SET™ Pulse CO-Oximetry,

comfortable and connected to their families and

caregivers, manual steps are streamlined, data

from multiple sources are integrated and easier to

we saw how new noninvasive measurements,

interpret in less time, device control is centralized,

previously only possible through invasive or

and all patients can receive best-in-class care

complex procedures, helped automate care by

through real-time decision support systems — made

quickly and easily identifying important aspects

possible through predictive algorithms and expert

of patient status, such as monitoring for carbon

learning systems.

monoxide in the blood not only of asymptomatic

patients but also of fire services personnel at the

Healthcare technology that was once considered

scene of a fire. We also saw how adding continuous

and noninvasive hemoglobin measurements to

supplement intermittent and delayed lab results

science fiction is becoming reality. We have already
automated and improved care with both SET® and
rainbow®. The third chapter of our automating care

could change patient management, for example,

story is poised to sustain and enrich our heritage of

by monitoring hemoglobin levels during surgery to

advancing medicine. It is an exciting time for patients,

help clinicians avoid unnecessary blood transfusions

clinicians, and for all of us at Masimo as we continue

when hemoglobin is stable or speed up necessary

pursuing our long-term mission of improving patient

transfusions when hemoglobin is dropping.

outcomes and reducing cost of care.

Joe Kiani

Chairman and CEO

2017 Financial Highlights

Revenues
In millions of dollars

Product revenues
Royalty and other revenues

439.0

32.5

406.5

405.4

49.0

356.4

349.1

49.0

300.1

307.1

47.5

259.6

798.1

56.8

741.3

694.6

30.8

663.8

630.1

30.8

599.3

586.6

29.8

556.8

547.2

29.8

517.4

493.2

28.3

464.9

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

Earnings Per Share

Non-recurring

$5.65

$3.49

$1.21

$0.88

$1.05

$1.07

$1.02

$0.53

$2.36

$1.55

$2.22

$1.30

2008

2009

2010

2011

2012

2013

2014

2015

20161

2017

1 Included in the FY2016 Historical GAAP Earning Per Share was $3.49 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.

Financial Results Summary

2017 Total Revenues

$798,108,000

2017 EPS

$2.36

2017 New Product Highlights

Among the many new products you will see in this annual report, we announced the following in 2017:

Measurements

RPVi

SpHb
2.0

Devices

Created with our unwavering commitment to improve noninvasive measurements, RPVi
was designed to provide enhanced specificity to changes in fluid volume compared to PVi1

Next Generation Spot-Check SpHb (noninvasive hemoglobin) technology with the
rainbow DCI®-mini sensor for improved motion tolerance, faster time to display SpHb

results, and enhanced field performance

•

Rad-G™ pulse oximeter, developed in partnership with
the Bill & Melinda Gates Foundation, to enable guided

screening in low-resource settings around the world

•

Rad-67 handheld Pulse CO-Oximeter®, providing
Next Generation Spot-Check SpHb and rainbow

SET technology and advanced communication

capabilities in a portable spot-check device with

touch screen user interface

•

Rad-97 portable and compact Pulse CO-Oximeter,

for hospital and telehealth home monitoring hub,

including configurations with integrated NomoLine

capnography and noninvasive blood pressure

(NIBP) measurement

Rad-97

Rad-G

Rad-67

rainbow PVi (RPVi), a multi-wavelength version of the currently available PVi. PVi, while being

a noninvasive technology to help clinicians monitor fluid responsiveness in mechanically

•

rainbow® DCI Mini Super Sensor, providing the ability to simultaneously measure total hemoglobin
(SpHb), carboxyhemoglobin (SpCO), methemoglobin (SpMet), arterial oxygen saturation (SpO2),

ventilated patients, in studies has been shown to be as good as invasive techniques.

and other measurements for a total of nine parameters on the same noninvasive sensor

Sensors

•

RD rainbow Lite SET single-patient-use adhesive sensors, featuring Oxygen Reserve Index (ORi)
along with rainbow® PVi (RPVi) and Masimo SET® Measure-through Motion and Low Perfusion

technology (SpO2, PR, and Pi), for cost-effective access to these advanced parameters

Hospital Automation Solutions

•

Root with Kite, expanding visibility of patient data for clinicians by allowing data from Masimo devices

to be simultaneously viewed on a TV or tablet in customized configurations depending on the area of

care, including patient alarms for quick notification of changes in a patient’s physiological status

•

UniView, which gathers data from multiple sources such as patient monitors, ventilators, anesthesia

gas machines, IV pumps, lab and radiology results, and surgical views, to project on large displays

integrated patient information from all connected devices and systems in the hospital

•

Root with Early Warning Score (EWS) with the ability to use either predefined EWS protocols or

multiple customized EWS profiles and contributors for a specific care area or patient population

•

Trace, a software solution offering clinicians the ability to review and focus on the patient’s most

important data patterns, in the format that provides the most insight

rainbow DCI-mini sensor

RD rainbow Lite SET
single-patient-use sensor

Root with Kite

UniView

Root with EWS

Trace

1 Masimo data on file.

Automating
Care

Automating CareAutomating Care

Challenges to
Improving Value
in Healthcare

Changes in healthcare payment systems have contributed to the shift from

a volume-based focus of increasing procedures and patients toward a
value-based focus of improving quality and decreasing costs.1

While hospitals are clearly focused on improving value, clinicians are faced

with a number of barriers including:

•

Heavy cognitive and physical workload

Increasing documentation demands with decreasing time for patients

Variability in clinical knowledge and skill

Emphasis on manual assessments and procedures

Lack of effective communication and care coordination systems

Complex and cluttered care environments

Disparate and disconnected sources of data

Lack of accurate, relevant, and timely data

As a result, care delivery can be inefficient and ineffective with a high

amount of variability in quality and cost — both between hospitals

and between different clinicians at the same hospital.

1 Obama B. JAMA. 2016 Aug 2; 316(5): 525–532.

Care delivery can be inefficient and ineffective with
a high amount of variability in quality and cost

Automating Care

Automating some aspects of healthcare can give skilled clinicians the time and tools to

consistently deliver optimal care at a lower cost. Masimo’s approach to automating care is

intended to help healthcare systems:

•

Simplify care delivery

Maximize resources on patient care

Decrease variability

Decrease errors of omission

•

Improve patient outcomes

Increase patient satisfaction

Reduce costs

Masimo’s approach will help healthcare systems by:

Automating Assessment of the Patient Status Through Measurements

•

Delivering accurate data with context to reduce the time spent responding to

•

false alarms and verifying measurements

Enabling simple, noninvasive ways to obtain data

Filling in the gaps in awareness by continuously monitoring instead of relying

only on intermittent and delayed measurements

Automating Clinician and Patient Interactions Through Products

•

Creating decision support tools by monitoring data over time

Providing customized approaches to best fit various patients, care areas, and clinicians

• Displaying data in a way that makes it simple and convenient to identify relevant data

•

Integrating and aggregating measurements from disparate sources

• Expanding data flow in both directions through dynamic and seamless data exchange

• Prioritizing events and enabling seamless documentation

•

Improving the ease and quality of communication between caregivers and patients

Increasing patient comfort and family engagement to improve patient satisfaction

• Facilitating patient flow and scheduling to ease handoffs, transfers, and discharges

Automating Patient Management Across the Continuum of Care with Solutions

•

Combining best-in-class approaches to each care area

Reducing manual steps and procedures

Providing a platform for potential future advancements such as centralized device

control, decision support, and closed loop management

•

Extending automation technologies into the home

Automating some aspects of healthcare can
give skilled clinicians the time and tools to
consistently deliver optimal care at a lower cost

Measurements:
Automating Assessment
of Patient Status

22
22

23
23

MeasurementsSET®

Solving the Unsolvable
with SET

Overcoming the Limitations of Conventional Pulse Oximetry

Prior to Masimo Signal Extraction Technology®
(SET®), pulse oximetry was often unreliable when

Twenty-nine years ago, two young engineers

named Joe Kiani and Mohamed Diab asked how

it was needed most — during patient motion

pulse oximetry could work during motion and low

and low perfusion. The industry considered

the problem unsolvable and clinicians and

perfusion and in doing so, started a revolution
in patient monitoring. Masimo SET® works by

patients were forced to live with false alarms

recognizing that both arterial and venous blood

that hampered productivity and missed true

alarms that impacted patient care. Conventional

can pulsate. Using parallel signal processing
engines — DST, FST, SST, and MST — Masimo SET®

pulse oximetry inaccuracy during motion

and low perfusion is caused by its difficulty

separates the true arterial signal from sources of
noise, including the venous signal.2 By measuring

in determining the true arterial blood signal

— because moving venous blood appears to
pulsate like arterial blood.1

through patient motion and low perfusion,
Masimo SET® has helped pulse oximetry

become a clinically reliable tool.

R/IR

DIGITIZED, FILTERED, AND NORMALIZED

R/IR

DST®

FST®

(Conventional Pulse Oximetry)

Adaptive Filter

SST™

Adaptive Filter

MST™

EVALUATION AND ANALYSIS

Masimo SET® has helped pulse
oximetry become a clinically

reliable tool for accurately

monitoring patient status

POST PROCESSOR

Masimo SET® DST 97%

50% 66%

97% 100%

SpO2%

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 the arterial signal and non-arterial and venous signal 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.

SpO2

Arterial Oxygen Saturation

Pulse Rate

Perfusion Index

PVi

RRp

Pleth Variability Index

Respiration Rate from the Pleth

“Conventional pulse oximeters are a fair-weather
friend. Masimo SET® is a foul-weather friend.”

Jeremy Swan, MD
(1922-2005)
Former Chairman of the Masimo Scientific Advisory Board
Former Chairman Emeritus, Cedars Sinai Medical Center’s Division of Cardiology

Masimo SET
Comparative Studies

s
e
d
u
t
s

o
r
e
b
m
u
N

120

100

102

Positive

Neutral

Negative

Masimo SET®: Validated by Independent

and Objective Research

Over 100 independent and objective studies
have shown that Masimo SET® outperforms other

pulse oximetry technologies during motion and

low perfusion conditions, providing clinicians with

increased sensitivity and specificity to help them
make critical patient care decisions.1

1 Published clinical studies on pulse oximetry and the benefit of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent
and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles. RRp is not available in the U.S.

Unleashing Breakthrough
Performance with SET ®

Performance of 20 Pulse Oximeters During Motion and Low Perfusion6

Before Masimo SET® pulse oximetry, up to 90% of alarms that occurred outside the operating room were
false alarms.1-3 In a study of twenty-thousand surgical patients, not only did conventional pulse oximeters

fail to monitor 7% of the time in the operating room with the highest risk patients (ASA class IV), but the
use of conventional pulse oximetry did not appear to reduce the rate of post-operative complications.4,5

“Masimo SET® is advantageous because even though
it significantly reduces false alarms, it doesn’t do
that by ignoring physiological changes.”

Christian Poets, MD
Department of Neonatology, University Children’s Hospital, Tübingen, Germany

Volunteer subjects
(N=70) were tested in a
cool environment 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%. Drop outs
were included.6

100

)

(

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T

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

40
40

50 60

100

False Alarm Rate — 100-Specificity (%)

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 Moller JT et al. Anesthesiology.
1993 Mar;78(3):436-44. 5 Moller JT et al. Anesthesiology. 1993 Mar;78(3):445-53. 6 Barker SJ. Anesth Analg. 2002;95(4):967-72.

Automating Pulse Oximetry Monitoring
and Expanding Clinical Impact

By reducing false alarms and increasing true
alarm detection,1 Masimo SET® has helped

automate pulse oximetry monitoring by

significantly reducing the time required by

clinician assessment, have been shown to help

clinicians reduce retinopathy of prematurity
in neonates,2 improve critical congenital heart
disease screening in newborns,3 and reduce ICU

clinicians to respond to false alarms and verify

measurements while also increasing clinicians’

transfers and rapid response team activations
on the general ward.4 Today, Masimo SET® is

ability to rely on the pulse oximeter to help

the primary pulse oximetry at 17 of the top 20

make patient management decisions. Outcome
studies with Masimo SET®, in conjunction with

hospitals listed in the 2017-18 U.S. News and
World Report Best Hospitals Honor Roll.5

Alarm Reliability During Motion and Low Perfusion1

Nellcor N-600
43%

50%

40%

30%

20%

10%

50%

40%

30%

20%

10%

Nellcor N-600
28%

Missed True Alarms

False Alarms

Volunteer subjects (N=10) were tested in a cool environment during motion and low perfusion conditions and
the false alarm rate was calculated during 120 full oxygenation events (specificity) and the true alarm rate was
calculated during 40 deoxygenated events (sensitivity). 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%. Results shown are calculated
by combining the sensitivity and specificity of both machine-generated and volunteer-generated motion.1

Compared to the Nellcor N-600 during motion and
low perfusion, Masimo SET® reduced false alarms
by 82% (28% vs. 5%) and reduced missed true
alarms by 93% (43% vs. 3%)1

1 Shah N et al. J Clin Anesth. 2012 Aug;24(5):385-91. 2 Castillo A et al. Acta Paediatr. 2011 Feb;100(2):188-92. 3 de-Wahl Granelli A et al. BMJ. 2009;338.
4 Taenzer AH et al. Anesthesiology. 2010;112(2):282-287. 5 https://health.usnews.com/health-care/best-hospitals/slideshows/the-honor-roll-of-best-hospitals.

Reducing Retinopathy of
Prematurity with SET ®

A follow-up study was performed at two separate

no decrease of severe ROP at the center using

centers within Emory University in which the same

Nellcor but there was a 58% reduction (from 12%

Premature infants in neonatal intensive care are routinely administered supplemental oxygen to help

physician and nurse staff worked in both centers.

Both centers simultaneously changed their neonatal

oxygen targeting policy and one of the centers
switched from Nellcor to Masimo SET® pulse

preserve vital organ function. However, too much oxygen administration can cause severe eye damage

oximetry. In the first phase of the study, there was

to 5%) of severe ROP at the center using Masimo
SET®. In the second phase of the study, the center
still using Nellcor switched to Masimo SET® and

experienced a similar reduction (from 13% to 6%)
of severe ROP.2

from retinopathy of prematurity (ROP). Clinicians use pulse oximetry to help guide when and how much

oxygen to provide, but unreliable pulse oximetry measurements can result in over-administration of
oxygen and subsequent ROP. Three studies have shown Masimo SET®, coupled with changes in
practice, helps clinicians reduce the rate of severe ROP in premature infants.1-3

In the first study, following the implementation of
Masimo SET® with a new oxygen protocol in the

from 12.5% to 2.5%. The ROP rates were compared

over the same time period to the data reported by

neonatal intensive care unit at Cedars-Sinai Medical

the Vermont Oxford Network (VON), a nonprofit

Center, the incidence of severe ROP in very low birth

weight infants decreased over a five-year period

voluntary collaboration of >400 NICUs that maintains
a database including >25,000 infants.1

Severe Retinopathy of Prematurity Rate2

Nellcor N-395
13%

Nellcor N-395
12%

Nellcor N-395
13%

)
P
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14%

12%

10%

Retinopathy of Prematurity Rates in Very Low Birth Weight Infants

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

V
I
-
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S
-
P
O
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14%

12%

10%

1997

1998

1999

2000

2001

Incidence of ROP stages 3 to 4 for infants with birthweight of 500 to
1500 g at CSMC and in the VON for the years 1997 to 2001.1

Cedars-Sinai Medical Center (CSMC), after implementation
of Masimo SET® with a new oxygen protocol
Vermont Oxford Network (VON)

“Masimo SET® has played a critical role in helping
to virtually eliminate severe infant eye damage.”

Augusto Sola, MD
American Academy of Pediatrics Christopherson Award winner
for his contribution to international child health

In the most recent study at Yale New Haven Medical Center, the outcomes of 304 very low birth weight infants
whose oxygen targeting was performed with non-Masimo SET® pulse oximetry were compared with 396

post-initiative infants whose oxygen targeting was performed with a new oxygen protocol after switching to
Masimo SET® pulse oximetry. After the switch, there was a 37% reduction in incidence of severe ROP (from
24.6% to 15.4%) and a 53% reduction in ROP requiring surgery.3

1 Chow LC et al. Pediatrics. 2003 Feb;111(2):339-45. 2 Castillo A et al. Acta Paediatr. 2011 Feb;100(2):188-92. 3 Bizzarro MJ et al. J Perinatol. 2014 Jan;34(1):33-8.

Challenges to Identifying a
Life-Threatening Disorder

Critical congenital heart disease (CCHD) is a serious heart defect that is present at birth as a result of abnormal

heart formation during early embryonic development. CCHD prevents the heart from pumping blood

effectively so organs and tissues throughout the body do not receive enough oxygen, which can lead to organ
damage and life-threatening complications.1 CCHD occurs in approximately one to two babies per 1,000
live births and requires intervention soon after birth to prevent significant morbidity and mortality.2,3

Some babies with CCHD can appear healthy at first, so in the past up to 30% of deaths due to CCHD
were in babies discharged from the hospital before their heart defects were detected.4

“She died in my arms so I thought I had done

something wrong, but it turned out I had done nothing

wrong. The coroner called me two days later and for the

first time in my life, I heard the phrase, ‘congenital heart

disease.’ Now, I believe that that simple screening might
have given my daughter a shot. She might have lived.”5

Kristine Brite McCormick
Mother of Cora, a baby girl who unexpectedly died from CCHD

In the past, up to 30% of deaths due

to CCHD were in babies discharged

from the hospital before their heart
defects were detected.4

Limitations of Conventional Pulse Oximetry

In theory, pulse oximetry would identify lower oxygen saturation measurements in

babies with CCHD. However, in one of the earliest CCHD studies evaluating pulse

oximetry, researchers abandoned use of a conventional pulse oximeter due to its
inability to obtain measurements in some babies and a high false positive rate.6

1 NIH US National Library of Medicine, Genetics Home Reference (https://ghr.nlm.nih.gov/condition/critical-congenital-heart-disease) 2 Wren C et al. Arch Dis Child Fetal Neonatal
Ed 2008;93:F33-5. 3 Chang RK et al. Arch Pediatr Adolesc Med 2008;162:969–74. 4 Motulsky H. Intuitive biostatistics. Oxford: Oxford University Press, 1995. 5 Cora’s Story. 2013
Patient Safety Summit. Kristine Brite McCormick. 6 Granelli et al. Acta Paediatrica 2005;94:1590-1596.

Improving Screening for Critical
Congenital Heart Disease with SET ®

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 use of Masimo SET® pulse oximetry.1 A follow-up study of 20,055 infants
showed Masimo SET® measurements alone identified 75% of CCHD cases.2 In the largest CCHD screening
study to date — including over 122,738 subjects — the combined use of Masimo SET® and clinical
assessment increased screening sensitivity from 77% to 93% versus clinical assessment alone.3

CCHD Screening with Masimo SET®1

CCHD
screening
with EVE™
p. 194

n = 39,821 babies

Physical Exam Alone

Physical Exam + Masimo SET®

Sensitivity for CCHD Detection

Specificity for CCHD Detection

63%

98%

83%

99.8%

CCHD Screening with Masimo SET® 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 a single
preductal or postductal SpO2 measurement was ≤90%; or 2) If in three repeat measurements, both preductal and postductal
SpO2 were <95%, or the difference between the two measurements was >3%.1

Enabling a New Standard of Care

In 2011, CCHD screening with motion-tolerant

pulse oximetry was added to the U.S. Department

it has been estimated that millions of babies are
now being screened.5

of Health and Human Services’ Recommended
Uniform Screening Panel. Masimo SET® pulse

oximeters and sensors were exclusively used in
the two studies1,2 (59,876 subjects) that were the

basis for the CCHD workgroup recommendation
for universal CCHD screening.4 As a result, the

U.S. has gone from virtually no CCHD screening
to near universal CCHD screening today.5 In 2017,

both European and Canadian workgroups also

With Masimo SET® now proven as an effective CCHD

screening tool, Masimo looks forward to helping more

clinicians save newborn lives as CCHD screening

spreads to other parts of the world. Masimo also

believes it is possible that CCHD detection rates could

increase even further, based on research performed

with the perfusion index (Pi) measurement from Masimo
SET®. Using Pi, investigators have observed that in some

recommended universal CCHD screening with
motion-tolerant pulse oximetry.6,7 Outside the U.S.,

babies without oxygen saturation abnormalities,
a Pi <0.70 can identify additional cases of CCHD.8

“Screening all babies in maternity units with Masimo SET®
pulse oximetry significantly improves CCHD detection.”

Anne de-Wahl Granelli, PhD

1 de-Wahl Granelli A et al. BMJ. 2009;338. 2 Ewer AK et al. Lancet. 2011 Aug 27;378(9793):785-94. 3 Zhao QM et al. Lancet. 2014 Aug 30;384(9945):747-54.
4 Kemper et al. Pediatrics, 2011, Nov;128(5):e1259-67. 5 http://www.newbornfoundation.org/impact 6 Manzoni P et al. The Lancet Child & Adolescent Health. 2017; 1(2):88 – 90.
7 Wong KK et al. Can J Cardiol. 2017 Feb;33(2):199-208. 8 de-Wahl Granelli et al. Acta Paediatr. 2007;96(2):1455-1459. Eve is not available in the U.S.

PVi®

Limitations of Existing
Methods to Support
Fluid Therapy

Intravenous fluid administration is one of the most common hospital interventions. Clinicians

use fluid therapy in the operating room and intensive care unit to improve blood flow, or cardiac
output.1 Although fluid administration can be critical to enable organ preservation and improve

patient status, both the over- and under-administration of fluid are associated with increased
post-operative complications.2,3 In addition, there is a large degree of variability between
clinicians in the use of fluid during surgery.4

Multiple studies have shown that traditional “static” parameters are not reliable predictors
of fluid responsiveness5 — defined as an increase in cardiac output with fluid administration.

Therefore, experts recommend the use of more accurate “dynamic” parameters derived

from the arterial pressure waveform, such as pulse pressure variation (PPV) and stroke

volume variation (SVV). These parameters are considered “dynamic” because in mechanically

ventilated patients, they measure dynamic physiologic variation over the respiratory cycle

— which enable accurate monitoring of the likelihood of fluid responsiveness before fluid is
administered to the patient.6

A meta-analysis of 31 randomized controlled trials showed that using dynamic parameters

such as PPV or SVV in goal-directed fluid management reduced surgical complications by
32%.7 While studies have shown dynamic parameters to be beneficial, most dynamic

methods remain invasive, complex, and/or costly.

1 Perel A. Anesth Analg. 2008;106 (4):1031-33. 2 Bellamy MC. Br J Anaesth 2006;97:755–7. 3 Thacker JKM et al. Ann Surg 2016;263:502–10.
4 Lilot M et al. Br J Anaesth 2015;114(5):767-76. 5 Michard F et al. Chest. 2002;121(6):2000-08. 6 Vallet B et al. Ann Fr Anesth Reanim. 2013
Jun;32(6):454-62. 7 Grocott MP et al. Br J Anaesth. 2013 Oct;111(4):535-48.

A meta-analysis of 31 randomized controlled

trials showed that using dynamic parameters such

as PPV or SVV in goal-directed fluid management
reduced surgical complications by 32%7

Enabling Noninvasive Fluid
Responsiveness Monitoring with PVi

Masimo SET® pulse oximetry can noninvasively

Similarity of Arterial Pressure and

provide a dynamic parameter from the

Plethysmographic Waveforms

plethysmographic waveform called Pleth Variability

Index (PVi) which, like pulse pressure variation

(PPV) and stroke volume variation (SVV), provides a

measure of dynamic physiologic variation over the

respiratory cycle. Because PVi is displayed on the

same monitor and measured with the same sensors
already being applied for Masimo SET® pulse

oximetry or rainbow SET Pulse CO-Oximetry, PVi

can help automate fluid responsiveness monitoring

when other methods are not justified.

PPmax

PPmin

Arterial Pressure Waveform

Pimax

Pimin

PVi can help automate fluid

responsiveness monitoring when

other methods are not justified

Plethysmographic Waveform

Relation between respiratory variation in the arterial
pressure and plethysmographic waveforms in
mechanically ventilated patients. Adapted from
Cannesson et al., 2005.1

How PVi Works

Perfusion index (Pi) reflects the amplitude of

the pulse oximeter waveform and is calculated

as the pulsatile infrared signal, indexed

against the non-pulsatile infrared signal. PVi is

an automatic measure of the dynamic changes

in Pi that occur over the respiratory cycle.

PVi =

Pimax - Pimin
Pimax

x 100

The greater the plethysmographic waveform

variation in amplitude, the higher the PVi

value. Studies show that higher PVi values

indicate a mechanically ventilated patient is
more likely to respond to fluid administration.1

However, PVi may also show changes that

reflect multiple physiologic factors such as

vascular tone, circulating blood volume, and

intrathoracic pressure excursions. Masimo
also introduced rainbow® PVi (RPVi), a multi-

wavelength version of PVi, designed to

provide enhanced specificity to changes in

fluid volume.

RPVi
p. 66

1 Cannesson M et al. Crit Care. 2005 Oct 5;9(5):R562-8.

Comparing PVi to Other Methods for
Fluid Responsiveness Monitoring

Monitoring Fluid Responsiveness

In multiple studies in mechanically ventilated

patients in the operating room and intensive

care unit, Masimo’s noninvasive Pleth

Variability Index (PVi) has shown a similar

ability to monitor fluid responsiveness as

invasive dynamic parameters such as pulse

pressure variation (PPV) and stroke volume
variation (SVV).1-3 Masimo rainbow® PVi (RPVi)

is also available and is designed

to provide enhanced specificity

to changes in fluid volume.

RPVi
p. 66

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%.2

100

)

(

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S

PVi vs. Pulse Pressure Variation to
Monitor Fluid Responsiveness2

PVi vs. Stroke Volume Variation to
Monitor Fluid Responsiveness3

This observational study evaluated 20 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%.3

100

)

(

y
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S

PVi, AUC = 0.97

SVV, AUC = 0.99

CVP, AUC = 0.56

40
60
100-Specificity (%)

100

Pleth Variability Index (PVi)

Arterial Pulse Pressure Variation (PPV)

Cardiac Index (CI)

Pulmonary Capillary Wedge Pressure (PCWP)

Central Venous Pressure (CVP)

40
60
40
100-Specificity (%)

100

1 Published studies on PVi can be found on our website at: http://www.masimo.com. 2 Cannesson M et al. Br J Anaesth. 2008;101(2):200-6.
3 Zimmermann M et al. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.

PVi has shown a similar ability to monitor

fluid responsiveness as invasive dynamic
parameters such as PPV and SVV.1-3

Advancing
Goal-Directed Fluid
Therapy with PVi

Impact on Fluid Therapy and Outcomes

Pleth Variability Index (PVi) has been shown to help clinicians
reduce intra-operative fluid administration1-3 and lactate levels1,2 —
considered an important predictor of patient outcomes.4

PVi has also been shown to help reduce length of

stay and costs as part of multi-modal perioperative
management.3 Masimo rainbow® PVi (RPVi) is also

available and is designed to provide enhanced

specificity to changes in fluid volume.

RPVi
p. 66

Effect on Fluid Administration and Lactate Levels During Surgery

In a randomized controlled trial of 82 abdominal surgery patients,

compared to management by the static parameter central venous

pressure (CVP), PVi-based, goal-directed fluid management helped

clinicians reduce the volume of intra-operative fluid infused and
reduced intra-operative and post-operative lactate levels.1

)
1
-
L
I
o
M
m

(

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e
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e
L
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t
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a
L

2.5

2.0

1.5

1.0

0.5

0.0

PVi Group

Control Group

Start of
the surgery

Intraoperative

At 24 Hr

At 48 Hr

Clinical and Financial Benefits of Using Enhanced Recovery After Surgery

Protocol Including PVi for Goal-Directed Therapy

In a study of colorectal surgery patients managed with an Enhanced Recovery After

Surgery (ERAS) protocol, PVi was integrated into multi-modal perioperative management.

Compared to the conventional approach, the ERAS approach including PVi resulted in a

69% decrease in intra-operative fluid administration, a 32% decrease in length of stay,
a 47% decrease in complications, and a 35% decrease in 30-day hospital costs.3

Outcome

Intra-operative
net fluid balance

Conventional
Approach
without PVi

ERAS Approach
Including PVi

Relative Reduction
with ERAS Approach
Including PVi

2,733 mL

848 mL

Length of Stay

6.8 days

4.6 days

Any complication

30%

16%

30-day direct costs

$20,435

$13,306

69%

32%

47%

35%

All p values <0.05

Inclusion of PVi in Clinical Guidelines

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

for fluid management. In 2012, the United Kingdom’s National Health Service (NHS)

included PVi in its Intra-Operative Fluid Management Pack, which serves as a guide for
hospitals implementing fluid responsiveness monitoring to improve patient outcomes.5

In 2013, the French Society for Anaesthesia and Intensive Care (SFAR) included PVi in
its guidelines for optimal hemodynamic management of surgical patients.6 In 2016,

the American Society for Enhanced Recovery (ASER) and Perioperative Quality Initiative

(POQI) indicated that dynamic variables from both arterial and plethysmographic
waveforms were feasible to help monitor fluid responsiveness.7

Compared to the conventional approach,

the ERAS approach including PVi resulted in
savings of $7,129 in 30-day direct costs.7

1 Forget P et al. Anesth Analg 2010;111(4):910-4. 2 Yu Y et al. J Clin Monit Comput. 2015 Feb;29(1):47-52.
3 Thiele RH et al. J Am Coll Surg. 2015 Apr;220(4):430-43. 4 Vincent JL et al. Crit Care. 2016 Aug 13;20(1):257.

5 UK National Health Service. 2012. Accessed at: http://webarchive.nationalarchives.gov.uk/20130701151030/http://www.ntac.nhs.uk/web/FILES/Intra_
Operative_Fluid_Management/IOFM_Adoption_pack_update_Jan_2013.pdf. 6 Vallet B et al. Ann Fr Anesth Reanim. 2013 Jun;32(6):454-62.
7 Thiele RH et al. Perioper Med (Lond). 2016 Sep 17;5:24.

RRp®

Monitoring Breath Rate
with RRp

Traditional approaches to measuring respiration rate, or the number of breaths per minute, have limitations.

Manually counting the number of breaths provides only intermittent data. Impedance monitoring with chest
ECG leads is frequently used but has limited accuracy.1 Capnography requires a mask or nasal cannula so
it can result in low tolerance in conscious patients.2 Masimo’s rainbow Acoustic Monitoring requires only a

small, adhesive sensor on the neck and offers an excellent alternative to traditional methods, with similar
accuracy as capnography but with high patient tolerance.1-3

With respiration rate from the pleth (RRp), Masimo can provide another alternative for continuous respiration
rate — using the same Masimo SET® or rainbow SET sensor that is already being applied to measure other

optical-based measurements. While RRp cannot detect cessation of breathing, continuous RRp monitoring

is appropriate for situations in which other continuous respiration rate methods are not considered feasible

but intermittent, manual counting is not sufficient. RRp may also be appropriate for spot-check respiration

rate measurements in the clinic, with emergency medical services, or at a patient’s home.

Changes in the Plethysmographic Waveform During Breathing

Continuous RRp monitoring is appropriate for situations
in which other continuous respiration rate methods
are not considered feasible but intermittent, manual
counting is not sufficient

RRp Accuracy

Number
of Subjects

Number of
Estimates

Bias (rpm)

Precision (rpm)

ARMS

* (rpm)

194

1,090

0 .2

1 .9

Advanced signal processing is utilized to analyze baseline, amplitude, and frequency changes to the plethysmographic waveform
over the respiratory cycle to calculate respiration rate.

RRp accuracy was determined in healthy volunteers by comparing the RRp value to a reference respiration rate value in the range of
4 to 35 respirations per minute (rpm).4

RRp is measured only when the respiratory movement-induced signal is present in the pulsatile plethysmographic waveform, may not be available during certain conditions
such as very irregular breathing and excessive movement, and may not immediately indicate changes in respiration rate. RRp is not available in the U.S. 1 Yang S et al. J Clin Monit
Comput. 2017 Aug;31(4):765-772. 2 Patino M et al. Anesth Analg. 2017 Jun;124(6):1937-1942. 3 Ramsay MA et al. Anesth Analg. 2013 Jul;117(1):69-75. 4 Masimo data on file.

* The ARMS Accuracy is calculated based upon measurement values that are statistically distributed; approximately 68% of

the measured values fell within ± the ARMS value when compared to the reference device in a controlled study.

RRp is not available in the U.S.

SpHb

SpOC™

RPVi

Total Hemoglobin

Oxygen Content

rainbow® Pleth Variability Index

ORi

SpCO

SpMet

SpfO2

Oxygen Reserve Index

Carboxyhemoglobin

Methemoglobin

Fractional Oxygen Saturation

rainbow SET measurements also include
all Masimo SET® measurements: SpO2, PR, Pi, PVi, RRp

rainbow® Technology

Shining Light on
Physiology with rainbow ®
Pulse CO-Oximetry

After solving the “unsolvable” problems of motion and low perfusion with Masimo SET® pulse oximetry,
we set our sights higher with the invention of rainbow® Pulse CO-Oximetry. By leveraging multiple

wavelengths of light and breakthrough signal processing, multiple noninvasive and continuous

parameters that previously could only be measured by invasive techniques are now possible.

How rainbow® Pulse CO-Oximetry Works

rainbow® Pulse CO-Oximetry uses more than seven wavelengths
of light to measure blood characteristics based on light
absorption. Advanced signal processing algorithms and unique
adaptive filters work together to isolate, identify, and quantify
hemoglobin, carboxyhemoglobin, methemoglobin, and four
additional parameters. The results are then displayed numerically
and graphically on select Masimo and OEM partner instruments.

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

Automating Assessment of the
Patient Status in Multiple Ways

With 12 measurements now available from a single optical sensor, Masimo’s
rainbow® technologies provide noninvasive and continuous measurements that

automate patient care by helping clinicians quickly and easily identify important

aspects of patient status that were otherwise unknown — either because they

were not assessed or were only assessed intermittently.

Masimo’s rainbow® technologies may help clinicians:1

•

Reduce unnecessary blood transfusions, facilitate more timely

transfusions, and identify hemoglobin changes that may be associated
with bleeding with SpHb monitoring2,3,4

•

Reduce mortality with PVi and SpHb monitoring as part of a
vascular filling protocol5

•

Monitor for low hemoglobin with spot-check SpHb
Indicate impending hypoxia earlier with ORi6

• Simplify fluid responsiveness monitoring with RPVi

•

Monitor for carbon monoxide in the blood with SpCO

Reveal elevated methemoglobin levels from drug reactions with SpMet

Overcome the limitations of conventional pulse oximetry with SpfO2

Masimo’s rainbow® technologies provide noninvasive and
continuous measurements that automate patient care by

helping clinicians quickly and easily identify important aspects

of patient status that were otherwise unknown — either because

they were not assessed or were only assessed intermittently

1 Published studies can be found on our website at: http://www.masimo.com. 2 Awada WN et al. J Clin Monit Comput. 2015 Dec;29(6):733-40. 3 Ehrenfeld JM et al. J Blood Disorders Transf.
2014. 5:237. 4 McEvoy M et al. Am J Crit Care. 2013 Nov;22(6 Suppl):eS1-13. 5 Nathan N et al. Anesthesiology. 2016;A1103(abstract). 6 Szmuk P et al. Anesthesiology. 2016 Apr;124(4):779-
84. Masimo’s rainbow® measurements are not intended to replace lab testing but can provide immediate and additional information to aid patient assessment. Clinical decisions
regarding therapeutic interventions should be based on the clinician’s judgment considering among other factors: patient condition, continuous monitoring data, and laboratory
diagnostic tests using blood samples. ORi, RPVi, and SpfO2 are not available in the U.S.

SpHb®

Risks and Costs of Red
Blood Cell Transfusions

Red blood cell transfusions are the most common

Appropriate Use of Transfusion7

procedure performed in hospitals today, occurring in
about one of every ten inpatient stays.1 The decision

to transfuse is subjective, as evidenced by the high

variability in transfusion practices between physicians
and different types of procedures.2

12%

Multiple trials and meta-analyses have also reported

risk associated with inappropriate transfusions and

29%

59%

some suggest that restrictive blood transfusion
practices may improve clinical outcomes.3-5 Even

without taking morbidity-associated costs into

account, the cost to acquire, store, and administer

blood in the U.S. is estimated between $786 and

$1,183 per unit — so inappropriate transfusions can
significantly increase cost of care.6

When an expert international consensus panel

systematically reviewed data from 494 published

studies, they concluded that 59% of transfusions
were “inappropriate”.7

Appropriate

Uncertain

Inappropriate

The Joint Commission and the American Medical

Association have listed transfusions in their top five

interventions targeted for “overuse” and noted that

“while blood transfusions can be life-saving, they

also carry risks that range from mild complications to
death”.8 To improve the quality and reduce the cost

As a result, there is a growing global recognition

of the need to reduce unnecessary transfusions.

of care, many hospitals are implementing patient
blood management programs and protocols.9

1 Healthcare Cost and Utilization Project: Most frequent procedures performed in U.S. hospitals. 2013. 2 Frank SM et al. Anesthesiology. 2012 Jul;117(1):99-106.
3 Rohdes JM et al. JAMA. 2014 Apr 2;311(13):1317-26. 4 Salpeter SR et al. Am J Med. 2014 Feb;127(2):124-131. 5 Villanueva C et al. N Engl J Med 2013;368:11-21.
6 Shander A et al. Transfusion. 2010;50(4):753-765. 7 Shander A et al. Transfus Med Rev. 2011 Jul;25(3):232-246. 8 Proceedings from the National Summit on Overuse.
September 24, 2012. 9 SABM PBM Directory http://www.sabm.org/programsbystate.

Adding to Traditional Blood Sampling
for Hemoglobin Measurement with SpHb

Limitations of Traditional Blood Sampling Methods

Even when bleeding can be observed by clinicians, visual estimation of blood loss can be inaccurate.1,2

Hemoglobin concentration often drops when bleeding occurs, so clinicians naturally rely on laboratory

hemoglobin measurement to help assess bleeding. However, invasive blood samples can only provide

intermittent and often delayed laboratory hemoglobin results. This means that clinicians can make

treatment decisions without also knowing the patient’s real-time hemoglobin status.

SpHb: Helping Clinicians Make More Informed and Timely Assessments

Noninvasive and continuous hemoglobin (SpHb) monitoring helps automate the patient’s hemoglobin

status and provides real-time visibility to changes — or lack of changes — in hemoglobin between invasive

blood samples.

SpHb monitoring may provide additional insight between invasive blood samples, such as when:3

•

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

Comparison Between Hemoglobin Without SpHb Monitoring vs. with SpHb Monitoring

Without SpHb Monitoring

With SpHb Monitoring

n
b
o
g
o
m
e
H

Draw blood

Time

SpHb

Lab Hemoglobin

1 Rothermel RD et al. Surgery. 2016 Oct;160(4):946-953. 2 Guinn NR et al. Transfusion. 2013 Nov;53(11):2790-4.
3 Barker SJ et al. Anesth Analg. 2016 Feb;122(2):565-72. SpHb is not intended to replace lab testing. 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.

Label vial and
send to lab

Multiple steps in laboratory
hemoglobin determination

Perform lab analysis

Wait...

Get results

Wait...

Validating SpHb Compared to
Common Invasive Methodologies

Variability in Hemoglobin Measurements

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

of the variation that should be expected from laboratory devices. The lack of awareness stems from the

fact that clinicians do not typically obtain two or more laboratory hemoglobin measurements from the
same patient at the same time.1 Hemoglobin measurement variation can be caused by, among other
things, patient physiology, phlebotomy, blood sample handling, and lab instrument variability.1

Accuracy of SpHb and Other Methods Compared to Reference Hemoglobin

The results of a study conducted in a surgical intensive care unit illustrate the variation that can be

expected between hemoglobin measurements from different devices. A total of 471 hemoglobin

measurements were evaluated from 62 patients. Measurements from 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 as compared to the central laboratory

hemoglobin analyzer. 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.2

Now Included in Guidelines

In 2017, both the European Society of Anaesthesiology’s Guidelines for the Management of Severe

Perioperative Bleeding and the Italian Ministry of Health’s Blood Management Program Guidelines
included noninvasive and continuous hemoglobin monitoring as a recommended tool.3,4

e
v
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n

e
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f
f
i

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

SpHb

CO-oximeter

HemoCue

)
L
d
/
g

(

b
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)
L
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1.0

g/dL (ARMS)

8 10

6
16
Hematology Analyzer tHb (g/dL)

)
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1.3

g/dL (ARMS)

8 10

6
16
Hematology Analyzer tHb (g/dL)

1.1

g/dL (ARMS)

8 10

6
16
Hematology Analyzer tHb (g/dL)

Bias ± Standard Deviation = 0.0 ± 1.0 g/dL

Bias ± Standard Deviation = 0.9 ± 0.6 g/dL

Bias ± Standard Deviation = 0.3 ± 1.3 g/dL

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

SpHb

CO-oximeter

HemoCue

-2

-4

-6

R=0.64

)
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)

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0
Difference in Consecutive
Hemoglobin Values (tHb) (g/dL)

)
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-8

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0
Difference in Consecutive
Hemoglobin Values (tHb) (g/dL)

)
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R=0.39

-8

-8 -6

-4 -2

0
Difference in Consecutive
Hemoglobin Values (tHb) (g/dL)

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

1 Berkow L. J Clin Monit Comput. 2013 Oct;27(5):499-508. 2 Frasca D et al. Critical Care. 2011 Oct;39(10):2277-82. ARMS was calculated as defined by ISO 80601-2-61. 3 Kozek-Langenecker
SA et al. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. 4 Centro Nazionale Sangue, Ministero della Salute, Italy, LINEE CNS Guidelines on the Patient Blood Management. Available from:
http://www.centronazionalesangue.it/node/458. Published clinical studies on SpHb accuracy can be found on our website at: http://www.masimo.com.

Helping Manage Blood Transfusion
Decisions with SpHb Monitoring

In two studies of high and low blood loss surgery, noninvasive and continuous hemoglobin (SpHb)

monitoring helped clinicians reduce blood transfusions.

High Blood Loss Surgery

Low Blood Loss Surgery

A prospective cohort study of 106 neurosurgical patients evaluated adding SpHb monitoring to standard

The researchers in a randomized controlled trial

of care blood management and reported that it resulted in decreased blood utilization in high blood

of 327 patients undergoing elective orthopedic

loss neurosurgery, while also facilitating earlier transfusions. The investigators concluded, “Adding SpHb

surgery conducted at Massachusetts General Hospital

monitoring to standard of care blood management resulted in decreased blood utilization in high blood
loss neurosurgery, while facilitating earlier transfusions.”1

concluded, “We believe that the availability of SpHb
decreases inappropriate transfusion.”2

SpHb Helped Clinicians Reduce Blood
Transfusions in High Blood Loss Surgery1

SpHb Helped Clinicians
Decrease the Time to Transfusion1

SpHb Helped Clinicians Reduce Blood
Transfusions in Low Blood Loss Surgery2

1.9

0.9

average RBC
units reduced
per patient

1.0*

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2.5

2.0

1.5

1.0

0.5

50.2

d
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)
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minutes reduction in
time to transfuse

9.2*

4.5%

s
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87%

reduction in
blood transfusion
frequency

0.6%**

Standard Care Group

SpHb Group

Standard Care Group

SpHb Group

Standard Care Group

SpHb Group

Prospective cohort study in 106 neurosurgery patients * p<0.001
Patients were enrolled into either a cohort group (Standard Care Group) that received intraoperative hemoglobin
measurement by intermittent blood sampling, or an intervention group (SpHb Group) in which SpHb was continuously
monitored. In each group, if researchers noted hemoglobin trended downward below 10g/dL, a red blood cell transfusion
was started and continued until hemoglobin trended upward, above 10g/dL. The blood sampling technique was the same
for patients in both the Standard Care Group and the SpHb 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 (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.1

** p=0.03

"We believe that the
availability of SpHb decreases
inappropriate transfusion"2

1 Awada WN et al. J Clin Monit Comput. 2015 Dec;29(6):733-40. 2 Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:237. SpHb is not intended to replace lab testing but it can
provide immediate and additional information to aid patient assessment. 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.

Identifying Changes in Hemoglobin
Associated with Bleeding with
SpHb Monitoring

In addition to assisting with transfusion management, noninvasive and continuous hemoglobin (SpHb)

monitoring may help clinicians inside and outside the operating room identify changes in hemoglobin
that may be associated with bleeding.1,2

Risk and Cost of Internal Bleeding

Internal bleeding is considered a significant risk factor for patients, and late detection further increases risk
and cost.3 Vital signs are not a reliable indicator of bleeding, but a drop in hemoglobin over a period of
time is considered a reliable indicator of bleeding.4 However, traditional hemoglobin measurement requires

blood sampling and laboratory analysis, which means results are often intermittent and delayed. This means
that detection of changes in hemoglobin due to internal bleeding can be significantly delayed.5

Example of How SpHb Monitoring Can Help Identify Hemoglobin Changes Associated with Bleeding2

A declining SpHb trend may allow clinicians to investigate dropping hemoglobin levels sooner.2

)
L
d
/
g

(
e
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a
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b
H

9.0

8.5

8.0

7.5

7.0

6.5

6.0

tHb lab test

Masimo SpHb

Blood transfusion initiated

Patient transported to
OR for splenectomy

Standing lab order

Lab tHb ordered early due
to declining SpHb values

Hours

1 Barker SJ et al. Anesth Analg. 2016 Feb;122(2):565-72. 2 McEvoy M et al. Am J Crit Care. 2013 Nov;22(6 Suppl):eS1-13. 3 Herwaldt LA. Infect Control Hosp Epidemiol. 2003;
24(1):44-50. 4 Bruns B et al. J Trauma. 2007; 63(2):312-5. 5 Dutton DP et al. Anesthesiology. 2014 Sep;121(3):450-8.

Differentiating Causes of
Hemoglobin Drops Using
SpHb and PVi Together

While hemoglobin decreases are often due to blood loss, they can also occur due to blood dilution
that occurs as a result of excess fluid administration — decreasing delivery of oxygen to the tissues.1

Excess fluid administration can cause tissue edema and subsequent morbidity and increased length
of stay.2 This unintended or “iatrogenic anemia” can also cause clinicians to order blood transfusions
in the absence of significant bleeding.3,4

By using SpHb and PVi together, it is possible to noninvasively monitor both hemoglobin and fluid

responsiveness on a single device. This visibility may help automate the assessment of the cause of
hemoglobin drops — and potentially help clinicians avoid the over-administration of fluid or blood.1

Hepatic Surgery: Example of Hemoglobin Drop Caused by Blood Loss and Fluid Administration1

crystalloid

)
L
d
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g

(

b
H

3
16:50

Spinal Surgery: Example of Hemoglobin Drop Caused by Fluid Administration1

crystalloid + colloid

No Bleeding

colloid

16:57

17:04

17:11

17:18

Time

)30
%

(

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0
17:26

)
L
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/
g

(

b
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0
9:17

Crystalloid

10:29

11:41

12:53

14:05

15:17

16:29

Time

SpHb and PVi were continuously monitored during hepatic surgery. The gradual PVi increase to very high levels
along with SpHb decrease from about 12 to 10 g/dL may indicate hypovolemia due to blood loss. Subsequent
fluid administration with crystalloid resulted in a PVi decrease along with another SpHb decrease from about 10
to 8 g/dL that may indicate hemodilution and iatrogenic anemia.1

)

(

V
P

0
17:41

SpHb

PVi

SpHb and PVi were continuously monitored during spine surgery. The PVi decrease along with SpHb
decrease from about 10 to 8 g/dL may indicate hemodilution and iatrogenic anemia.1

SpHb

PVi

By using SpHb and PVi together, it is possible
to noninvasively monitor both hemoglobin and
fluid responsiveness on a single device

1 Perel A. Crit Care. 2017 Nov 25;21(1):291. 2 Chappell et al. Crit Care, 2014 Oct 13;18(5):538.
3 Soni N. Transfusion Med. 2008 Aug;18(4):209-10. 4 Shander A et al. Anesthesiol Clin. 2016 Dec;34(4):711-730.

Improving Outcomes
in Surgical Patients
with SpHb and PVi

A recent study evaluated the impact of using both

noninvasive and continuous hemoglobin (SpHb) and

Pleth Variability Index (PVi) on anesthesia-related
surgical mortality.1

In a study 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

“We know that anemia and inadequate
volume filling are two important factors in
morbidity and mortality after anesthesia.”2

Nathalie Nathan, MD
Head of the Department of Anesthesiology
Centre Hospitalier Universitaire de Limoges, in Limoges, France

“(SpHb and PVi) allowed earlier transfusion

and reduces mortality at a scale of a whole

hospital with different clinical practices
(and practitioners) and unselected patients”1

Reduction in Mortality Between Non-Monitored
Group and SpHb/PVi Group1

1.0

0.7

30%

Reduction

y
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3
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1.0

0.8

0.6

0.4

0.2

Non-SpHb/PVi Group

SpHb/PVi Group

The study included 18,867 patients, of whom 3,540
underwent SpHb and PVi monitoring installed in all
operating rooms, recovery rooms, and intensive care
units, along with Masimo Patient SafetyNet*. Patients
in the SpHb/PVi group received vascular filling with
crystalloids or blood, according to the clinical algorithm.
Demographic, anesthesia, surgical, and transfusion data
were collected in electronic files and Patient SafetyNet.
The researchers compared the transfusion rate within
the first postoperative 48 hours and the mortality rates
for each group at 30 and 90 days following surgery.
The researchers found that SpHb/PVi group had a 30%
reduction in mortality at 30 days (odds ratio 0.7) and a
25% reduction in mortality at 90 days (odds ratio 0.75)
compared to the non-monitored group. The overall
transfusion rate and number of units transfused within
48 hours were not significantly different between
groups, but non-cardiac surgical patients in the SpHb/
PVi group were transfused more often while they were
still in the operating room (72.9% vs. 56.1%) instead of
later in their hospital stay.1

1 Nathan N et al. Anesthesiology. 2016;A1103(abstract). 2 Vlessides M. Anesthesiology
News Feb 15. 2017. Retrieved from http://www.anesthesiologynews.com. * The use of
the trademark SafetyNet is under license from University HealthSystem Consortium.

RPVi™

Simplifying
Fluid Responsiveness
Monitoring with RPVi

Pleth Variability Index (PVi), available with Masimo SET® pulse oximetry,1 is now available in a multi-

wavelength version called rainbow PVi (RPVi). While PVi has been shown to help clinicians monitor
fluid responsiveness,1 PVi is also reflective of changes in vasomotor tone, intra-thoracic pressure

excursions, and other physiologic factors. RPVi may further simplify fluid responsiveness monitoring
for clinicians because it is designed to provide enhanced specificity to changes in fluid volume.2

Case Example of PVi vs. RPVi vs. PPV2

)

(

V
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V
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/
i
V
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R

0
100

150

200

250

300

350

Time (min)

In this surgical case, compared to PVi, RPVi was less prone to variability from factors other than fluid
responsiveness and trended more closely with PPV.

PVi

RPVi

PPV

RPVi is specifically designed to
provide enhanced specificity
to changes in fluid volume2

1 Published studies on PVi can be found on our website at: http://www.masimo.com. 2 Masimo data on file. RPVi is not available in the U.S.

ORi™

Going Beyond Pulse Oximetry
in Monitoring Oxygenation

However, pulse oximetry cannot monitor hyperoxia. During supplemental oxygen administration, clinicians

can use the partial pressure of oxygen (PaO2) to assess hyperoxia, but this requires invasive blood sampling

and laboratory analysis which is intermittent and delayed. Between invasive samples, significant changes in

PaO2 cannot be assessed and therefore unexpected hypoxia or unintended hyperoxia can occur.

Inability of Pulse Oximetry to Monitor Hyperoxia

Limitations of Pulse Oximetry During Supplemental Oxygen Administration in Identifying Impending Hypoxia

Oxygen is transported in the arterial blood by hemoglobin and pulse oximetry enables continuous

oxygen saturation monitoring in the hypoxic (low oxygenation) or normoxic (normal oxygenation) ranges.

Clinicians often administer supplemental oxygen to surgical or critically ill patients, which is transported in

the blood by plasma to achieve a moderate hyperoxic (higher than normal oxygenation) state and provide

a supply of reserve oxygen — should it be needed.

100

)

(

2
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2
O
a
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x
O

Hypoxia

Normoxia

Hyperoxia

70
Partial Pressure of Oxygen, PaO2 (mmHg)

100

110

120

130

140

The oxyhemoglobin dissociation curve can be used to visually represent the oxygenation ranges and shows the inability
of SpO2 to monitor hyperoxic states, requiring direct PaO2 measurement.

Between invasive samples, significant changes in
PaO2 cannot be assessed and therefore unexpected
hypoxia or unintended hyperoxia can occur.

ORi is not available in the U.S.

ORi: Noninvasive Monitoring
of the Hyperoxic Status

Oxygen Reserve Index (ORi) represents a fundamental

step forward in oxygenation visibility. ORi is made

possible through multi-wavelength light absorption

in the rainbow SET Pulse CO-Oximetry platform that

enables the monitoring of blood characteristics related

to the moderate hyperoxic state.

Oxygen Reserve Index (ORi) is a relative indicator of the

changes in PaO2 in the moderate hyperoxic 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

Oxygenation State (in PaO2 mmHg)

600+

≈200

)

g
H
m
m

(

100

Hyperoxia

Moderate
Hyperoxia

Normoxia

Hypoxia

Oxygen
Reserve

PaO2

SaO2/SpO2

ORi provides additional insight in the moderate hyperoxia range,
above hypoxic and normoxic levels indicated by SpO2/SaO2.

1 Scheeren TWL et al. J Clin Monit Comput. 2017 Aug 8. ORi is not available in the U.S. Factors
including peripheral tissue metabolism, peripheral perfusion, hemoglobin concentration and
cardiac output may affect the absolute value of ORi. ORi is not available in the U.S.

ORi represents a fundamental step

forward in oxygenation visibility

ORi Clinical Application

In patients receiving supplemental oxygen, such

as those in surgery, under conscious sedation, or
in the intensive care unit, ORi may:1

• Provide an early alarm when oxygen reserve

drops before any changes in SpO2 occur

• Reflect response to oxygen administration,

such as in a preoxygenation period before

intubating and extubating

• Facilitate oxygen titration and prevent

unintended hyperoxia

Indicating
Impending Hypoxia
Earlier with ORi

Clinical Evidence for the Utility of ORi

In a study published in Anesthesiology, researchers

found that during prolonged apnea in healthy

anesthetized children, Oxygen Reserve Index (ORi)

detected impending desaturation a median of 31.5
seconds before noticeable changes in SpO2 occurred.1

Early Warning Time with ORi1

s
t
n
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i
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a
P
f

o
r
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b
m
u
N

0-10

11-20

21-30

31-40

41-50

51-60

Seconds

33 pediatric surgical patients were enrolled in the
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 with ORi by the number of patients
observed is summarized in the histogram.1

“Our major finding is that monitoring the ORi before and

during intubation detected impending desaturation in median
of 31.5 seconds before noticeable changes in SpO2 occurred”1

1 Szmuk P et al. Anesthesiology. 2016 Apr;124(4):779-84. 2 Applegate RL et al. Anesth
Analg. 2016 Sep;123(3):626-33. 3 Simpao AF et al. Anesthesiology. 2016; 124(4):750-
751. ORi is not available in the U.S.

“All anesthesiologists should appreciate advanced warning of impending

oxygen desaturation. Every second counts during those crucial moments,

and novel technology that has the potential to warn clinicians sooner

than the current technology is worth a much closer look”3

In a study published in Anesthesia & Analgesia,

researchers found a significant relationship between

change in PaO2 and change in ORi. The researchers

concluded: “Decreases in ORi to near 0.24 may provide

advance indication of falling PaO2 approaching 100
mmHg when SpO2 is >98%.”2

Case Example of Early Warning with ORi1

)
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1.0

0.8

0.6

0.4

0.2

0.0

ORi

SpO2

100

)

(

2
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p
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Elapsed Time Since Start of Induction (min)

ORi levels rise after 100% FiO2 period. ORi levels
drop prior to 30% FiO2 and intubation periods, and
minutes before the SpO2 drop. ORi then rises during
re-oxygenation. ORi was retrospectively determined
using offline data analysis.

SpCO®

Helping Emergency
Personnel Monitor
Carbon Monoxide in
the Blood with SpCO

Carbon Monoxide: A Silent Killer

Carbon monoxide (CO) is a toxic, colorless, odorless gas that is a product of combustion.

Unintentional, non-fire related CO poisoning is the leading cause of poisoning deaths in the U.S.
and results in over 21,000 emergency department visits per year.1 Symptoms of CO exposure are
non-specific so they are often overlooked, and some victims have no symptoms at all.2

First responders are at the greatest risk because 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.3,4 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

in dangerous situations and increasing the risk of heart disease or stroke — two conditions that
account for nearly 50% of on-duty firefighter deaths.5,6

Researchers using SpCO to monitor emergency department

patients concluded that 69% of patients with CO poisoning
would not have been identified without SpCO monitoring.12

1 Sircar K et al. Am J Emerg Med. 2015 Sep; 33(9): 1140–1145. 2 Centers for Disease Control and Prevention (CDC). MMWR Morb
Mortal Wkly Rep 2005;54:36 –9. 3 Hampson NB et al. Crit Care Med. 2009 Jun;37(6):1941-7. 4 Bledsoe BE. J Emerg Med Svcs.
2007l 32:54-59. 5 Jakubowski G. FireRescue Magazine. 22(11):52-55, 2004. 6 Bledsoe BE. FireRescue Magazine. September
2005. 7 Augustine JJ. JEMS. 2007. May;64-71. 8 Bledsoe BE et al. Prehosp Emerg Care. 2010 Jan-Mar;14(1):131-3.
9 Suner S. et al. J Emerg Med. 2008 May;34(4):441-50. 10 Roth D et al. Ann Emerg Med. 2011 Jul;58 (1): 74-9.
11 Sebbane M et al. Respir Care. 2013 Oct;58(10):1614-20. 12 Roth Det al. Int J Clin Pract. 2014 Oct;68(10):1239-
45. 13 National Fire Protection Association 1584. 2015. Accessed at: http://www.nfpa.org.

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

Deadly Exposure Revealed with SpCO

Saving Lives Every Day

Noninvasive carboxyhemoglobin (SpCO) enables

Industry-leading organizations have lined up

quick and noninvasive monitoring of CO levels in the

to support CO education and the National Fire

blood, and may lead to the identification of elevated

Protection Association (NFPA) released an updated

CO levels that might otherwise go unnoticed in

Fire Rehabilitation Standard (NFPA 1584) which

requires fire fighters exposed to smoke at incident

scenes and during training be assessed on the
scene for elevated CO levels.13

front-line settings such as fire rehabilitation and
mass casualty scenarios.7,8 Results from clinical

studies conducted on emergency room patients

demonstrate that SpCO technology may be a

valuable tool for monitoring a large number of
patients for possible CO exposure,9,10 supporting
the possible use of SpCO in emergency patients.11

A recent study at the Medical University of Vienna

assessed SpCO in 32,396 emergency room patients.

The researchers concluded that of the 32 patients

with a diagnosis of CO poisoning, 22 (69%)

would not have been identified without
SpCO monitoring.12

“There is nothing more important in our profession than firefighter safety.
The new 1584 standard builds on the older standard and more comprehensively
addresses medical monitoring and carbon monoxide poisoning of the
firefighter. I am excited to see this updated standard and that Masimo is at the
forefront of making sure firefighters go home at the end of their shifts.”

Gary Ludwig
Fire Chief, Champaign, Illinois, USA

SpMet®

Revealing Elevated
Methemoglobin in
the Blood with SpMet

The Dangers of Methemoglobinemia

Methemoglobinemia is a blood disorder in which there is an abnormal amount of methemoglobin, a form

of hemoglobin that is unable to effectively bind to oxygen. Many drugs commonly used in hospitals — such

as lidocaine, benzocaine, dapsone, and nitrates — may cause a dangerous reaction known as acquired
methemoglobinemia.1 Inhaled nitric oxide (iNO) therapy, and even topical anesthetics containing
benzocaine or prilocaine, can cause elevated levels of methemoglobin in neonates and infants.2,3

Occupational exposure on the skin to analine, a chemical used in furniture making, or with inhalation of
nitrobenzene, a chemical used to make analine, can also cause severe methemoglobinemia.4

While methemoglobinemia can occur in all care areas

and patients, it is often unrecognized and undiagnosed1

Prevalence of Methemoglobinemia

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, indicate that while
methemoglobinemia can occur in all care areas and patients, it is often unrecognized and undiagnosed.1

Results from a Retrospective Study at Two Johns Hopkins Hospitals Over a 28-month Period1

2,167

Patients

138

Methemoglobinemia Cases

Near Fatalities

Death

Monitoring Methemoglobin
with SpMet

Masimo rainbow® Pulse CO-Oximetry enables noninvasive and continuous monitoring of

methemoglobin in the blood. SpMet helps clinicians monitor for elevated methemoglobin in care

areas where the drugs that cause methemoglobinemia are most common, such as in procedure labs

and the operating room. With real-time information at the patient bedside, SpMet may help clinicians

respond quickly to elevated methemoglobin levels and thereby address potentially

life-threatening situations.

SpMet Clinical Case

In the following case, SpMet correlates with the methemoglobin values from a laboratory
CO-oximeter (MetHb) and also responds to an injection of methylene blue at approximately two hours.5

%
b
H
t
e
M

%
t
e
M
p
S

100

)

(

2
O
p
S

SpMet%

MetHb% (lab)

SpO2

2
Time (hours)

SpMet may help clinicians respond quickly to elevated
methemoglobin levels and thereby address potentially
life-threatening situations

1 Ash-Bernal R et al. Medicine (Baltimore). 2004 Sep. 83(5):265-73. 2 Riou Y et al. Pediatric Research (1998) 43, 295–295. 3 U.S. Food & Drug, Consumer Updates, Benzocaine and
Babies: Not a Good Mix. 4 Lee CH et al. Ann Occup Environ Med. 2013 Nov 1;25(1):31. 5 Annabi EH et al. Anesth Analg. 2009 Mar;108(3):898-9. SpMet is intended to be used to
monitor methemoglobin levels in the blood. 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.

SpfO2™

Overcoming a
Limitation of Conventional
Pulse Oximetry with SpfO2

Potential Inaccuracy in the Presence of Dyshemoglobins

All two-wavelength pulse oximeters (including

In the presence of dyshemoglobins, this means

Masimo’s) can only measure “functional” oxygen

pulse oximeters will report falsely high oxygen

saturation with SpO2, which means they cannot

saturation levels. Laboratory CO-oximeters can

distinguish oxygenated hemoglobin from

measure “fractional” oxygen saturation, which takes

dyshemoglobins, including the most prevalent
forms of carboxyhemoglobin and methemoglobin.1

into account the presence of dyshemoglobins in

oxygen saturation measurement, but measurements

are only possible with invasive blood sampling and

laboratory analysis.

100

)

(

2
O
p
S

Case Illustrating Increased Accuracy of SpfO2
with Elevated Carboxyhemoglobin2

27.5

25.0

22.5

20.0

17.5

15.0

12.5

10.0

7.5

5.0

2.5

)

(

b
H
O
C

SpO2

SaO2

O2Hb

SpfO2

COHb

30
Time (minutes)

0
60

In the presence of elevated carboxyhemoglobin levels and a hypoxic state,
SpO2 can overestimate oxygen saturation levels while SpfO2 can provide truer
estimates of oxygen saturation.

Masimo SpfO2 Fractional Measurement

By utilizing multiple wavelengths of light, Masimo rainbow SET Pulse CO-Oximeters

can measure SpfO2, the first noninvasive fractional oxygen saturation measurement.

SpfO2 allows truer arterial oxygenation monitoring in patients with elevated

dyshemoglobins — common throughout hospital and pre-hospital settings — as

compared to functional oxygen saturation.

1 Barker SJ et al. Anesthesiology. 1989 Jan;70(1):112-7. 2 Masimo data on file. SpfO2 is not available in the U.S.

NomoLine™

Monitoring Capnography
and Gas with NomoLine

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 During surgery, capnography and gas monitoring also provide insight into the

effectiveness of the anesthesia breathing circuit, helping maintain proper gas concentrations and ventilation

levels. Masimo’s NomoLine capnography and gas monitoring technologies complement our breakthrough

noninvasive portfolio with innovative, multi-spectral technologies for measuring respiratory gases and

inhaled anesthetic agents. The solutions range from integrated OEM solutions, to external “plug in and

measure” gas analyzers, to handheld devices.

NomoLine Capnography and Gas Parameters

EtCO2

RRc

N2O

Agent
ID

End Tidal CO2

Respiration Rate
from capnography

Oxygen

Nitrous Oxide

Agent ID

Overcoming Common Sampling Problems with NomoLine Technology

Traditional capnography solutions utilize

NomoLine technology reduces common

compounds such as Nafion to attract and trap

problems associated with conventional

water which enters the sampling line due to

sidestream gas analysis. Incorporating a unique,

condensation of the expired patient gas. The

patented polymer, NomoLine allows water in the

Nafion portion of the sampling line absorbs water

sampling line to evaporate into the surrounding

before it enters the gas analyzer and is the most

air while leaving oxygen, carbon dioxide, and

costly per-patient component of the sampling line.

anesthetic gases unaffected. This eliminates the

These components, however, continuously absorb

need for a water trap and issues related to their

water, which can occlude the patient sampling

handling, and enables a NomoLine to last much

line, causing readings to degrade over time or

longer than conventional capnography sampling

potentially result in alarms or no readings at all.

line solutions.

G as sa m ple fro m
p atie nt circuit

Gas sample tube

How NomoLine Works

Gas and condensed moisture from
the patient enters through the gas
sample tube, condensed moisture
and aspirated water are separated
and collected using a hydrophilic
absorbent, then diffused through
the polymer cover and evaporated
into surrounding air.

Nomo polymer cover

Hydrophobic bacteria filter

Hydrophilic absorbent

Gas sampling port connector

Mainstream and Sidestream Options

Some capnography and gas monitoring technologies offer only a sidestream approach. With

NomoLine, Masimo offers multiple capnography and gas measurements delivered through either

mainstream or sidestream options. Clinicians can now benefit from capnography and gas monitoring

in a range of hospital environments — from the operating room, to intensive care, to the general ward.

Fast Start Up and No Calibration Delays During Monitoring

NomoLine capnography and gas monitoring technologies do not require a warm-up period, enabling

fast start ups with no delay. In addition, NomoLine capnography and gas monitoring technologies do

not auto calibrate during monitoring, eliminating delays present with other technologies.

Masimo offers a variety of capnography
and gas solutions including internal
boards, external modules, and both
mainstream and sidestream options.

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

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

rainbow Acoustic Monitoring®

Protecting More Patients by
Monitoring Every Breath with
rainbow Acoustic Monitoring

To expand the rainbow® platform’s promise of breakthrough noninvasive measurements, we have grown

beyond optically-based technologies to include a measurement derived from sound.

The Need for Respiration Rate Monitoring

Opioid-based pain medications can slow

oxygenation and ventilation monitoring for

and eventually stop breathing in some

patients, which makes continuous monitoring

all patients receiving opioid-based pain
medications.1,2 Conscious sedation can also

of respiration rate especially important for

post-surgical patients receiving patient-

induce respiratory depression and place patients
at considerable risk of serious injury or death.3

controlled analgesia for pain management.

However, the use of traditional capnography for

The Anesthesia Patient Safety Foundation and

The Joint Commission recommend continuous

respiration rate monitoring may be limited by
patient tolerance.4

Introducing rainbow Acoustic Monitoring

Patient Tolerance5

rainbow Acoustic Monitoring uses breathing sounds

from an acoustic sensor on the neck to provide
Acoustic Respiration Rate (RRa®), an accurate,

easy-to-use, and reliable monitoring solution
that also results in higher patient tolerance.5

RRa may facilitate monitoring of respiratory

compromise and patient distress, offering a

breakthrough in patient safety for post-surgical
patients and for conscious sedation procedures.6-8

While Masimo offers capnography solutions,

rainbow Acoustic Monitoring may be better suited

for post-surgical monitoring, conscious sedation,

and anyone who cannot tolerate a nasal cannula —

such as pediatric and neonatal patients.

100

Ability to Detect Respiratory Pause6

97.5%

62.5%

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.

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.

1 Stoelting RK et al. APSF Newsletter. 2011. (www.apsf.org). 2 The Joint Commission Sentinel Event Alert. Issue 49, August 8, 2012. https://www.jointcommission.org/assets/1/18/SEA_49_
opioids_8_2_12_final.pdf 3 American Society of Anesthesiologists, “Standard for Basic Anesthetic Monitoring,” American Society of Anesthesiologists, Inc., Park Ridge, 2011.

4 Friesen RH et al. J Clin Monit. 1996 Mar;12(2):155-9. 5 Patino M et al. Anesth Analg. 2017 Jun;124(6):1937-1942. 6 Ramsay M et al. Anesth Analg. 2013 Jul;117(1):69-75.
7 Applegate RL et al. Anesth Analg. 2016 Apr;122(4):1070-8. 8 Goudra BG et al. Open J Anesthesiol. 2013; 3:74-79. RRa for neonatal application is not available in the U.S.

Evaluating Respiration Rate Technologies

Each technology for respiration rate measurement has advantages and disadvantages.

Monitoring
Technology

Parameters

Advantages

Disadvantages

Ideal
Applications

Capnography

• Respiration rate

(RRc)

• End tidal CO2
concentration
(EtCO2)

NomoLine
p. 80,128,130

Acoustic
monitoring

• Acoustic

respiration rate
(RRa)

RAM
p. 82

• Also provides
indication of
cellular metabolism
with EtCO2

• Waveform

considered useful
by some clinicians
for monitoring
breathing

• Similar or better
accuracy than
capnography

• Patient tolerance

• Waveform can

visually indicate
low RR or
respiratory pause

• Patient tolerance in
conscious patients

• Cannula placement

• Surgery,

procedural
sedation

• Mouth breathing
with cannulas

• No EtCO2 values

• Difficulty

monitoring in high
ambient noise
or high vibration
environments

• General ward,
procedural
sedation,
non-intubated
surgery

Pulse oximetry

RRp
p. 46

• Respiration rate
from the pleth
waveform of SET®
pulse oximetry
(RRp)

• No added sensor

• Patient tolerance

• Inability to detect
respiratory pause

• General ward

and spot-check
environments
such as the
home or clinic

Available Masimo Technologies for Measuring Respiration Rate

RRc

RRp

RRa

Respiration Rate
from capnography

Respiration Rate from the Pleth

Acoustic Respiration Rate

RRp is not available in the U.S.

PSi

Estimating Depth of
Sedation with SedLine®
Brain Function Monitoring

Patients respond differently to anesthetics and sedatives, which can lead to over- or under-administration

in surgery, during conscious sedation, and in the intensive care unit. Some studies have suggested that
greater sedation depth is associated with higher rates of post-operative delirium and mortality.1,2

SedLine brain function monitoring provides continuous information and can help automate the monitoring

of a patient’s response to anesthesia. With four simultaneous channels of frontal electroencephalogram

(EEG) waveforms, SedLine enables bilateral data acquisition and processing of EEG signals. SedLine also

offers the Patient State Index (PSi), a processed EEG parameter that is related to the effect of anesthetic

agents, and a Density Spectral Array (DSA) display, which contains left and right spectrograms representing

the power of the EEG on both sides of the brain.

PSi has been shown to help clinicians administer
lower doses of both inhaled and intravenous
anesthetics without an increase in unwanted events.3,4

SedLine's Impact on Emergence

PSi has been shown to help clinicians administer lower doses of inhaled anesthetics without an increase
in unwanted events.3 In a randomized controlled trial of 306 surgical patients at Stanford Medical Center,

PSi was shown to help clinicians administer lower doses of intravenous anesthetics and achieve shorter
emergence time, extubation time, and time to discharge from the operating room.4

PSi

Patient State Index

1 Watson PL et al. Crit Care Med. 2008 Dec;36(12):3171-7. 2 Brown CH et al. Anesth Analg. 2014 May;118(5):977-80. 3 Sayed E et al. Saudi J Anaesth. 2016 Jul-Sep;10(3):288-94.
4 Drover DR et al. Anesthesiology. 2002 Jul;97(1):82-9.

Improving Anesthetic Drug Response
with Next Generation SedLine

Patient State Index (PSi) with Next Generation SedLine offers improved anesthetic drug response1 and

utilizes Masimo’s Parallel Signal Processing Engines to extract a clearer EEG signal, making PSi less

susceptible to EMG interference and with improved performance in low power EEG cases.

Rigorous Scientific Study Helps Develop and Validate Next Generation PSi Performance1

With the goal of significantly advancing the

Generation SedLine PSi, and 65 validation cases.

science of brain function monitoring, a rigorous

Modified Observer's Assessment of Alertness/

clinical study was recently completed in adult

Sedation (MOAAS) scores, a subjective score of

volunteer subjects at University Medical Center

responsiveness, were recorded after step change.

Groningen in The Netherlands.

SedLine brain function monitoring data and vital

signs were collected in all subjects.

A total of 41 subjects completed the study with

data included from 145 cases. During each case,

To evaluate the performance of Original PSi and

each subject was given a combination of inhalant

Next Generation PSi, independent EEG experts

and intravenous anesthetic agents with stepwise

reviewed the 65 validation cases with both

increasing doses until burst suppression and

Original PSi and Next Generation PSi (blinded

decreasing doses thereafter. By design, each subject

to the version), along with additional clinical

was scheduled for four data collection sessions

information (MOAAS scores, EEG waveforms,

on different days; one time each for Propofol-only,

drug doses, vital signs). Compared to the expert-

Propofol with Remifentanil, Sevoflurane-only, and

assessed anesthetic depth, an error was defined as

Sevoflurane with Remifentanil. The set of 145 cases

a case when expert assessment of PSi was ‘Low’ or

was then partitioned into 80 training cases that were

‘High’ and success was defined as a case when the

used to help develop the algorithm for the Next

expert assessment of PSi was ‘Good’.

“Next Generation PSi has enhanced signal stability and a better

description of the dose/response relationship. Next Generation PSi has

therefore improved capacity as a pharmacodynamic monitor of anesthesia
compared to the original PSi”1

Drs. Kuizenga, Colin, Vereecke, and Struys
University Medical Center Groningen, Dept of Anaesthesiology, Groningen, Netherlands

Overall PSi Performance in Response

to All Anesthetic Drugs Tested

92%

72%

Expert Scoring of Next Generation SedLine

EEG experts scored the improvement in

PSi performance in response to anesthetic

drugs between the original SedLine PSi
and Next Generation SedLine PSi.1

Specific anesthetic drug scoring found:

• 31% improvement with Sevoflurane

• 20% improvement with Propofol

100%

d
o
o
G

s
a
d
e
t
a
R
e
c
n
a
m
r
o
f
r
e
P

S
P
s
e
s
a
C

o
%

75%

50%

25%

Original PSi

Next Generation PSi

Experts found an overall 20% improvement in Next Generation PSi
performance in response to all anesthetic drugs tested.

Case During Step-wise Dosing of Sevoflurane

100

120

140

160

180

Time (minutes)

Next Generation PSi

Original PSi

100

S
P

e
n
a
r
u
fl
o
v
e
S
%

100

120

140

160

180

Time (minutes)

In this case with Sevoflurane only, EEG experts rates Next Generation PSi as ‘good’ and Original PSi as ‘high’.
During high doses of Sevoflurane at points A and B, Original PSi is higher than Next Generation PSi.

Inspiration

Expiration

1 Kuizenga MH et al. Proceedings from Euroanaesthesia 2017. #01AP07-4 (abstract).

Reducing Electromyography (EMG)
Susceptibility with Next Generation SedLine

Patient State Index (PSi) with

Next Generation SedLine is less

influenced by electromyography
(EMG).1 EMG can interfere with

EEG signals used in brain function

monitoring and researchers have

found that EMG interference existed
in up to 38% of monitored patients.2

100

30 mm/sec

PARALLEL SIGNAL
PROCESSING ENGINES

Engine Detects EMG

Clear Signal

EEG

EEG
EMG

EEG

EEG
EMG

5 uV/mm

36 50

PSi

This image captures
a moment when Next
Generation SedLine
detects EMG in the
two engines depicted.

S
P

Case with Period of EMG Interference3

EMG

100

120

140

160

180

Time (minutes)

The case demonstrates Next Generation SedLine’s improvement to PSi in the presence of
EMG interference.

Next Generation PSi

Original PSi

1 Masimo data on file. 2 Narasway et al. Critical Care Med. 2002 Jul;30(7):1483-7. 3 Retrospective analysis, Masimo data on file.

Enhancing Low Power EEG Performance
with Next Generation SedLine

Next Generation PSi Searches for EEG Features Across Many Frequency Bands

Power across all frequency bands decreases with age.1 Low power can provide a challenge for conventional

brain function monitors when noise is present in the signal.

22-year-old Patient

59-year-old Patient

100

S
P

Case with Periods of Low Power EEG2

Low Power
EEG

Low
Power
EEG

100

120

140

Time (minutes)

The case demonstrates Next Generation SedLine’s improvement to PSi in low power EEG.

Next Generation PSi

Original PSi

These two subjects were administered Propofol and were in a comparable anesthetic state, but their EEG waveforms and DSA
screen varied.2

Multitaper Density Spectral Array (DSA)

Next Generation PSi Uses Adaptive Signal Processing with Band-Independent Features

Next Generation SedLine also offers clinicians the flexibility of choosing to display either an enhanced

Multitaper Density Spectral Array (DSA), or a standard Hanning DSA. The DSA contains left and right

spectrograms representing the power of the EEG on both sides of the brain.

Next Generation PSi uses

adaptive signal processing with

band-independent features to

offer improved PSi performance

in cases of low power EEG.

BETA

ALPHA

THETA

DELTA

G
N
H
C
R
A
E
S

Next Generation SedLine processes
across all EEG bands.

Next Generation SedLine Adaptive Signal Processing

Conventional Monitor

When using a Multitaper DSA, EEG data are transformed into the frequency domain, which may provide a better display of EEG features.

1 Purdon P L et al. Br J Anaesth. 2015 Jul;115 Suppl 1:i46-i57. 2 Retrospective analysis of clinical data on file.

O3®

Indicating Brain
Oxygenation with
O3 Regional Oximetry

rSO2

Regional Oxygen Saturation

Importance of Monitoring Brain Oxygenation

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 levels in the brain.

Decreases in cerebral oxygen saturation are associated with post-operative cardiac dysfunction,1
neurological injury,2,3 increased length of hospital stays,3 and increased time on mechanical ventilation.4

Early detection and correction of imbalances in oxygen delivery to the brain are important tools in helping
patients avoid post-operative morbidity and adverse outcomes.5

Automating Brain Oxygenation Monitoring with O3 Regional Oximetry

Masimo’s O3 regional oximetry uses four wavelengths of light to monitor oxygen saturation (rSO2) in both

sides the brain in adult and pediatric patients. O3 regional oximetry can help clinicians automate assessment

of the brain oxygenation status and identify low oxygenation or significant changes in oxygenation.

O3 regional oximetry can help clinicians automate

monitoring of the brain oxygenation status and identify

low oxygenation or significant changes in oxygenation

Accuracy of O3 Regional Oximetry

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. O3 regional oximetry provided absolute root-mean-squared error of 4% and
relative root-mean-squared error of 2.1%.6 This 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.7

O3 Regional Oximetry Accuracy Specifications

Body Weight

Trending Regional Oxygen Saturation (rSO2)
Accuracy (RMS)*

Absolute Regional Oxygen Saturation (rSO2)
Accuracy (RMS)**

Adult

≥ 40 kg

Pediatric

< 40 kg

Masimo rSO2 Responsiveness During Surgery

EtCO2 increased

)

(

2
O
S
r

100

150

200

250

300

350

Time (minutes)

At 120 minutes, EtCO2 increased. The rSO2 from O3 regional oximetry is sensitive to changes in blood flow
that occur due to vasodilation after the increase in EtCO2, moving from approximately 50% to almost 80%.7

1 Schoen J et al. Crit Care. 2011;15(5):R218. 2 Colak Z et al. Eur J Cardiothorac Surg. 2015 Mar;47(3):447-54. 3 Slater JP et al. Ann Thorac Surg. 2009;87:36-45. 4 Goldman S et al.
Heart Surg Forum. 2004;7(5):E376-81. 5 Booth EA et al. Surg. Neurol Int. 2010; 1: 75. 6 Redford D et al. Anesth Analg. 2014 Dec;119(6):1315-9. 7 Masimo data on file. * 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. ** Absolute rSO2 accuracy (RMS) was determined by
testing on healthy adult volunteers with light to dark pigmentation in the range of 45% to 85% SavO2 against
30% arterial and 70% jugular venous blood oxygen saturations, measured with a laboratory CO-Oximeter.

Combining O3 and SedLine for
Simultaneous Brain Monitoring

PSi

rSO2

Most brain function monitoring and regional oximetry technologies have sensors

that compete for the same space on the patient’s forehead, preventing simultaneous

monitoring of both monitoring modalities and forcing clinicians to choose one.

Masimo has specifically designed the O3 and SedLine sensors to not interfere with

each other, enabling simultaneous monitoring with both modalities. The combination

of O3’s accurate regional oximetry measurements and Next Generation SedLine brain

function monitoring provides clinicians with even more information about the brain’s

response to anesthesia and surgery on the same monitoring platform.

Patients can be monitored
with SedLine or O3 only, or
SedLine and O3 together
for a more complete brain
monitoring picture.

Products:
Automating Clinician
and Patient Interactions
in the Care Environment

ProductsSensors

Optimizing Clinician Workflow

•

Two styles of sensors for use on different patient types

Delivering Multiple
Advancements with
the RD Sensor System

Sensor technology is at the core of our noninvasive measurement technologies.

The RD Sensor System is intended to replace our existing optical sensor lines

and was designed with the following in mind:

Enhancing Patient Comfort

•

Small and thin optical components

•

Low profile internal components allow the sensor to better conform to finger shape

with less pressure on the measurement site

•

Flat sensor cable — flat, lightweight sensor

cable with smooth edges lies comfortably

on the patient’s hand or foot

•

Lightweight connector — made from

materials that result in a lightweight

connector with no moving parts

Wrap-around style

• Easily removed and reapplied

Sensor graphics to guide

proper sensor application

• Assists with sensor application

for optimal performance

Up to 84%
less waste

Fold-over style

• Offering a more secure application to the

digit and more intuitive sensor alignment

Quick connection

• Intuitive sensor to cable

connection

• Tactile and audible feedback

ensuring proper connection

Helping Hospitals Meet Their Green Initiatives

•

Lightweight sensor results in

less material waste

•

Sleek, recyclable packaging

reduces storage space

Three Sensor Lines Based on Your Measurement Needs

100

RD rainbow Lite SET Sensor, RRp, RPVi, ORi, and SpfO2, are not available in the U.S.

101

RD SET

RD rainbow Lite SET

RD rainbow SET

• SpO2, PR, Pi, PVi, RRp

• SpO2, PR, Pi, PVi, RRp, RPVi, ORi

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

Advancing Two-LED Monitoring
with RD SET™ Sensors

RD SET Sensor Options and Application

SpO2

PVi

RRp

RD SET Adt

RD SET Pdt

RD SET Sensors use two wavelengths of light and are designed for use with Masimo SET® pulse oximetry.

As part of the RD Sensor System, RD SET Sensors were designed to enhance patient comfort, optimize

clinician workflows, and help hospitals meet their green initiatives.

RD SET Sensors use two wavelengths of light to provide Masimo SET® parameters

RD SET Neo

RD SET Inf

Volume: 100.5 inches3
(255.2 cm3)

RD SET NeoPt

RD SET NeoPt-500

Helping Hospitals Meet Their Green Initiatives

•

Lighter than traditional cable-based sensors

•

Up to 84% less waste with Adult RD SET sensors
versus traditional cable-based sensors1

Volume: 181.3 inches3
(460.4 cm3)

Sleek recyclable
packaging reduces
storage space by 44%1

Traditional Cable Based
Sensor Box
Box of 20

RD SET
Sensor Box
Box of 20

RD SET Adt
• Finger application

RD SET Pdt
• Finger application

RD SET Neo
• Adult finger application

102

1 Masimo data on file. Waste calculated by comparing the sensor and packaging weight of
traditional cable based sensors versus Adult RD adhesive sensors.
RRp is not available in the U.S.

RD SET Neo
• Neonatal foot application

RD SET Inf
• Thumb application

RD SET NeoPt-500
• Foot application

103

Customizing Applications with
Masimo SET ® Specialty Sensors

SpO2

PVi

RRp

Masimo SET® Sensors are also available in a variety of specialty sensors for specific clinical applications.

E-1® Sensor

The E-1 single-patient-use ear sensor is placed in the cavum conchae (the deep hollow

near the ear canal opening) and provides an alternative to digit sensors. The ear site

enables faster detection of saturation changes compared to digit sites during low

perfusion, and provides easy access in scenarios where the digit and forehead may not

be accessible, such as emergency transport.

Newborn Sensor

Every second matters during newborn resuscitation when oxygen saturation is rapidly
changing. The Newborn Sensor together with Masimo SET® technology automatically

configures the fastest response time with maximum sensitivity —allowing clinicians to

focus on the patient, not device settings.

Trauma Sensor

In trauma situations, SpO2 can change rapidly and peripheral perfusion can be very low.
The Trauma Sensor together with Masimo SET® technology automatically configures the

fastest response time with maximum sensitivity in adult trauma patients.

Blue® Sensor

Cyanotic heart disease refers to congenital heart defects that result in a low blood oxygen
level that can cause the skin to turn a bluish color.1 The Blue Sensor with Masimo SET®

pulse oximetry is specifically designed for use with cyanotic infant, neonatal, and pediatric

patients with congenital heart disease, and is accurate on cyanotic patients with oxygen
saturation as low as 60%.2 Studies have demonstrated that the Blue Sensor offers improved
accuracy in cyanotic infants and children compared to Nellcor sensors3,4 and standard
Masimo sensors.3 In a study on cyanotic infants, the Blue Sensor was shown to help
clinicians accurately maintain targeted oxygen saturation levels.5

TFA-1® Sensor

The TFA-1 transflectance forehead adhesive sensor provides an alternative

to traditional digit sensors. The forehead site enables faster 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.

TFA-1 Faster Response to Oxygenation Changes

)

(
n
o
i
t
a
r
u
t
a
S
n
e
g
y
x
O

40
Time (seconds)

TFA-1 sensor with Masimo SET®
DCI® digit sensor with Masimo SET®

A Faster indication of desaturation
B Faster indication of resaturation*

104

1 Waldman JD et al. Pediatr Clin North Am. 1999 Apr;46(2):385-404. 2 Masimo data on file and FDA 510(k) K051439. 2005. 3 Harris BU et al. Pediatr Care Med. 2016
Apr;17(4):315-20. 4 Cannesson M et al. Ann Fr Anesth Reanim. 2008 Oct;27(10):808-12. 5 Cox PN et al. Anesthesiology. 2007;107:A1540. (abstract). * Data on file.
RRp is not available in the U.S.

105

Accessing Advanced Parameters
with RD rainbow Lite SET™ Sensors

RD rainbow Lite SET Sensor Options and Application

SpO2

PVi

RRp

RPVi

ORi

RD rainbow Lite SET Adt

RD rainbow Lite SET Pdt

RD rainbow Lite SET Sensors are designed for use with Masimo rainbow SET Pulse
CO-Oximetry and provide two additional rainbow® parameters, ORi and RPVi, in
addition to all SET® parameters. RD rainbow Lite Sensors include the same patient

comfort, accuracy, workflow, and green initiative benefits as RD SET Sensors, but

use four wavelengths of light instead of the two wavelengths of light used in RD SET

Sensors. RD rainbow Lite Sensors can provide large clinical value but are offered at

only a small incremental price above RD SET Sensors.

RD rainbow Lite SET Sensors use four wavelengths of light to
provide ORi and RPVi in addition to all SET® parameters

RD rainbow Lite SET Neo

RD rainbow Lite SET Inf

RD rainbow Lite SET Adt
• Finger application

RD rainbow Lite SET Pdt
• Finger application

RD rainbow Lite SET Neo
• Adult finger application

RD rainbow Lite SET Neo
• Neonatal foot application

RD rainbow Lite SET Inf
• Finger application

RD rainbow Lite SET Inf
• Thumb application

106

* RD rainbow Lite SET Sensors, RRp, RPVi, and ORi are not available in the U.S.

107

Advancing Multi-wavelength Monitoring
with RD rainbow SET™ Sensors

RD rainbow SET Sensor Options and Application

SpO2

PVi

RRp

SpHb

SpOC

RPVi

ORi

SpCO

SpMet

SpfO2

RD rainbow SET Sensors are designed for use with Masimo rainbow SET Pulse CO-Oximetry,
using more than seven wavelengths of light to provide rainbow® parameters in addition to all SET®

parameters. As part of the RD Sensor System, RD rainbow SET Sensors were designed to enhance

patient comfort, optimize clinician workflows, and help hospitals meet their green initiatives.

RD rainbow SET Sensors use more than seven wavelengths of light to provide
rainbow SET parameters

RD rainbow SET Adt

RD rainbow SET Pdt

RD rainbow SET Neo

RD rainbow SET Inf

Helping Hospitals Meet Their Green Initiatives

Lightweight design and sleek, recyclable

packaging with RD rainbow SET

46%

less material
waste1

64%

reduction in
storage space1

Compared to previous generation rainbow® Disposable R1 25.

RD rainbow SET Adt
• Finger application

RD rainbow SET Pdt
• Finger application

RD rainbow SET Neo
• Adult finger application

RD rainbow SET Neo
• Neonatal foot application

RD rainbow SET Inf
• Finger application

RD rainbow SET Inf
• Thumb application

108

1 Masimo data on file. RRp, RPVi, ORi, and SpfO2 are not available in the U.S.

109

Sensors

Enhancing Patient
Safety with X-Cal®

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 communicate with each

How X-Cal Works

X-Cal helps reduce measurement inaccuracy and patient safety risks that may be caused by

violations of the aforementioned principles, such as with imitation cables and sensors that use

components and manufacturing processes that do not meet Masimo quality and performance

specifications. These specifications are required to provide consistent high performance. 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, such as inaccurate measurements that may lead to false alarms or

even mask true events such as hypoxemia, X-Cal technology is designed to automatically track

the aggregate time that individual cables and sensors are used for active patient monitoring.

When a specific sensor or cable has been used well beyond its expected life, the system notifies

the user, reducing the likelihood of a sensor or cable failure that could affect patient safety or

create work-flow inefficiencies for clinical and biomedical staff.

other so they can operate as an integrated system.

X-Cal also includes Site ID, which encodes the sensor with a unique identifier upon use.

The origin of the "X-Cal" name comes from "calibration", since X-Cal sensors store unique

characteristics of individual sensors that permit X-Cal-enabled Masimo technology boards to

adapt to the specific sensor in use. In addition to facilitating improved performance, the X-Cal

design permits sensors designed in the future to be compatible with an X-Cal enabled board

installed in a host monitor.

Sensor

Cable

Monitor

When all three components are genuine and within their expected life, the

system works as intended. However, when any one component is compromised,

erroneous measurements may occur which can impact patient safety.

X-Cal technology can alert you when an unreliable or imitation sensor or cable is connected, and also when a sensor or
cable has been used beyond its expected life.

110

111

Continuous Monitor

Adapting to
Changing Monitoring
Needs with Radical-7®

Radical-7 incorporates rainbow SET technology to enable measurements of 13 parameters in a bedside monitor.

SpO2

PVi

RRp

Radical-7 is highly adaptable as a 5-in-1 monitor

SpHb

SpOC

RPVi

ORi

SpCO

SpMet

SpfO2

RRa

•

Integration with the Root patient monitoring

•

Use with SatShare® to upgrade the performance

and connectivity platform

of conventional pulse oximetry in legacy multi-
parameter monitors to Masimo SET® performance

112

Radical-7 with RRp, RPVi, ORi, and SpfO2 are not available in the U.S.

113

•

Standalone Monitor

•

Handheld

•

Transport

Radical-7

•

Customize the display to view the highest

•

Use simple gestures to move, expand, or

priority parameters for your clinical setting

collapse parameter trends for deeper analysis

•

Configure parameter and alarm settings by

•

Audible and visual alarms allow quick identification

patient population, with the option to select from

of alarming parameters with two speakers for

pre-configured Patient Profiles

added safety in case one speaker ever fails

Rechargeable Battery

• 4-hour battery life for

extended monitoring

as handheld device

Connectivity Options

•

Integrated wireless

connectivity with

802.11 radio and

Bluetooth

Intuitive User Interface

• Easily navigate and

configure settings

using the high-

definition, multi-

touch display

114

Electronic Charting

• Automated

documentation of patient

data using Masimo

Patient SafetyNet or Iris
Gateway™ to interface

with hospital EMR system

Waveform View

• High resolution

plethysmographic

waveform and

optional acoustic

waveform from RRa

to provide real-time

physiologic visibility

Automatic Display

Rotation

• Versatile screen

automatically adjusts

to device orientation

Seamless Upgrade to Root

• Docking capability on

Root patient monitoring

and connectivity system

for expanded view,

measurement, and

documentation capabilities

115

Continuous Monitor

Getting to the
Root of Better Care

Root is a powerful patient monitoring and connectivity platform that can automate

clinician interactions with data, display, documentation, and patients. Root can be

configured in numerous ways to meet various clinical needs.

Multiple Measurement Options

•

Radical-7 or Radius-7

Root includes a dock for the Radical-7

handheld monitor or Radius-7 patient-worn

monitor, enabling a large screen display of
Masimo SET® pulse oximetry or rainbow SET

Pulse CO-Oximetry measurements.

•

Integrated Blood Pressure and Temperature

In addition to Masimo technologies,

clinicians can also use Root to measure

noninvasive blood pressure (NIBP) and

temperature with optional internal modules.

In addition, customers have an external

temperature option with Masimo’s Caregiver

handheld, touch-free thermometer that

requires no disposables.

•

Masimo Open Connect

Through Masimo Open Connect (MOC), Root augments breakthrough rainbow SET measurements

with multiple additional technologies — including SedLine brain function monitoring, O3 regional

oximetry, and NomoLine capnography and gas monitoring. Through MOC partner development,

multiple additional technologies will be available on Root in the future.

MOC-9 ports enable expansion measurements from Masimo or MOC partners.

Available Connectivity with Iris

Root’s Iris ports enable connectivity with third-party devices such as infusion pumps, ventilators, and

anesthesia machines. Root integrates multiple streams of data for electronic medical record (EMR)

documentation and remote reviewing, simplifying workflows and helping caregivers make quicker

assessments, which may enable earlier intervention and better clinical decisions.

116

117

Iris ports act as a connectivity hub for third-party standalone devices, such as IV pumps and ventilators.

Root®

Versatile, High-visibility Display

The adaptive display on Root is designed to aid clinicians’ rapid assessment of patient status.

In Analog view, virtual gauges show measurement values in relation to alarm ranges.

No alarm

Caution state

Alarm state

With alarm status visualizer, a three-dimensional, anatomical image associates alarm status with green, yellow, or red colors.

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 the general floor.

In Trend view, each measurement value is displayed alongside its graphical trend.

118

Screen views and parameter sizing are easily customized with a simple tap, swipe, pinch,
drag-and-drop, or three-finger-swipe for screen capture.

119

Patient-worn Monitors

Mobilizing Measurements
with Radius-7®

The Power of Masimo’s Breakthrough Measurements in a Patient-worn Monitor

Studies have shown that patient ambulation is a key factor in faster patient recovery,1 but movement can

cause frequent drop outs and false alarms with conventional pulse oximetry. Radius-7 with rainbow SET
Pulse CO-Oximetry leverages SET® Measure-through Motion and Low Perfusion performance to enable

accurate monitoring while the patient is moving, along with continuous monitoring for earlier identification

of clinical deterioration.

SpO2

PVi

RRp

SpHb

SpOC

RPVi

ORi

SpCO

SpMet

SpfO2

RRa

120

1 Needham D et al. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. Radius-7 with RRp, RPVi, and SpfO2 are not available in the U.S.

121

Radius-7

Untethered Monitoring and Ambulation

Placed on the patient arm or wrist with a comfortable disposable strap, Radius-7 is designed to promote

greater patient comfort and independence and reduce the need for nurses to disconnect the monitor

each time the patient gets out of bed.

Keeping Patients Connected to Clinicians

Root with Radius-7 can alert clinicians to critical changes in a patient’s physiologic status at the bedside

or with supplemental remote monitoring and notification remotely through Masimo Patient SafetyNet,

ensuring patients can be continuously monitored and connected to caregivers while they are moving —

in or outside their rooms. Bluetooth wireless technology allows short-range communication with Root

and optional WiFi enables longer-range communication throughout the hospital.

Flexible Functionality

Radius-7 has two “hot-swappable” rechargeable modules with a 12-hour battery (one on Radius-7,

one charging in Root), providing seamless replacement at shift change and automatic pairing with

Root to minimize disruptions to nursing workflow. Radius-7 also has a display shut-off feature to

minimize patient distraction and support privacy while ambulating.

Radius-7 is the first and only wearable and wireless device to enable noninvasive and continuous

monitoring of rainbow SET measurements while patients are mobile, including indices of:

•

Oxygenation and

•

Respiration

•

Hemoglobin

Circulation

Respiration rate monitoring

Noninvasive and continuous

Oxygen saturation (SpO2)

through either rainbow

hemoglobin (SpHb)

and pulse rate monitoring
with Masimo SET® Measure-

Acoustic Monitoring for

monitoring with rainbow

acoustic respiration rate

SET Pulse CO-Oximetry

through Motion and Low

(RRa) or through the

may help clinicians identify

Perfusion pulse oximetry

plethysmographic waveform

changes in hemoglobin

for reliable detection of

desaturation and accurate

pulse rate while dramatically
reducing false alarms1,2

(RRp) to identify respiratory
depression or tachypnea3

that may be associated

with bleeding and stable

hemoglobin to help reduce

inappropriate transfusions

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1 Taenzer AH et al. Anesthesiology. 2010 Feb;112(2):282-7. 2 Pyke J et al. Patient Safety & Quality Healthcare. May/June 2009. 3 Ramsay MA et al. Anesth Analg. 2013 Jul;117(1):69-75.
Radius-7 with RRp, RPVi, and SpfO2 are not available in the U.S

123

Each Radius-7 comes with two rechargeable, “hot-swappable” modules, enabling uninterrupted monitoring and a quick exchange
at the bedside.

Surveillance Monitoring

Personalizing Monitoring
with MyView™

MyView empowers clinicians to see things their way. While the type of displayed information can change

MyView in Patient SafetyNet automatically senses when a clinician approaches and highlights their

dramatically by clinician and care area, patient monitors historically function in a static manner with the

patients for easy viewing.

same parameters, waveforms, and trends displayed in the same location at all times.

MyView technology — a feature enabled by Masimo Patient SafetyNet — allows wireless sensing of the

device, clinician, and patient 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 information but rather a color-coded device alarm status.

When no clinician is present, select a device display that is primarily green, yellow, or red, depending

on the alarm status, with parameters displayed in smaller font within the parameter well. This eliminates

a common distraction for the patient and family members while limiting unnecessary concerns and

questions. When clinicians enter the room, MyView recognizes them and displays their preferred view.

Clinician-centric view with the use of a smartphone or presence tag allows caregivers to see the

customized information most important to them as they approach a patient.

124

MyView is not available in the U.S.

125

Continuous Monitors

Expanding Measurements
with Masimo Open Connect®

Root enables flexible measurement expansion through Masimo Open Connect (MOC)

with either wired external modules (MOC-9) or wireless communication (MOC-C).

Masimo MOC Measurements

Three Masimo measurement technologies

are currently available for Root through

MOC-9 modules:

•

SedLine brain function monitoring
O3 regional oximetry
NomoLine capnography and gas monitoring

SedLine brain function
monitoring

O3 regional
oximetry

NomoLine capnography
and gas monitoring

MOC-9 ports allow up to three modules to be connected at one time.

SedLine brain function monitoring and O3 regional oximetry are plug-and-play
MOC-9 modules for Root.

126

127

Capnography & Gas

Offering Solutions for a Variety
of NomoLine® Capnography
and Gas Applications

IRMA AX+
EtCO2, RR, N2O,
Inhalation Anesthetic
Agent Identification

EtCO2

RRc

FiCO2

NIBP

IRMA CO2
EtCO2, RR, FiCO2

NomoLine capnography and gas monitoring is available in multiple configurations to meet various clinical needs.

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. With minimal warm-up time, ISA supports quick

assessment 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. IRMA’s mainstream capability

allows clinicians to monitor directly from the breathing circuit and avoid sampling lines.

ISA OR+
EtCO2, RR, N2O, O2, Inhalation
Anesthetic Agent Identification

ISA AX+
EtCO2, RR, N2O, Inhalation
Anesthetic Agent Identification

ISA CO2
EtCO2, RR, FiCO2

128

ISA CO2 is a plug-and-play module for Root that can be quickly
disconnected from and re-deployed to any available Root.

129

Overcoming the Challenges of
Traditional Gas Sampling with
NomoLine Cannulas

Designed for low-flow applications, with functionality in any orientation, NomoLine sampling

lines can be used in a variety of clinical scenarios on both intubated and non-intubated adult,

pediatric, infant, and neonatal patients, in both low- and high-humidity configurations.

NomoLine Technology Benefits

• Revolutionary polymer collects and removes

•

Designed for low tidal volumes and high

water in the sampling line to extend product

breath rates to provide suitability for a

life and eliminate the need for a water trap

wide range of clinical applications

•

Hydrophobic bacteria filter protects the ISA

•

Cannulas with soft, ergonomically curved

module from bacteria and water intrusion

design provide greater patient comfort

A selection of convenient single-patient-use cannulas.

•

Leak-free, click-in gas sampling port

connector enables easy-to-use sampling lines

130

131

“We believe that Root with Masimo Open Connect can
do for patient monitoring what the PC did for computing:
speed up the patient innovation cycle, reduce the cost of
equipment, and prolong the useful life of the equipment.”

Joe Kiani
Chairman and CEO, Masimo

In 2017, Masimo and Mdloris announced the first MOC-9 module, with Analgesia
Nociception Index (ANI) technology.1 The ANI MOC-9 module for Root will provide an

objective, noninvasive, and continuous way to monitor the pain level of patients. Multiple

additional MOC-9 modules and MOC-C apps are in development by MOC partners.

Continuous Monitors

Fueling Innovation with
Masimo Open Connect

When new monitoring technologies are introduced, traditional multi-parameter monitoring companies

often wait for significant market adoption to occur before integrating these new technologies in their

products. This means that new technologies are often only available in standalone versions. Hospitals

often have a strong desire to add new technologies to existing multi-parameter monitors, so the lack

of an integrated solution can limit hospital adoption and patient benefit.

Designed to Stimulate Third-Party Innovation

Masimo's unique approach to medical technology

Third parties can then independently develop, obtain

integration through Masimo Open Connect

regulatory approvals, and commercialize their own

(MOC) partnerships addresses these barriers to

external MOC-9 module or Masimo Open Connect

new technology adoption in patient monitoring.

Control (MOC-C) app for Root using Masimo's MOC

Root's open architecture and built-in connectivity

software development kit (SDK). Masimo’s engineering

enable third-party companies to bypass barriers

team will support MOC partner development as

and time it takes for traditional multi-parameter

needed and Masimo's commercial team will help

monitor integration by controlling their own Root

increase awareness of the availability of MOC-9

integration project.

modules and MOC-C apps from MOC partners. In

turn, MOC partners will use their existing distribution

channels to sell their MOC-9 module or MOC-C app

to Masimo customers already using Root, as well as

offering the product to their potential customers as an

additional way to deploy their technology.

132

1 The ANI Module is not available for sale.

133

Up to three MOC-9 modules can be used at the same time on Root.

Surveillance Monitoring

Addressing Safety Challenges
on the General Ward with
Patient SafetyNet™

A sentinel event is defined as an unanticipated

recommended implementation of better dosing

death or serious injury to a patient that is not related

along with continuous oxygenation and ventilation

to the natural course of the patient's illness. The

last thing anyone expects when otherwise healthy

monitoring (instead of spot checks) in post-
surgical patients.1 This alert reported the incidence

patients are admitted for routine procedures is that

of respiratory depression at 0.5%, which means

they won’t go home due to a sentinel event. The

a hospital with 10,000 surgeries per year would

combination of pain management medications and

experience one patient per week with respiratory

lower staff-to-patient ratios on general care floors

depression. Failure to recognize respiratory

make it less likely that a clinician can be there to

depression and institute timely intervention can

observe an alarm that could precede an avoidable

lead to cardiopulmonary arrest, resulting in brain

adverse event.

In August 2012, The Joint Commission Sentinel

Event Alert on the safe use of opioids in hospitals

injury or death. A retrospective multi-center study

of 14,720 cardiopulmonary arrest cases showed

that 44% were respiratory related and more than
35% occurred on the general care floor.2

Connecting Patients and Caregivers Quickly, Easily, and Accurately

Masimo Patient SafetyNet remote monitoring and clinician notification system combines bedside

monitoring with Masimo’s monitoring technologies with clinician notification via pager, IP phone, or

smart phone. Patient SafetyNet provides patient safety on the general floor in a system that can be

integrated into your existing wired or wireless network. Patient SafetyNet may facilitate appropriate

early clinical response, preemptions of sentinel events, and avoidance of unnecessary transfers, while
helping you meet The Joint Commission,1 Institute for Safe Medication Practices (ISMP),3 Anesthesia
Patient Safety Foundation (APSF),4 and American Society of Anesthesiologists (ASA) guidelines.5

The last thing anyone expects when otherwise healthy
patients are admitted for routine procedures is that
they won’t go home due to a sentinel event

134

1 The Joint Commission Sentinel Event Alert. 2012;49. 2 Peberdy, et al. Resuscitation. Sep;58(3):297-308. 3 Weinger MB, et al. APSF
Newsletter. 2011;26(2):21-40. 4 ISMP Medication Safety Alert! Newsletter. 2009. 5 Practice Guidelines for the Prevention, Detection,
and Management of Respiratory Depression Associated with Neuraxial Opioid Administration. Anesthesiology. 2009;110:1–1.

135

Impact of Patient SafetyNet at One Hospital

0patients suffered preventable

brain damage or died over
a 5-year period4

50reduction in unplanned transfers

over a 10-year period5

60reduction in rescue events

over a 10-year period5

1.48million in annual

cost savings4

“In my opinion as Quality and Safety Officer, our results strongly
demonstrate that continued patient surveillance with Masimo
SET® and Patient SafetyNet increase healthcare value by
significantly improving clinical outcomes while reducing costs.”

George Blike, MD
Dartmouth-Hitchcock Medical Center

Improving Outcomes on the
General Ward with Patient SafetyNet

Reducing Rescues and ICU Transfers

Clinicians understand the risks of not continuously

Following the initial implementation and positive

monitoring patients on the general floor. In the past,

results in one post-surgical ward, Patient SafetyNet

excessive false alarms due to patient motion often

with Masimo bedside devices was expanded to

precluded continuous monitoring in these care
areas. In the last decade, Masimo SET® has been

cover more than 200 inpatient beds in all medical

and surgical units. In subsequent articles published

shown to improve the process of care in neonates

in the Anesthesia Patient Safety Foundation

and pediatric patients due to its Measure-through
Motion and Low Perfusion performance.1,2 However,

Newsletter in 2012 and The Joint Commission

Journal on Quality and Patient Safety in 2016,

in a landmark study published in Anesthesiology in

researchers reported that Patient SafetyNet enabled

2010, researchers found that continuously monitoring

the facility, over a five-year period, to achieve their

adult patients on a post-surgical floor at Dartmouth-

Hitchcock Medical Center using Masimo Patient

goal of zero preventable deaths or brain damage
due to opioids,4 and over a ten-year period,

SafetyNet with Masimo bedside devices resulted in a

maintain a 50% reduction in unplanned transfers

65% reduction of rapid response team activations
and a 48% reduction in transfers back to the ICU.3

and 60% reduction in rescue events, despite
increases in patient acuity and occupancy.5

Proven Cost-effectiveness

As a result of the Patient SafetyNet implementation, Dartmouth-Hitchcock Medical Center saved $1.48
million annually,4 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 justifications now in place, hospitals are

increasingly implementing general floor monitoring with Masimo technologies.

136

1 Hay WW et al. J Perinatol. 2002 Jul-Aug;22(5):360-6. 2 Brouillette LL et al. Anesth Analg. 2002
Jan;94(1 Suppl):S47-53. 3 Taenzer AH et al. Anesthesiology. 2010;112(2):282-287. 4 Taenzer AH
et al. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012. 5 McGrath SP et
al. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

137

Surveillance Monitoring

Simplifying and Integrating
Multiple Measurements
with Halo Index™

Halo Index Mimics an Expert Clinician

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 physiologic deterioration — analyzing patient history

and extracting key continuous vital sign parameter characteristics to monitor global patient status over time.

Halo Index uses available Masimo parameters and is scalable to include additional information from the

patient record. 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 of global patient status.

An increase in a patient’s Halo Index may indicate the need for clinicians to more closely assess the patient.

Halo Index: How it Works

To calculate Halo Index, parameters are continuously analyzed over relevant time intervals in order to

extract parameter characteristics. It is important to note that the parameter characteristics are not merely

instantaneous values, but include historical parameter data and parameter relationships to support an

integrated assessment of a patient's underlying physiology.

Monitoring of
Multiple Parameters

Extraction of Multiple
Characteristics from
Each Parameter

Assessment of
Each Parameter
Characteristic Using
Clinical Knowledge Base

Cumulative Halo Index

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.

138

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

139

Continuous Monitors

Deploying Root with
Noninvasive Blood Pressure
and Temperature

With the addition of noninvasive blood pressure and temperature monitoring capabilities,

Root can also function as a powerful and versatile vital signs monitor, suitable for use at the

bedside or as a rolling spot-check device.

Integrated Temperature

Oral temperature probe enables quick spot-check

temperature measurements.

Integrated Noninvasive Blood Pressure

Spot-check and customizable interval measurement options.

•

Spot-check blood pressure measurements can

be taken at any time

•

Automatic interval mode routinely takes blood

pressure measurements once every desired time

interval, eliminating the need to do so manually

•

Stat interval mode continuously measures blood

pressure for a desired duration of 5 or 10 minutes

Non-contact Temperature Option with Caregiver*

Root is also available with an easy-to-use, clinical-grade infrared thermometer with Bluetooth connectivity.

•

Comparable accuracy to oral measurements

Simple, one-button operation delivers instant

results, reducing time to take temperature

measurements
Bluetooth automates data transfer to

•

a connected Masimo device enabling

streamlined integration into the bedside

device and EMR
Non-contact module reduces costs and

•

waste by eliminating the need to purchase

additional disposables such as probe covers

140

* Masimo Caregiver is not available for sale.

141

Continuous Monitors

Computing an Early
Warning Score with Root

Integrating multiple spot-check measurements into an Early Warning Score (EWS) can aid in the
automatic monitoring of potential patient deterioration.1 Root can automatically calculate an EWS

from existing device measurements and additional clinician inputs which represents the potential

degree of patient deterioration. EWS contributor scores are calculated using measured values and

clinician input, then combined into an aggregate EWS. 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 Masimo Patient SafetyNet or Iris Gateway.

Early warning scores are based on multiple contributors, including vital signs such as oxygen

saturation, pulse rate, respiration rate, body temperature, and systolic blood pressure — and

contributors entered by clinicians, which can include customized inputs which clinicians are

prompted to enter, such as level of consciousness, use of supplemental oxygen, and urine output.

The weighting and number of contributors differ depending upon which EWS protocol is used.

Root can be customized with up to eight EWS profiles using one of multiple predefined EWS

protocols or a custom-configured EWS in which hospitals determine their own set of required

contributors and their relative weights to create an EWS unique to their care environment.

Contributor
Scores, Not
Measured
Values

Spot-check Calculation with
Time/Date Stamp

Time Since
Last EWS
Calculation

142

1 Alarm N et al. Resuscitation. 2014 May;85(5):587-94.

143

Based Upon
Root Measurements

Based Upon
Clinician Input Data

Aggregate Early
Warning Score

Hospital Automation Connectivity

Keeping Patients and
Clinicians Connected to
the EMR through Adaptive
Connectivity Engine

Patient Admit / Association

Patient SafetyNet and Root interface with hospital Admit Discharge Transfer (ADT) systems allowing clinicians

to associate patients to their data through a drop-down list or barcode scanning.

•

Patient data, including EWS,

•

Patient SafetyNet or Iris

• Patient SafetyNet or Iris

is captured by Root

Gateway converts data into HL7

Gateway automates data

transfer to the hospital EMR

Documentation / Results Out / Electronic Charting

Hospitals are increasingly using electronic medical

and more time caring for patients. Patient SafetyNet

Patient SafetyNet provides automated documentation of patient data to the EMR at hospital-specified intervals,

records (EMRs) to chart changes in vital signs and

and Iris Gateway incorporate Adaptive Connectivity

and also enables clinician bedside verification to reduce time required for documentation at the EMR workstation.

document clinical interventions. Compared to

Engine (ACE), which enables two-way, HL7-based

manual documentation, automatic transfer between

connectivity to other hospital systems, including

medical devices and EMRs can improve productivity
and reduce the likelihood of transcription errors.1

Masimo Patient SafetyNet and Iris Gateway

provide clinicians with a solution to automate the

transmission and subsequent recording of key data

to and from Root devices and the EMR, helping

clinicians spend less time recording information

EMR systems. ACE significantly reduces the

complexity of integrating and validating custom HL7

implementations, which means the EMR validation

can be completed quickly, cost-effectively, and

often without the aid of EMR vendors. Masimo’s

entire approach to connectivity is based on this

fundamental principle: automating patient care with

open, scalable, and standards-based architecture.

144

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

145

Bedside documentation of vital signs from Root along with common fields such
as urine output, level of consciousness, and pain scale.

Hospital Automation Connectivity

Automating Workflows
for Data Collection

Guided Workflows

Variability in clinician workflows can reduce the consistency of care and reduce productivity. Root or

Rad-97 with Iris or Masimo Patient SafetyNet allow hospitals to customize and automate workflows

for spot-check or continuous monitoring scenarios. Hospitals can create their own rules engine

in Iris or Patient SafetyNet to enable onscreen direction in all connected devices to guide which

measurements to capture and which additional data to input on Root. Based on measurement or

score values, clinicians can also be prompted to enter more information or take specific actions.

Capturing Data Even When Devices Are Not Connected

Most spot-check vital signs monitors require a continuous wireless network connection to enable

vital signs documentation to the electronic medical record (EMR). Root and Rad-97 bypass this

limitation with the ability to locally store the data collected from multiple patients, and then

automatically transfer the collected data via Bluetooth to a network relay station that enables

documentation to the EMR. This feature is expected to minimize manual documentation from

disconnected devices and lessen the need for additional wireless infrastructure.

Data transfer

• Once connection is established with Iris
Gateway. Rad-97 / Root will start pushing
the Spot Check result to the Iris Gateway.

Router & Server

• A mini PC running Iris Gateway
software will connect through
a wired connection to
the router.

Rad-97 / Root

• In Spot Check mode, connected

wirelessly through the router with
private SSID.

Hospitals can configure Root to prompt
clinicians to take specific actions based
on specific measurements or early
warning score thresholds

Root enables vital sign documentation at the bedside for both
measurements and hospital-configured manual inputs

Root and Rad-97 can locally store the spot-check data collected from multiple patients, and then automatically transfer
the collected data via Bluetooth to a network relay station that enables documentation to the EMR

146

147

Hospital Automation Connectivity

Connecting and
Controlling Third-Party
Devices with Iris™

Device Interoperability Challenges

Despite advances in medical technology, the lack of device interoperability is a serious patient
safety risk.1 Data generated from medical devices often remain captive within each device

and may not be captured in patient records. Existing approaches for device interoperability

may require separate hardware, software, and/or network infrastructure which can clutter the

patient room, burden IT management, and increase the complexity and cost of care.

Root with Iris Gateway

Root’s Iris ports, along with Iris Gateway, integrate monitoring and connectivity to bridge

medical device data silos. Device connectivity with Iris is vendor agnostic and is designed

to leverage existing network infrastructure and reduce costs while enhancing workflows and

decision support. With Iris, Root can be used to associate patients with multiple third-party

devices and systems and connect them to the electronic medical record (EMR). Root with

Iris is appropriate both in high-acuity settings like the operating room or intensive care unit

and in low-acuity settings like the general floor. Whenever medical device data are readily

available in the EMR, clinicians have a more complete, timelier picture of the patient.

Automatic transfer between medical devices
and EMRs could improve productivity and
reduce the likelihood of transcription errors2

Workflow
Automation
EWS/Barcode

Iris Analytics

UniView

Third Party
Device
Connectivity

Third Party
System
Connectivity

Surveillance
Monitoring

Iris Connectivity
Solutions

Full Receipt
Notification and
Escalation

High
Fidelity Data

Two-way
Communication

148

1 Weininger S et al. Anesth Analg. 2017 Jan;124(1):127-135. 2 The Value of Medical Device Interoperability. West Health Institute. 2013.

149

Iris

•

Third-party standalone devices and systems can

•

Iris Gateway converts all Masimo and third-party

• Root’s built-in Iris ports act as a connectivity hub

•

Iris Gateway interfaces with EMRs for

silo valuable patient data

standalone device data into HL7

for third-party standalone devices

documentation and device data

Iris Gateway and Patient SafetyNet

In addition to automated documentation of patient data from multiple devices in the EMR, Patient

Together, Root with Iris, Iris Gateway, and Patient SafetyNet are helping to connect clinicians, patients,

SafetyNet with Iris Gateway further enhances connectivity by allowing patient data to be remotely

and their data more closely than ever.

viewed at central stations and supplemental alarms and alerts to be transmitted to clinicians.

•

Simplified Workflow with Barcode ADT
Integration

•

Bedside Device Connectivity

•

Customizable View Station

•

Mobile Clinician Notification

150

1 Hay WW et al. J Perinatol. 2002 Jul-Aug;22(5):360-6. 2 Brouillette LL et al. Anesth Analg. 2002 Jan;94(1 Suppl):S47-53.
3 Taenzer AH et al. Anesthesiology. 2010;112(2):282-287.

4 Taenzer AH et al. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

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

151

Surveillance Monitoring

Seeing Your Patient No Matter
Where You Are with Replica™
and Built-in Camera

With Patient SafetyNet, when clinicians are out

make video calls — all from a single app. Notification

of the patient room, patients are continuously

verification can be limited with standard paging

monitored and clinicians are notified when an alarm

and VoIP phones, only escalating notifications once

occurs. Replica takes connecting with patients

fixed time periods have elapsed. Replica enables

through Patient SafetyNet to a new level, delivering

timely notification escalation because it has the

patient data — including urgent notification of alerts

ability to verify that a clinician's smart phone is

and alarms — to the hand of any clinician. Replica

powered on and has displayed the notification,

also allows clinicians to monitor patient data in

as well as whether they have acknowledged or

real time, modify device settings, and receive and

declined the notification.

Replica Views

Rad-97 and Root with camera allow clinicians to see and hear patients from a Masimo Patient SafetyNet View Station or from Replica.

• Receive and accept or

decline alerts

• View all patients in
dashboard view

• View real-time data

• View all alerts

152

1 Weininger S et al. Anesth Analg. 2017 Jan;124(1):127-135. 2 The Value of Medical Device Interoperability. West Health Institute. 2013.

153

Augmented Display

Extending Visibility
with Kite™

Masimo bedside monitoring devices provide clinicians with many types of data. During complex care,

monitoring can involve so many forms of real-time output — all of value to clinicians — that displaying

them simultaneously on the primary device's smaller display may be inconvenient or impractical.

Maximizing Focus with Kite

Kite expands visibility of patient data for clinicians

Kite’s supplementary display can be customized to

by allowing data from Masimo devices to be

enable clinicians to view monitoring parameters,

simultaneously viewed on different displays in

waveforms, and other data they require for that

customized configurations. Kite connects to

patient and type of care or operation. Kite also

Masimo devices via a wired or wireless connection

projects patient alarms from the monitoring

on the same IP network and displays monitoring

device, providing quick notification of changes

data from the connected device on a TV or tablet.

in a patient’s physiological status.

“Kite greatly enhanced the visibility of the Masimo
monitor. During bypass I could easily view cerebral blood
flow, allowing time to validate adequate perfusion to my
patient and maintain my attention on my bypass circuit.”

Dr. Don Marketto, D.O., Anesthesiologist
Mountain View Regional Hospital, Las Cruces, New Mexico

154

Ideal for Operating Rooms, Emergency Rooms, and Individual Patient Rooms

All the clinicians in the room can easily view multiple monitoring modalities on a large,

centrally-located screen, in the clinicians' preferred configuration.

Kite During Surgery

Kite in the ICU

155

Augmented Display

Bringing Next Generation
Data Aggregation and
Display with 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 Iris

Gateway, which gathers data from multiple sources, UniView will be able to project, on large displays,

integrated patient information from all connected systems in the hospital. UniView will provide a

central, convenient, and customizable display of data from patient monitors, ventilators, anesthesia

gas machines, IV pumps, lab and radiology results, surgical views, and a myriad of other sources. In

high acuity departments 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.

UniView will take the aggregation and customizable
display of patient data to a new level

UniView capabilities are designed to expand in the future to include therapeutic device control

with automated decision support and eventual closed loop therapies, increasing care consistency

and decreasing lag time between decision and execution.

UniView’s automated data integration and display
are designed to help clinicians identify changes in
patient status and coordinate complex decisions,
resulting in optimized treatment.

156

* Masimo UniView is currently not available. Potential future functionality has not been reviewed by the FDA or other regulatory bodies.

157

Augmented Display

Virtualizing
Monitoring
with AirGlass

Masimo AirGlass brings the adaptable and

customizable display concept of UniView to a

personal level through augmented reality. Using

AirGlass, clinicians such as anesthesiologists and

surgeons no longer need to physically adjust

monitors or take their eyes off the patient to

receive monitoring and therapeutic device data.

Clinicians can also use AirGlass while they are out

of the room to continue monitoring the patient.

Seeing what's in front of them while always

keeping patient data in sight allows clinicians to

remain focused on the patient while coordinating

patient management decisions.

By using motion gestures in the air with their hands, Masimo
AirGlass allows clinicians to interact with data, such as
enlarging key information and responding to alerts and alarms.

“Healthcare technology that was once considered
science fiction is becoming reality.”

Joe Kiani, Chairman and CEO
Masimo

158

* AirGlass is not available for sale.

159

Continuous Monitors

Flexible Uses with Powerful Expandability

Taking Flexibility to the
Next Level with Rad-97™

Rad-97 incorporates Masimo rainbow SET Pulse CO-Oximetry — and optional NomoLine capnography or

noninvasive blood pressure — to enable measurements of 17 parameters in a portable and upgradeable

bedside monitor. Rad-97 will also allow future expandability through Bluetooth communication with

Masimo Caregiver for non-contact thermometry and third-party measurement devices such as weight

scales and glucometers.

SpO2

PVi

RRp

SpHb

SpOC

RPVi

ORi

SpCO

SpMet

SpfO2

RRa

EtCO2

RRc

FiCO2

NIBP

• Bedside monitor

• Connection to Masimo

• Spot-check vital signs

• Optional Masimo

Patient SafetyNet for

monitoring with

Caregiver for non-

remote monitoring of

optional cart

contact thermometry

multiple patients as well

as clinician notification

with Bluetooth

communication

Optional camera enables

remote viewing and

communication with the patient

Real-time EtCO2 waveform

provides an easily interpretable

display of capnography

measurements

Connectivity solutions facilitate

electronic charting of patient

data in the EMR, automated by

Patient SafetyNet or Iris Gateway

Integrated port for direct

connection of either

NomoLine sampling lines

for capnography or NIBP

Use simple gestures on the

multi-touch screen to move,

expand, or collapse parameter

trends for real-time analysis

Data can be displayed in

numeric view or trend view

Customizable display allows

for quick monitoring of patient

status and provides pertinent

data at a glance

Ethernet, Nurse Call Interface,

and USB ports enable

seamless integration into

wired infrastructures

Light Emitting Gas Inlet indicator

illuminates in different colors

to provide visual indicators of

capnography module status

160

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

161

Spot-check Monitors

Redefining Handheld
Monitoring with the
Revolutionary Rad-67™

SpO2

PVi

SpHb

SpOC

SpCO

SpMet

Next Generation SpHb

Next Generation SpHb significantly advances noninvasive hemoglobin spot-checking with improved motion

tolerance, faster time to display SpHb results, and enhanced field performance in low hemoglobin ranges.

•

Improved motion tolerance

Enhanced SpHb field performance

Results displayed in as few as 30 seconds

“The ability to monitor noninvasive hemoglobin (SpHb) is a great advancement.
Once low SpHb is reported, confirmation with a conventional laboratory test
will further explore the possible causes.”

Dr. Aryeh Shander
Chief of Anesthesiology & Critical Care Medicine, Englewood Hospital and Medical Center

162

Rad-67 is not available in the U.S.

163

Next Generation SpHb

Next Generation SpHb significantly advances noninvasive hemoglobin spot-checking with improved motion

tolerance, faster time to display SpHb results, and enhanced field performance in low hemoglobin ranges.

The following table represents the accuracy of SpHb measurements obtained using Rad-67 with Next

Generation Spot-check SpHb Technology and measurements using an invasive point-of-care device, each
compared to a laboratory reference device.1

Accuracy of Next Generation SpHb and Invasive Point-of-care Device

vs. Laboratory Hematology Analyzer

Dataset

Number of
Subjects

Number of
Samples

Precision (g/dL)

Bias (g/dL)

Root-Mean
Square (ARMS)
Accuracy2 (g/dL)

SpHb vs. Laboratory

Hematology Analyzer

Invasive Point-of-care Device vs.

289

542

Laboratory Hematology Analyzer

289

(Capillary Blood Draw)

1.0

1.1

0.4

-0.1

1.1

Wired and wireless

connectivity enables

transfer of patient data

Rechargeable battery with

up to 6-hour battery life

Intuitive touchscreen and

finger gestures facilitate

quick navigation

High definition, color

LCD display with ambient

light sensor automatically

adjusts screen brightness

to optimize visibility

•

Improved motion

•

Enhanced SpHb

•

Results displayed

tolerance

field performance

in as few as 30

in the lower

seconds

hemoglobin ranges

164

1 Masimo study. Data collected at six different centers on healthy and sick subjects. 2 Rounded ARMS accuracy obtained meets the 1 g/dL accuracy requirement. 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. SpHb monitoring with Rad-67 is not intended to replace laboratory blood testing. Blood samples should be analyzed by
laboratory instruments prior to clinical decision making. Rad-67 is not available in the U.S.

•

Feedback screens

•

Label spot-check

•

Download patient

•

Bluetooth enables

provide alerts

measurements with

data directly from

printing of results at

regarding signal

unique patient

the device using a

the point of care

quality and possible

identifiers for

wired or wireless

solutions

convenient historical

connection

data review

165

Capnography & Gas

Accessing Immediate
Capnography at the Point of
Patient Contact with EMMA™

The Masimo Emergency Mainstream Analyzer (EMMA) is a compact, portable, and lightweight mainstream

capnograph that requires minimal warm-up time, with full accuracy in 15 seconds.

EtCO2

RRc

EMMA is ideal for short-term monitoring of end-tidal CO2 levels and respiration rate in adult, pediatric,

and infant patients. EMMA is often used during anesthesia, emergency care, and intensive care, where

capnography is also 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

166

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

167

iSpO2 Rx enables spot-check of
continuous monitoring with Masimo
single-patient-use or reusable sensors
and is powered by a smart phone
or tablet with data display on the
Masimo Professional Health app

Spot-check Monitors

Carrying the Most Powerful
Pulse Oximeter in Your
Pocket with MightySat™ Rx

MightySat Rx is the first fingertip pulse oximeter with Masimo SET® parameters, and is the only
fingertip oximeter with Pleth Variability Index (PVi) and respiration rate from the pleth (RRp).*

SpO2

PVi

RRp

MightySat Rx is intended for professional use

functionality. The app enables users to view

or by patients as required, with prescription.

their measurements in real time or over a

The compact, battery-powered unit with color

trended graphical display on a compatible

screen can be rotated for real-time display of

smart device. The app also interfaces with

the pleth waveform and other measurements.

the Apple Health Kit for iOS users, further

Optional Bluetooth wireless functionality

expanding its utility. The app empowers

enables measurement display via a free,

clinicians and patients by allowing the

downloadable app on iOS and Android

captured data to be shared via email.

mobile devices, or transmission to a third-
party app through a wireless protocol.1

Through Bluetooth communication, MightySat

Rx data can also be integrated into multiple

The Masimo Professional Health App includes

third-party telehome monitoring solutions for

a high resolution plethysmographic waveform,

complex care management, chronic disease

audible pulse tone feature, and trending

management, and readmission management.

168

1 Masimo provides its communication protocol to qualified third parties by written agreement. Contact Masimo for details.
* MightySat Rx with RRp not available in the U.S.

169

View measurements on a compatible
smart device.

Trend measurements over time and
view graphically.

Share data via email or through
Bluetooth wireless protocol.1

Spot-check Monitors

Providing Better Data
for Better Performance
with MightySat

The same revolutionary Masimo SET® technology available for professional use in the MightySat Rx is also

available as MightySat for personal use by consumers for health and wellness applications.

SpO2

PVi

RRp

What Better Data Means to You

MightySat is ideal for people who know they want a fingertip pulse oximeter and want the best available

technology. MightySat is also for people who want to improve their health, wellness, or fitness by providing

more accurate SpO2 and pulse rate as well as key measurements that are not available on other health and

wellness devices.

“MightySat is very easy to use and a great tool for all levels

of athletes. The accurate data from MightySat helps me

get the most from my workouts.”

Garry Harris
Professional Basketball Player, Denver Nuggets

App Features

Do More with Your Data

Leverage the free Masimo

Personal Health App for

expanded capabilities.

•

Ability to create multiple

•

Tag your sessions

user profiles

•

Share multiple sessions

•

Share your data through

email and social media

•

View live measurements

•

Automatically store your

throughout the app

data in Apple Health and

TrainingPeaks

•

Set your low and high

•

Audible notifications

thresholds for each

depending on your

measurement

preferences and settings

170

1 Masimo provides its communication protocol to qualified third-parties by a written agreement. Contact Masimo for details. * MightySat Rx with RRp not available in the U.S.

171

Data Download & Analytics

Analyzing Patient
Data with Trace™

Trace is the first reporting software compatible with the full capabilities of the Masimo Root patient

monitoring and connectivity platform, including Radical-7 and Radius-7 Pulse CO-Oximeters, Root with

integrated noninvasive blood pressure and temperature, and connected MOC-9 modules such as SedLine

brain function monitoring, NomoLine capnography and gas monitoring, and O3 regional oximetry.

With its unique versatility and customizability and with access to all of Masimo’s advanced measurement

technologies, Trace offers clinicians the ability to retrospectively review and focus on the patient data

patterns that matter most for each case, in a user-friendly format.

Powerful Retrospective Analysis

• Create easy-to-read patient reports

that include parameter trends,

histograms, event annotations, and

key statistics

• Conveniently review reports for

advanced Masimo measurements

• Connect remotely to networked

Masimo devices

• Rapidly transfer up to 96 hours of

device parameter data

• Review and generate additional

reports for past patient data

172

173

OEM Solutions

Integrating Technology
into Leading
Multi-parameter Monitors

Industry-leading Pulse Oximetry

Clinicians all around the world count on Masimo SET® pulse oximetry to help them care for patients.

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 SET Pulse CO-Oximetry.

Dräger®
Infinity M540
with rainbow SET technology

GE®
CARESCAPE VC150
with rainbow SET technology

Philips®
MX800
with rainbow SET technology

MX-7™
Low power rainbow®

OEM board

MSX™
Very low power SET®

OEM board

Physio-Control®
LIFEPAK 15
with rainbow SET technology

Welch Allyn®
Connex 6300 Series
with rainbow SET technology

ZOLL®
X Series
with rainbow SET technology

174

175

Select
OEM Partners

select partners

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.

select partners

176

177

Technologies and Products

TECHNOLOGIES AND PARAMETERS

SURVEILLANCE MONITORING

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

• Total Hemoglobin (SpHb®)
• Oxygen Content (SpOC™)
• rainbow Pleth Variability Index (RPVi™)
• Oxygen Reserve Index (ORi™)

• Carboxyhemoglobin (SpCO®)
• Methemoglobin (SpMet®)
• Fractional Arterial Oxygen Saturation (SpfO2™)
• Acoustic Respiration Rate (RRa®)

• Plus all Masimo SET®

measurements

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

CONTINUOUS MONITORS

SPOT-CHECK MONITORS

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

Replica™
Supplemental remote monitoring
clinician notification

CIRCUIT BOARDS

SENSORS

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

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

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

Rad-5®
Masimo SET®
Pulse Oximeter

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

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

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

Rad-57®
rainbow SET
Pulse CO-Oximeter

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

SAMPLING
LINE

EXTERNAL MEASUREMENT
TECHNOLOGIES

MX-7™
Low power rainbow® OEM board

MSX™
Very low power SET® OEM board

178

RD SET™
SpO2, PR, Pi, PVi, RRp

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

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

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

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

rainbow®
Acoustic Sensor
RRa

RD SedLine® Sensor
PSi

O3® Sensor
rSO2, SpO2*

NomoLine™
Sampling line

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®** & iSpO2®** Rx
SpO2, PR, Pi

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

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

180

Improving Patient
Outcomes and Reducing
Cost of Care®

181

Solutions:
Automating Patient
Management Across
the Continuum of Care

182

183

SolutionsPhysician Office

Improving Office Visits through Accurate and Advanced Measurements with Connectivity

SpO2

RRp

SpHb

NIBP

In busy physician office environments, inaccurate data and inefficient monitors can make it difficult to

deliver quality, efficient care. Masimo’s physician office solutions help automate patient management

by providing quick and accurate data with seamless documentation.

Simplifying Workflows with Automatic Charting

Iris Gateway facilitates the seamless documentation

of patient data from Masimo devices to the

electronic medical record system.

Iris Connectivity
p.148

Rad-97
p.160

Compact and Mobile Vital Signs with Rad-97

Rad-97 features Masimo rainbow SET Pulse

CO-Oximetry with optional noninvasive

hemoglobin (SpHb), integrated capnography or

noninvasive blood pressure (NIBP), and wireless,

non-contact temperature with Masimo Caregiver.

Rad-67
p.162

Quick Assessment with Rad-67

Rad-67 features rainbow SET Pulse CO-Oximetry

and facilitates handheld spot-checking along with

optional noninvasive hemoglobin (SpHb).

MightySat Rx
p.168

Spot-check on the Go with MightySat Rx

MightySat Rx fingertip pulse oximeter puts the
power of Masimo SET® pulse oximetry in any

clinician’s pocket.

184

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

185

Pharmacy Clinics

Empowering Patients with an Alternative to Traditional Office Visits

SpO2

RRp

SpHb

NIBP

Temp

Patients are increasingly seeking care in non-traditional settings such as in-pharmacy clinics. However,

current approaches typically require that a clinician be on-site to take measurements, do not offer

physician consultation, and do not enable real-time prescription transmission and pick up.

Root with DIAB

Root with Radical-7 enables rainbow SET Pulse

directly by video with a remote physician or nurse.

CO-Oximetry measurements, along with integrated

The pharmacy receives immediate prescription

noninvasive blood pressure (NIBP) and temperature

orders from the remote clinician, allowing patients

measurements. Combined with these built-in

to receive their medications on the spot.

measurements, Doc in a Box (DIAB), a Masimo

software solution for Root, can enable automated in-

Root with DIAB is designed to reduce the need

pharmacy assessment, interaction, and prescription

for an on-site clinician or medical assistant to take

dispensing. When Root with DIAB is deployed in a

measurements, shorten the time for the patient to

pharmacy, patients use Root to take their own vital

receive medical advice, and enable more efficient

signs measurements and use DIAB to communicate

consultation and prescription fulfillment.

• Guided data collection

186

Root with DIAB is not available. RRp is not available in the U.S.

•

Initial welcome and

• Vital signs results

•

Communication with

•

Physician sends

patient account set

displayed

remote clinician in

prescription order

up or log in

real time

in real time for

immediate patient

pickup on-site

187

Emergency
Medical Services

Rapid Monitoring Devices for First Responders

SpO2

RRp

SpHb

SpCO

SpMet

EtCO2

RRc

For first responders, assessments and interventions are often made in challenging conditions. Masimo’s

versatile, portable, and rugged devices enable quick spot-checking on the scene and during transport

to aid assessment and help hospitals prepare for appropriate and timely care transitions.

Rapid On-Scene Spot-checking with Advanced Handheld Devices

Integrated Solutions

Rad-67
p.162

EMMA
p.166

Rad-67 Pulse CO-Oximeter

EMMA Capnograph

Featuring color touchscreen operation and

Clear, real-time end-tidal CO2 waveforms help

rainbow SET Pulse CO-Oximetry measurements,

give clinicians the ability to confirm effective

Rad-67 optional noninvasive measurements

resuscitation, assess the depth and effectiveness

include carboxyhemoglobin (SpCO), hemoglobin

(SpHb), methemoglobin (SpMet), and respiration

of compressions, and recognize the return of
spontaneous circulation (ROSC).1,2

rate from the pleth (RRp).

Masimo rainbow SET Pulse CO-Oximetry

is integrated in defibrillator monitors from

multiple companies, enabling advanced

measurements inside life-saving devices.

Versatile Sensor Solutions

Access a variety of sensor solutions

designed to facilitate rapid monitoring,

to stay securely in place during

challenging conditions, and for

monitoring sites less susceptible to

changes in peripheral perfusion.

Physio-Control®
LIFEPAK 15

ZOLL® X Series

Integrated
solutions
p.174

E1 sensor
p.104

The E1 ear sensor provides an alternative monitoring site during emergency
situations and can identify desaturation and resaturation faster than digit sensors.

188

1 Neumar RW et al. Circulation. 2010 Nov 2;122(18 Suppl 3):S729-67. 2 2010 American Heart Association. Rad-67 and RRp are not available in the U.S.

189

Emergency Department

Responding Rapidly in a Constrained Environment

SpO2

RRp

SpHb

SpCO

SpMet

EtCO2

RRc

NIBP

Temp

Radius-7
p.120

Patient
SafetyNet
p.134

Iris
Connectivity
p.148

Continuous, Tetherless

Surveillance Monitoring with

Device Connectivity

Monitoring with Radius-7

Masimo Patient SafetyNet

with Iris

Radius-7 enables continuous,

Patient SafetyNet is a remote

When connected to Iris Gateway

tetherless monitoring of

monitoring and clinician

or Patient SafetyNet, Root

patients in the waiting room

notification system which displays

automates the flow of patient

with supplemental remote

information from any connected

data to the EMR, which may help

monitoring on Root, which

Masimo device at a central station

streamline workflows (including

may help clinicians adjust care

and allows alarms and alerts to

the triage process), improve

The emergency department (ED) is burdened by high patient volume, varying patient acuity, and a large

in patient status.

number of standalone monitoring devices that often lack connectivity. Scarcity of time and space necessitate

rapid patient assessment and triage to limit unanticipated patient deterioration and patient dissatisfaction.

From handheld monitors and vital signs monitors with automated data transfer to the electronic medical

record (EMR), to wearable, tetherless, and portable devices designed for short-term monitoring, Masimo

offers a number of solutions to enhance assessment and streamline clinician workflow in the ED.

prioritization based on changes

be sent directly to clinicians.

productivity, and reduce the
likelihood of transcription errors.1

Rad-67
p.162

Trauma
Sensor
p.104

EMMA
p.166

Efficient Vital Signs Monitoring with Root

Root offers quick and efficient spot-checking of SpO2, pulse

rate, respiration rate, blood pressure, and temperature

with a single, portable monitor. Root also enables optional,

advanced spot-checking of noninvasive hemoglobin

(SpHb) and carbon monoxide in the blood (SpCO).

Root allows all measurements and customized clinical

assessments, including pain and responsiveness scores

such as "alert, voice, pain, unresponsive,” or APVU, scores

to be automatically transferred to the EMR.

Root with
Noninvasive
Blood Pressure and
Temperature
p. 140

190

1 The Value of Medical Device Interoperability. West Health Institute. 2013.
2 Neumar RW et al. Circulation. 2010 Nov 2;122(18 Suppl 3):S729-67. 3 2010
American Heart Association. RRp and Rad-67 are not available in the U.S.

Powerful, Handheld Monitoring

Fast Response Time with

Flexible Capnography

with Rad-67

the Trauma Sensor

with EMMA

Rad-67 features color

In trauma situations, SpO2 can

EMMA is a compact, lightweight,

touchscreen operation and

change rapidly and peripheral

mainstream capnograph that

rainbow SET Pulse CO-Oximetry

perfusion can be very low.

requires minimal warm-up time

measurements to enable quick

spot-checking of SpO2 and

The Trauma Sensor together
with Masimo SET® technology

and accuracy in 15 seconds.

EMMA provides real-time EtCO2

pulse rate, as well as optional

automatically configures the

waveforms help clinicians to

noninvasive hemoglobin (SpHb)

fastest response time with

confirm effective resuscitation,

and carboxyhemoglobin (SpCO).

maximum sensitivity in adult

assess the depth and effectiveness

trauma patients.

of compressions, and recognize

the return of spontaneous
circulation (ROSC).2,3

191

Newborn Care

Advanced Technology for When Every Second Counts

SpO2

RRp

EtCO2

RRc

Accurate and timely monitoring is vital to assessing newborns. Masimo is committed to helping clinicians care

for this at-risk patient population and has designed solutions specifically for newborns and their unique needs.

Aiding Newborn Resuscitation

Newborn Sensor
The Newborn Sensor automatically configures Masimo SET® pulse

•

oximeters for the fastest response time and maximum sensitivity

settings, allowing clinicians to focus on patient care during newborn

resuscitation. The Velaid SofTouch design allows for quick application

and repositioning on newborn skin and the hook and loop attachment

strip helps keep the sensor secure, even when the site is wet.

Newborn
Sensors
p.104

EMMA Capnograph
Primary methods of confirming endotracheal tube placement include

•

the detection of exhaled CO2. Neonatal Resuscitation Program (NRP)

guidelines recommend that a CO2 detector be connected to the

EMMA
p.166

endotracheal tube immediately after insertion to confirm the presence
of CO2 during exhalation.1

The portable EMMA mainstream capnograph is designed to fit easily

onto a breathing circuit and provides a real-time end-tidal carbon

dioxide (EtCO2) waveform displayed in as few as 15 seconds, in

addition to displaying EtCO2 and respiration rate (RR) measurements.

192

1 American Academy of Pediatrics (AAP). (2016). Textbook of Neonatal
Resuscitation, 7th Ed. RRp is not available in the U.S.

193

Newborn Care

Simplifying CCHD Screening with Eve

CCHD and
Masimo SET®
p. 34

Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry has helped clinicians increase

CCHD detection through effective screening, savings the lives of babies throughout the world.

Eve is an intuitive critical congenital heart disease (CCHD) newborn screening application that transforms

Radical-7 or Rad-97 into a simple yet powerful tool designed to help clinicians to quickly, reliably, and
consistently screen newborn babies for CCHD. Eve combines the accuracy of Masimo SET® with a

pre-ductal to post-ductal synchronization algorithm intended to help clinicians reduce calculation errors.

Eve simplifies the CCHD screening process by providing visual instructions, animations, an automatic

synchronization algorithm, and a detailed, easy-to-interpret display of results. The ability to label results

with unique patient identifiers for both mother and newborn facilitates intuitive session management and

seamless electronic charting. Eve also allows clinicians to incorporate perfusion index into screening, which
has been shown to increase sensitivity to the detection of CCHD in infants with pathologically low perfusion.1

•

Animations provide visual guidance to assist

•

Automated calculation, with an easy-to-interpret

clinicians through the screening process

results screen, may reduce calculation errors

•

Settings allow clinicians to incorporate

•

EMR integration via Masimo Patient SafetyNet

perfusion index (Pi) measurement, which may
increase sensitivity to detection of CCHD1

or Iris Gateway facilitates workflow and may

help reduce reporting errors

Rad-97 and Radical-7 with Eve.*

194

1 de-Wahl Ganelli et al. Acta Paediatr. 2007 Oct;96(10):1455-1459.
* Radical-7 and Rad-97 with Eve are not available in the U.S.

195

Operating Room and
Post-Anesthesia Care Unit

Optimizing Surgical Care with Advanced Measurements and Integrated Monitoring

SpO2

PVi

RRp

SpHb

SpMet

ORi

RPVi

EtCO2

RRc

Agent
ID

PSi

rSO2

In today’s operating room (OR), clinicians are faced with increasingly complex patient conditions and

the need to monitor changing patient status accurately and completely. Some continuous monitoring

modalities have limited accuracy and some physiologic variables are only measured intermittently,

if at all. With multiple standalone monitoring and therapeutic devices, clinicians must manually view

each device separately to assimilate all of the data.

Masimo’s solutions in the OR help automate care of the surgical patient by providing accurate

measurements with standard-of-care monitoring modalities during challenging conditions;

advanced noninvasive and continuous measurements that could previously only be measured

intermittently and invasively; and connectivity, documentation, and display products that simplify

workflows and data interpretation.

Accurate Pulse Oximetry that Enables Noninvasive Fluid Responsiveness Monitoring

Masimo SET® pulse oximetry provides accurate measurements during challenging conditions

along with pleth variability index (PVi) for noninvasive fluid responsiveness monitoring in

PVi
p. 40

mechanically ventilated patients.

Advanced Hemoglobin and Oxygenation Monitoring with rainbow SET Pulse CO-Oximetry

Masimo rainbow SET Pulse CO-Oximetry includes all Masimo SET® measurements and

also provides advanced noninvasive and continuous measurements such as hemoglobin

(SpHb), which may help with patient blood management, oxygen reserve index (ORi),

which can provide visibility to the patient’s oxygen status in the moderate hyperoxic range

and provide an advanced warning of impending desaturations, and rainbow PVi (RPVi),

which can simplify noninvasive fluid responsiveness monitoring.

rainbow SET
p. 48

Measurement Integration in Multi-parameter Monitoring Systems or Root

Both Masimo SET® and rainbow SET are available in multiple leading

multi-parameter monitors, as well as via Radical-7 and Radical-7 in Root.

Partnerships
p. 176

Root
p. 116

196

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

197

Masimo’s OR technologies are available through Root or through OEM partners such as Philips IntelliVue MX800.

Operating Room and
Post-Anesthesia Care Unit

Accurate Brain Monitoring

with SedLine and O3

SedLine
and O3
p. 86 and 94

Next Generation SedLine brain function

monitoring uses advanced signal processing

to overcome limitations of previous generation brain function

monitoring and provide a more accurate and responsive

indication of the brain’s response to anesthesia and

sedation. O3 regional oximetry provides accurate cerebral

oxygenation, even when CO2 levels are changing. Both

SedLine and O3 sensors can be placed on the forehead at

the same time, overcoming previous inabilities to monitor

both modalities simultaneously. SedLine and O3 are available

on Root and select multi-parameter monitoring systems.

Overcoming Previous Limitations

with NomoLine Capnography

and Gas Monitoring

NomoLine
p. 80, 128, 130

NomoLine technology provides accurate

capnography and gas with an innovative sampling line that

eliminates the need for a water trap and enables cost-effective,

hassle-free consumables. NomoLine technology is available on

Root and select multi-parameter monitoring systems.

Expandable Root Monitoring

and Connectivity Platform

Root
p. 116

Masimo’s standard-of-care and advanced

measurements are all available on the Root

patient monitoring and connectivity platform, offering

a highly customizable and expandable solution that

occupies a minimal footprint in the OR. Iris in combination

with Root facilitates automated data transfer from Root

and multiple third-party standalone monitors — such as IV

pumps, ventilators, and anesthesia machines — to hospital

electronic medical record (EMR) systems.

Integrate Data to

Simplify Interpretation

UniView provides large displays

with integrated patient data from

UniView
and AirGlass
p. 156 and
158

all connected systems in the hospital, and AirGlass

provides a wearable display solution leveraging

augmented reality technology.

Post-Anesthesia Care Unit

NomoLine
p. 80, 128, 130

Advanced Surveillance in the

After surgery in the post-anesthesia

care unit (PACU), it is important to

recognize any signs of patient deterioration as

soon as possible so clinicians can quickly intervene.

Varying patient flow can create low clinician-to-

patient ratios and make it more difficult to manually

observe patient deterioration. Masimo’s monitoring

solutions help clinicians care for post-operative

patients at risk of respiratory depression and other

unforeseen complications.

NomoLine capnography provides a continuation

of OR monitoring in the PACU. For patients who

are not tolerant to a cannula or mask, rainbow

Acoustic Monitoring offers noninvasive and

continuous respiration rate (RRa) with similar

accuracy to capnography but with the benefit

of higher patient tolerance.

The Measure-through Motion and Low-Perfusion
capabilities of Masimo SET® pulse oximetry can

significantly reduce false alarms in the PACU

and reduce the burden for clinicians otherwise

responding to false alarms.

Masimo SET®
p. 24

198

Airglass is not available.

199

Neonatal Intensive Care

Sensors Designed for Neonatal Patients

Focusing on the Most Vulnerable Patients

Specialty
sensors
p. 104

SpO2

PVi

RRp

SpMet

EtCO2

RRc

From the beginning, Masimo has remained dedicated to improving care in the neonatal intensive care unit (NICU)

so even the most fragile patients have bright futures. While some companies may choose not to develop products

specifically for neonates because the market is small compared to the adult market, Masimo takes the opposite approach.

Masimo endeavors to develop new products for neonates first because their clinical need is greatest and because if a

product can be made to work reliably on neonates, it is very likely to work well on pediatric and adult patients.

Reducing False Alarms and Retinopathy of Prematurity with Masimo SET®

The Measure-through Motion and Low Perfusion performance of Masimo SET® pulse oximetry

significantly reduces false alarms and the time spent by NICU clinicians responding to and investigating

alarms. As a result, clinicians can spend more time on patient care. Perhaps more importantly, studies
have shown that the accuracy of Masimo SET®, coupled with changes in practice, helps clinicians reduce the

ROP
p. 32

rate of severe retinopathy of prematurity (ROP) in premature infants by helping avoid too much oxygen administration.

Compared to Nellcor sensors in the NICU, Masimo SET® sensors can last up
to 2.3 times longer (9.1 vs. 3.9 days).1 In addition, Masimo’s SofTouch line of

sensors are designed to be used whenever skin sensitivity issues are a concern,

such as with extremely low birth weight infants. Masimo SofTouch sensors

incorporate soft foam and VelAid hook and loop attachment wraps that come

in a variety of configurations to address a wide range of clinical situations.

The Blue Sensor with Masimo SET® pulse oximetry is specifically designed

for use with cyanotic infant, neonatal, and pediatric patients with congenital

heart disease, and is accurate on cyanotic patients with oxygen saturation as
low as 60%.2

Monitoring for Methemoglobinemia with SpMet

Many drugs commonly used in hospitals — such as lidocaine, benzocaine, dapsone, and nitrates —

may cause a dangerous reaction known as acquired methemoglobinemia. Inhaled nitric oxide (iNO)

therapy, and even topical anesthetics containing benzocaine or prilocaine, can cause elevated levels

of methemoglobin in neonates and infants. Masimo rainbow SET Pulse CO-Oximetry offers a way to

SpMet
p. 76

monitor noninvasive and continuous methemoglobin (SpMet). Real-time SpMet monitoring may help

clinicians intervene quickly and appropriately in cases involving elevated methemoglobin levels.

Capnography Solutions

with NomoLine

Masimo NomoLine capnography offers

multiple sidestream capnography

solutions to meet the challenges of

ventilation monitoring in the NICU.

NomoLine technology is designed for

low-flow applications, with a very low

sampling rate of 50 ml/min, supporting

use on patients with low tidal volumes

and high breath rates, common

characteristics of neonatal patients.

NomoLine
p. 80, 128, 130

200

1 Erler T et al. J Perinatol. 2003 Mar;23(2):133-5. 2 Masimo data on file

and FDA 510(k) K051439. 2005. NomoLine has not obtained CE mark

for neonates. RRp is not available in the U.S.

201

Intensive Care

SpO2

PVi

SpHb

SpMet

ORi

RPVi

EtCO2

RRc

Patients in the intensive care unit (ICU) are at high risk of deterioration and with so many modalities to apply, so much

data to manage, and so many alarms requiring a response, monitoring can be challenging. Adding to the challenge,

rooms are often cluttered with disparate monitoring and therapeutic devices. Masimo’s ICU solutions provide accurate

standard-of-care measurements during challenging conditions, advanced noninvasive and continuous measurements

that were previously only intermittent and/or invasive, and connectivity, documentation, and display products that

simplify workflows and data interpretation.

Accurate Pulse Oximetry that Translates to Better Clinical Care with Masimo SET®

The Measure-through Motion and Low Perfusion performance of Masimo SET® pulse oximetry

significantly reduces false alarms and the time spent by ICU clinicians responding to and

investigating alarms. As a result, clinicians can spend more time on patient care. Compared to
non-Masimo SET® technology in the ICU, use of Masimo SET® in the ICU resulted in 34% fewer
arterial blood gas tests performed (4.1 vs. 2.7 tests per patient).1

Masimo SET®
p. 24

Accurate measurements may also help optimize therapeutic management in the ICU. Compared to non-Masimo SET®
technology in the ICU, use of Masimo SET® resulted in 49% faster ventilator weaning time (348 vs. 176 minutes) with
the same number of ventilator changes.1 Use of Masimo SET® along with a ventilator weaning protocol has also been
reported to result in reduced oxygen requirements, decreased ventilator time, and reduced ICU length of stay.2

Noninvasive Fluid Responsiveness Monitoring with PVi

From the same sensor and monitor used for pulse oximetry monitoring, Masimo SET® also offers

the unique ability of pleth variability index (PVi) to noninvasively monitor fluid responsiveness in

PVi
p. 40

mechanically ventilated patients.

202

1 Durbin CG et al. Crit Care Med. 2002 Aug;30(8):1735-40. 2 Patel DS et al. Advance for Managers of Respiratory Care. Oct 2000: 9(9):86. ORi and RPVi are not available in the U.S.

203

Intensive Care

Advanced Hemoglobin and Oxygenation Monitoring with rainbow SET Pulse CO-Oximetry

Masimo rainbow SET Pulse CO-Oximetry includes all Masimo SET® measurements and

also provides advanced noninvasive and continuous measurements such as:

•

Noninvasive and Continuous hemoglobin (SpHb), which may help with patient blood management

Oxygen Reserve index (ORi), which can provide an advanced warning of desaturations and may

help provide insight into a patient’s oxygen status in the moderate hyperoxic range

•

rainbow PVi (RPVi), which provides noninvasive fluid responsiveness monitoring

SpHb,
RPVi and ORi
p. 54, 66
and 72

Monitoring Depth of Sedation with SedLine

Overcoming Previous Limitations with

Brain Function Monitoring

NomoLine Capnography and Gas Monitoring

SedLine
p. 86

NomoLine
p. 80, 128, 130

Next Generation SedLine brain function monitoring

NomoLine technology provides accurate capnography

uses advanced signal processing to provide a more

and gas measurements while reducing common

accurate and responsive indication of the brain’s

problems associated with conventional sidestream gas

response to sedation. SedLine technology is available

analysis. The innovative sampling line uses a patented

on the Root monitor.

polymer which collects and removes water in the

sampling line, eliminating the need for a water trap

and enabling cost-effective, hassle-free consumables.

NomoLine technology is available on Root and select

multi-parameter monitoring systems.

Measurement Integration in Multi-parameter Monitoring Systems or Root

Both Masimo SET® and rainbow SET are available in

many leading multi-parameter monitors, as well as

via Radical-7 and Radical-7 in Root.

Masimo’s ICU technologies are available through Root or through
OEM partner products such as Philips IntelliVue MX800.

Root and
Partnerships
p. 116 and 176

Expandable Root Monitoring

and Connectivity Platform

Iris
Connectivity
p.148

Integrate Data to

Simplify Interpretation

UniView
p.156

Masimo’s standard-of-care and

UniView provides large displays with

advanced measurements are all available

integrated patient data from all connected

on the Root patient monitoring and connectivity platform,

systems in the hospital.

offering a highly customizable and expandable solution

that occupies a minimal footprint in the OR. Iris in

combination with Root facilitates automated data transfer

from Root and multiple third-party standalone monitors —

such as IV pumps, ventilators, and anesthesia machines —

to hospital electronic medical record (EMR) systems.

204

ORi and RPVi are not available in the U.S.

205

General Ward

Helping Improve Safety and Efficiency While Reducing Costs

SpO2

RRp

Three Options for Ventilation Monitoring

The Root patient monitoring and connectivity platform offers three options for

continuous respiration rate monitoring, each with advantages and disadvantages.

Respiration
Rate Options
p. 84

RRa

SpHb

ORi

EtCO2

RRc

For patients on supplemental oxygen, Oxygen Reserve Index (ORi)
using rainbow SET Pulse CO-Oximetry is designed to provide an early
indication of impending desaturation for patients in the moderately
hyperoxic range.

Clinicians on the general ward are challenged by low nurse-to-patient ratios and increasing case complexity and

variability between patients. Continuous monitoring provides constant surveillance for the greatest ability to identify early

patient deterioration, but traditional approaches can result in numerous false alarms and can also tether patients to their

beds. Intermittent spot-check monitoring is typically the minimum level of monitoring required, but can require manual

documentation and clinical assessment to recognize changes in patient status. Masimo offers an integrated portfolio of

solutions designed to keep patients on the general ward safe and mobile while helping clinicians improve workflows.

Overcoming Alarm Fatigue with Masimo SET®

Continuous monitoring with conventional pulse oximetry can result in false alarms that burden

clinicians and make continuous monitoring difficult. The Measure-through Motion and Low
Perfusion performance of Masimo SET® pulse oximetry significantly reduces false alarms and

Masimo SET®
p. 24

the time spent by general ward clinicians responding to and investigating alarms. As a result,

continuous monitoring on the general ward is feasible.

Over a ten-year period in the general wards at Dartmouth-Hitchcock Medical Center, the use of
Masimo SET® pulse oximetry and Masimo Patient SafetyNet has resulted in a sustained alarm

frequency of approximately two alarms per patient per 12-hour nursing shift — in spite of
increasing patient acuity and unit occupancy.1

Patient
SafetyNet
p. 134

206

1 McGrath SP et al. The Joint Commission Journal on Quality and Patient Safety.
2016 Jul;42(7):293-302. RRp is not available in the U.S.

207

General Ward

Powerful and Flexible Monitoring and Connectivity with Root and Radius-7

Root is a powerful and flexible multi-modal monitoring and connectivity hub that brings

together advanced rainbow SET Pulse CO-Oximetry, vital signs measurements, and

capnography measurements on an easy-to-interpret and customizable display. Root

Radius-7
p. 120

EMR
p. 144

includes a dock for the Radical-7 handheld monitor or Radius-7 tetherless monitor that enables accurate monitoring while

the patient is mobile, along with continuous monitoring for identification of clinical deterioration. Root also serves as a central

connectivity hub, with automated electronic charting of Masimo and third-party device data and alarms to electronic medical

record (EMR) systems, which may improve clinician workflows through the reduction of manual data documentation.

Remote Monitoring and Notification with Patient SafetyNet and Replica

Masimo Patient SafetyNet optimizes patient safety and clinician workflows through

centralized, supplemental remote monitoring and automated charting. Near real-time

information from any connected Masimo device, as well as supported third-party devices

such as ventilators, is displayed at a central station, allowing clinicians in the ward or at

an enterprise level to quickly monitor the status of up to 200 devices per server, review

trend data, and investigate alarms. Patient SafetyNet with Replica also allows clinicians

to monitor patient measurements and high fidelity waveforms remotely and in real time,

modify device settings, and receive and make video calls — all from a single app.

Replica
p. 152

Patient
SafetyNet
p. 134

Improving Clinical and Cost Outcomes with Patient SafetyNet

Researchers at Dartmouth-Hitchcock Medical Center reported
that Masimo SET® pulse oximetry and Patient SafetyNet enabled

the facility, over a five-year period, to achieve their goal of zero

preventable deaths or brain damage due to opioids, 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.1,2

Patient
SafetyNet
p. 134

Efficient Vital-Signs Monitoring with Root and Rad-97

Used in conjunction with Patient SafetyNet or Iris Gateway, Root

can be placed on a roll stand as a portable spot-check vital signs

monitor. Powerful Early Warning Score (EWS) calculations aggregate

Root VS
and Rad-97
p. 140 and
160

EWS
p. 142

Automating
Workflows
p. 146

information from multiple vital signs and clinical observations to generate a score that represents the potential degree

of patient deterioration, arming clinicians with more information to help make appropriate care decisions.

Patient SafetyNet provides automated documentation to the EMR of patient data at hospital-specified intervals, and

also enables clinician bedside verification to reduce the time required for documentation at the EMR workstation.

If Root and Rad-97 are not connected to the network, they can also store data collected from multiple patients and

then automatically transfer the collected data via Bluetooth to a network relay station that enables documentation to

the EMR, minimizing manual documentation and lessening wireless infrastructure demand in care areas where wireless

networks may not be feasible.

208

1 Taenzer AH et al. Anesthesiology. 2010 Feb;112(2):282-287. 2 Taenzer AH et al. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

209

Post-Acute Care

Improving Patient Safety for Ventilator-Dependent Patients

SpO2

PVi

RRp

EtCO2

RRc

When caring for ventilator-dependent patients outside the hospital environment in long-term care or sub-

acute care settings, accurate oxygenation and ventilation monitoring are vital to providing high-quality care

and improving patient safety. Many long-term acute care facilities are faced with low clinician-to-patient

ratios and alarm fatigue, while needing to administer many different active therapies, wean patients off

ventilation, and chart patient data. In sub-acute care facilities, ventilator-dependent patients still require

continuous monitoring to recognize changes in status.

Masimo’s noninvasive monitoring solutions can help clinicians in post-acute care environments improve

patient safety and enhance workflows.

Root and
Rad-97
p. 116 and
160

Efficient Spot-Check Monitoring with Root or Rad-97

Root or Rad-97 can be placed on a roll stand to enable use as a portable spot-check vital signs monitor.

Powerful Early Warning Score (EWS) calculations on Root aggregate information from multiple vital signs

and clinical observations to generate a score that represents the potential degree of patient deterioration

and can provide greater insight into patient status, arming clinicians with more information to help make

appropriate care decisions.

Masimo SET®
p. 24

Pocket Spot-checks with MightySat Rx and EMMA

Overcoming Alarm Fatigue with Masimo SET®

Continuous monitoring with conventional pulse oximetry can result in false alarms that burden

clinicians and make continuous monitoring difficult in the post-acute care environment. The
Measure-through Motion and Low Perfusion performance of Masimo SET® pulse oximetry

significantly reduces false alarms and the time spent by clinicians responding to and investigating alarms.

Continuous Oxygenation and Ventilation Monitoring

Root or Rad-97 with NomoLine Capnography features Masimo SET® pulse oximetry and an

integrated sidestream gas analyzer for capnography — meeting continuous oxygenation and

NomoLine
p. 80, 128, 130

ventilation monitoring needs in a single device.

210

1 McGrath SP et al. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302. 2 Taenzer AH et al. Anesthesiology. 2010 Feb;112(2):282-287.
3 Taenzer AH et al. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012. RRp is not available in the U.S.

For spot-check measurements on the go, the MightySat Rx fingertip

pulse oximeter helps physicians quickly and efficiently measure oxygen

saturation, pulse rate, perfusion index, and respiration rate. In addition,

the small, portable EMMA capnograph is designed to fit easily onto a

breathing circuit and provides a real-time end-tidal carbon dioxide (EtCO2)

waveform displayed in as few as 15 seconds, in addition to EtCO2 and

respiration rate (RRc) measurements. These pocket-sized solutions can be

easily kept with the clinician during rounds or integrated into crash carts.

Supplemental Remote Monitoring

Masimo Patient SafetyNet optimizes patient safety and clinician workflows

through centralized, supplemental remote monitoring and automated

charting of up to 200 devices on a single server, along with Iris for

integrated documentation of data from ventilator and IV pumps.

EMMA and
MightySat Rx
p. 166 and 168

Patient
SafetyNet
p. 134

211

Home Care

Hospital-Grade and Easy-to-Use Monitoring at Home

SpO2

PVi

RRp

Telehome Care with Rad-97

Rad-97
p. 160

Monitoring in the home environment can be even more challenging than the hospital. Technologies that

For monitoring in patients with chronic diseases such as chronic obstructive pulmonary disease or heart failure, or to

provide accurate measurements while being easy to apply and operate are critical to home monitoring success.

monitor a newly discharged medical or surgical patient in the home, the Rad-97 Pulse CO-Oximeter offers a unique

Masimo offers multiple solutions for home monitoring, customizable for each clinician’s and patient’s needs.

Transition to Home for Medically-Fragile Patients

The American Thoracic Society recommends continuous monitoring using pulse oximetry for children requiring
mechanical ventilation, especially when the child is asleep or unobserved.1 Compared to other alternative
technologies during challenging conditions, Masimo SET® pulse oximetry significantly reduces false alarms and

increases true alarm detection, easing the burden on caregivers.

Rad-97 is a compact pulse oximeter with intuitive multi-touch display that is easy to use for clinicians and

non-clinicians alike. Home mode on Rad-97 provides home users access only to relevant settings and messages,

while hiding others and locking alarm settings, reducing the chances of inadvertent interference.

combination of powerful measurements, an easy-to-use interface, and advanced remote monitoring and communication
capabilities. Rad-97, in addition to SET® pulse oximetry and advanced parameter monitoring technology through
rainbow® noninvasive monitoring, is available with optional integrated blood pressure or capnography measurements.

With its intuitive touchscreen interface, Rad-97 is easy to use for clinicians and non-clinicians alike, and can be easily

customized to meet the needs of home users. The device can also be configured in Home mode to streamline use and

minimize complexity, and its innovative communication capabilities allow monitoring data from a variety of third-party

Bluetooth-enabled devices used at home, including thermometers, weight scales, and glucometers, to seamlessly

transfer to Rad-97 — and from there to anywhere in the world, in real time. The optional integrated camera allows remote

clinicians to interact with patients over live audio and video. Rad-97 brings hospital-grade technology to the home in a

single, compact, integrated device that is a monitoring, connectivity, and telecommunications hub.

Patient Surveillance using

Patient SafetyNet

MightySat Rx for Hospital-grade

Spot-checks in the Home

Patient
SafetyNet
p. 134

MightySat Rx
p. 168

With its built-in enterprise WiFi capability, Rad-97 has

For patients that do not require advanced measurements

the ability to connect wirelessly from the home to

or continuous monitoring, the pocket-sized MightySat

supplemental patient monitoring systems in the hospital,

Rx can be used for quick spot-check measurements of

including Masimo Patient SafetyNet, allowing clinicians

oxygen saturation (SpO2) and pulse rate (PR), and its built-

to remotely observe patient status while facilitating

in Bluetooth capability enables communication with a

automatic data transfer to hospital electronic medical

variety of third-party home monitoring solutions.

record (EMR) systems.

212

1 An Official American Thoracic Society Clinical Practice Guideline: Pediatric Chronic Home Invasive Ventilation. Am J Respir Crit Care Med. Vol 193, Iss 8, pp e16-e35, Apr 15, 2016.
RRp is not available in the U.S.

213

Global Health

Advancing Assessment in Low-Resource Settings

SpO2

RRp

Masimo is committed to deploying its lifesaving technologies in low resource settings in developing countries.

Pneumonia Deaths are Preventable

Pneumonia remains the single largest treatable infectious cause of death in children worldwide, causing over 900,000
deaths each year among children under 5 years of age.1 In settings where supplemental oxygen is available, the addition
of pulse oximetry to standard integrated management of child illness protocols could reduce pneumonia mortality rates.2

Recently, the World Health Organization (WHO) has been conducting a multi-country evaluation of enhanced community
case management of pneumonia with the use of Masimo SET® pulse oximetry by community health workers.3

Enhanced Monitoring is Promising

Enhancing spot-check monitoring in challenging conditions and environments is critically important to reducing the

global burden of pneumonia. Moreover, enhanced monitoring may empower healthcare providers by supporting

informed decisions related to pneumonia assessment.

Rad-G for Monitoring in Low-Resource Settings

Rad-G is a combined pulse oximeter designed primarily for spot-checking in low-resource settings. The validation of the

device is supported in part by a grant from the Bill and Melinda Gates Foundation (BMGF), announced in November

2016, as part of a partnership with Masimo to facilitate spot-checking by health workers in low-resource areas.

Low-cost yet rugged, with a rechargeable battery and LCD display, Rad-G uses Masimo Measure-through Motion
and Low Perfusion SET® pulse oximetry technology to measure SpO2, along with respiration rate from the pleth

(RRp), pulse rate (PR), and perfusion index (Pi).

“The introduction of the Rad-G is a critical milestone in our partnership with
the Bill and Melinda Gates Foundation to help improve pneumonia screening.
We are grateful to have the opportunity to bring our proven SET® pulse oximetry
technology to areas of the world that are in desperate need of better healthcare,
and look forward to making a positive difference in the lives of many children.”

Joe Kiani
Chairman and CEO, Masimo

214

1 Pneumonia Fact Sheet, World Health Organization (WHO), September 2016. http://www.who.int/mediacentre/factsheefts/fs331/en/. 2 Floyd J et al. Nature. 2015 Dec
3;528(7580):S53-9. 3 World Health Organization (WHO), 2016. Rad-G and RRp are not available in the U.S.

215

Company Info and
Philanthropy

216

217

Company InfoCompany Info

Senior
Management
Team

From left to right: Matthew Anacone, Senior Vice
President, North America Sales; Yongsam Lee,
Executive Vice President, Chief Information Officer;
Tao Levy, Executive Vice President, Business
Development; Tom McClenahan, Executive Vice
President, General Counsel; Jon Coleman, President,
Worldwide Sales, Professional Services & Medical
Affairs; Joe Kiani, Chief Executive Officer;
Anand Sampath, Chief Operating Officer;
Bilal Muhsin, Executive Vice President, Engineering,
Marketing, and Regulatory Affairs; Micah Young,
Executive Vice President, Chief Financial Officer;
Stacey Orsat, President EMEA; Tetsuro Maniwa,
President Japan

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

218

219

Company Info

Awards

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

2006 Application of Technology for
Noninvasive Methemoglobin and
Carboxyhemoglobin Monitoring

2009 Patient Monitoring CEO of the Year

2005 Innovative Product
and Technology

2017 Anti-Defamation League
Humanitarian Award

2013 Zenith Award at the American
Association of Respiratory Care Congress

American Association for Respiratory Care

2009 Zenith Award

2017 European Patient Blood
Management Network Platinum Award

2013 Best Clinical Application of
Technology Award for SpHb

2009 Best in Class

2003 Platform ABBY for Innovations
in Healthcare

2003 Technology of the Year in
Patient Monitoring

BECKER’S

Hospital Review

2017 Becker's Hospital Review
Top 50 Leaders in Patient Safety

2013 EMS World Top Innovation Award
for EMMA

American Association for Respiratory Care

2008 Zenith Award

2003 New Standard of Care

BECKER’S

Hospital Review

2016 Becker's Hospital Review
Top 50 Leaders in Patient Safety

2013 Hot Product Award
for EMMA and iSpO2

2008 Best in Class

2001 Medical Design Excellence

2015 Life Sciences IP Champion Award

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

2008 Outstanding Medical
Device Company

2001 Distinguished Leadership

2015 SafeCare Person of the Year

2012 National Entrepreneur of the Year
Life Sciences Award Winner

2008 Outstanding Growth

2001 Innovative Product and Technology

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

2008 Excellence in Medical Technology

2000 Technology Excellence

2015 GOLD Medical Design
Excellence Award for Root

2011 High-Tech Innovation for the Pronto-7

2007 Patient Monitoring Technology
Leadership of the Year

2000 Outstanding Medical Device Company

American Association for Respiratory Care

2014 Zenith Award

2011 WINNER

2011 Medical Design Excellence Gold
for the Pronto-7

2014 Hubert H. Humphrey
“Dawn of Life” Award

2011 Product Design Award
for the Pronto-7

BECKER’S

Hospital Review

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

2010 Respiratory Product
Best-in-Class Award

2007 Groundbreaking Innovation
of rainbow® SET

2007 Excellence in Technology
Innovation for Noninvasive
Total Hemoglobin Monitoring

2006 Medical Design Excellence

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

220

221

Global Reach

Company Info

Masimo is committed to improving patient

care globally, with over 4,600 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

R&D Center

MNP Tower, 1021 West Hastings Street
Suite 500, Vancouver, B.C. V6E 0C3, Canada

Manufacturing Centers

U.S. Manufacturing
15776 Laguna Canyon Rd, 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

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

Canada
4878 Rue Levy Street, Suite 200
Saint-Laurent, Québec H4R 2P1, Canada
Tel: 888 336 0043
China
Unit 4905, Office Tower of Raffles City,
No. 268 Xizang Road(M), Huangpu District,
Shanghai 200001 P.R.C.
Tel: +86 (21) 6378 8998

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

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

Brazil
Rua General Fernando de Vasconcellos
Cavalcante de Albuquerque 80
0677 – 020 Cotia, San Paolo
Tel: + 55 11 3149 8181

Headquarters

Manufacturing Centers

Country Offices

Subsidiaries

Masimo Distributors

Masimo OEM Partners

Masimo Capnography OEMs

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

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

Poland
Plac Kontytucji 5/17, Zurawia 45
00-657 Warszawa, Poland

Saudi Arabia
360 Sulaymaniyah Building, no 17
Prince Sultan Abdulaziz Street
Al-Sulaymaniyah District, P.O. Box 4288
Postal Code: 11491. Riyadh, Saudi Arabia
Tel: +966 11 4721113

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

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

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

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

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

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

Third Parties

Masimo Distributors
Masimo OEMS
Masimo Capnography OEMS

222

223

Philanthropy

Patient Safety Movement
Foundation

A Revolutionary Approach to Global Patient Safety

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 global geopolitical changes

are wreaking havoc and suffering on an massive scale. Masimo is proud to be right in the thick of things,

helping out wherever we can.

ZERO Preventable Deaths by 2020

In February 2018, the Patient Safety Movement Foundation (which the The Masimo Foundation for Ethics,
Innovation, and Competition in Healthcare founded in 2012 and continues to sponsor) hosted the 6th annual

World Patient Safety, Science & Technology Summit in London. President Bill Clinton, Secretary of State

for Health and Social Care Rt Hon Jeremy Hunt, MP and the World Health Organization’s Director-General

Dr. Tedros Adhanom Ghebreyesus keynoted the event. Diverse stakeholders from all parts of the global

healthcare ecosystem came together to advance a vital mission: eliminating 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

believe can eliminate preventable patient deaths. It is simply a matter of connecting all the dots.

For more information, visit:
www.PatientSafetyMovement.org

Rt Hon Jeremy Hunt

Tedros Adhanom Ghebreyesus, M.D.

President Bill Clinton

Secretary of State for Health and Social Care,

United Kingdom

Director-General,

World Health Organization

Founder of the Clinton Foundation and
42nd President of the United States

Keynote speakers at the 2018 World Patient Safety, Science, & Technology Summit in London.

Helping Our Neighbors All Over the World

In addition to continuing support for the Patient Safety Movement Foundation, some additional efforts to help improve

lives around the world include:

• Co-founding the United for Oxygen Alliance, a public-private partnership that seeks to expand access to medical

oxygen and pulse oximetry for women and children in Ethiopia and beyond.

•

In partnership with the Newborn Foundation, developing the BORN (Born Oximetry Routine for Newborns)

Project, with the goal of reducing newborn mortality from CCHD, pneumonia, and sepsis.

• Co-founding the “Every Breath Counts” Coalition, dedicated to eliminating all pneumonia-related deaths.
Masimo recently co-produced a documentary, United for Oxygen, examining the problem in more detail.

• Donating medical equipment to hospitals in Jordan to help improve patient care for the more than one million refugees
from Syria and Iraq now living in Jordan, as well as supporting the work of Doctors Without Borders in the area.

• Partnering with Smile Train to help ensure the safety of patients undergoing cleft lip and/or palate surgery in

low-resource settings around the world.

• Equipping hospitals in Macedonia with much-needed medical equipment.
• Funding school construction in Uganda.
• Funding UNICEF to provide assistance to refugees.
• Developing a program to increase hiring of refugees, the disabled, and veterans.
• Joining the Tent Partnership for Refugees Coalition, committed to supporting refugees around the world,

and making a commitment to implement child and family health screening initiatives for and with refugees in

countries that have accepted large refugee populations.

• Entering into a 4-year global impact partnership with the WFSA (World Federation of Societies of
Anesthesiologists), “Safe Anesthesia - ASAP,” to improve anesthesia care in low-resource countries.

224

225

Financial Performance

Condensed Consolidated Balance Sheets
(unaudited, in thousands)

ASSETS

Current assets

Cash and cash equivalents
Trade 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

December 30, 2017

December 31, 2016

$315,302
121,309
95,944
3,494
28,070

564,119
99,600
164,096
27,123
20,617
23,898
10,782

$305,970
101,667
72,542
981
26,067

507,227
79,948
135,996
29,376
19,780
38,975
9,223

$910,235

$820,525

LIABILITIES AND STOCKHOLDERS’ EQUITY

December 30, 2017

December 31, 2016

Current liabilities

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

Total current liabilities

Deferred revenue
Other liabilities

Total liabilities
Commitments and contingencies
Stockholders' Equity

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

Total stockholders’ equity

Total liabilities and stockholders' equity

$33,779
39,515
38,052
4,292
35,929
—

151,567
237
51,520

203,324

—
52
(472,536)
461,494
(2,941)
720,842

706,911

$910,235

$34,335
43,180
28,266
76,316
38,198
71

220,366
25,336
14,587

260,289

—
50
(404,276)
382,263
(7,027)
589,226

560,236

$820,525

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

Revenue:

Product
Royalty and other revenue

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 (income) expense

Income before provision for income taxes
Provision for income taxes

Net income including noncontrolling interests
Net income (loss) attributable to noncontrolling interests

Year Ended
December 30, 2017

Year Ended
December 31, 2016

$741,324
56,784

798,108
263,008

535,100

275,786
61,953
—

337,739

197,361
(2,013)

199,374
67,758

131,616
—

$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
—

Net income attributable to Masimo Corporation stockholders:

$131,616

$300,666

Basic

Diluted

Weighted-average shares used in per share calculations:

Basic

Diluted

$2.55

$2.36

51,516

55,874

$6.07

$5.65

49,530

53,195

226

227

Financial PerformanceFinancial Performance

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

Cash flows from operating activities:

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

Year ended
December 30, 2017

Year ended
December 31, 2016

$131,616

$300,666

Depreciation and amortization
Stock-based compensation
Loss on disposal of property, equipment and intangibles
Provision for doubtful accounts
Provision for amount due from former foreign agent
Gain on deconsolidation of variable interest entity
Benefit from deferred income taxes
Changes in operating assets and liabilities:
Increase in trade accounts receivable
Increase in inventories
Increase in deferred cost of goods sold
Increase in prepaid expenses
(Increase) decrease in prepaid income taxes
Increase in other assets
(Decrease) increase in accounts payable
(Decrease) increase in accrued compensation
Increase (decrease) in accrued and other current liabilities
(Decrease) increase in income taxes payable
(Decrease) increase in deferred revenue
Increase in other liabilities

Net cash provided by operating activities

20,061
17,187
522
251
10,477
—
24,023

(19,772)
(22,923)
(19,438)
(3,855)
(2,498)
(10,952)
(4,057)
(4,292)
11,156
(72,087)
(27,370)
28,013

56,062

16,817
12,503
658
259
—
(273)
5,405

(21,243)
(10,831)
(8,251)
(3,422)
1,355
(1,609)
11,048
5,675
(11,929)
73,755
41,977
6,565

419,125

Cash flows from investing activities:

Purchases of property and equipment
Increase in intangible assets
Acquisition of long-term equity investments
Reduction in cash resulting from deconsolidation
of variable interest entity

Year ended
December 30, 2017

Year ended
December 31, 2016

(43,684)
(3,079)
(1,145)
—

(19,707)
(4,644)
(200)
(763)

Net cash used in investing activities

(47,908)

(25,314)

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

Repurchases of common stock

Net cash used in financing activities

Effect of foreign currency exchange rates on cash

Net increase in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of period

Cash, cash equivalents and restricted cash at end of period

—
—
—
(71)
62,205

(66,272)
(4,138)

3,269

7,285
308,198

$315,483

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

(68,218)
(216,624)

(1,451)

175,736
132,462

$308,198

228

229

Forward Looking
Statements

All statements other than statements of historical

looking statements. These risks include, but are not

customers; our ability to retain and recruit senior

reliance on these forward-looking statements,

facts included in this annual report that address

limited to, those related to: actual foreign currency

management; product liability claims exposure;

which speak only as of the date hereof, even if

activities, events or developments that we expect,

believe, or anticipate will or may occur in the

exchange rates; our dependence on Masimo
SET® and Masimo rainbow SET™ products and

our ability to obtain expected returns from the

subsequently made available by us on our website

amount of intangible assets we have recorded; the

or otherwise. We do not undertake any obligation

future are forward-looking statements. Forward-

technologies for substantially all of our revenue;

maintenance of our brand; the amount and type

to update, amend or clarify these forward-looking

looking statements include statements which are

our ability to protect and enforce our intellectual

of equity awards that we may grant to employees

statements, whether as a result of new information,

predictive in nature, which depend upon or refer

property rights; potential exposure to competitors’

and service providers in the future; our ongoing

future events or otherwise, except as may be

to future events or conditions, or which include

assertions of intellectual property claims; the

litigation and related matters; and other factors

required under applicable securities laws.

words such as “expects,” “anticipates,” “intends,”

highly competitive nature of the markets in which

discussed in the “Risk Factors” section of our most

“plans,” “believes,” “estimates” or the negative of

we sell our products and technologies; our ability

recent periodic reports filed with the Securities and

NOTE REGARDING THIS ANNUAL REPORT

these words or other similar terms or expressions

to continue developing innovative products and

Exchange Commission (“SEC”), including our most

Please note that this annual report does not

that concern our expectations, strategy, plans or

technologies; the lack of acceptance of any of

recent Annual Report on Form 10-K, Quarterly

constitute our “annual report to security holders” for

intentions. These forward-looking statements are

our current or future products and technologies;

Reports on Form 10-Q and Current Reports on

purposes of the requirements of the SEC. For a copy

based on management’s current expectations

obtaining regulatory approval of our current and

Form 8-K, all of which you may obtain for free

of our annual report to security holders required

and beliefs and are subject to uncertainties

future products and technologies; the risk that the

on the SEC’s website at www.sec.gov. Although

under Rule 14a-3 of Regulation 14A of the Securities

and factors, all of which are difficult to predict

implementation of our international realignment

we believe that the expectations reflected in our

Exchange Act of 1934, as amended, please refer to

and many of which are beyond our control and

will not continue to produce anticipated

forward-looking statements are reasonable, we

our Annual Report on Form 10-K for the fiscal year

could cause actual results to differ materially and

operational and financial benefits, including a

do not know whether our expectations will prove

ended December 31, 2017, which you may obtain for

adversely from those described in the forward-

continued lower effective tax rate; the loss of our

correct. You are cautioned not to place undue

free on the SEC ‘s website at www.sec.gov.

230

231

Automating Care

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

© 2018 Masimo. Masimo, SET, rainbow, rainbow Acoustic Monitoring, rainbow ReSposable, rainbow SET, RD rainbow SET, RD rainbow Lite SET, RD SET, 3D Desat Index Alarm,
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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 .

60560/PLM-11047C-0518