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Masimo rainbow Acoustic Monitoring Technology Cleared for Market in Japan

TOKYO and IRVINE, Calif., Oct. 10, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that it has received Japanese Ministry of Health Labor & Welfare (MHLW) regulatory clearance for its Rad-87® Pulse CO-Oximeter with rainbow® Acoustic Monitoring technology—providing noninvasive and continuous acoustic respiration rate (RRa™) measurements that are accurate, easy-to-use, and enhance patient compliance.  Available for the first time in Japan, RRa represents a breakthrough solution for measuring respiration rate in real-time to track and trend patient breathing—offering automated assessments that may enable earlier detection of respiratory compromise and patient distress.


Respiration rate is defined as the frequency of breathing expressed as the number of breaths per minute and is considered a critical vital sign in assessing the physiological status of hospitalized patients. Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia (PCA) for pain management as sedation can induce respiratory depression and place patients at considerable risk of serious injury or death.(1-4) Although the Anesthesia Patient Safety Foundation (APSF) recommends continuous oxygenation and ventilation monitoring in all patients receiving opioids,(5-6) current methods for respiration rate monitoring are limited by reliability or patient tolerance.

Dr. Toshiyasu Suzuki, MD, PhD, Professor of Anesthesiology, Tokai University School of Medicine in Kanagawa Japan, who is one of the first Rad-87 with RRa users, stated, “The number of surgeries has been increasing at acute care hospitals since DPC started in Japan. As a result, the number of postoperative patients sent to the general ward has increased and nurses have more workload, especially at night shift. We have concerns about patient safety.  Anesthesiologists tend to administer postoperative patients muscle relaxant and/or pain relief drugs such as Morphine, Fentanyl, Remifentanil. Those patients are often at risk of respiratory failure when excessive amount of these drugs are administered. The respiratory monitoring for those patients is currently done by pulse oximeter and/or a visual observation, however that is not enough.  Now we have a solution. I strongly recommend Rad-87 with RRa: it is a simple use and the RRa accuracy is as good as ETCO2, on top of that SpO2 can be monitored at the same time.  I am assured that Rad 87 with RRa will be a powerful tool for clinicians and nurses on a postoperative patient risk management.”

Michael Ramsay, M.D., Chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center in Dallas, Texas, stated, "Breathing adequately is what matters most. Masimo acoustic respiration rate (RRa) provides clinicians with the ability to automatically and continuously monitor the breathing status of post-surgical patients in general care or post-anesthesia settings—alerting them to the first sign of an abnormal or compromised breathing pattern that may be indicative of airway obstruction or respiratory distress. And, the Masimo Acoustic Sensor is virtually unnoticeable when worn—making it extremely patient-friendly."

Masimo rainbow Acoustic Monitoring features an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient's neck to detect upper airway acoustic vibrations on the surface of the skin during the respiratory cycle. Using patented acoustic signal processing that leverages Masimo's revolutionary Signal Extraction Technology (SET), the respiratory signal is separated and processed to display continuous RRa measurements.

Masimo Founder and CEO, Joe Kiani, stated, "Solving 'unsolvable' problems that have plagued patient monitoring is key to advancing medicine and improving patient care. Masimo rainbow Acoustic Monitoring addresses a longstanding and growing need to accurately and easily monitor patient breathing, which is expected to improve patient safety and decrease the cost of care in hospitals. It also adds another compelling reason for hospitals to choose the Masimo rainbow SET upgradeable platform for pulse oximetry, Pulse CO-Oximetry, and now Acoustic Monitoring."1

Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert: Patient controlled analgesia by proxy. Chicago: JCAHO, 20042

Institute for Safe Medication Practice. Safety issues with patient-controlled analgesia: Part 1-How errors occur. Huntingdon Valley: ISMP, 2003 3

Institute for Safe Medication Practices. Safety issues with patient-controlled analgesia: Part II - How to prevent errors Huntingdon: ISMP, 2003 4

Bird M. Acute pain management: a new area of liability for anesthesiologists ASA Newsletter. Park Ridge: American Society of Anesthesiologists, 20075

Weinger MB. Dangers of Postoperative Opioids: APSF Workshop and White paper address prevention of postoperative respiratory complications. APSFNewsletter, 2006;21:61-7.

Stoelting RK, Weinger MB. Dangers of Postoperative Opioids -- Is There a Cure? APSF Newsletter, 2009;24:25-26. MasimoMasimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems.  In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events.  More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion.  In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI).  In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events.  In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices.  Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world.  Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care ... by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at

Forward-Looking StatementsThis press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to:  risks related to our assumptions regarding the repeatability of clinical results, risks related to our belief that Masimo rainbow acoustic monitoring technology and RRa respiration rate measurements provide accurate, reliable, real-time data for all patients under all conditions and offer automated assessments, which may enable earlier detection of respiratory compromise and patient distress, as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Dana Banks
Phone: (949) 297-7348

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine  are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.


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