BARCELONA, Spain, June 3, 2013 /PRNewswire/ -- Masimo (NASDAQ: MASI) today at the European Society of Anesthesiology Meeting announced the CE Mark and international Limited Market Release* of Root™, an intuitive patient monitoring and connectivity platform that is destined to transform patient care from the operating room to the general floor. High-impact innovations in Root include:
- Radical-7®- Masimo's breakthrough rainbow® and SET® measurements from Masimo's Radical-7® handheld monitor that docks into Root, instantly interpretable, with a 10-inch high visibility, intuitive navigation touchscreen display
- MOC-9™- Flexible measurement expansion through Masimo Open Connect™ (MOC-9™) with SedLine® brain function monitoring and Phasein™ capnography MOC-9 modules from Masimo or third-party measurement byother companies to expand the platform's measurements & capabilities
- Iris™- Built-in connectivity gateway through Iris™ for standalone devices such as IV pumps, ventilators, hospital beds, and other patient monitors
- MyView™-Automatic display of parameters, waveforms, and viewing configuration based on the clinician's presence through MyView™ technology
Instantly Interpretable, High Visibility Display of the Radical-7's Breakthrough Measurements
Root provides a docking station for Masimo's Radical-7 handheld monitor to enable instant interpretation of its breakthrough measurements on a high visibility, brilliant 10-inch touchscreen display. The adaptive display provides waveforms along with either a trend view in which each measurement value is displayed alongside a graph of its values over time, or an analog view for quick assessment through gauges showing measurement values in relation to alarm ranges.
When docked with Root, the Radical-7's screen transforms into an alarm status visualizer, with a three-dimensional, anatomical image that associates device measurements with anatomical alarm status.
Root's display helps clinicians fully utilize the Radical-7's capabilities with noninvasive and continuous monitoring of:
- Total hemoglobin (SpHb®) to help clinicians reduce blood transfusions and detect bleeding(1,2,3)
- Pleth Variability Index (PVI®) to help clinicians assess fluid responsiveness and improve fluid management(4,5,6,7)
- Acoustic respiration rate (RRa™) for patient-tolerant ventilation monitoring with similar accuracy as capnography(8)
- Accurate oxygen saturation (SpO2) and pulse rate during challenging conditions with Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry,(9) proven to help clinicians reduce retinopathy of prematurity,(10) screen newborns for critical congenital heart disease,(11,12) reduce ventilator weaning time,(13) and save lives while reducing rapid response activations and intensive care unit transfers on the general floor."(14)
Intuitive, Touchscreen Navigation for Easy and Adaptable Use in Any Environment
With a simple tap, swipe, or drag-and-drop, views, sizing, and settings can be customized on the fly to suit any environment, clinician preference, or patient-specific need. This allows Root to be adaptively used across the continuum of care – even when needs vary widely by care area.
"Root displays rainbow® measurements in a manner so that at any moment I can see what I want to see and how I want to see it – a great advantage to the anesthesiologist in a data-rich operating room," stated Dr. Keith Ruskin, Professor of Anesthesiology at Yale-New Haven Hospital in New Haven, Conn. "Root makes it easy to use SpHb and PVI together to optimize transfusions and perform goal-directed fluid management."
Flexible Measurement Expansion through Masimo Open Connect™ (MOC-9™)
MOC-9, along with the Radical-7's breakthrough measurements, work together to create the ultimate patient monitoring platform for flexible use anywhere in the hospital, from the operating room to the general floor, conscious sedation, and intensive care unit.
The SedLine brain function monitoring MOC-9 module for Root advances brain function monitoring to improve the care of patients under anesthesia or sedation. The core product is a state-of-the-art EEG-based brain function monitor utilizing four simultaneous EEG channels. SedLine measures the effects of anesthesia and sedation by monitoring electrical activity on both sides of the brain at the same time, to enable more individualized titration and improve the care of patients under anesthesia or sedation. With demonstrated reliability under challenging clinical conditions and superior resistance to cautery, SedLine offers a cost-effective solution for brain function monitoring that helps clinicians achieve targeted sedation throughout all phases of anesthesia—in the OR and ICU.
The Phasein capnography MOC-9 module for Root provides precise ETCO2 and respiratory rate measurements with crisp waveforms and virtually no start up time. In addition, with the Nomoline™ "No Moisture" sample line, customers can choose from a single patient use Nomoline version – designed for extended life in high humidity environments – or the multi-use Nomoline adapter for cost-effective, repeated use on different patients with only the cannula itself being replaced with each patient.
"Combining Masimo SET® Pulse Oximetry and the breakthrough noninvasive rainbow® measurements with specialty measurements like brain function monitoring and capnography in the same platform creates a new level of safety and convenience," stated Dr. Michel Struys, Professor and Chair of Anesthesiology at the University of Groningen in the Netherlands. "Instead of using multiple standalone devices, we can now see everything on one screen to streamline care and improve efficiency."
Designed for Third-Party Development of Expanded Measurements
Root is also designed to allow other companies to expand the platform's measurements with their own measurements through MOC-9 by following Masimo's established development and validation process.
Rick Fishel, Masimo's President of Worldwide OEM Business, stated: "As a serial innovator, Masimo understands that disruptive technologies that improve patient care rarely come from large, established companies. Market barriers and development costs often keep small, innovative companies from delivering their products to the clinicians and patients who need them most. With Root, Masimo is providing an open invitation to other companies, from small to large, to develop and commercialize their innovations through Masimo's ever-expanding customer base."
Built-in Connectivity Gateway through Iris™
Despite medical technology advances, the lack of device communication and integration creates risks to patient safety in hospitals around the world. Without device interoperability, critical patient information can go unnoticed – leaving busy clinicians in the dark and vulnerable patients in danger. Existing approaches for device interoperability require separate hardware, software, and/or network infrastructure, which can clutter the patient room, increase complexity, burden IT management, and increase costs.
To address these challenges, each Root can also be used as a connectivity gateway to integrate multiple standalone devices such—as IV pumps, ventilators, hospital beds, and other patient monitors—when used as part of the optional Iris connectivity package in Masimo Patient SafetyNet™. Iris allows standalone device information to be remotely viewed with Patient SafetyNet, transmitted through notification systems or sent to electronic health record (EHR) systems to facilitate better patient care and meaningful use. Device connectivity with Iris is designed to leverage existing network infrastructures and reduce costs while enhancing clinical workflows and decision support to improve patient safety, whether the clinician is at the bedside, down the hall, or across the globe.
MyView Technology
MyView is a wireless, presence detection badge system that enables clinicians to automatically display customized clinical profiles on Masimo devices, such as Root. When a clinician approaches the bedside, a clinician-worn MyView badge signals the Radical-7 and Root to display a pre-selected set of parameters and waveforms tailored to the individual clinician's preferences for easy viewing. Masimo measurements and the flexibility with which they can be displayed continue to expand; however, this doesn't mean that all clinicians need to see all of the information in the same way. While a physician may want to see all parameters and waveforms, a medical assistant may want to see a few parameters and no waveforms.
"Root represents nearly 25 years of relentless innovation aimed at improving patient safety," said Joe Kiani, founder and CEO of Masimo. "With Root, Masimo seeks to usher in a new era of patient care. Root not only enables breakthrough measurements to become ubiquitous, but displays those measurements in an easily interpreted manner alongside integrated data from multiple devices to automate the process of care and improve patient safety. To facilitate the transformation of patient care, Root will be offered at a breakthrough price point, too."
For more information on Root, visit www.masimo.co.uk/root.*
Companies interested in developing a MOC-9 measurement can request more information online at: www.masimo.co.uk/root/MOC-9.
The Root™ Monitoring and Connectivity Platformis CE Marked and the information contained in this release is applicable to audiences in European CE Mark countries only.
1 Ehrenfeld J.M., et al. American Society of Anesthesiologists. 2010;LB05.
2 Awada W.F.N., et al. Proceeding of the Society for Technology in Anesthesia Annual Meeting, 2013: p. 51.
3 Shander et al. Transfusion. 2010;50(4):753-765.
4 Cannesson M, et al. Br J Anaesth. 2008 Aug;101(2)200-6
5 Loupec T, et al. Crit Care Med. 2011 Feb;39(2):294-9.
6 Byon H, et al. Br J Anaesth. 2013 Apr;110(4):586-91.
7 Forget P, et al. Anesth Analg. 2010 Oct;111(4):910-4.
8 Ramsay M.A.E., et al. Anesth. Analg 2013 June;,ANE.0b013e318290c798.
9 Shah N, et al. J Clinical Anaesthesia. 2012 Aug;24(5):385-91.
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11 de-Wahl Granelli A., et al. BMJ. 2009 Jan 8;338.
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13 Durbin, et al. Critical Care Medicine. 2002 Aug.;30(8): 1735 to 1740.
14 Taenzer A, et al. Anesthesiology, 2010 Feb;112(2):282-7.
About Masimo
Masimo (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 help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow ® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. 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 commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can be 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 www.masimo.com.
Forward-Looking Statements
This 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 assumptions regarding timing of regulatory clearances and commercial availability in other countries; risks related to our assumptions that Root will provide a connectivity platform for any standalone device; and risks related to our assumption that Root will support/enable any third-party development of new measurements, technologies, product through MOC-9; 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 www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. 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 forward-looking 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:
Mike Drummond
Masimo Corporation
(949) 297-7434
mdrummond@masimo.com
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. All other trademarks, service marks, trade names, logos and icons, registered or not, are the property of third parties as named/indicated.
Press Note: The included product photos illustrating various features and display screens on Root™ are available for media use and publication only.
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