ISA OR+ MOC-9 Module Supports Anesthesia Agent and Ventilation Management
IRVINE, CA -- (Marketwired) -- Masimo (NASDAQ: MASI) today announced FDA 510(k) clearance and CE Mark of ISA(tm) OR+ multigas monitoring, a Masimo Open Connect (MOC-9) Module for the Root® patient monitoring and connectivity platform. During general anesthesia, the ISA OR+ monitors the inhaled and exhaled concentration of five anesthetic gas agents (Sevoflurane, Isoflurane, Halothane, Desflurane, Enflurane), carbon dioxide (CO2), nitrous oxide (N2O), and oxygen (O2), in addition to respiration rate. When technology modules are connected with Root, multiple additional parameters are available including Masimo SET® pulse oximetry, noninvasive and continuous hemoglobin (SpHb®), PVI®, SedLine® brain function monitoring, and O3(tm) Regional Oximetry.*
Earlier in 2014, Masimo announced the availability the ISA CO2 MOC-9 module, which provides end-tidal CO2 concentration and respiration rate.
Key features and benefits of ISA OR+ include:
- Requires only 50 ml sampling flow to support monitoring
- Time-saving in critical situations with virtually no warm-up time and full accuracy performance in less than 20 seconds
- Automatic anesthetic agent identification
- Supports monitoring patients with high respiration rates, up to 150 bpm
- Low-power consumption and automatic temperature and pressure compensation
- Provides minimal alveolar concentration (MAC), which is calculated from the measured anesthetic agents and N2O
- Appropriate for monitoring adult, pediatric, or infant patients in a range of clinical environments including the operating room and intensive care unit
- Compatible with Masimo's Nomoline Adapter and the Nomoline Airway Adapter Set to interface with endotracheal tubing.
*O3 Regional Oximetry is FDA 510(k) pending and is not available for sale in the United States.
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(tm) technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC(tm)), 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(tm), 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(tm), the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa(tm)). 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.
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 risks related to our assumptions regarding the repeatability of clinical results, risks related to our assumptions that Masimo ISA OR+ provides clinicians with accurate and continuous inhaled anesthetic agent monitoring for all patients, 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.
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 are trademarks or registered trademarks of Masimo Corporation