IRVINE, CA -- (Market Wire - Sep 27, 2004) -- Irvine, Calif.-based Masimo, the innovator of Signal Extraction Pulse Oximetry today announced the introduction of the LNOP TC-I ear pulse oximetry sensor. The sensor, used to record a patient's blood-oxygen level, pulse rate and perfusion index, was developed with feedback from The Cleveland Clinic, ranked as one of the nation's best hospitals by U.S. News & World Report.
Pulse oximetry technology involves applying a sensor to the skin to record a patient's blood-oxygen levels. A monitor continuously displays the data, and visual and audible alarms alert caregivers to unusual blood-oxygen levels and abnormal heart rates. Previously, pulse oximetry has been highly effective in monitoring those patients who are motionless, asleep and who have satisfactory circulation. Masimo is the innovator of Signal Extraction Technology for reliable pulse oximetry monitoring, even during patient motion and low perfusion.
In addition, the conventional pulse oximeter has had drawbacks for those patients having cardiac surgery or other surgical procedures where access to a typical monitoring site, such as the finger or toe, is not readily accessible. Many sites available during these procedures have lower levels of blood flow and, therefore, are more susceptible to physiologic, mechanical, thermal and optical noise that can mask low-level pulse oximetry signals.
The TC-I, Tip-Clip, ear sensor was designed by Masimo with assistance from the biomedical, clinical and nursing staff at The Cleveland Clinic. The goal was to create an ear sensor that would not drop out or freeze data under low perfusion and motion conditions, and that could obtain faster readings on central oxygenation changes than digit sensors because of its proximity to the heart.
The resulting TC-I has a smaller and lighter design, with a unique clear, soft, silicone lens material for better grip, and a slightly concave photo-detector for optimum conformity to the contours of the ear.
"Ear pulse oximetry sensors provide our operating rooms with a stable and highly reliable reusable probe, something that we have been trying to obtain for several years," said John Petre, Ph.D., Head of Clinical Engineering & Information Services, for the Division of Anesthesiology and Critical Care at The Cleveland Clinic.
A recent clinical study performed by Daniel Redford, MD, of University of Arizona compared the bias and precision of the TC-I sensor placed on the earlobe to the bias and precision of the Masimo LNOP digit sensor. While the Masimo digit sensor predictably performed better than the Masimo TC-I ear sensor, the difference was not large and validated the usefulness of the TC-I sensor when digits are unavailable or inappropriate for specific monitoring needs.
"The Cleveland Clinic relies on pulse oximetry to enhance patient safety," said Fawzy G. Estafanous, MD, Chairman, Division of Anesthesiology and Critical Care Medicine. "We began using Masimo SET over two years ago to measure blood-oxygen levels to enhance the level of care we can provide to patients at risk of cardio-respiratory complications."
Joe E. Kiani, Chairman and CEO of Masimo, stated, "The TC-I ear sensor has been a great addition to our sensor offering. Clinicians and researchers have given us very positive feedback on the design and performance of this product. We thank the Cleveland Clinic team for their assistance." Mr. Kiani continued, "The adoption of Masimo SET by The Cleveland Clinic is also a great honor for us. The Cleveland Clinic is a leading standard-setting healthcare institution. Our close working relationship with The Cleveland Clinic has resulted in improvement in our products for all of our customers."
About Masimo
Masimo, founded in 1989, is the innovator and leader of read-through motion and low perfusion pulse oximetry. Masimo develops, licenses, and markets advanced medical signal processing technologies and products for the non-invasive monitoring of vital signs. Masimo Signal Extraction Technology, or Masimo SET, represents the standard of care for pulse oximeters. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world. Masimo is headquartered in Irvine, Calif. Additional information about Masimo and its products can be found at www.masimo.com.
Masimo is currently offering a $250,000 guarantee to hospitals seeking an upgrade to next generation pulse oximetry. If Masimo does not outperform Nellcor in an objective clinical trial, Masimo will pay that hospital $250,000 towards the purchase of Nellcor oximetry. Contact Masimo for more details.
For more information contact:
Masimo Corp.
Brad Langdale
(949) 297-7009
blangdale@masimo.com









