Masimo today announced the FDA 510(k) clearance and market release of Masimo's new uSpO2™ universal pulse oximetry cable for use with GE Healthcare's ApexPro® Telemetry Systems. GE Healthcare is the first to integrate Masimo's low power platform with SET® Measure-Through Motion and Low Perfusion SpO2 technology into patient-worn monitors designed for use in ambulatory patient care environments.
Masimo's new FDA-Cleared uSpO2(TM) cable provides plug-and-play Masimo SET(R) pulse oximetry functionality with GE's ApexPro(R) Telemetry Systems.
Ambulatory care environments such as telemetry and cardiac step-down units often use patient-worn monitors to conduct continuous monitoring during patient ambulation. In addition to the motion artifact caused by this ambulation, cardiac patients can experience low peripheral perfusion on an intermittent or consistent basis. However, these monitoring conditions have proven to be particularly challenging for conventional pulse oximetry technology and may lead to inaccurate pulse oximetry measurements and nuisance alarms that detract from patient care.1 As demonstrated in more than 100 independent and objective studies, Masimo SET® pulse oximetry is clinically proven to virtually eliminate false alarms1 and increase a clinician's ability to detect life-threatening events2 under challenging conditions including patient motion and low peripheral perfusion.
Masimo's uSpO2™ (pictured) is a "Board-in-Cable" external pulse oximetry solution that provides a simple way to add Masimo SET® pulse oximetry for devices that are not designed to have SpO2 integrated inside the device. The uSpO2™ cable embeds a Masimo MS-2040 circuit board within a completely self-contained cable that attaches to the patient sensor.
The uSpO2™ cable adapted for the GE ApexPro® Telemetry Systems provides full Masimo SET® pulse oximetry capabilities with proven accuracy during patient motion and low perfusion, while reducing Masimo's power consumption to approximately 60 milliwatts, which reflects a 97% reduction to initial SET® SpO2 platforms and a 52% reduction vs current SET® platforms.
Masimo's new uSpO2™ cable has been adapted to provide plug-and-play functionality with GE's ApexPro® Telemetry Systems. As a result, clinicians can upgrade their monitoring capabilities by purchasing Masimo's uSpO2™ cable for their GE ApexPro Telemetry System – without the cost of additional hardware or software. And for the hundreds of GE customers who have standardized on Masimo SET® SpO2 technology within their GE bedside monitors, the uSpO2™ cable enables standardization of SpO2 technology and sensors as patients transition between care areas—from bedside monitors in hospital rooms to patient-worn transmitters in ambulatory care areas. This measurement technology and sensor standardization can help healthcare providers reduce costs, while enhancing workflow, care processes, and efficiencies.
Today's announcement builds on a long-term existing partnership between GE Healthcare and Masimo. Earlier this year, GE Healthcare and Masimo jointly announced an expanded long-term agreement under which GE Healthcare would incorporate Masimo rainbow® SET® technology into many of GE Healthcare's patient monitoring products.
Rick Fishel, Masimo President of Worldwide OEM Business and Corporate Development, stated, "Masimo is focused on delivering innovative technology solutions that allow caregivers to better address the needs of their patients under the most challenging environments. We are pleased that GE Healthcare is the first patient monitoring company to combine Masimo's low power SET® technologies in ambulatory patient applications, further enhancing GE's comprehensive wireless solutions that enable caregivers to work more productively and respond to critical situations faster. We believe this new level of functionality in GE's patient-wearable monitors capitalizes on our technology partnership and reflects our shared corporate visions to improve patient outcomes while reducing the cost of healthcare delivery."
1 Shah N, Ragaswamy H, Govindugari K, Estanol L. "Performance of three new-generation pulse oximeters during motion and low perfusion in volunteers." Journal of Clinical Anesthesia. 2012 (10.1016/j.jclinane.2011.10.012) Available online here.
2 Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P.; Blike, George T. "Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study." Anesthesiology, February 2010, Vol. 112, Issue 2. Available online