Masimo Announces CE Marking of Rad-97 Pulse CO-Oximeter and Connectivity Hub

Masimo has received CE marking of noninvasive blood pressure (NIBP) measurements for the Rad-97 Pulse CO-Oximeter and connectivity hub. Rad-97 offers Measure-through Motion and Low Perfusion SET pulse oximetry and upgradeable rainbow noninvasive blood constituent monitoring technology in a compact standalone monitor configuration which can also collect and remotely transmit data from connected devices.
 
Rad-97 with NIBP enables clinicians to measure arterial blood pressure for adult, pediatric, and neonatal patients, with three measurement modes: spot-check, automatic interval (which measures blood pressure routinely, at a desired interval), and stat interval (which continually measures blood pressure for a desired duration). An integrated port allows clinicians to connect a blood pressure cuff inflation hose directly to Rad-97, and is compatible with both disposable and reusable cuffs, for a variety of patient types, designed for reliability and patient comfort.
 
With the addition of NIBP to Rad-97, clinicians can easily and automatically chart blood pressure data directly from the same monitoring device that measures oxygen saturation, total hemoglobin, and other noninvasive parameters. In hospital settings and when used in conjunction with Masimo Iris Gateway or Patient SafetyNet,* data from Rad-97 and other devices connected via the Iris hub can be sent directly to the patient’s electronic medical record. With Patient SafetyNet, alarms and alerts from connected devices are seamlessly forwarded to clinicians.
 
Rad-97 includes built-in wireless connectivity, via Wi-Fi and Bluetooth. Using Bluetooth or a wired USB connection, Rad-97 can connect to nearby devices, such as glucometers and weight scales, and can allow the data from the connected device to be transmitted remotely. Rad-97 will be available for use on home and enterprise networks to connect to remote monitoring systems, including Patient SafetyNet.
 
Additional devices can be simultaneously attached to Rad-97 using the Iris hub.

Rad-97 features a high-resolution, 1080p HD color display with user-friendly multi-touch navigation, allowing clinicians to easily customize the device to best suit their monitoring and viewing needs. Users can also rapidly configure the device to accommodate different patient populations using customizable profiles. A rechargeable battery lasting seven hours allows Rad-97 to be used in situations where portability or extended operation without access to power are needed. An optional roll stand allows for tetherless device transport, offering additional flexibility when space is limited.
 
Rad-97 will also be available with an optional camera, which can be used in conjunction with Masimo Patient SafetyNet. The camera will provide a high resolution, high-frame rate video feed, as well as audio, to the Patient SafetyNet view-station. When used at home, camera-equipped Rad-97 will allow patients and clinicians to interact remotely, making it well-suited as a point-of-care device for potential telehealth applications.
 
Like Radical-7, Rad-97 features Measure-through Motion and Low Perfusion pulse oximetry (SpO2), pulse rate (PR), and perfusion index (PI). Clinicians can add other monitoring solutions such as the rainbow SET measurements PVi, total hemoglobin (SpHb), methemoglobin (SpMet), acoustic respiration rate (RRa), carboxyhemoglobin (SpCO), and oxygen content (SpOC). Additional parameters such as Oxygen Reserve Index (ORi) and respiration rate from the pleth (RRp) are also available, making Rad-97 the smallest Masimo bedside device currently capable of monitoring the full rainbow SET platform.
 
“Rad-97 brings our core SET and rainbow technologies to a compact design, which allows broader applications in many new settings, including the home, with its hub and telepresence capabilities,” said Joe Kiani, founder and CEO of Masimo. “We’re excited to extend its range of possibilities with the addition of integrated blood pressure measurement.”
 
Rad-97 is not available in the United States.
 
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

Masimo develops noninvasive monitoring technologies. In 1995, the company debuted Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.^3,4,5 Masimo SET is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb), oxygen content (SpOC), carboxyhemoglobin (SpCO), methemoglobin (SpMet), and more recently, Pleth Variability Index (PVi) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index. In studies with SpHb, reductions in blood transfusion* were observed,^6,7 and when used with PVi, a reduction in 30-day mortality was observed.⁸ In 2014, Masimo introduced Root, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2 pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
 
References:
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.