19 September 2017 - - Irvine, California-based noninvasive monitoring technologies specialist Masimo (NASDAQ: MASI) has received FDA 510(k) clearance and full market release of Rad-97 Pulse CO-Oximeter, including configurations with integrated NomoLine capnography and noninvasive blood pressure (NIBP) measurement from SunTech Medical, the company said.
Rad-97 offers Masimo noninvasive and continuous monitoring, through measure-through motion and low perfusion SET pulse oximetry and upgradeable rainbow technologies, in a compact, standalone monitor that incorporates advanced customizability, connectivity, and device integration capabilities.
The device can be customized for each monitoring use case, and can also rapidly configured to accommodate different patient populations using customizable profiles.
A rechargeable battery lasting approximately four hours allows Rad-97 to be used in situations where extended operation without access to AC power is needed. An optional roll stand allows for tetherless device transport, offering additional flexibility in situations where space is limited.
Rad-97 features built-in enterprise WiFi capability, and supports point-to-point Bluetooth wireless connections with compatible devices.
The intuitive interface helps to simplify charting workflows for vital sign monitoring and patient data capture. Rad-97 is also compatible with existing nurse call systems.
Rad-97 will also be available with an optional camera that will provide a high-resolution video feed, as well as audio, allowing patients and clinicians to communicate remotely with compatible Patient SafetyNet software, making it well-suited for telehealth.
Rad-97 with capnography features an integrated ISA CO2 module with NomoLine sampling lines for sidestream capnography, with an adapter for intubated patients. It displays continuous end-tidal carbon dioxide (EtCO2) monitoring with numeric, trend, and waveform viewing options, as well as fractional concentration of inspired carbon dioxide (FiCO2) and respiration rate.
With Rad-97 NIBP, oscillometric blood pressure is available in three NIBP 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, compatible with both disposable and reusable cuffs, for adult, pediatric, and neonatal patients, allows clinicians to connect a blood pressure cuff inflation hose directly to Rad-97.
Masimo medical technology company, develops, manufactures, and markets noninvasive monitoring technologies worldwide. The company provides its products directly, as well as through distributors and original equipment manufacturers partners to hospitals, emergency medical service providers, physician offices, veterinarians, long term care facilities, and consumers.