Reflectance Medical CareGuide Oximeter for Muscle Oxygen Saturation Cleared in U.S.

Reflectance Medical CareGuide Oximeter for Muscle Oxygen Saturation Cleared in U.S.

Reflectance Medical’s first product will be the CareGuide™ Oximeter, which noninvasively, continuously and simultaneously measures muscle oxygen saturation (SmO2). Software upgrades will allow the sensor to simultaneously determine pH (acidosis) and hematocrit within muscle tissue. The combination of these three parameters will provide a very early indication of impaired tissue perfusion, the imbalance between available oxygen and tissue demand, as well as immediate, continuous feedback on the efficacy of therapy aimed at improving tissue perfusion. The system is based on a unique implementation of near infrared spectroscopy. The system1 consists of the following:

CareGuide™ Sensor: The sensor contains unique and innovative optical elements to collect muscle spectra from the patient. The spectra are processed by proprietary algorithms to calculate muscle oxygen, pH and hematocrit. Values are updated regularly and displayed on a monitor screen.

CareGuide™ Disposable: The single-use disposable provides a clean patient contact surface. The disposable is packaged with a proprietary material to ensure that the reusable sensor optics remain within spec. The disposable may be used for up to 72 hours.

CareGuide™ Display: Reflectance Medical’s CareGuide™ sensor is available to be interfaced to partner display units.

The sensor is placed on the skin, over the patient’s arm or leg muscle. The user presses the start button to begin data collection. The system automatically optimizes itself to collect the best possible spectrum for each individual patient irrespective of skin color or fat thickness. Data collection is continuously updated. Trend screens display values over time, with one tab for each parameter. Current values for each parameter are always displayed.

CareGuide™ Technology -

Near Infrared Reflectance Spectroscopy (NIRS)

Pulse oximetry measures the percentage of arterial blood which carries oxygen by passing two wavelengths of NIR light through the finger. The pulse oximeter determines the fraction of arterial hemoglobin which contains oxygen in blood leaving the heart (SpO2). Reflectance Medical’s technology creates and analyzes a complete NIR spectrum over the entire wavelength range 740 – 880 nm. The key to Reflectance Medical’s technology are its novel algorithms to calculate important medical parameters from these absorbance spectra collected from muscle tissue. Reflectance Medical’s data processing algorithms first correct patient spectra to strip out patient differences related to skin color, fat thickness, and muscle structure. Each corrected spectrum is then processed by the 3 calibration equations contained in the monitor to calculate muscle oxygen saturation, muscle pH and blood hematocrit. Muscle oxygenation informs the care provider on how the tissue is utilizing oxygen delivered by the arterial blood. Muscle pH is a measure of tissue acidosis and low muscle pH provides a warning that therapies to improve tissue perfusion may be insufficient.

Useful Features & Benefits

Compared to traditional, intermittent methods for measuring oxygen and pH (blood sampling), the CareGuide™ monitor obtains and displays information continuously and noninvasively for 3 separate parameters that are extremely valuable in the management of critically ill patients. Values are displayed as trends, allowing quick evaluation of patient condition and prognosis. CareGuide™ is the only product that displays 3 different and complimentary measures of tissue perfusion that are key in managing challenging, critically ill patients. The parameters monitored by CareGuide™ are complimentary to arterial oxygen saturation reported by the pulse oximeter. Both arterial oxygen saturation and the CareGuide™ parameters are important in providing complete care for critically ill patients.

Reflectance Medical of Westborough, MA received FDA 510(k) clearance to market the company’s CareGuide Oximeter, reflectance medical careguide sensor Reflectance Medical CareGuide Oximeter for Muscle Oxygen Saturation Cleared in U.S.a hemoglobin oxygen saturation monitor of skeletal muscle tissue (SmO2).

According to the company, this is the first device approved by the FDA to continuously monitor SmO2, as well as the first to assess tissue perfusion in patients with pigmented skin.

The device uses near-infrared light to penetrate muscle tissue and measure the muscle oxygen saturation non-invasively, an indicator of whether a muscle is receiving sufficient oxygen for its labors.

More about the system from the product page:

Software upgrades will allow the sensor to simultaneously determine pH (acidosis) and hematocrit within muscle tissue. The combination of these three parameters will provide a very early indication of impaired tissue perfusion, the imbalance between available oxygen and tissue demand, as well as immediate, continuous feedback on the efficacy of therapy aimed at improving tissue perfusion. The system is based on a unique implementation of near infrared spectroscopy. The system consists of the following:

CareGuide™ Sensor: The sensor contains unique and innovative optical elements to collect muscle spectra from the patient. The spectra are processed by proprietary algorithms to calculate muscle oxygen, pH and hematocrit. Values are updated regularly and displayed on a monitor screen.

CareGuide™ Disposable: The single-use disposable provides a clean patient contact surface. The disposable is packaged with a proprietary material to ensure that the reusable sensor optics remain within spec. The disposable may be used for up to 72 hours.

CareGuide™ Display: Reflectance Medical’s CareGuide™ sensor is available to be interfaced to partner display units.

Source : http://www.reflectancemedical.com/ourtechnology.php

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