Reflectance Medical’s first and second products are the CareGuide™ 1100 and Mobile CareGuide™ 2100 Oximeters, which noninvasively, continuously and simultaneously measure 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:
Mobile CareGuide™ 2100 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 may be displayed on a standalone monitor, smart tablet2 or patient monitoring device.
Mobile CareGuide™ 2100 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™ 1100 Display: Reflectance Medical’s CareGuide™ sensor is available to be interfaced to a standalone display or interfacing the Mobile CareGuide™ 2100 sensor to a partner display unit.
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 (SmO2) informs the care provider on how the tissue is utilizing oxygen delivered by the arterial blood. Muscle pH (pHm) is a measure of tissue acidosis and pHm 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. CareGuide™ is the only FDA-cleared product to continuously monitor SmO2 and assess tissue perfusion on patients with pigmented skin. 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.
1 CareGuide™ and Mobile CareGuide™ have FDA 510(k) clearance for SmO2 measurements only for commercial sale to hospitals.
2 Smart tablets are not provided by Reflectance Medical and do not have FDA 510(k) clearance for commercial sale to hospitals.