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The Multi-Parameter Mobile CarcGuide™ 3100 Oximeter with Tablet is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHm data on an Android Tablet display, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet provides display of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet has not been demonstrated in disease states.

The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses Near Infrared (NIR) Spectroscopy to calculate muscle oxygen saturation (SmO2) and muscle pH (pHm) and displays those parameters as real-time values and historical trends on a tablet device. The sensor contains algorithms that calculate SmO2 and pHm from collected spectra and communicates the current SmO2 and pHm results to an Android tablet with display software through a proprietary protocol. The Android tablet (qualified models Acer A500 and Asus Google Nexus 7) contains 3d party software that locks down the tablet so that only the CareGuide software may run and no other application or operating software can be modified. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with a USB connection to the Android tablet. The sensor is identical to the predicate (K130079) Multi-parameter Mobile CareGuide 3100 Oximeter. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses the same disposable element as the Multi-Parameter Mobile CareGuide 3100 Oximeter, a disposable sleeve that isolates the sensor optical elements from the patient's skin.

The Multi-Parameter Mobile CareGuide™ 3100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHm data on a third party device, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB or CAN connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter has not been demonstrated in disease states.

The Multi-Parameter Mobile CareGuide 3100 Oximeter sensor uses Near Infrared (NIR) Spectroscopy to calculate muscle oxygen saturation (SmO2) and muscle pH (pHm). The Multi-Parameter Mobile CareGuide 3100 Oximeter is a multiple parameter oximeter. The sensor contains algorithms that calculate SmO2 and pHm from collected spectra and communicates the current SmO2 and pHm results to a 30 party display or patient monitor through a proprietary protocol. The Multi-Parameter Mobile CareGuide 3100 Oximeter reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with either a USB connection or CAN connection to the 310 party display/patient monitor. The sensor is identical to the predicate (K122645) Mobile CareGuide 2100 Oximeter hardware containing six major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject; (3) a microprocessor to control the optical components; (4) a microprocessor to perform the spectral analysis and generate the calculated SmO2 and pHm; (5) one of two different communications components to transmit in CAN or USB format; (6) a battery to power all components. The Multi-Parameter Mobile CareGuide 3100 Oximeter uses the same disposable element as the Mobile CareGuide 2100 Oximeter, a disposable sleeve that isolates the sensor optical elements from the patient's skin.

The Mobile CareGuide™ 2100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The Mobile CareGuide 2100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Mobile CareGuide 2100 Oximeter provides output of the most recent value of SmO2, as well as operational device information. The Mobile CareGuide 2100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Mobile CareGuide 2100 Oximeter has not been demonstrated in disease states.

The Mobile CareGuide 2100 Oximeter sensor uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2). The Mobile CareGuide 2100 Oximeter is a self-contained, medical oximeter. The sensor contains algorithms that calculate SmO2 from collected spectra and communicates the current SmO2 result to a 310 party display or patient monitor through a proprietary protocol. The Mobile CareGuide 2100 Oximeter reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with either a USB connection or CAN connection to the 30 party display/patient monitor. The sensor contains 6 major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject; (3) a microprocessor to control the optical components; (4) a microprocessor to perform the spectral analysis and generate the calculated SmO2; (5) one of two different communications components to transmit in CAN or USB format; (6) a battery to power all components. The Mobile CareGuide 2100 Oximeter Ray is a disposable sleeve which isolates the sensor optical elements from the patient's skin.

The CareGuide™ Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The CareGuide displays the most recent value of SmO2, as well as a graphical trend of previous SmO2 measurements. The CareGuide System should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the CareGuide™ Oximeter has not been demonstrated in disease states.

The CareGuide sensor uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2). The CareGuide Display is an all-in-one touch screen off-the-shelf computer. The display contains the user interface software, the algorithms that calculate SmQ2 from collected spectra, displays the current SmO2 result and trends previous results. The CareGuide reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with a USB connection to the CareGuide display. The sensor contains 3 major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject and (3) a microprocessor to control the optical components. The CareGuide Ray is a disposable sleeve which isolates the sensor optical elements from the patient's skin.