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The Vital Sync™ System is intended for display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.

The Vital Sync™ System is a bedside data management system that receives historic digital data produced by primary external devices through device specific cables, accepts manual data entry, and displays and stores this information for review and archiving by healthcare professionals.

The noninvasive INVOS 5100C is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual.

The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for oxyhemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. This method of "spatial resolution" also allows estimation of scattering to improve measurement accuracy.

The noninvasive INVOS 5100C is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual. The clinical value of trend data has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for oxyhemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. This method of “spatial resolution” also allows estimation of scattering to improve measurement accuracy.

The noninvasive INVOS 5100C is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the INVOS System has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. This is similar to the noninvasive technology widely used in pulse oximeters to monitor oxygen saturated hemoglobin percentage in arterial blood. An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for hemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. The INVOS 5100C tissue oximeter is a multi-channel monitor with continuous recording and display of readings of regional tissue hemoglobin oxygen saturation from 4 separate sensors simultaneously. The monitor is connected to 2 preamplifiers, each of which in turn supports 2 sensors. It has USB connectivity for dynamic data capture, storage and transfer as well as a digital output port.

The noninvasive INVOS 5100B is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain of an individual. It also is intended for use as an adjunct trend monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in infants, children, or adults at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the INVOS System has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

The principles of operation of the cerebral oximeter system are based on the assumption that hemoglobin exists in two principal forms in the blood: oxygenated hemoglobin (HbO2) and reduced hemoglobin (Hb). Functional oxygen saturation (SO2) is defined as the ratio of oxyhemoglobin (HbO2) to total hemoglobin (HbO2 + Hb) and is commonly presented as a percentage. SO2 = (HbO2 / (HbO2 + Hb)) * 100% Since oxygenated and reduced hemoglobin are different colors and absorb light as a known function of wavelength, selected wavelengths of light can be used to assess the relative percentage of these two constituents. This fundamental approach of assessing the color of blood using various wavelengths of light to measure hemoglobin oxygen saturation trends is used in all currently marketed oximetry systems. For cerebral monitoring, a disposable sensor of medical grade materials is applied to the patient's forehead (Figure 1). The sensor incorporates a light source and two return signal detectors at different predetermined distances from the light source. The signal detector nearest the light source (3 cm) is considered the "shallow detector" and the further detector from the light source (4 cm) the "deep detector." While the light reaching the deep detector has sampled about the same amount of skin, scalp, and skull as the light reaching the shallow detector, it has sampled more brain tissue. This difference is used to help separate out the brain signal and suppress anatomical differences in patients. The additional information unique to the deep signal return is predominately from brain tissue blood which is composed mostly of venous blood. The information contained in the shallow and deep signal returns is processed by an algorithm to measure changes in hemoglobin oxygen saturation in a small region of tissue beneath the sensor, predominately in the brain. For non-cerebral monitoring, a somatic sensor which is similar to the cerebral sensor is placed on skeletal muscle in an area free of large fat deposits, bony protuberances and hair. Since the tissue being interrogated is relatively homogeneous, the resultant rSQ2 index is an average of the hemoglobin oxygen saturation of blood in the region of tissue below the sensor. The SomaSensor is connected to a preamplifier (1.4 x 7.65 x 3.75 in.) which is placed close to the patient and amplifies the rSO2 signal. The signal is then carried to a display unit (8.4 x 9.6 x 8.5 in.) where the values and trends are displayed on the screen. The display unit controls all functions of the system with selections made by keys with onscreen labels. The system will operate for up to 120 minutes on battery, enabling patient transport without loss of data.

The CorRestore patch is intended for cardiac reconstruction and repair.

The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed boyine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered. A silicone balloon (CRB) is optional to allow the surgeon to check left ventricular diastolic volume prior to closure.

The CorRestore patch is intended for use as an intracardiac patch for cardiac reconstruction and repair.

The CorRestore Patch is an oval tissue patch made from glutaraldehyde fixed bovine pericardium. It is intended to be used as an intracardiac patch for cardiac reconstruction and repair. It is identical to other marketed bovine pericardium patches except that it incorporates an integral suture bolster (also made of fixed bovine pericardium) in the shape of an oval ring and is packaged with accessories needed for cardiac repair and reconstruction. The CorRestore Patch comes as a kit including a patch and suture strip (1.4 x 16 cm), both manufactured from processed bovine pericardium. Optionally included is a set of various sutures needed for implantation. To assist the surgeon in determining the appropriate size, a separate disposable sizer kit is offered.

The noninvasive INVOS 3100A Cerebral Oximeter should be used in adults as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood in the brain of an individual. Because INVOS values are relative within an individual, the INVOS should not be used as the sole basis for decisions as to diagnosis or therapy. The value of data from the INVOS has not been demonstrated in disease states.

The principles of operation of the cerebral oximeter system are based on the assumption that hemoglobin exists in two principal forms in the blood: oxygenated hemoglobin (HbO>) and reduced hemoglobin (Hb). Functional oxygen saturation (SO2) is defined as the ratio of oxyhemoglobin (HbO2) to total hemoglobin (HbO2 + Hb) and is commonly presented as a percentage. SO2 = (HbO2 / (HbO2 + Hb)) * 100% Since oxygenated and reduced hemoglobin are different colors and absorb light as a known function of wavelength, selected wavelengths of light can be used to assess the relative percentage of these two constituents. This fundamental approach of assessing the color of blood using various wavelengths of light to measure hemoglobin oxygen saturation trends is used in all currently marketed oximetry systems. A disposable sensor of medical grade materials is applied to the patient's forehead (Figure 1). The sensor incorporates a light source and two return signal detectors at different pre-determined distances from the light source. The signal detector nearest the light source (3 cm) is considered the "shallow detector" and the further detector from the light source (4 cm) the "deep detector." While the light reaching the deep detector has sampled about the same amount of skin, scalp, and skull as the light reaching the shallow detector, it has sampled more brain tissue. This difference is used to help separate out the brain signal and suppress anatomical differences in patients. The additional information unique to the deep signal return is predominately from brain tissue blood which is composed mostly of venous blood. The information contained in the shallow and deep signal returns is processed by an algorithm to measure changes in hemoglobin oxygen saturation in a small region of tissue beneath the sensor, predominately in the brain. The SomaSensor is connected to a preamplifier (1.75 x 7.4 x 5.4 in.) which is placed close to the patient and amplifies the rSO2 signal. The signal is then carried to a display unit (6.5 x 12.5 x 13.5 in.) where the values and trends are displayed on the screen. The display unit controls all functions of the system with selections made by keys with on-screen labels. The system will operate for up to 20 minutes on battery, enabling patient transport without loss of data.