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The Crit-Line Clip Monitor (CLiC) is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. CLiC measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

The intended use of the Crit-Line III (CLM III) Monitor is as a continuous real-time monitor for non-invasive hematocrit, oxygen saturation, and percent change in blood volume measurement. The CLM III is used primarily as a monitor for dialysis treatments. The CLM III uses the principle of light absorption and scattering through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT). The HCT values are then used to calculate the related Blood Volume (BV) percentage change relative to the starting BV based on the beginning HCT. The CLM III consists of a microprocessor-controlled main circuit board located within the display housing. The display housing contains the sensor clip driver measurementcalculation circuitry and display screen circuitry. The sensor clip with optical system (LED array and a photodetector array) is tethered to the main housing and circuit board by a multi-conductor cable. The cable connects to a single-use, sterile cuvette (K935958) installed in-line with the arterial line of the dialysis tubing set. Calculations performed on the main circuit board within the display housing yield the hematocrit, oxygen saturation and the related value of blood volume measurement results and are displayed on the LCD display screen. Modifications to the previously cleared Crit-Line III Monitor include: 3. Miniaturization/Re-packaging The CLiC Monitor incorporates all hardware/electronic components - miniaturized and contained within the sensor clip housing, for measuring indicated parameters (HCT O2 SAT). The primary modification of the device involves integrating a miniaturized microprocessor with the required electronic circuitry and software to drive the existing optical system (LED and photo-detector array) within the plastic sensor clip housing. The CLiC utilizes the same, previously cleared Crit-Line technology (K972470), sensor clip and optical system. The operating principles and fundamental measurement methods of the CLiC are the same as the predicate device. 4. Distributed Process Technology A standard USB cable replaces the tethering multi-conductor cable used in the CLM III Monitor. USB-compatible hardware and software are incorporated in the CLiC housing. The CLiC can be hosted on a medical grade computer system (Windows OS) that can interface with, power a USB peripheral and operate supporting drivers. CLiC interlocks with a singleuse, sterile cuvette (K935958) which is located in-line with the arterial line of the dialysis tubing set for indicated measurements. The lightwave measurements are performed autonomously by the CLiC. Blood parameters are then calculated and transmitted to the host computer display microprocessor in text format by means of the USB interface. The accompanying display software installed on the host computer system facilitates the display of measured parameters: hematocrit, oxygen saturation and blood volume changes on the display screen.