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The IVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of pH, pCO2, pO2, potassium and glucose. pH, pCO2, pO2: Measurement of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Potassium: Measurement of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by high or low potassium levels. Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathetic hypoglycaemia and of pancreatic islet cell carcinoma. IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO2, pO2, potassium and glucose.

The IVD-GE02 system is an in-vitro diagnostic device for the determination of specified analytes in blood using electrochemical principles. The IVD-GE02 is essentially a modular system consists of the following components .- - A dedicated combined PC and monitor with a touch screen . - · A disposable cartridge containing - o Sensor - o Electronic circuitry, including an ASIC (Application Specific Integrated Circuit), to process sensor signals and drive the fluid management system. - ◆ An instrument containing - o Fluid management components (tubing, pumps and valves) - o The cartridge (see above) - o An injection port for samples, calibration solutions and QC solutions - o Wiring to connect the cartridge to the fluid management components - Syringes with calibration solutions packed in sealed foil bags . - Containers with flush solutions ◆ ◆ - A waste container - A dedicated printer and associated cables - An ambient temperature and pressure sensor - Cables to connect the monitor to the instrument and a power supply unit - Packaging - Label Copy