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Intended Use: The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and oximetry in whole blood. The ABL80 FLEX CO-OX analyzer system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. Indications for use: These tests are only performed under a physicians order: pH, pO2.and pCO2 . pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acidbase disturbances. Potassium (cK+): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Sodium (cNa+): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. Calcium (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Chloride (cCl-): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis. Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin plus reduced hemoglobin. FO2Hb: oxyhemoglobin as a fraction of total hemoglobin FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. FMetHb: methemoglobin as a fraction of total hemoglobin. FHHb: reduced hemoglobin as a fraction of total hemoglobin.

The ABL80 FLEX CO-OX with AQURE connectivity is a portable, automated system intended for in vitro testing of samples of whole blood. The device is manufactured by SenDx Medical Inc, Carlsbad, CA, USA. ABL80 FLEX CO-OX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes and solution packs are available. The various sensor cassette models include models for the different parameter configurations. Four measuring principles are employed in ABL80 FLEX analyzers. - Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related ● to the concentration of the sample (the Nernst equation). - . Amperometry: The magnitude of an electrical current flowing through a sensor chain is proportional to the concentration of the substance being oxidized or reduced at an electrode in the chain. - . Conductometry: Specific impedance of a sample as measured by two conducting electrodes held at a constant voltage is directly proportional to the conductive properties of that sample. - . Spectrophotometry: Light passes through a cuvette containing a hemolyzed blood sample. The specific wavelengths absorbed and their intensity generates an absorption spectrum used to calculate oximetry parameters. This measuring principle is used in the ABL80 FLEX CO-OX analyzer only. The modification consists of integration with the Data Management software called AQURE system. The software enables the initiation of device actions on connected ABL80 FLEX analyzers.