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  • Recorders designed to record physical, chemical, or other characteristics of the conditions existing during in-vitro diagnostic (IVD) tests; they are mainly intended for recording the conditions inside the testing chambers of IVD equipment. These recorders are intended for data examination after the events have occurred. IVD test recorders usually consist of an electromechanical or electronic device that includes amplifiers, data processors, and memory (e.g., electronic, optical, chart) to store the information. Some recorders may include a display and/or integral printers; other recorders provide output to computers for analysis of the recorded information employing dedicated software. The recorders usually store information regarding the parameters of the conditions during laboratory procedures (e.g., temperature, humidity, pH) and/or about the performance of the equipment used during the tests. Some IVD test recorders warn of a hazardous condition when predetermined parameters of the test are outside a pre-established range.
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