Abbott FreeStyle LibrePro Operator's Manual

56, Table 6: Dierence Measures by BG Reference Levels* BG Reference Reference Glucose Level (mg/dL) Number of GM- Reference Pairs Median Absolute Relative Dierence (%) Mean Absolute Relative Dierence (%) Overall 11918 11.1 13.9 40-50** 152 13.5 19.1 51-80** 841 10.0 12.6 81-180 639…

64, Table 13: Number and Percent of Results within BG Reference* Day Number of GM- Reference Pairs Within ±15% / ±15 mg/dL Within ±20% / ±20 mg/dL Within ±30% / ±30 mg/dL Within ±40% / ±40 mg/dL Outside ±40% / ±40 mg/dL 1 1087 61.8 74.1 91.5 96.9 3.1 2-5 4005 64…

73, IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment – guidance Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz 10 V/m Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2.5 GHz P is the maximum output power rating of the transmitter in watts (W)…

48, Table 1: Number and Percent of Results within YSI Reference YSI Glucose Level (mg/dL) Number of GM- Reference Pairs Within ±15% / ±15 mg/dL Within ±20% / ±20 mg/dL Within ±30% / ±30 mg/dL Within ±40% / ±40 mg/dL Outside ±40% / ±40 mg/dL Overall 12323 71.8 83.8 95.2 98.5 …

45, Abbott FreeStyle LibrePro Labeling Symbols Consult instructions for use Use-by date Temperature limit Catalog number Manufacturer Serial number Batch code Do not use if package is damaged Type BF applied part Keep dry CODE Sensor code Non-ionizing radiation Do not re-use Caution MR unsafe Humidity limit…

72, IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment – guidance Conducted RF IEC 61000-4-6 6 Vrms 150 kHz to 80 MHz 6 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the System, including cables, than the recommended …