Stability of Sensor Calibration

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Section 18

Appendix B: Specifications

18 Appendix B: Specifications (con’t)

FreeStyle Navigator system typically requires a calibration at 10, 12, 24 and 72 hours after insertion of the sensor. This section presents information about the performance of the system by the 4 calibration periods. The table (Table 6d) breaks each calibration period into smaller slots and summarizes the difference from YSI in each slot. The data below demonstrates that there is little change in the system performance within each period.

Table 6d. Distribution of the difference from the YSI in the different calibration windows

Calibration Period		Percent Readings	Percent Readings	Percent Readings
		Within 20%* of	Within 30%* of	Within 40%* of
		the YSI	the YSI	the YSI
Cal 1	First Calibration Period	80	88	94
(typically occurs 10 hrs		80	88	94
(typically occurs 10 hrs
after sensor insertion)
	First Third of Second	83	94	98
	Calibration Period	83	94	98
Cal 2	Calibration Period
Cal 2
(typically occurs 12 hours	Second Third of Second	83	94	98
after sensor insertion)	Calibration Period	83	94	98
after sensor insertion)	Calibration Period
	Final Third of Second	84	95	98
	Calibration Period	84	95	98
	Calibration Period
	First Third of Third	84	94	98
	Calibration Period	84	94	98
Cal 3	Calibration Period
Cal 3
(typically occurs 24 hours	Second Third of Third	80	92	97
after sensor insertion)	Calibration Period	80	92	97
after sensor insertion)	Calibration Period
	Final Third of Third	80	91	95
	Calibration Period	80	91	95
	Calibration Period
	First Quarter of Final	86	93	96
	Calibration Period	86	93	96
	Calibration Period
Cal 4	Second Quarter of Final	84	92	96
Cal 4	Calibration Period	84	92	96
(typically occurs 72 hours	Calibration Period
(typically occurs 72 hours
after sensor insertion)	Third Quarter of Final	80	93	98
	Calibration Period	80	93	98
	Calibration Period
	Final Quarter of Final	82	93	97
	Calibration Period	82	93	97
	Calibration Period

*The absolute difference from the YSI reading is measured in mg/dL if the YSI reading is at or below 75 mg/dL.

Sample Glucose Traces

The following figures show examples of glucose traces from the In-Clinic study. These traces are representative examples of excellent, average and poor performance of the system. These traces show an overlay of the continuous glucose readings from the FreeStyle Navigator system and the blood glucose measurements made using the laboratory YSI reference. The blood glucose measurements that were used to calibrate the system are marked with ‘x’ in the traces. Glucose results from the FreeStyle Navigator system are shown using circles and the glucose results from the laboratory reference (YSI) are shown using triangles. Time (hours since sensor insertion) is on the horizontal axis, and glucose value in mg/dL is on the vertical axis.

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PRT03831-xxx specifications

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Arkon PRT03831-xxx manual Stability of Sensor Calibration, Sample Glucose Traces

Models: PRT03831-xxx

18 Appendix B: Specifications (con’t)