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4.4 Calibration
Intelligo CGM can be optionally calibrated in order to maintain better accuracy
throughout the monitoring process. The time points for calibration are as follows:
Factory Calibration
Enter the factory calibration code when you start the CGM.
Optional Calibrate
Calibration shall be done optionally. The purpose of calibration is to keep the sensor
glucose readings more accurate.
Caution
Blood glucose must be entered manually during calibration. It must be
calibrated by accurate blood glucose values in order to obtain accurate sensor
glucose readings.
4.4.1 How to calibrate
Accurate blood glucose values need to be entered for each calibration. Blood
glucose for calibration must be between 2.2 and 22.2 mmol/L (40 mg/dL and 400
mg/dL) and shall be within 3 minutes after testing.
a)
If the blood glucose measured by the glucose meter is outside the range of 2.2-
22.2 mmol/L (40 mg/dL - 400 mg/dL), it cannot be used for calibration.
b)
Before calibration, make sure the transmitter and mobile App are connected.
c)
Use a blood glucose meter to routinely test blood glucose for calibration. Do
not replace the glucometer during the monitoring process. The accuracy of
different brands of blood glucose meters and test strips will vary.
d)
The accuracy of blood glucose readings used for calibration may affect the
accuracy of sensor glucose readings.
The steps to enter the blood glucose value during calibration are as follows:
a)
Wash hands and dry, make sure the blood glucose test strips are stored properly
during the shelf life, and make sure the blood glucose meter can work normally;
Caution
Intelligo Free CGM should not be calibrated during a rapid change of glucose
levels and the general rate of change is 0.11 mmol/L (1.98 mg/dL) per minute.
Do not calibrate when the single arrow or double arrow is displayed on the
App interface which indicates that your blood glucose level
increases/decreases by 0.11-0.17 mmol/L (1.98 mg/dL - 3.06 mg/dL) or over
0.17 mmol/L (3.06 mg/dL) per minute. Calibration can significantly affect the
accuracy of sensor glucose readings when glucose value rises or falls.
In order to obtain more accurate data, it is recommended to test and calibrate
the blood glucose before going to bed at night and during fasting the next
morning.