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11. CALIBRATION: Calibration is required when using the meter for the first time or using a new lot of test strips A. Calibration Procedure: Remove the glucose calibrator from the new pack of test strips Peel the clear cover away from the corner with three bumps to open the calibrator package Hold the calibrator with the LOT number facing you. Insert the calibrator into the meter until it stops. This turns the meter on. LAB-POCT-006 Revision No. 01 Page 5 of 9 Controlled Document The LOT number of the pack of test strips you are using appears on the display This will calibrate the meter 12. QUALITY CONTROL: Control tests are performed. Each time a new vial of test strips is opened. If the meter has been dropped. Twice in a month (two levels of controls) When the test strips have been exposed to extreme heat, humidity or cold. When patient test results contradict clinical symptoms. After the meter has been calibrated. If a QC result falls within the defined control range, it is acceptable to proceed with patient testing. A. QC Testing Procedure: Open the foil test strip packet at the notch and tear down to remove the test strip Insert the test strip into the meter until it stops. This will turn on the meter Check the lot number of the test strip foil you are using appears. The blinks, press the qc vial button on the bottom left of the meter until the check [] sign appears on the upper side of the meter, meter is now ready for you to apply control solution to the test strip Sake the control solution bottle to mix the solution. Apply a drop of control solution to the whit area of the test strip. Hold the control solution to test strip until you see 3 short lines on the meter screen. This means you have applied enough blood. screen will show a 5 second countdown. View the result, the control test is complete when the result appears on the meter screen The result will stored in the memory as a control solution result Compare the control solution result with the range printed on the blood glucose test strip instructions of use. The result should fall within the range Document the blood glucose result with date, time, and operator’s initials on flow sheet or chart as required.