Abbott FreeStyle Navigator User Manual Download

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Important Things to Remember About System Calibration

(con’t)

Important:

In clinical trials, we observed that the sensor signal sometimes temporarily decreases from

the true value. This typically happens at night during sleep, and recovers rapidly when the user moves

or is awakened. However, in order to avoid being affected by this phenomenon the system should not be

calibrated when the wearer is asleep.

You may not be able to calibrate the system if your glucose levels are changing rapidly. (e.g. during or

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after exercise, meals or insulin dosing). Under such conditions, the system may not ask you to calibrate;

instead, it will delay its request until conditions are acceptable.
You

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MUST

successfully complete 4 calibration tests. You will calibrate at approximately 10, 12, 24 and

72 hours after sensor insertion. If you do not complete calibration tests successfully in the allotted time

periods, your glucose readings will NOT be displayed and alarms will be inactive. The system may

ask you to perform additional calibrations between 2nd and 3rd calibrations depending on the sensor

signal. In such cases, you will be prompted with a message to do additional BG tests.
The receiver will beep (or vibrate) to prompt you to do a calibration. The receiver will display a blood

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drop icon

and the message “Do BG Test.” The system will prompt you with alarm messages when

your calibrations are unsuccessful.
You will not have continuous monitoring until you have successfully completed the first calibration (at

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least for the first ten hours after sensor insertion).
If you get a request for a calibration or expect additional calibration requests during a time when you

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do not want to be disturbed (e.g. sleep time), you can choose to wait to perform additional BG tests

at a later point in time. If you choose to wait and the allotted time window for calibration has expired,

please note that you will not get glucose results until you have performed a successful calibration.

You can turn off the System Alarms (or set to vibrate) if you do not want to be disturbed by frequent

requests for calibration. In order to silence the alarms that warn you when the allotted time window for

a calibration has expired, you must turn off the data loss alarms and all the four glucose alarms (Low

Glucose, High Glucose, Projected Low Glucose and Projected High Glucose).

Before You Get Started

Installation and operation of the FreeStyle Navigator® Continuous Glucose Monitoring System requires

using a specialized introducer needle to insert the glucose sensor into the skin. Infection, inflammation,

or bleeding at the glucose sensor insertion site are possible risks of inserting a sensor into your skin.

The glucose sensor should be removed if redness, pain, tenderness, or swelling develops at the sensor

insertion site.

Cautions:

Before adjusting treatment for diabetes management based on the continuous glucose results from your

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FreeStyle Navigator system, perform a Blood Glucose mode test to confirm the continuous result.
A portion of the membrane polymer will remain in the skin each time the sensor is removed. Although

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no health effects were observed or reported in clinical studies, the long term effects of the sensor

membrane fragments remaining in the skin have not been determined.
Performance of the FreeStyle Navigator system has not been evaluated in pregnant women.

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Performance of the system under conditions of fluctuating hydration levels such as during renal dialysis

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has not been evaluated.

Customer Care: 1-866-597-5520

Section 1

Getting Acquainted