Setting up Your Reader for the First Time:

Before using the System for the first time, the Reader must be set up.
1. Press the Home Button to turn on the Reader.

2. If prompted, use the touchscreen to select your preferred language for the Reader. Touch OK to continue. Note: Use the pad of your finger. Do NOT use your fingernail or any other object on the screen.

3. Set the Current Date using the arrows on the touchscreen. Touch next to continue.

4. Set the Current Time. Touch next to continue.

CAUTION: It is very important to set the time and date correctly. These values affect the Reader data and settings.

5. The Reader now displays important information about two key topics to help you use the system:

• How to understand the Glucose Trend Arrow included on the Glucose Reading screen.

• How to return to the Home Screen from any other screen.

Touch next to move to the next topic. At the end of the Reader setup, touch done to go to the Home Screen.

Note: Charge the Reader if the battery level is low. Only use the USB cable and power adapter included with the System.

Checking Your Glucose:

1. Turn the Reader on by pressing the Home Button or touch Check Glucose from the Home Screen.

2. Hold the Reader within 4 cm (1.5 inches) of your Sensor to scan it. Your Sensor wirelessly sends glucose readings to the Reader. If sounds are turned on, the Reader beeps when the Sensor has been successfully scanned. Note: If the Sensor is not successfully scanned within 15 seconds, the Reader displays a prompt to scan the Sensor again. Touch OK to return to the Home Screen and touch Check Glucose to scan your Sensor.

3. The Reader displays your current glucose reading along with your glucose graph and an arrow indicating the direction your glucose is going.

Caution & Warnings:

Contraindications:

• The Sensor must be removed prior to Magnetic Resonance Imaging (MRI).

WARNING:

• Do not ignore symptoms that may be due to low or high blood glucose. If you have symptoms that do not match the Sensor glucose reading or suspect that your reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter.
• If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
• The FreeStyle Libre 2 Flash Glucose Monitoring System (“System”) contains small parts that may be dangerous if swallowed.

Cautions and Important System Information:

What the System has not been evaluated for:

• The System has not been evaluated for use with other implanted medical devices such as pacemakers.
• The System has not been evaluated for use in persons on dialysis or people less than 4 years of age.

How to store the Sensor:

• Store the Sensor Kit between 4°C and 25°C. While you don’t need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 4°C and 25°C.

When is Sensor Glucose different from Blood Glucose:

• Glucose levels in the interstitial fluid can be different from blood glucose levels and may mean that Sensor glucose readings are different from blood glucose.
• You may notice this difference during times when your blood glucose is changing quickly, for example after eating, taking insulin, or exercising.

When to remove the Sensor:

• On rare occasions, you may get inaccurate Sensor glucose readings. If you believe your glucose readings are not correct or do not match how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove your Sensor and apply a new one.
• Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
• If you have a medical appointment that includes strong magnetic or electromagnetic radiation, for example an X-ray, MRI (Magnetic Resonance Imaging), or CT (Computed Tomography) scan, remove the Sensor you are wearing and apply a new one after the appointment. The effect of these types of procedures on the performance of the system has not been evaluated.

What to know about wearing the Sensor:

• Do not reuse Sensors.
• The Sensor and Sensor Applicator are designed for single use.
• Reuse may result in no glucose readings and infection.
• Not suitable for re-sterilization.
• Further exposure to irradiation may cause inaccurate results.

What to know about Glucose Alarms:

• For you to receive alarms, they must be turned ON and you should ensure that your Reader is within 6 metres (20 ft) of you at all times. The transmission range is 6 meters (20 ft) unobstructed. If you are out of range, you may not receive glucose alarms.
• To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on.

What to know about the Reader’s Built-in Meter:

• The Reader is designed to be used only with FreeStyle Optium blood glucose and blood ketone test strips and MediSense control solution.
• The Reader is for use by a single person. It must not be used on more than one person including other family members due to the risk of spreading infection. All parts of the Reader are considered biohazardous and can potentially transmit infectious diseases, even after cleaning the Reader.
• Avoid getting dust, dirt, blood, control solution, water or other substances in the Reader’s USB and test strip ports.

Interfering Substances:

• You can take standard doses of ascorbic acid (vitamin C) and still make treatment decisions with the Sensor.
• Taking higher than the maximum recommended daily allowance (RDA) of ascorbic acid may affect the Sensor readings and make them look higher than they really are.