FreeStyle Libre 2

Getting to Know The System: The FreeStyle Libre 2 Flash Glucose Monitoring System ("System") has two main parts: a handheld Reader and a disposable Sensor that the patient wears on the body. Use the Reader to wirelessly scan the Sensor and display the glucose readings. The Reader only works with FreeStyle Libre 2 Plus Sensors and cannot be used with other Sensors. The FreeStyle Libre 2 Plus Sensor automatically communicates with the Reader and can give glucose alarms if the patient chooses to turn those on. The Reader also has a built-in meter for blood glucose and ketone testing.
IMPORTANT: Safety information about the System is in the User's Manual. Read all of the information in the User's Manual and the FreeStyle Optium blood glucose and ketone test strip instructions for use before using the System.
The System comes in a Reader Kit and a Sensor Kit. When opening the kits, check that the contents are undamaged and that all parts listed are complete. If any parts are missing or damaged, contact Customer Service.
Reader Kit: For use with: FreeStyle Libre 2 Plus Sensor.
The Reader gets glucose readings from the Sensor and can also issue glucose alarms if they are turned on. It can store approximately 90-days of glucose history and notes the patient enters about activities, such as taking insulin, eating food, or exercising. This information can help the patient understand how these activities affect the glucose.
The Reader Kit includes: FreeStyle Libre 2 Reader, USB Cable, Power Adapter, User's Manual, Quick Start Guide, Performance Data Insert.
FreeStyle Libre 2 Reader parts: Touchscreen.
USB Port: Used to charge the Reader and connect it to a computer.
Home Button: Turns the Reader on/off and takes the patient to the Home screen from any other screen.
Test Strip Port: Insert a test strip here to use the built-in meter.
The Reader Home Screen provides access to information about the glucose and the System. Press the Home Button to get to the Home Screen.
Home Screen: Current time set on the Reader.
Battery charge remaining.
Sound/Vibration setting.
Signal Status: Shows if Sensor is communicating with Reader.
Sensor Status: Information about the current Sensor.
Settings: Touch to access Alarms, Reminders, and other Reader settings.
Check Glucose: Touch to check the Sensor glucose.
Review History: Touch to review information about the past glucose readings.
Note: Sound/Vibration setting and Signal Status symbols only display if any of the alarms are turned on.
The Sensor Glucose Readings screen appears after the patient uses the Reader to scan the Sensor. The Reading includes the Current Glucose, a Glucose Trend Arrow indicating which way the glucose is going, and a graph of the current and stored glucose readings.
Sensor Glucose Readings: Message: Touch for more information.
Add Notes: Touch to add notes to the glucose reading.
Current Glucose: Glucose from the latest scan.
Glucose Trend Arrow: Direction the glucose is going.
Rapid-Acting Insulin Note.
Food Note.
Glucose Graph: Graph of the current and stored glucose readings.
Sensor Kit: For use with: FreeStyle Libre 2 Reader.
The Sensor measures and stores glucose readings when worn on the body. It initially comes in two parts: one part is in the Sensor Pack and the other part is in the Sensor Applicator. By following the instructions, the patient prepares and applies the Sensor on the back of the upper arm. The Sensor has a small, flexible tip that is inserted just under the skin. The Sensor can be worn for up to 15 days.
The Sensor Kit includes: Sensor Pack, Sensor Applicator, Product insert.
Sensor Kit Parts: Sensor Pack: Used with the Sensor Applicator to prepare the Sensor for use.
Sensor Applicator: Applies the Sensor to the body.
Sensor: Measures the glucose while on the body (only visible after applied).

The FreeStyle Libre 2 Flash Glucose Monitoring System Reader ("Reader") when used with a FreeStyle Libre 2 Plus Flash Glucose Monitoring System Sensor ("Sensor") is indicated for measuring interstitial fluid glucose levels in people (age 2 and older) with or without diabetes mellitus, including pregnant women. The Reader and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin.
The indication for children (age 2-12) is limited to those who are supervised by a caregiver who is at least 18 years of age. The caregiver is responsible for managing or assisting the child to manage the Reader and Sensor and also for interpreting or assisting the child to interpret Sensor glucose readings.

Please read the insert and User Manual for complete instructions on using the system.
Setting up The 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 the preferred language for the Reader. Touch OK to continue.
Note: Use the pad of the finger. Do NOT use the 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 the patient 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.
Using The Sensor: CAUTION: The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using the Sensor Pack and Sensor Applicator. Sensor Packs and Sensor Applicators with the same Sensor code should be used together or the Sensor glucose readings may be incorrect.
Intense exercise may cause the Sensor to loosen due to sweat or movement of the Sensor. If the Sensor comes loose, the patient may get no readings or unreliable readings, which may not match how the patient feels. Follow the instructions to select an appropriate application site.
Applying The Sensor: 1. Apply Sensors only on the back of the upper arm. Avoid areas with scars, moles, stretch marks, or lumps.
Select an area of skin that generally stays flat during the normal daily activities (no bending or folding). Choose a site that is at least 2.5 cm (1 inch) away from an insulin injection site. To prevent discomfort or skin irritation, the patient should select a different site other than the one most recently used.
2. Wash application site using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding.
Note: The area MUST be clean and dry, or the Sensor may not stick to the site.
3. Open the Sensor Pack by peeling the lid off completely. Unscrew the cap from the Sensor Applicator and set the cap aside.
CAUTION: Do NOT use if the Sensor Pack or the Sensor Applicator seem to be damaged or already opened. Do NOT use if past expiration date.
4. Line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack. On a hard surface, press down firmly on the Sensor Applicator until it comes to a stop.
5. Lift the Sensor Applicator out of the Sensor Pack.
6. The Sensor Applicator is prepared and ready to apply the Sensor.
CAUTION: The Sensor Applicator now contains a needle. Do NOT touch inside the Sensor Applicator or put it back into the Sensor Pack.
7. Place the Sensor Applicator over the prepared site and push down firmly to apply the Sensor to the body.
CAUTION: Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury.
8. Gently pull the Sensor Applicator away from the body. The Sensor should now be attached to the skin.
Note: Applying the Sensor may cause bruising or bleeding. If there is bleeding that does not stop, remove the Sensor, and apply a new one at a different site.
9. Make sure the Sensor is secure after application.
Put the cap back on the Sensor Applicator. Discard the used Sensor Pack and Sensor Applicator. See Disposal under Cautions for Usage.
Start The Sensor: 1. Press the Home Button to turn on the Reader.
2. Touch Start New Sensor.
3. Hold the Reader within 1 cm of the Sensor to scan it. This starts the Sensor. If sounds are turned on, the Reader beeps when the Sensor has been successfully activated. The Sensor can be used to check the glucose after 60 minutes.
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 Start New Sensor to scan the Sensor.
Checking The Glucose: 1. Turn the Reader on by pressing the Home Button or touch Check Glucose from the Home Screen.
2. Hold the Reader within 1 cm of the Sensor to scan it. The 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 the Sensor.
3. The Reader displays the current glucose reading along with the glucose graph and an arrow indicating the direction the glucose is going.
Notes: The graph displays glucose readings up to 350 mg/dL. Glucose readings above 350 mg/dL are displayed at 350 mg/dL.
The 'Time changed on Reader' symbol may appear, indicating the Reader time was changed. Gaps in the graph may result or glucose readings may be hidden.
All available glucose data is used to make the graph so the patient can expect to see some differences between the graph line and previous current glucose readings.
The Glucose Trend Arrow gives the patient an indication of the direction the glucose is going. (See table.)

Click on icon to see table/diagram/image

Reviewing The History: Reviewing and understanding the glucose history can be an important tool for improving the glucose control. The Reader stores about 90 days of information and has several ways to review the past glucose readings, notes, and other information.
1. Press the Home Button to turn on the Reader. Press the Home Button again to go to the Home Screen.
2. Touch the Review History icon.
3. Use the arrows to view the available options.
IMPORTANT: Work with a health care professional to understand the glucose history.
Removing The Sensor: 1. Pull up the edge of the adhesive that keeps the Sensor attached to the skin. Slowly peel away from the skin in one motion.
Note: Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol.
2. Discard the used Sensor. See Disposal under Cautions for Usage.
When the patient is ready to apply a new Sensor, follow the instructions in the Applying The Sensor and Starting The Sensor as previously mentioned. If the last Sensor was removed before 15 days of use, the patient will be prompted to confirm that the patient would like to start a new Sensor when the patient first scans it.
Replacing The Sensor: The Sensor automatically stops working after 15 days of wear and must be replaced. The patient should also replace the Sensor if the patient notices any irritation or discomfort at the application site or if the Reader reports a problem with the Sensor currently in use. Taking action early can keep small problems from turning into larger ones.
CAUTION: If the glucose readings from the Sensor do NOT seem to match with how the patient feels, check to make sure that the Sensor has not come loose. If the Sensor tip has come out of the skin, or the Sensor is coming loose, remove the Sensor and apply a new one.

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

Do not ignore symptoms that may be due to low or high blood glucose. If the patient has symptoms that do not match the Sensor glucose reading or suspect that the reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter. If the patient is experiencing symptoms that are not consistent with the glucose readings, consult a health care professional.
The FreeStyle Libre 2 Flash Glucose Monitoring System ("System") contains small parts that may be dangerous if swallowed.
Note: For information on what the Sensor glucose reading means, refer to the User's Manual of the device that the patient is using with the Sensor.

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 2 years of age.
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. The patient may notice this difference during times when the blood glucose is changing quickly, for example after eating, taking insulin, or exercising.
When to remove the Sensor: On rare occasions, the patient may get inaccurate Sensor glucose readings. If the patient believes the glucose readings are not correct or do not match how the patient feels, perform a blood glucose test on the finger to confirm the glucose. If the problem continues, remove the Sensor and apply a new one.
Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If the patient notices significant skin irritation around or under the Sensor, remove the Sensor and stop using the System. Contact a health care professional before continuing to use the System.
If the patient has 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 the patient is 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 the patient to receive alarms, they must be turned ON and the patient should ensure that the Reader is within 6 meters (20 ft) of the patient at all times. The transmission range is 6 meters (20 ft) unobstructed. If the patient is out of range, patient 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.

Reader: Cleaning: Clean the Reader as often as desired using a cloth dampened with a mixture of 1 part household bleach to 9 parts water. Gently wipe the exterior of the Reader and allow to air dry. Cracking, flaking, or damage of the Reader housing are signs of deterioration. If the patient notices any of these signs, stop using the Reader and contact Customer Service.
CAUTION: Do NOT place the Reader in water or other liquids. Avoid getting dust, dirt, blood, control solution, water, or any other substance in the test strip or USB ports.
Maintenance: The System has no serviceable parts.
Disposal: This product should be disposed of in accordance with all applicable local regulations related to the disposal of electronic equipment, batteries, sharps, and materials potentially exposed to body fluids.
Contact Customer Service for further information on the appropriate disposal of system components.
Sensor: User Safety, Storage, and Handling: The Sensor Pack is sterile unless opened or damaged.
The Sensor has been tested to withstand immersion into one meter (3 ft) of water for up to 30 minutes. It is also protected against insertion of objects >12 mm diameter. (IP27).
Disposal: Refer to User's Manual for disposal instructions.

Store the Sensor Kit between 4°C and 25°C. While the patient doesn't need to keep the Sensor Kit in a refrigerator, patient can as long as the refrigerator is between 4°C and 25°C.
Do not freeze. Do not use if expiration date has passed.

Sensor: STEP 1: Select site.
STEP 2: Wash site using a plain soap, dry, and then clean with alcohol wipe. Allow site to air dry.
STEP 3: Peel lid completely off Sensor Pack.
Unscrew cap from Sensor Applicator.
CAUTION: Sensor codes must match on Sensor Pack and Sensor Applicator. Do NOT use if damaged or already opened.
STEP 4: Line up dark marks on Sensor Applicator and Sensor Pack. On a hard surface, press down firmly on Sensor Applicator until it comes to a stop.
STEP 5: Lift Sensor Applicator out of Sensor Pack.
STEP 6: Sensor Applicator is ready to apply Sensor.
CAUTION: Sensor Applicator now contains a needle. Do not touch inside Sensor Applicator or put it back into Sensor Pack.
STEP 7: Place Sensor Applicator over site. Push down firmly to apply Sensor.
CAUTION: Do NOT push down on Sensor Applicator until placed over prepared site to prevent unintended results or injury.
STEP 8: Gently pull Sensor Applicator away.
STEP 9: Make sure Sensor is secure. Discard the used Sensor Pack and Sensor Applicator.
See Disposal section in the User's Manual or under Cautions for Usage.

Personal Care

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