Description

The Sensor measures and stores glucose readings when worn on your 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, you prepare and apply the Sensor on the back of your upper arm. The Sensor has a small, flexible tip that is inserted just under the skin. The Sensor can be worn for up to 14 days.

The Sensor Glucose Readings screen appears after you use the Reader to scan your Sensor. Your Reading includes your Current Glucose, a Glucose Trend Arrow indicating which way your glucose is going, and a graph of your current and stored glucose readings.

Comments

*Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.

The Freestyle Libre 2 is the only CGM systems with real-time alarms that measures glucose levels every minute, with the highest level of accuracy standards over 14 days. With a 14-day wear time, the FreeStyle Libre 2 system is the longest-lasting, self-applied CGM sensor currently available, eliminating the need for fingersticks.

The FreeStyle Libre 2’s next-gen sensor, which is a third less bulky than other CGM sensors, is worn on the ba ck of the upper arm for up to 14 days and measures glucose every minute to help users and their healthcare providers make informed treatment decisions. With a one-second scan using the handheld reader, users can see their glucose reading, trend arrow and eight-hour history.

Directions

Applying Your Sensor

Step 1: Apply Sensors only on the back of your upper arm. If placed in other areas, the Sensor may not function properly and could giv e inaccurate readings. Avoid areas with scars, moles, stretch marks, or lumps.

Select an area of skin that generally stays flat during your normal daily activities (no bend ing or folding). Choose a site that is at least 1 inch (2.5 cm) away from an insulin injection site. To prevent discomfort or skin irritation, you should select a different site other than the one most recently used.

Step 2: Wash application site using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily resid ue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding.

Note: The area MUST be clean and dry following these instructions, or the Sensor may not stay onfor the full 14 day wear period.

Step 3: Open the Sensor Pack by peeling the lid off completely. Unscrew the cap from the Sensor Applica tor 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.< /p>

Step 4: Line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack. On a hard surface, press firmly down on the Sensor Applicator until it comes to a stop.

Step 5: Lift the Sensor Applicator out of the Sensor Pack.

Step 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.

Step 7:: Place the Sensor Applicator over the prepared site and push down firmly to apply the Sensor to your body.

Caution: Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury.

Step 8: Gently pull the Sensor Applicator away from your body. The Sensor should now be attached to your skin .

Note: Applying the Sensor may cause bruising or bleeding. If there is bleeding that does not stop, remove the Sensor and contact your health care professional.

Step 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 according to lo cal regulations.

Checking Your Glucose

Step 1: Turn the Reader on by pressing the Home Button or touchCheck Glucose from the Home Screen.

Step 2: Hold the Reader within 1.5 inches (4 cm) of your Sensor to scan it. Your Sensor wirelessly sends glucose readings to the Reader. If sounds are turned on, the Rea der 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.

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

Warnings and Precautions

Before you use the FreeStyle Libre 2 System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System. The User’s Manual includes all safety information and instructions for use. Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes. Failure to use the System according to the instructions for use may result in you missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If your glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.

Do not ignore symptoms that may be due to low or high blood glucose:

If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.

Use your blood glucose meter to make diabetes treatment decisions when you see the symbol during the first 12 hours of wearing a Sensor, if your Sens or glucose reading does not match how you feel, or if the reading does not include a number.

Choking hazard:

The System contains small parts that may be da ngerous if swallowed.

What to know before using the System:

Review all product information before use.

Take standard precautions for transmissio n of blood borne pathogens to avoid contamination.

Make sure that your Reader and Sensor kits are kept in a safe place, under your control. This is important to help prev ent anyone from accessing or tampering with the System.

Who should not use the System:

Do not use the System on people less than 4 years of age. Th e system is not cleared for use in people under 4 years of age.

Do not use the System if you are pregnant, on dialysis, or critically ill. The System is not cleare d for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System.

Performance of the S ystem when used with other implanted medical devices, such as pacemakers, has not been evaluated.

p>What should you know about wearing a Sensor:

Wash applicati on site on the back of your upper arm 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. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.

The Sensor can be worn for up to 14 days. Remember to always have your next Sensor available before your current one ends so you can keep getting your glucose readings.

You must scan the Sensor to get your real-time current glucose level as the Reader will not provide this information withou t a scan.

In the event that your Sensor stops working and you do not have another Sensor readily available, you must use an alternate method to measure your glucose level s and inform your treatment decisions.

The System is designed to detect certain conditions which may occur where the Sensor is not working as intended and shut it off, te lling you to replace your Sensor. This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may not be performing as intended.

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.

Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable low readings. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate applicationsite.

Contradictions:

Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

MRI/CT/Diathermy: The System must be remo ved prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage theSensor and may impact proper function of the device which could cause incorrect readings.

p> What should you know about wearing a Sensor:

Wash application site on the back of your upper arm 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. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.

The Sensor can be worn for up to 14 days. Remem ber to always have your next Sensor available before your current one ends so you can keep getting your glucose readings.

You must scan the Sensor to get your real-time c urrent glucose level as the Reader will not provide this information without a scan.

In the event that your Sensor stops working and you do not have another Sensor readil y available, you must use an alternate method to measure your glucose levels and inform your treatment decisions.

The System is designed to detect certain conditions whic h may occur where the Sensor is not working as intended and shut it off, telling you to replace your Sensor. This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may not be performing as intended.

Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you noti ce 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.

Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable low readings. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate applicationsite.Contradictions:

Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend syst ems.

MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathe rmy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.