FreeStyle Libre 2 Quick Reference Guide

Important User Information

Before using the FreeStyle Libre 2 System, it is essential to review all product instructions and the Interactive Tutorial. Access the tutorial at www.FreeStyleLibre.com for quick access to important aspects and limitations of the system. The User's Manual provides comprehensive safety information and usage instructions.

Visit www.FreeStyleLibre.com for "Tips for Kids". Consult a healthcare professional for guidance on using Sensor glucose information to manage diabetes.

Note that during the first 12 hours of Sensor wear, a specific symbol will appear, and Sensor values cannot be used for treatment decisions. Confirm Sensor glucose readings with a blood glucose test during this period if the symbol is displayed.

Indications for Use

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device designed for diabetes management in individuals aged 4 and older. It features real-time alarms and is intended to replace blood glucose testing for treatment decisions, unless otherwise indicated. The system also tracks trends and patterns, aiding in the detection of hyperglycemia and hypoglycemia, thereby facilitating therapy adjustments. Interpretation of readings should consider glucose trends and sequential readings over time.

The system can autonomously communicate with digitally connected devices and can be used independently or in conjunction with these devices for therapy decisions.

Understanding Indications for Use

The FreeStyle Libre 2 System is suitable for individuals aged 4 and older. It is important to consider all on-screen information before making treatment decisions after scanning the Sensor. Avoid taking a correction dose within two hours of a meal dose to prevent "insulin stacking" and low glucose.

WARNING: The system can replace blood glucose testing, except in specific situations where a blood glucose test is necessary to ensure accurate readings. Perform a blood glucose test if readings are suspected to be incorrect or do not match how you feel, or if symptoms of low or high glucose are ignored. A blood glucose test is also required when the specific symbol appears during the first 12 hours of Sensor wear, or if the Sensor glucose reading lacks a Current Glucose number.

Contraindications

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 removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment, as the effects on the System's performance have not been evaluated and may cause incorrect readings.

WARNING: Do not ignore symptoms inconsistent with glucose readings; consult a healthcare professional. Use a blood glucose meter for treatment decisions when the specific symbol is displayed during the first 12 hours of Sensor wear, if readings do not match how you feel, or if no number is displayed. If using the FreeStyle Libre 2 app, ensure access to a separate blood glucose monitoring system.

Cautions and Limitations

Alarms: For alarms to be received, the device must be on and within 20 feet. Ensure sufficient device charge and that sounds/vibration are enabled on the Reader to prevent missed alarms. Alarms do not include glucose readings; a Sensor scan is required. Proper phone configuration is necessary for app functionality and alarms.

Before Using the System: Review all product information. Take precautions for blood-borne pathogen transmission. Keep devices and Sensor kits secure and under control to prevent unauthorized access or tampering.

Who Should Not Use the System: Do not use the System on individuals under 4 years of age, pregnant, on dialysis, or critically ill, as its performance in these groups is not known. Evaluate performance with implanted medical devices like pacemakers.

Wearing a Sensor: Clean the application site on the upper arm with soap and an alcohol wipe, allowing it to air dry. This ensures proper Sensor adhesion for the 14-day wear period. Always have a replacement Sensor available. Scan the Sensor for real-time glucose levels. If the Sensor malfunctions, use an alternate method for glucose measurement. Contact Customer Service at 1-855-632-8658 for Replace Sensor messages. Be aware of potential skin sensitivity to the adhesive.

Sensor Loosening or Falling Off: Intense exercise may cause Sensor loosening. If the Sensor tip comes out of the skin, readings may be inaccurate. Remove and replace the Sensor, contacting Customer Service if it becomes loose or falls off before the wear period ends.

Sensor Reuse: Sensors and applicators are for single use only. Reuse can lead to infection and inaccurate readings.

Sensor Breakage: If a Sensor breaks inside the body, contact a healthcare professional.

Storing the Sensor Kit: Store between 36°F and 82°F. Refrigerate if temperatures may exceed 82°F. Store in a cool, dry place, avoiding parked cars on hot days. Maintain 10-90% non-condensing humidity.

When Not to Use the System: Do not use if the Sensor Kit, Pack, or Applicator appears damaged or opened. Do not use if contents are past the expiration date. Do not use if the Reader appears damaged.

System Information

The FreeStyle Libre 2 System is for single-person use only. Data is not shared between the FreeStyle Libre 2 app and Readers.

Applying the Sensor: Ensure Sensor Packs and Applicators match by Sensor code. Wash hands before handling. Change application sites to prevent discomfort or irritation. Apply only to the back of the upper arm. Select a flat, scar-free site at least 1 inch from insulin injection sites.

Sensor Glucose vs. Blood Glucose

Differences in glucose readings between the System and fingerstick tests can occur due to physiological differences in interstitial fluid and capillary blood, especially during rapid blood glucose changes.

X-Rays

Remove the Sensor before X-ray exposure, as its effect on performance is unevaluated and may cause damage or incorrect readings.

Removing the Sensor

If the Sensor becomes loose or the tip comes out, readings may be unreliable. Remove and replace the Sensor, contacting Customer Service if issues persist. If glucose readings are inconsistent with how you feel, perform a fingerstick test to confirm. If problems continue, remove the current Sensor, apply a new one, and contact Customer Service.

Reader's Built-in Meter

The FreeStyle Libre 2 Reader's built-in meter is designed for use with FreeStyle Precision Neo test strips and MediSense Glucose and Ketone Control Solution only. Using other test strips may cause errors or prevent the meter from functioning. The meter does not have ketone testing functionality and is not intended for neonates, critically-ill patients, or for diabetes diagnosis/screening.

Charging the Reader

Ensure the charging location allows for easy unplugging of the power adapter. Be cautious of the Reader and power adapter surface temperatures during charging and normal use, especially for individuals with peripheral circulation disorders.

Interfering Substances

Ascorbic acid (vitamin C) supplements, especially those exceeding 500 mg daily, can falsely elevate Sensor glucose readings. Avoid supplements with high doses of ascorbic acid, such as Airborne® and Emergen-C®.