FreeStyle Libre 2 Plus Sensor — Continuous Glucose Monitor

The FreeStyle Libre 2 PLUS sensor is a sterile, single-use medical device supplied in an insertion kit. Each package contains:

• Sensor Applicator: Spring-loaded device for safe, accurate, and virtually painless subcutaneous insertion.
• Sensor Pack: Sterile sealed container holding the sensor unit with a flexible microfilament sensing element (approx. 5 mm long and 0.35 mm wide).
• Material Composition: Hypoallergenic medical-grade adhesive patch, biocompatible polymer housing, glucose oxidase enzyme coating, integrated micro-battery.
• Accessories: Product manual and alcohol prep pads (where included).

Working Principle (Medical Device Technology): The FreeStyle Libre 2 PLUS sensor utilizes an electrochemical enzymatic detection method. A thin, flexible filament inserted under the skin measures glucose levels in the interstitial fluid. The glucose oxidase enzyme on the electrode reacts with glucose, generating an electrical signal proportional to glucose concentration. The integrated microprocessor processes this measurement every minute and wirelessly transmits reading data via Bluetooth Low Energy (BLE) to the receiving device.

The FreeStyle Libre 2 PLUS sensor is indicated for use under the following medical conditions:

• 🔹 Type 1 and Type 2 Diabetes: Continuous tracking of interstitial glucose levels in individuals with diabetes mellitus to optimize glycemic management and guide insulin administration.
• 🔹 Glycemic Variability Assessment: Detection of asymptomatic nocturnal hypoglycemia, postprandial glucose spikes, and trend evaluation for lifestyle adjustments.
• 🔹 Insulin Delivery System Integration: Designed for compatibility with select automated insulin delivery (AID) systems and smart insulin pens (depending on market availability).

The FreeStyle Libre 2 PLUS sensor seamlessly connects with digital applications and health monitoring platforms to deliver real-time insights:

• 📱 FreeStyle LibreLink Mobile App: Compatible with iOS (iPhone) and Android smartphones. Users scan the sensor via NFC to view glucose readings and receive automatic Bluetooth alarms for high or low glucose levels.
• 📲 FreeStyle LibreLinkUp App: Allows family members and caregivers to remotely view real-time glucose readings and receive alarm notifications from the user's sensor.
• 📟 FreeStyle Libre 2 Reader: A standalone hardware device designed for users who prefer not to use a smartphone for scanning readings and managing alarms.
• 💻 LibreView Cloud Ecosystem: Enables automatic data uploading to generate comprehensive analytical reports (including Time-in-Range / TIR) and securely share progress with healthcare professionals.

Storage and handling conditions for the FreeStyle Libre 2 PLUS sensor:

• 🌡️ Temperature Range: Store the sensor kit between 2 °C and 30 °C. Do not freeze.
• 💧 Environment: Keep in a dry location with relative humidity between 10% and 90%. Protect from direct sunlight and heat sources.
• ⏳ Operational Lifespan: Sensor operates for up to 15 days post-activation. Expiration date is printed on the outer packaging.

The manufacturer does not provide comprehensive dedicated protection features, except for the batch number and series. Authenticity verification of FreeStyle Libre 2 PLUS relies on standard packaging identifiers:

• 🔍 Serial and Lot Information: The box exterior displays clearly printed product codes (REF 71901-01), Lot Number (LOT/Batch), Serial Number (SN), and Expiration Date.
• 📦 Packaging Integrity: Genuine Abbott boxes feature sealed factory security seals, intact sterile sensor packaging, CE 0086 markings, and official Abbott European representative details.