FreeStyle Libre System - Sensor and Reader

Overview FreeStyle Libre System - Sensor and Reader

The Abbott FreeStyle Libre System, comprising a reader and sensor, measures interstitial fluid glucose levels in individuals aged 4 and above with diabetes, including pregnant women. This system is intended for self-managing diabetes, including insulin dosing, replacing routine finger-stick blood glucose testing. Enjoy discreet glucose monitoring with the FreeStyle Libre; eliminate the inconvenience of frequent finger pricks. The system tracks glucose and ketone levels. A one-second scan provides real-time glucose readings, the preceding eight hours of data, and a trend indicator (up, down, or stable). Ninety days of data are stored for comprehensive glucose level review. Continuous glucose monitoring reveals patterns and trends. The reader's test strip port facilitates blood glucose and ketone level measurements. To operate the reader, press "Home," select a language, set the date and time, define your target glucose range, and then scan the sensor (applied to the upper arm). Glucose levels and trends display on the screen. **Caution:** Ignore no symptoms suggestive of hypo- or hyperglycemia. Discrepancies between sensor readings and symptoms necessitate a finger-stick blood glucose test verification; consult your healthcare provider for inconsistent readings. Children (4-17) require adult (18+) supervision for system use and data interpretation. The system contains small, potentially ingestible parts. Avoid exposing reader ports to dust, dirt, blood, solutions, water, or other substances. Interstitial fluid glucose readings may differ from capillary blood glucose levels, particularly during rapid blood glucose fluctuations (e.g., post-meal, insulin administration, exercise). The system is not re-sterilizable; re-irradiation may compromise accuracy. The FreeStyle Libre Sensor, a leading sensor-based glucose monitoring system globally, eliminates the need for frequent finger pricks. This accurate, painless, and user-friendly system provides a trend indicator (up, down, or stable) and stores up to 90 days of data. The sensor is water-resistant (immersion up to 1 meter for 30 minutes) and protected against objects exceeding 12mm diameter (IP27). Ninety days of data are stored. The trend arrow shows glucose level direction. Apply the sensor to a flat, clean, dry area on the back of your upper arm, at least 2.5cm from an insulin injection site and avoiding moles, scars, or tattoos. Use the applicator to firmly attach the sensor. Readings appear after scanning with the reader. The included alcohol swab (reliject pre-injection swab, 70% isopropyl alcohol) is for skin cleansing before sensor application. For external use only; single-use and discard after use; never use to disinfect medical devices. **Caution:** Ignore no symptoms suggestive of hypo- or hyperglycemia. Discrepancies between sensor readings and symptoms necessitate a finger-stick blood glucose test verification; consult your healthcare provider for inconsistent readings. Store the sensor between 4°C and 25°C (refrigeration optional within this range); do not freeze. Do not use if expired. Standard ascorbic acid doses minimally affect readings; higher doses may elevate readings. The system contains small parts; keep away from children and eyes. Rinse with water if a swab contacts the eyes. Discontinue use if skin irritation occurs; do not reuse. Remove the sensor before MRI.

How to Use FreeStyle Libre System - Sensor and Reader:

Identify a flat, stable area on your upper arm's back, unaffected by daily movement (avoid bending or flexing). Exclude sites with moles, scars, or tattoos, and ensure at least 2.5cm (1 inch) separation from any insulin injection point. For optimal comfort and to minimize skin irritation, use a different application site than your previous one. Cleanse the area with soap and allow complete drying before sensor placement. Fully remove the sensor's protective lid. Detach and retain the applicator cap. Align the dark markers on the sensor and applicator. Press firmly and completely onto the sensor applicator against a solid surface. Position the applicator over the prepared skin and press down until the sensor adheres. Carefully remove the applicator. The sensor is now affixed; glucose readings will display after scanning with the reader.

Safety Instruction of FreeStyle Libre System - Sensor and Reader:

• The sensor package maintains sterility until compromised by opening or damage.
• Maintain the sensor kit within a temperature range of 4°C to 25°C. Refrigeration isn't mandatory, but permissible provided the refrigerator temperature remains within this same 4°C to 25°C range.
• Avoid freezing. Discard after the expiration date.
• Interference Considerations: Normal dosages of ascorbic acid (vitamin C) will not impede sensor function. However, exceeding the recommended daily intake of ascorbic acid may lead to falsely elevated sensor readings.
• The pre-injection swab is identified on its label as "reliject."
• One specimen collected via swab.
• Cleanse the skin before injecting.
• Contains 70% isopropyl alcohol.
• The FreeStyle Libre flash glucose monitoring device incorporates miniature components posing a potential ingestion hazard.
• Store out of reach of children.
• Avoid contact with eyes.
• Rinse with water if a swab touches the area.
• Stop using the product if a skin rash or irritation develops.
• Discard after the expiration date.
• Single use only.
• Magnetic Resonance Imaging (MRI) requires sensor removal beforehand.