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General| Sensor Wear Duration | 14 days |
|---|---|
| Operating Temperature | 10°C to 45°C (50°F to 113°F) |
| Calibration | Factory calibrated |
| Data Transfer | NFC |
| Water Resistance | Sensor is water-resistant in up to 1 meter (3 feet) of water for a maximum of 30 minutes |
| Requires Finger Prick | No |
| Reader/Receiver | Dedicated reader or compatible smartphone with LibreLink app |
| Accuracy | MARD (Mean Absolute Relative Difference) of 9.4% |
| Warm-up Time | 60 minutes |
| Data Storage | Reader: 90 days |
Purpose and target users of the glucose monitoring system.
Situations where the system should not be used.
Critical safety precautions and potential hazards.
Important notes for safe and effective system use.
Components included in the Reader Kit.
Components included in the Sensor Kit.
Software for viewing reports and changing reader settings.
Guidance on using the sensor for glucose monitoring.
Step-by-step guide to applying the sensor to the skin.
Procedure to activate and start using a new sensor.
How to scan the sensor and view glucose readings.
Guidance on using system data for initial treatment decisions.
Advanced strategies for interpreting data and making decisions.
Entries for each time sensor scanned or blood glucose test performed.
Graph of sensor glucose readings by day.
Information on last 7, 14, 30, or 90 days of data.
Procedures for cleaning and disinfecting the Reader.
Steps to resolve issues with the reader not turning on.
Solutions for sensor adhesion and skin irritation issues.
Troubleshooting sensor start-up and reading issues.
Explains error codes and how to resolve them.
Technical details about the sensor.
Technical details about the Reader.
Summary of the clinical study to evaluate system performance.
Data on CGM and venous blood measurement agreement.
Data on CGM and capillary blood glucose measurement agreement.
