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Specifies the intended use and target patient population for the CGM system.
Outlines critical safety alerts, contraindications, and necessary precautions for system use.
Step-by-step instructions for correctly applying the glucose monitoring Sensor to the body.
Guides users through the process of activating and starting a new Sensor with the app.
Advises on using glucose readings and trend data for informed diabetes management decisions.
Lists common problems, their causes, and recommended solutions for the system.
Specifies the intended use and target patient population for the CGM system.
Outlines critical safety alerts, contraindications, and necessary precautions for system use.
Step-by-step instructions for correctly applying the glucose monitoring Sensor to the body.
Guides users through the process of activating and starting a new Sensor with the app.
Advises on using glucose readings and trend data for informed diabetes management decisions.
Lists common problems, their causes, and recommended solutions for the system.
General| Sensor Type | Continuous Glucose Monitoring (CGM) |
|---|---|
| Sensor Wear Duration | 14 days |
| Connectivity | Bluetooth |
| App Compatibility | FreeStyle Libre 3 app (iOS and Android) |
| Data Update Frequency | Every minute |
| Warm-up Time | 60 minutes |
| Accuracy | MARD (Mean Absolute Relative Difference) of 7.9% |
| Calibration | Factory calibrated |
| Battery Life | Sensor lasts for 14 days, no battery replacement required |
| Data Storage | 8 hours of data stored on the sensor |
| Alerts | High and low glucose alerts |
| Measurement Range | 40 to 400 mg/dL (2.2 to 22.2 mmol/L) |
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