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General| Sensor Wear Time | Up to 14 days |
|---|---|
| Calibration | Factory calibrated |
| Sample Type | Interstitial fluid |
| Warm-up Time | 1 hour |
| Connectivity | USB |
| Operating Temperature | 10°C to 45°C (50°F to 113°F) |
| Type | Continuous Glucose Monitoring (CGM) |
| Water Resistance | IP27 |
| Data Transfer | USB |
| Battery Life | 7 days of typical use |
| Data Storage | Up to 90 days of glucose data |
System for detecting trends and tracking patterns in persons with diabetes.
Conditions where the System must be removed or is not recommended.
For health care professionals to review, analyze, and evaluate glucose readings for diabetes management.
Performs internal diagnostics to check display, sounds, and touchscreen functionality.
Details the clinical study conducted to evaluate the System's performance.
Characterizes agreement between System and venous blood glucose measurements.
Information on how long sensors can be worn and their average duration.
Details any device-related serious adverse events and common mild skin irritation.
Declaration regarding electromagnetic emissions and compliance for the System.
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