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Specifies the intended use of the CGMS for monitoring glucose levels in individuals aged 14+.
Identifies suitable users for the CGMS, focusing on people with diabetes needing regular monitoring.
Lists patient conditions or situations where the CGMS should not be used, such as unconsciousness or severe impairment.
Details important safety measures and warnings for accurate and safe CGMS operation, including MRI use and small parts.
Details the various components included in the GlucoRx AiDEX™ Continuous Glucose Monitoring System.
Guides users through downloading, installing, registering, and logging into the CGMS app.
Explains initial app setup including Bluetooth, notifications, and alert preferences for personalized use.
Provides instructions on pairing, applying, removing, and managing the transmitter and sensor for continuous monitoring.
Details how to use app dashboards for glucose data, trends, history, events, and setting up alerts.
Covers changing app display language and managing account settings like terms of service and account deletion.
Instructions on cleaning and maintaining the transmitter and sensor system for optimal performance.
Explains how to perform control solution tests to verify meter and strip accuracy.
General| Type | Blood Glucose Meter |
|---|---|
| Display | LCD |
| Measurement Time | 5 seconds |
| Sample Size | 0.5 µL |
| Connectivity | Bluetooth |
| Model | AiDEX RC2101 |
| Blood Sample | Capillary whole blood |
| Measuring Range | 1.1 - 33.3 mmol/L |
| Operating Temperature | 10°C - 40°C |
| Operating Humidity | 10% - 90% RH |
| Memory | 500 results |
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