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Defines the intended use and patient population for the CGMS.
Specifies patient suitability and requirements for blood glucose testing.
Lists conditions or patient types for whom the device is not recommended.
Outlines general warnings and safety measures for device usage.
Specific safety advice for the blood glucose meter function.
Lists the main parts of the AiDEX ™ Continuous Glucose Monitoring System.
Provides detailed explanations and illustrations of each device component.
Step-by-step guide for correctly applying the glucose sensor to the skin.
Instructions on how to safely remove the used glucose sensor.
Guide to initial date, time, and timezone configuration for the PDA.
Steps to initiate and confirm a newly applied sensor.
Instructions for calibrating the sensor for accurate glucose readings.
How to set high and low glucose alert thresholds on the PDA.
Steps to adjust the PDA's date, time, and timezone settings.
Process for connecting a new transmitter to the PDA.
Description of the system's notification and alarm mechanisms.
Explains various PDA alarms and recommended actions.
Procedures for blood collection and performing glucose tests.
Details the process of performing a blood glucose test using fingertip blood.
Provides guidance on comparing PDA readings with laboratory results.
Instructions for performing quality control tests to ensure meter accuracy.
Information on system messages and alerts during testing.
Instructions for charging the Personal Diabetes Assistant battery.
Guidance on cleaning and disinfecting the PDA and transmitter.
Procedures for device disposal and handling recommendations.
Recommendations for transporting and storing the device.
Technical details including model numbers, operating conditions, and use life.
Information on EMC compliance and usage guidelines.
Explanation of symbols used throughout the user manual.
General| Brand | Microtech |
|---|---|
| Model | AiDEX |
| Category | Blood Glucose Meter |
| Language | English |
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