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General| Sample Size | 0.5 µL |
|---|---|
| Test Time | 5 seconds |
| Measurement Range | 20-600 mg/dL |
| Memory | 500 tests |
| Automatic Shutoff | 2 minutes after last action |
| Operating Conditions | 10 - 40 °C; 10 - 90% relative humidity |
| Storage Conditions | below 90% relative humidity |
Defines the system's purpose for in vitro diagnostic use for self-testing by patients.
Lists all items provided with the mylife™ Pura™ blood glucose monitoring system.
Identifies external parts like display, buttons, test strip port, and battery cover.
Details the location of the battery cover, meter battery, and backlight battery.
Explains the meaning of symbols and indicators shown on the meter's display.
Lists essential safety warnings before using the blood glucose monitoring system.
Details the minimum and maximum blood sample sizes for accurate testing.
Describes the parts of the test strip, including sample entry and electrode contacts.
Provides instructions for proper handling, storage, and usage of test strips.
Steps to activate the meter for the first time after installing batteries.
Guidance on how to change the meter's batteries and associated precautions.
Procedure for setting the date and time, including format selection.
Configures audible feedback volume and finalizes meter setup.
Instructions for manually and automatically switching the meter on and off.
Details on how to turn the meter's backlight on and off, including auto-off.
Steps to prepare the lancing device, insert lancet, and adjust depth.
Procedure for obtaining blood sample, applying it, and viewing test results.
Safe methods for disposing of used lancets and protective covers.
Steps for testing at alternative sites and important precautions to consider.
Explains how the view window indicates sufficient or insufficient blood sample.
How to interpret 'Lo' and 'Hi' results and when to contact a healthcare professional.
Situations requiring a quality control test to verify BGMS functionality.
Steps for performing a quality control test using control solution.
Comparing control test results to the specified range for proper BGMS operation.
Guidelines for keeping the meter clean and in good working condition.
How to access stored test results and view them chronologically.
Using the meter's averaging function to review glucose levels over different periods.
Explanation of error codes related to test strips, meter function, and blood volume.
Interpreting low battery indicators and their impact on meter operation.
Troubleshooting issues related to ambient temperature and sample application.
Resolving 'Code Error' and issues arising from meter malfunction.
Details on measurement technology, range, memory, power, and dimensions.
Information on meter storage conditions and optional data transmission capabilities.
Outlines system limitations and scenarios where the BGMS may not be suitable or accurate.
Overview of the optional PC-Link system for transferring and managing meter data.
Contact details for obtaining support and assistance with mylife™ Pura™ products.
Details of the manufacturer's warranty for the mylife™ Pura™ meter.
Guidelines for the safe and compliant disposal of the meter, strips, and lancets.
Lists the primary components of the mylife™ Pura™ BGMS kit.
Identifies the lancing device and disposable lancets included in the system.
