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General| Device Type | Blood Glucose Meter |
|---|---|
| Sample Type | Capillary whole blood |
| Test Time | 5 seconds |
| Display | LCD |
| Voice Guidance | Yes |
| Operating Humidity | 10-90% RH |
| Measurement Range | 20-600 mg/dL |
| Operating Temperature | 10-40°C |
| Measurement Method | Electrochemical biosensor |
Defines the purpose and intended users of the Gmate® VOICE Blood Glucose Monitoring System.
Advises reading the manual and inserts before using the system.
Explains the electrochemical principle used by the meter to measure glucose.
Details the importance of setting the correct date and time for accurate record-keeping.
Lists the items included in the Meter kit and Starter kit.
Provides essential safety guidelines for using the blood glucose monitoring system.
Explains the two-step process for cleaning and disinfecting the meter and lancing device.
Lists critical cautions, such as not using the system on critically ill users or for diagnosis.
Details precautions like not disassembling, avoiding water, and protecting from extreme temperatures.
Describes the port for inserting test strips to start a test.
Explains the function of the meter's side buttons for navigation and settings.
Describes the LCD screen that shows results and other information.
Explains the port for transferring test results to a personal computer.
Highlights the speaking feature that provides audible test results.
Identifies the cover for accessing and replacing batteries.
Describes the sample tip and electrodes of the Gmate® Test Strip.
Explains various symbols and their meanings on the meter display.
Explains how to turn the meter on and access the settings menu.
Provides instructions on scrolling through and confirming settings using buttons.
Details the steps to adjust the volume level for audible feedback.
Explains how to decrease or increase the sound volume using the meter buttons.
Outlines the process for setting up alarm reminders on the meter.
Describes how to turn alarms on/off and set specific hour/minute times.
Explains how to set a timer for testing reminders after meals.
Details turning the timer on/off and setting hour/minute values.
Guides users through setting the year, month, and day on the meter.
Explains setting the hour, minutes, and choosing between 12-hour or 24-hour clock formats.
Describes how to select the preferred language for the meter display and prompts.
Lists the necessary items and important considerations before performing a blood glucose test.
Highlights critical points like using correct strips and maintaining temperature.
Explains the initial steps for obtaining a blood sample, starting with hand washing.
Details inserting a lancet, removing its cap, and replacing the device cover.
Guides on choosing the appropriate puncture depth based on skin type.
Describes how to position the lancing device and perform the puncture.
Advises on proper disposal of used lancets and reiterates single-use.
Explains the process of inserting a test strip and preparing the meter for a fingertip test.
Details how to apply blood to the test strip and the meter's reaction.
States the minimum blood sample volume required (0.5 microliter).
Explains how the blood glucose test result is displayed on the LCD screen.
Covers discarding the used strip and automatic result storage.
Explains 'HI' and 'Lo' readings and when to re-test or contact a professional.
Provides recommended blood glucose targets from the American Diabetes Association.
Lists crucial cautions for handling and storing Gmate® Test Strips to ensure accuracy.
Identifies the alternate sites (arm, forearm, hand, thigh, calf) for blood sampling.
Provides crucial advice on consulting professionals and avoiding specific body areas.
Details situations where alternate site testing is not recommended or may be less accurate.
Explains the procedure for obtaining blood samples from alternate sites.
Describes how to power on the meter and enter the mode to view stored test results.
Explains how the meter displays memory number and the last recorded test result.
Details using buttons to view older or current test results and memory numbering.
Explains how to enter the Average Mode to view 7, 14, and 30-day averages.
Explains inserting the test strip and checking code numbers for control solution testing.
Details marking the test as control solution and applying the solution to the strip.
Describes how to apply the control solution to the test strip tip.
Explains how the control solution test result is displayed on the meter.
Guides on comparing the result to the range on the test strip vial.
Lists potential causes for results outside the expected range and advises next steps.
Provides step-by-step instructions for removing old batteries and inserting new ones.
Includes notes on battery disposal and potential need to reset date/time.
Explains how to store the meter, strips, and control solution properly.
Advises on checking expiration dates for test strips and control solution.
Details the two-step process for cleaning and disinfecting the meter and lancing device.
Explains disinfection requirements and provides references for more information.
Discusses the system's expected lifespan and testing of the cleaning process.
Lists cautions related to storing the meter, strips, and control solution.
Provides essential safety information for caregivers regarding disease prevention.
Explains common error codes like E01, E03, E04 and their meanings.
Describes what low battery indicators mean and how they affect meter function.
Addresses issues where the meter does not enter test mode after inserting a strip.
Explains what to do if the test does not start after applying blood to the strip.
Lists the electrical and safety standards the meter has been tested against.
Outlines the warranty period and terms for the Gmate® VOICE Meter.
Presents data on the system's accuracy compared to a reference analyzer.
Details system accuracy for glucose concentrations below 75 mg/dL.
Details system accuracy for glucose concentrations at or above 75 mg/dL.
Shows accuracy results for fingertip tests compared to alternate sites.
Presents accuracy data for upper arm testing compared to fingertips.
Details accuracy results for forearm testing compared to fingertips.
Shows accuracy data for hand testing compared to fingertips.
Presents accuracy data for thigh testing compared to fingertips.
Details accuracy results for calf testing compared to fingertips.
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