SMART METER IGLUCOSE ESSENTIAL USER MANUAL Pdf Download (2025)

Table of Contents

Troubleshooting Page 4: Table Of Contents Page 5: Understanding Your Testing Tools Page 6: Your Meter Display Page 7: Meter Use And Precautions Page 8: Important Safety Information Page 10: Setting Up Your System Page 12: Set The Audio Feature Page 13: Set The Ketone Warning Page 14: Performing A Test Page 15: Preparing The Lancing Device Page 16: Getting A Blood Drop For Testing Page 17: Discarding The Used Test Strip Page 18: Expected Glucose Range For People Without Diabetes Page 19: Questionable Or Inconsistent Results Page 20: Precision And Accuracy Page 21: Comparing Meter And Laboratory Results Page 22: Testing With Control Solution Page 24: Understanding Control Test Result Page 25: Viewing Your Test Results Page 26: Maintenance And Troubleshooting Page 27: Caring For Your Glucose Monitoring System Page 29: Troubleshooting Guide Page 31: Technical Information Page 32: Speci Cations Page 35: Fcc Requirement

SMART METER IGLUCOSE ESSENTIAL USER MANUAL Pdf Download (1)

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1 Your Meter Display
2 Testing with Control Solution
3 Troubleshooting Guide
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User Manual

Blood Glucose Meter

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Table of Contents

Troubleshooting

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Summary of Contents for Smart Meter iGlucose Essential

Page 1 User Manual Blood Glucose Meter...
Page 2 Manufactured for: Smart Meter, LLC 6206 Benjamin Rd. Ste. 314 Tampa, FL 33634 Contact Smart Meter Customer Support Monday-Friday 9:00AM-5:00PM EST 844-445-8267 Please contact your healthcare provider for assistance after normal business hours Made in China Number: Date:...
Page 3 SMBGM-TMB-2282-G Blood Glucose Monitoring System Dear iGlucose®Essential System User, Thank you for choosing the iGlucose®Essential Blood Glucose Monitor- ing System! iGlucose®Essential Blood Glucose Monitoring System is designed for easy testing of blood glucose and helps you keep your blood glucose under control. Read this User Manual carefully before you use your meter system.
Page 4: Table Of Contents
TABLE OF CONTENTS 1. Understanding Your Testing Tools Your System Overview Your Meter Display Meter Use and Precautions Important Safety Information Limitations 2. Setting Up Your System Set the Date and Time Set the Audio Feature Set the Meal Marker Set the Hypoglycemia (Hypo) Warning Set the Ketone Warning 3.
Page 5: Understanding Your Testing Tools
Control Solution, iGlucose®Essential Lancing Device and iGlucose®Essential Lancets are not included in the meter box but are necessary for use, please contact Smart Meter Customer Support Monday-Friday 9:00AM-5:00PM EST 844-445-8267. Please contact your healthcare provider for assistance after normal business...
Page 6: Your Meter Display
If you need more time to check the display, repeat the above steps. All display segments should be clear and exactly like the picture below. If not, contact Smart Meter Customer Support Monday-Friday 9:00AM-5:00PM EST 844-445-8267 for help. Please contact your healthcare provider for assistance after normal business hours.
Page 7: Meter Use And Precautions
The low glucose test result may indicate hypoglycemia. Signal strength. Center area on the display that shows test results or error codes. Indicates the temperature is not suitable for testing. Test results are displayed as mg/dL. When strip is inserted, the drop will ash, indicating the system is ready to test.
Page 8: Important Safety Information
Check the expiration dates and discard dates on your test strips vial label and control solution vial label. Use only iGlucose®Essential Blood Glucose Test Strip with your iGlucose®Essential Blood Glucose Meter. Use only iGlucose®Essential Control Solution with your iGlucose®Essential Blood Glucose Meter and iGlucose®Essential Blood Glucose Test Strip. Keep the meter and all associated parts out of reach of children.
Page 9 Do not use the system above 10,413 ft (3,174 meters) in altitude. This meter is not intended for use in healthcare or assisted-use settings such as hospitals, physician o ces, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures.
Page 10: Setting Up Your System
SECTION 2: SETTING UP YOUR SYSTEM Before using your meter for the rst time, make sure to set up your meter properly. Set the Date and Time 1. Enter the setting mode and set the clock When the meter is o , press and hold until the meter beeps to enter the set-up mode.
Page 11 The month will now ash, press to adjust the month, press and hold until the meter beeps to set. The day will now ash. Press to adjust the day, press and hold until the meter beeps to set, then it will shift to the next digit for setting. 3.
Page 12: Set The Audio Feature
Set the Audio Feature After you set the time, press to select “On” or “OFF”. Press and hold to set. Set the Meal Marker After setting the audio feature, the symbols of will now ash, along with the word “On” or “OFF” on the display. Press to adjust to turn the meal marker function on or o , press and hold to set.
Page 13: Set The Ketone Warning
Notes: Hypo Alarm (Warning) is a reminder displayed on the meter for the user that the measured glucose level is equal or less than a settable glucose value that has been recommended by your healthcare professional. You can set the Hypo Alarm to let you know when your blood glucose is possibly too low.
Page 14: Performing A Test
SECTION 3: PERFORMING A TEST Set up your meter correctly and have all the materials you will need ready before you begin testing. This includes your iGlucose®Essential Blood Glucose Meter, iGlucose®Essential Blood Glucose Test Strips, and iGlucose®Essential lancing device and lancets. Preparing the Test Strip Wash and dry your hands and the test site well.
Page 15: Preparing The Lancing Device
Preparing the Lancing Device For ngertip sampling, adjust the depth penetration to reduce the discomfort. You do not need the clear cap for ngertip sampling. Unscrew the lancing device cover from the body of the lancing device. Insert a sterile lancet into the lancing device and push it until the lancet comes to a complete stop in the lancing device.
Page 16: Getting A Blood Drop For Testing
Adjustment: for delicate skin 2 and 3 for normal skin 4 and 5 for calloused or thick skin Note: Greater pressure of the lancing device against the puncture site will also increase the puncture depth. Getting a Blood Drop for Testing Pull the cocking barrel back to set the lancing device.
Page 17: Discarding The Used Test Strip
Note: If the blood sample does not ll the check window, do not add a second drop. Discard the test strip and start over with a new test strip. The meter counts down 5 seconds and your result appears on the display after a beep.
Page 18: Expected Glucose Range For People Without Diabetes
Press the release button to make sure that the lancet is in the extended position. Slide the ejection button forward to release the used or contaminated lancet in an appropriate container with a potential biohazard identi cation. Do not use your ngers to pull the used lancet out to prevent injury from the lancet.
Page 19: Questionable Or Inconsistent Results
Perform a control solution test (See Testing with Control Solution for instructions). After checking all the conditions listed above, repeat the test with a new test strip. contact Smart Meter Customer Support Monday-Friday 9:00AM-5:00PM EST 844-445-8267 for technical support or questions. Please contact your healthcare provider for assistance after normal business hours.
Page 20: Precision And Accuracy
Precision and Accuracy Linearity Results: Lot 1: y = 0.9982x-1.2760; R = 0.9975. Lot 2: y = 0.9945x-1.1411; R = 0.9982. Lot 3: y = 0.9949x+0.1534; R = 0.9973. All 3 Strips Lots: y = 0.9959x-0.7546; R = 0.9976. The results support the claimed measurement range of 20-600 mg/dL. The iGlucose®Essential blood glucose monitoring system was tested for within-run precision (300 measurements per glucose concentration for repeatability) using venous whole blood samples and intermediate...
Page 21: Comparing Meter And Laboratory Results
Table 1- Linear Regression Results Slope 0.9933mg/dL Intercept 0.3766 0.9941 Correlation coe cient (R) Number of sample Range tested 46.1 to 450.5mg/dL Table 2-Consumers Accuracy Results Accuracy for Home Use by Lay-Users iGlucose®Essential Blood Glucose Meter result may vary slightly from your actual blood glucose value.
Page 22: Testing With Control Solution
Testing with Control Solution Why Perform Control Tests Performing a control test lets you know that your meter and test strips are working properly to give reliable test results. You should perform a control test when: Once a week. When using or when opening a new vial of test strips. When you suspect that the meter and test strips are not working together properly.
Page 23 3. The meter turns on after a beep. An image of a test strip with a ashing blood drop will appear letting you know the meter is ready to test. 4. Shake the control solution vial thoroughly. Squeeze the control solution vial gently and discard the rst drop.
Page 24: Understanding Control Test Result
If your results still fall out of the range indicated on the test strip vial label, your meter or test strips may not be working properly. DO NOT use the system to test blood. Contact Smart Meter Customer Support Monday-Friday 9:00AM-5:00PM EST 844-445-8267.
Page 25: Viewing Your Test Results
Notes: If there are already 500 records in memory, the oldest record will be erased to make room for a new one. Control results of blood glucose are not included in the 7-day, 14-day and 30-day average calculation. Viewing Your Test Results When your meter is o , press button to turn meter on.
Page 26: Maintenance And Troubleshooting
SECTION 4: MAINTENANCE AND TROUBLESHOOTING Proper maintenance is recommended. Charging the Battery When the meter needs to be charged, the Empty Battery Symbol ( will appear. When the Empty Battery Symbol ( ) and ‘E11’ appear on the screen, the meter cannot be used. You must charge the battery before using your meter.
Page 27: Caring For Your Glucose Monitoring System
Warning Please note that the battery is not removable. If the battery needs to be separated for sorting and discarding due to scrap of the product, please keep it away from children. A lithium battery is poisonous. If swallowed, immediately contact your doctor or poison control center. Discard battery according to your local environmental regulations.
Page 28 If you notice any of these external changes to your meter or any changes to the performance of your meter stop using the meter and please contact Smart Meter Customer Support Monday-Fri- day 9:00AM-5:00PM EST 844-445-8267 for help. Please contact your healthcare provider for assistance after normal business hours.
Page 29: Troubleshooting Guide
Troubleshooting Guide What You See What It Means What You Should Do Wash and dry your hands The test result is and the test site well.Repeat above 600 mg/dL. the test using a new test strip. If your result still ashes “HI”, contact your healthcare professional as soon as possible.
Page 30 Let the meter adjust to this temperature for 20 minutes before performing a test. Restart the meter. If the problem Potential hardware continues, contact Smart Meter error. Customer Support Monday-Friday 9:00AM-5:00PM EST 844-445-8267. Please contact your healthcare provider for assistance after normal business hours.
Page 31: Technical Information
SECTION 5: TECHNICAL INFORMATION System Specifications: Feature Speci cation Measurement Range 20 - 600 mg/dL Measurement Result Plasma Glucose Sample Fresh capillary whole blood Sample Volume 0.8 L Test Time 5 seconds Power Source Rechargeable 3.7 Volt Lithium lon Battery Charging Time Direct current Rechargeable, 800 mAh, 3.7 Volt DC nominal,...
Page 32: Speci Cations
4G Specifications： Item Name Design Speci cation Throughput Downlink≥500Kbps, Uplink≥1000Kbps Latency ≤25ms Data shall be transmitted Data Integrity correctly and completely Accessibility Accessibility is high since 4G is broadband Signal Priority Routine priority using 4G access standard Warranty Please complete the warranty card that came with this product and mail it to Mio Labs Inc.
Page 33 Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 in (30 cm) to any part of the equipment, including cables speci ed by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Page 34 Guidance and Manufacturer’s Declaration-IMMUNITY to proximity elds from RF wireless communications equipment IEC60601 Test Level Compliance Immunity Test Level Maximum Immunity Test Test Frequency Modulation Power Level **Pulse 385 MHz Modulation: 1.8W 27 V/m 27 V/m 18Hz *FM+ 5 kHz 450 MHz deviation: 1kHz 28 V/m...
Page 35: Fcc Requirement
FCC Requirement RF Exposure Compliance This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End user must follow the speci c operating instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

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