Smart Meter iGlucose Plus Owner's Manual
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Smart Meter iGlucose Plus Owner's Manual

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Summary of Contents for Smart Meter iGlucose Plus

  • Page 1 Owner’s Manual...
  • Page 3 Plus Blood Glucose Monitoring System Owner Manual iGlucose is a trademark of Smart Meter LLC. iGlucose Plus Blood Glucose Monitoring System is manufactured for Smart Meter LLC by Bionime Corporation, No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan (R.O.C)

  • Page 4: Preface

    GSM technology to help you better manage your diabetes. The iGlucose Plus System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The iGlucose Plus System is intended to be used by a single person and should not be shared.

  • Page 5: Caution

    Bionime Corporation, No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan (R.O.C). CAUTION • The iGlucose Plus Blood Glucose Meter is for single patient use. Do not use on multiple patients. Do not share meter with anyone including other family members.
  • Page 6 • The iGlucose Plus Monitoring System should not be used to screen for or diagnose diabetes mellitus. • If the iGlucose Plus Blood Glucose Meter and iGlucose Test Strips are exposed to a substantial change in temperature, please wait 45 minutes before measurement.

  • Page 7: Limitations

    9 mg/dL you may get inaccurate and unreliable glucose results. Please check with your doctor before using the iGlucose Plus Blood Glucose Monitoring System. • Do not perform the blood glucose test at temperatures below 50°F (10°C) or above 104°F (40°C ), nor below 10% or above...
  • Page 8 Plus Please see the following references for further information. 1. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm224025.htm 2. CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk or Transmitting Bloodborne Pathogens”...

  • Page 9: Table Of Contents

    Plus TABLE OF CONTENTS PREFACE CAUTION LIMITATIONS THE IGLUCOSE PLUS BLOOD GLUCOSE MONITORING SYSTEM THE IGLUCOSE PLUS BLOOD GLUCOSE MONITORING METER THE IGLUCOSE PLUS BLOOD GLUCOSE METER ICONS THE IGLUCOSE BLOOD GLUCOSE TEST STRIP TURNING THE METER ON / OFF...
  • Page 10 Plus REMOVING THE IGLUCOSE BLOOD GLUCOSE TEST STRIP STUDY RESULTS OF TYPICAL IGLUCOSE PLUS USERS VIEW WINDOW APPEARANCE UNDERSTANDING TEST RESULTS AND MESSAGES ABOUT QUALITY CONTROL TESTING WHEN SHOULD A QUALITY CONTROL TEST BE PERFORMED? REQUIRED ITEMS FOR QUALITY CONTROL TESTS...
  • Page 11 Plus 10 EMERGENCY CARD...

  • Page 12: The Iglucose Plus Blood Glucose Monitoring System

    Plus THE IGLUCOSE PLUS BLOOD GLUCOSE MONITORING SYSTEM Your iGlucose Plus Blood Glucose Monitoring System consists of several items. Please identify each item, learn its name and how it is used. Quick Start Guide Owner’s Manual Meter, Test Strips...
  • Page 13 The iGlucose Plus Meter is a cellular device. When used with its corresponding iGlucose Test Strips, it measures glucose in a small drop of fresh capillary whole blood (minimum 0.75 µL).

  • Page 14: The Iglucose Plus Blood Glucose Monitoring Meter

    Plus THE IGLUCOSE PLUS BLOOD GLUCOSE MONITORING METER Test Strip Port Reset Switch Home Button ( Display Window Down Button ( Up Button ( Micro USB Battery Cover Product name IMEI Number...

  • Page 15: The Iglucose Plus Blood Glucose Meter Icons

    Plus 14 THE IGLUCOSE PLUS BLOOD GLUCOSE METER ICONS • Indicates a control solution test result • Unit of test result • Test result • Battery fully charged • Battery is low and must be recharged • Indicates a meal marker. A full apple for “Before Meal”...

  • Page 16: The Iglucose Blood Glucose Test Strip

    Electrode Contacts Sensing signal output terminals. CAUTION • The iGlucose Plus Blood Glucose Meter can only be used with the iGlucose Blood Glucose Test Strips and the RIGHTEST Control Solution GC550. The use of other test strips or control solutions can lead to incorrect results.

  • Page 17: Turning The Meter On / Off

    TURNING THE METER ON / OFF • To power on the iGlucose Plus Meter, press and hold the “Home” button until the meter turns on. The display will light up. In the next few seconds the meter will display “Searching” while the date and time automatically synchronize.

  • Page 18: Charging The Battery

    “Standby Mode”. The meter can be awakened by pressing any button or inserting a test strip. • To power off the iGlucose Plus Meter, make sure the screen is lit by pressing any button and then press and hold the “Home”...

  • Page 19: Reset Switch

    Plus 18 RESET SWITCH The iGlucose Plus comes with a Reset Switch. If you ever need to reset or power cycle the device, there is a small hole on the left side panel. When pressed, the iGlucose Plus will reset, which should resolve any issues.

  • Page 20: Setting The Date And Time Manually

    Plus SETTING THE DATE AND TIME MANUALLY 1. Press the “ ” button on the device. 2. Scroll to the “Date and time” option by using the “ ” or “ ” button and press the “Home” button to select. The “Date and...
  • Page 21 Plus 20 3. Scroll to the “Set Date” option by using the “ ” or “ ” button and press the “Home” button to select. The year appears. Use the “ ” or “ ” button to change the year as needed.

  • Page 22: Setting The Format For The Date Or Time

    Plus SETTING THE FORMAT FOR THE DATE OR TIME 1. Press briefly the “ ” button on the device. The Settings menu appears. 2. Scrolltothe “Dateandtime” optionbyusingthe “ ” or “ ” button and press the “Home” button to select. The “Date and Time”...

  • Page 23: Setting Preferred Meter Sound Volume

    Plus 22 SETTING PREFERRED METER SOUND VOLUME 1. Press briefly the “ ” button on the device. The Settings menu appears. 2. Scroll to the “Volume” option using the “ ” or “ ” button and press the “Home” button to select. The “Volume” menu appears.

  • Page 24: Airplane Mode

    Plus AIRPLANE MODE Just like other cellular devices, the iGlucose Plus has an Airplane Mode feature. Enabling Airplane Mode will disconnect the iGlucose Plus from a cellular network connection. A cellular connection will not be made again until Airplane Mode has been disabled.

  • Page 25: Choosing A Blood Testing Mode

    CHOOSING A BLOOD TESTING MODE To provide a better understanding of your blood glucose results the iGlucose Plus Blood Glucose Meter can help you record your results as “Before Meal” represented by a full apple icon “After Meal” represented by an eaten apple icon You select this icon for a blood glucose test done before a meal.

  • Page 26: Getting Ready For Testing

    GETTING READY FOR TESTING Before performing a blood glucose test, prepare the items below: • iGlucose Plus Blood Glucose Meter • iGlucose Blood Glucose Test Strips (Please check the expiration date on the test strip vial. Do not use expired test strips) .

  • Page 27: Preparing The Lancing Device

    Plus 26 PREPARING THE LANCING DEVICE Please follow the manufacturer's instructions for using the lancing device.

  • Page 28: Performing A Blood Glucose Test

    Press the “Home” button to get to the desired ”Before Meal” or “After Meal” icon on the screen. • Take one iGlucose Plus Blood Glucose Test Strip from the vial. Close the vial cap immediately. INSERTING THE TEST STRIP 1.
  • Page 29 Plus 28 4. The meter goes through an internal check that takes 3 seconds. Wait until a blood drop icon and “Apply a drop of blood” message appears on the display window. Once the message appears, apply the blood sample within 120 seconds.

  • Page 30: Applying A Blood Sample

    Plus APPLYING A BLOOD SAMPLE 1. Please follow the manufacturer's instructions for using the lancing device to choose the proper tool to help you get sufficient blood for the test. Note: The blood sample should come out by gently squeezing.
  • Page 31 Plus 30 2. Touch and hold the blood drop to the edge of sample port until the view window is filled with blood. Please see above drawing. 3. If the view window is not completely filled with blood the test will not start.

  • Page 32: Removing The Iglucose Blood Glucose Test Strip

    Please follow your healthcare professional’s instructions and discard used strips properly. • Healthcare professionals should evaluate their patients’ technique regarding the use of the iGlucose Plus Blood Glucose Monitoring System regularly. To accomplish this, it is recommended that blood glucose monitoring results be compared with a concurrently obtained laboratory measurement on the same blood sample.

  • Page 33: Study Results Of Typical Iglucose Plus Users

    • When the users’ results were equal or greater than 75 mg/dL in this study, the iGlucose Plus Meter gave results within 15% of their true blood glucose level 140 out of 147 times. Difference range...
  • Page 34 “Apply a drop of blood”. This takes 3 seconds from the time a test strip is inserted. During this time the iGlucose Plus Blood Glucose Meter performs an internal check. If the blood drop icon and the message are NOT showing on the screen, do not apply a sample to the test strip as it will result in an error message.

  • Page 35: View Window Appearance

    UNDERSTANDING TEST RESULTS AND MESSAGES Blood glucose test results are shown on the iGlucose Plus Blood Glucose Meter as mg/dL. If your blood glucose result is unusually high or low, or if you question your test results, repeat the test with a new iGlucose Blood Glucose Test Strip.

  • Page 36: About Quality Control Testing

    Consult your healthcare provider for appropriate disposal of used test strips and lancets. The iGlucose Plus Blood Glucose Meter displays results between 20 and 600mg/dL. If the test result is below 20 mg/dL, “Low” will appear on the screen. Please repeat your test with a new test strip.

  • Page 37: When Should A Quality Control Test Be Performed

    Plus Blood Glucose Monitoring System in the Control solution mode. Important: RIGHTEST Control Solution is not included in your iGlucose Plus system kit. For a bottle of RIGHTEST Control Solution, contact iGlucose Customer Support at 1-844-445-8267. If the test result is within the Control...

  • Page 38: Required Items For Quality Control Tests

    Plus REQUIRED ITEMS FOR QUALITY CONTROL TESTS To perform a quality control test, prepare the items below: • iGlucose Plus Blood Glucose Meter • iGlucose Blood Glucose Test Strips • RIGHTEST Control Solution GC550 CAUTION • Each time you open a new bottle of control solution, write the expiration date on the label.

  • Page 39: Performing A Quality Control Test

    “Home” button to select. The Control solution screen appears with the message “Control solution only, do not test blood”. 3. Take one iGlucose Plus Blood Glucose Test Strip from the vial and close the vial cap immediately. INSERTING THE TEST STRIP...
  • Page 40 Plus downwards with the strip view window facing you until it clicks and firmly stops. If not on yet, your meter will automatically turn on once the strip is inserted and the message “Strip Inserted” will be displayed. 3. The meter goes through an internal check that takes 3 seconds.
  • Page 41 Plus 40 Note: When a test mode is set for a Control Solution, the result will not be calculated into averages. a. Shake the bottle of RIGHTEST Control Solution GC550 well before opening the cap. Remove the bottle cap and place it on a flat surface.
  • Page 42 Plus d. The meter will now count down from 5 to 0 and will display the control solution test result. e. The control solution result will appear on the display for a few seconds and the meter will then revert to the home screen.
  • Page 43 • Do not touch the control solution to the sample port on the strip before seeing the message “Apply a drop of control solution”. The iGlucose Plus Blood Glucose Meter performs an internal check that takes 3 seconds. Touching the control solution to the sample port before prompted will result in an error message.

  • Page 44: Understanding Control Test Results

    Your control solution test results should fall within the control solution range printed on the test strip vial label. If the results are within the range, the iGlucose Plus Blood Glucose Monitoring System is working correctly. Example of control solution range printed on your test strip vial label.

  • Page 45: Recalling Test Results

    Please contact 1-844-445-8267. RECALLING TEST RESULTS The iGlucose Plus Blood Glucose Meter is able to automatically store a maximum of 500 test results with time and date. If your meter has stored 500 results, the newest test result will replace the oldest one.

  • Page 46: Obtaining Test Results History

    OBTAINING TEST RESULTS HISTORY The iGlucose Plus Blood Glucose System maintains a record in the device memory of each blood glucose reading for up to 500 readings. To obtain the list of previous blood glucose readings: Press the “...

  • Page 47: Caring For Your Meter

    If your test strip port is stained with blood, control solution or any liquid, please use a clean damp cloth listed below to clean it immediately. Do not immerse in water. Perform a quality control test to ensure the iGlucose Plus Blood Glucose Meter is working properly. Cleaning and Disinfecting Procedures...
  • Page 48 Plus Persons using blood glucose monitoring systems have been identified as one risk group due to the shared use of fingerstick (lancing) devices and point of care blood testing devices. The cleaning procedure is to remove dust, blood and body fluid from the surface and should be performed whenever the meter or lancing device is visibly dirty.
  • Page 49 Note: Clean and disinfect the outside of the device only. Do not remove battery cover when cleaning and disinfecting. To clean the iGlucose Plus Blood Glucose Meter: Thoroughly wipe the entire surface of the meter, especially the strip port, face/display, housing and buttons with the disinfecting wipes listed above to clean any possible dirt, dust, blood and other body fluids.
  • Page 50 Plus Note: Your iGlucose Plus Blood Glucose Meter has been tested to ensure that there is no change in the performance or external materials of the device after 125 cleaning cycles and 125 disinfecting cycles. The testing simulates 1 cleaning and disinfecting cycle per week over the typical life of the meter (more than 2 years).
  • Page 51 Plus 50 CAUTION • Users should wash their hands thoroughly with soap and water after handling the meter, lancing device or test strips. • Please examine your LCD screen, test strip port, buttons and surface of your meter and lancing device after cleaning and disinfecting cycles.

  • Page 52: Troubleshooting

    Plus TROUBLESHOOTING If problems remain, please contact the iGlucose Customer Support at 1-844-445-8267, or email us at support@iglucose.com. Problem Possible reason Solution(s) Recharge battery, or press reset Cannot turn on device Battery not charged. switch. Part of the display is Device is damaged.

  • Page 53: Display Messages And Problem-Solving Guide

    Plus 52 DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE When any of the following messages appear, there is a problem that requires your attention. Message Possible reason Solution(s) Review proper testing procedure and perform a quality check with Blood glucose result may be control solution.
  • Page 54 Plus Do a Quality Control Test or The meter has malfunctioned. press reset switch to check if the meter works properly. Meter detects an abnormal Repeat the test using a new test signal while testing. strip. Remove strip, check it and reinsert.
  • Page 55 Plus 54 FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. 15.105(b) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules.

  • Page 56: Specifications

    Plus SPECIFICATIONS Measurement Technology Oxidase Electrochemical Sensor Sample Capillary Whole Blood 0.75 μL minimum Sample Volume Measuring Range 20-600 mg/dL Test Time 5 seconds Memory Capacity 500 blood glucose results with date and time Power Saving Automatically turns to Standby mode Operating Temperature 50-104°F (10-40°C)

  • Page 57: Warranty

    Plus 56 WARRANTY Smart Meter LLC warrants that this product will be free from defects in materials and workmanship for five years from the date of purchase. This warranty does not apply to the performance of an iGlucose Plus Blood Glucose Meter that has been altered, misused, tampered with or abused in any way.

  • Page 58: Customer Service

    1) American Diabetes Association. Standards of medical care in diabetes-2016. 2016;39 (supp. 1 diabetes Care):S16. COMPONENT MANUFACTURER INFORMATION iGlucose Plus Blood Glucose Meter, iGlucose Test Strip, RIGHTEST Control Solution Manufacturer: Bionime Corporation. No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan.

  • Page 59: Logbook

    Plus 58 LOG BOOK Name: Address: Home Phone: Work Phone: Doctor: Doctor’s Phone: Pharmacy: Pharmacy Phone: Insulin/Pills: Log book date From: In case of emergency contact: DATE Blood Glucose Breakfast Insulin/ Medication Blood Glucose Lunch Insulin/ Medication Blood Glucose...
  • Page 60 Plus EMERGENCY CARD iGlucose Plus Blood Glucose Monitoring System • User Name: • Emergency Contact Phone No.: • Blood Type: • Doctor/Hospital: I am a person with diabetes. If you find me in a coma or stupor, please contact nearest emergency services immediately.
  • Page 61 Manufactured for: SMART METER LLC 6206 Benjamin Rd Ste 314 Tampa, FL 33634 101-3GM291-0A1 I-O-IGSYS2.5-U-0325 EN(US) Rev 2024.03...

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