Smart Meter iGlucose Owner's Booklet
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Smart Meter iGlucose Owner's Booklet

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

  • Page 4: Preface

    The iGlucose Blood Glucose Test Strips are for use with the iGlucose Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

  • Page 5: Caution

    (See “Performing a Quality Control Test”). • The iGlucose Meter can only be used with the iGlucose Blood Glucose Test Strips. Other test strips should not be used under any circumstances. The use of other test strips may give inaccurate...
  • Page 6 • The iGlucose Monitoring System should not be used to screen for or diagnose diabetes mellitus. • If the iGlucose Blood Glucose Meter and iGlucose Test Strips are exposed to a substantial change in temperature, please wait 45 minutes before measurement.
  • Page 7 • 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 90% relative humidity. • iGlucose Blood Glucose Test Strips are designed for use with capillary whole blood samples. Do not use serum or plasma samples.
  • Page 8 8 iGlucose ® 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

    ® table of contents preface Caution limitations the iGlucose blood glucose monitoring system the iGlucose blood glucose meter the iGlucose blood glucose meter icons the iGlucose blood glucose test strip turning the meter on / off charging the battery...
  • Page 10 10 iGlucose ® removing the iGlucose blood glucose test strip study results of typical iGlucose 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 ®...

  • Page 12: The Iglucose Blood Glucose Monitoring System

    12 iGlucose ® the iGlucose blood glucose monitoring system Your iGlucose® Blood Glucose Monitoring System consists of several items. Please identify each item, learn its name and how it is used.
  • Page 13 Circle of Care The iGlucose Blood Glucose Monitoring System consists of the iGlucose Blood Glucose Meter, the iGlucose Test Strips as well as Rightest® Control Solution. The iGlucose 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...

  • Page 14: The Iglucose Blood Glucose Meter

    14 iGlucose ® the iGlucose blood glucose monitoring meter Test Strip Port Display Window Home Button ( Up Button ( Down Button ( IMEI Number Battery Cover Meter Serial Product name Number Sim card...

  • Page 15: The Iglucose Blood Glucose Meter Icons

    ® the iGlucose blood glucose meter icons • Indicates a control solution test result • Unit of test result mg/dL • Test result mg/dL • 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® 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

    ® • When you open a new vial of iGlucose® Blood Glucose Test Strips, record the date on the vial. Discard the vial of test strips after 3 months from opening. • Store the iGlucose Test Strips, between 39-86°F (or 4-30°C) and in a location 10-90% relative humidity.

  • 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 Meter, make sure the screen is lit by pressing any button and then press and hold the “Home” button for 3 seconds.

  • Page 19: Replacing The Battery When Needed

    ® replacing the battery when needed • Take the new battery out of its plastic bag. • Open the back cover of the device by inserting your thumbnail into the small groove on the side of the meter near the bottom of the cover and lift the cover up.

  • Page 20: Synchronizing The Date And Time Automatically

    20 iGlucose ® synchronizing the date and time automatically The date and time are synchronized automatically when the meter is turned on and when the message “Date and Time Synchronized” appears. setting the date and time manually 1. Press the “ ” button on the device.

  • Page 21: Setting The Format For The Date Or Time

    ® press the “Home” button to select. The year appears. Use the “ ” or “ ” button to change the year as needed. Press the “Home” button to select and move on to the month. 4. Scroll using the “ ” or “...

  • Page 22: Setting Preferred Meter Sound Volume

    22 iGlucose ® 3. Scroll to the “Date Format” option by pressing the “ ” or “ ” button and press the “Home” button to select. 4. Press the “ ” or “ ” button to scroll to the desired date format.

  • Page 23: Choosing A Blood Testing Mode

    ® choosing a blood testing mode To provide a better understanding of your blood glucose results the iGlucose® Blood Glucose Meter can help you record your results as “Before Meal” represented by a full apple icon or “After Meal” represented by an eaten apple icon You select this icon for a blood glucose test done before a meal.

  • Page 24: Getting Ready For Testing

    Before performing a blood glucose test, prepare the items below: • iGlucose® 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 25: Preparing The Lancing Device

    ® preparing the lancing device 1. Hold the adjustable depth cap of the lancing device in one hand while holding the base in the other hand. Slightly force downward to separate the two parts. Please see drawing below. 2. Pull the two parts in opposite directions to remove the adjustable depth cap.
  • Page 26 26 iGlucose ®...

  • Page 27: Performing A Blood Glucose Test

    (pressing and holding the “Home” button). Press the “Home” button to get to the desired ”Before Meal” or “After Meal” icon on the screen. • Take one iGlucose® Blood Glucose Test Strip from the vial. Close the vial cap immediately. inserting the test strip 1.

  • Page 28: Applying A Blood Sample

    28 iGlucose ® 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 29 ® Note: The blood sample should come out by gently squeezing. The minimum blood sample size to test using the iGlucose® Blood Glucose Monitoring System is 0.75µL: Blood sample size above 3.0µL might contaminate the test strip port and the meter while blood sample size below 0.75µL may cause an inaccurate result or may prevent a meter reading.
  • Page 30 • If the view window is not completely filled with blood the test will not start. Discard the used test strip and repeat with a new iGlucose® Blood Glucose Test Strip. Please see section below on “View Appearance of Blood on the Strip”.

  • Page 31: Removing The Used Lancet

    ® removing the used lancet • Pull off the depth adjustable cap. Locate the protective lancet cover and place it on a flat surface. Without touching the used disposable lancet, securely insert the sharp lancet tip into the protective lancet cover. See drawing below.

  • Page 32: Removing The Iglucose Blood Glucose Test Strip

    32 iGlucose ® removing the iGlucose blood glucose test strip • Hold the iGlucose® Blood Glucose Test Strip by its right edge as shown. • Rotate the iGlucose Test Strip upwards (counterclockwise) and pull up simultaneously. • Take the iGlucose Test Strip out of the test strip port.

  • Page 33: Study Results Of Typical Iglucose Users

    • When the users’ results were equal or greater than 75 mg/dL in this study, the iGlucose Meter gave results within 15% of their true blood glucose level 140 out of 147 times. Difference range between Within ±5...
  • Page 34 Do not use expired iGlucose® Blood Glucose Test Strips. • The iGlucose Test Strip should be stored capped in their vial. Use each iGlucose Test Strip immediately after removing it from the vial to avoid exposure to light and humidity. Test strips that are left out of the vial should not be used for testing.

  • Page 35: View Window Appearance

    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. Caution is advised when glucose values are below 50 mg/dL or above 250 mg/dL.

  • Page 36: About Quality Control Testing

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

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

    • To confirm that you are following the correct testing procedures. • To prepare for your initial blood glucose test. • To check the iGlucose Test Strip or when opening a new vial of test strips. • To check your iGlucose Meter after it has been dropped, damaged or exposed to liquids.

  • Page 38: Required Items For Quality Control Tests

    To perform a quality control test, prepare the items below: • iGlucose® 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

    3. Take one iGlucose® Blood Glucose Test Strip from the vial and close the vial cap immediately. inserting the test strip Hold the iGlucose Test Strip between your thumb and middle finger with the view window facing you (colored side of the sample port facing you).
  • Page 40 40 iGlucose ® 2. Insert the iGlucose® Test Strip into the test strip port straight 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.
  • Page 41 ® 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 Wipe any residue of the control solution from the top of the cap with a wet tissue and then with a dry one. Tightly replace the cap on the Rightest® Control Solution GC550 bottle. g. Remove test strip from meter. See removing the iGlucose Test Strip.
  • 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® 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

    3 months ago. • Your iGlucose Blood Glucose Test Strip has expired. • You left the cap of the iGlucose Test Strip vial or the control solution off for a period of time. • You did not perform the test procedure correctly.

  • Page 45: Recalling Test Results

    Customer Support Center. Recalling Test Results The iGlucose 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® 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

    Do not immerse in water. Perform a quality control test to ensure the iGlucose® Blood Glucose Meter is working properly. Cleaning Lancing Device Use a clean damp cloth or the disinfecting towlettes listed below to wipe the outside of the lancing device.
  • Page 48 48 iGlucose ® 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 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 50 iGlucose ® Note: Your iGlucose® Blood Glucose Meter has been tested to ensure that there is no change in the performance or external materials of the device after 550 cleaning cycles and 550 disinfecting cycles. The testing simulates 2 cleaning and disinfecting cycles per week over the typical life of the meter (5 years).
  • Page 51 ” button, the lancing device release button or depth adjustable cap. You are unable to enter meter settings, function modes or ° recall your testing results. If you have any questions or concerns, please call the iGlucose® Diabetes Customer Support Center, 1-844-445-8267.

  • Page 52: Troubleshooting

    52 iGlucose ® Troubleshooting If problems remain, please contact the iGlucose® Customer Support Center at 1-844-445-8267, or email us at support@iglucose.com. Possible reason Solution(s) Problem Cannot turn on device No battery. Open the battery cover and check that Battery not charged.

  • Page 53: Display Messages And Problem-Solving Guide

    ® Display Messages and Problem-Solving Guide When any of the following messages appear, there is a problem that requires your attention. Possible reason Solution(s) Message Blood glucose result may be Review proper testing procedure and higher than 600 mg/dL.
  • Page 54 If you do not see the error message customer service again your meter is functioning properly and able to perform a test. Settings Averages If one of the above error messages still appears, please contact the iGlucose® Diabetes Customer Support Center at 1-844-445-8267.
  • Page 55 ® 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

    56 iGlucose ® Specifications Measurement Technology Oxidase Electrochemical Sensor Sample Capillary Whole Blood Sample Volume 0.75µL minimum 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...

  • Page 57: Warranty

    Smart Meter LLC. Note: During blood glucose measurement, the iGlucose Meter itself may come into contact with blood. All parts of the iGlucose Monitoring System are considered biohazardous and can potentially transmit infectious diseases. Please follow your healthcare professional’s direction to properly dispose of the used iGlucose...

  • Page 58: Customer Service

    If you have any questions or concerns, please contact the iGlucose® Customer Support Center at 1-844-445- 8267, or email us at support@iglucose.com. If you have questions or need assistance outside normal business hours, please contact your healthcare provider.

  • Page 59: Logbook

    ® 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 Dinner...

  • Page 60: Warranty Card

    60 iGlucose ® Warranty Card PLACE STAMP HERE Name: Tel: Address: Distributor name and address: Serial No.: Model Date of Purchase: (Please present this card for product replacement)

  • Page 61: Emergency Card

    ® Emergency Card iGlucose® 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 62 62 iGlucose ® Manufactured for: SMART METER LLC 201 E. Kennedy Blvd., Suite 880 Tampa, FL 33602 www.iglucose.com. IFU01-ENv2-1218...
  • Page 63 ®...

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