Owner’s Booklet
iGlucose® 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.
iGlucose® preface Thank you for selecting the iGlucose® Blood Glucose Monitoring System. This manual provides all the information you need to operate this product for accurate test results. Please read this entire manual before you start testing. For people living with diabetes, it is important to regularly monitor blood glucose levels to effectively reduce complications from the disease. The easy-to-use iGlucose Monitoring System provides accurate, reliable test results.
iGlucose® 5 Virus (HBV), or other blood borne pathogens. The iGlucose® Blood Glucose Monitoring System is supported by Smart Meter, LLC. We will make every effort to assist you. If you have any questions or concerns, please contact the iGlucose Diabetes Customer Support Center at 1-844-IGLUCOSE (1-844-445-8267) or email us at support@ iglucose.com. The iGlucose Monitoring System is manufactured by Bionime Corporation, No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan (R.O.C).
iGlucose® • The iGlucose® Blood Glucose Monitoring System is intended for in vitro diagnostic use only. The blood glucose test results using fresh capillary whole blood samples from the fingertip are calibrated to be equivalent to plasma samples. • 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.
iGlucose® 7 limitations • This device is not for use on anyone in a hyperglycemic hyperosmolar state, with or without ketosis. • Not for use with critically ill patients. • Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated results. • Inaccurate test results may be obtained at altitudes greater than 10,000 feet (3,048 meters) above sea level. • Hematocrit levels outside the 20-60% range may yield inaccurate results.
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” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.
iGlucose® 9 table of contents preface 4 Caution 5 limitations 7 the iGlucose blood glucose monitoring system 12 the iGlucose blood glucose meter 14 the iGlucose blood glucose meter icons 15 the iGlucose blood glucose test strip 16 turning the meter on / off 17 charging the battery 18 replacing the battery when needed 19 synchronizing the date and time automatically 20 setting the time and date manually 20 setting the format for the date or time 21 setting preferred meter sound vol
iGlucose® removing the iGlucose blood glucose test strip 32 study results of typical iGlucose users 33 view window appearance 35 understanding test results and messages 35 about quality control testing 36 when should a quality control test be performed? 37 required items for quality control tests 38 performing a quality control test 39 inserting the test strip 39 understanding control test results 44 recalling test results 45 obtaining readings averages 45 obtaining test results
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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.
iGlucose® 13 1. iGlucose® Blood Glucose Meter 2. iGlucose® Blood Glucose Test Strips 3. Rightest® Control Solution GC550 4. Meter Charger 5. Disposable Sterile Lancets (10 pcs) 6. Lancing Device 7. Owner´s Booklet 8. iGlucose® Blood Glucose Test Strip Package Insert 9. Rightest® Control Solution GC550 Package Insert 10. Quick Reference Guide - Meter, Test Strip and Lancing Device 11.
iGlucose® the iGlucose blood glucose monitoring meter Test Strip Port Display Window Up Button ( Home Button ( ) Down Button ( IMEI Number Meter Serial Number Sim card ) ) Battery Cover Product name
iGlucose® 15 the iGlucose blood glucose meter icons • Indicates a control solution test result mg/dL 109 mg/dL • Unit of test result • Test result • Battery fully charged • Battery is low and must be recharged • Indicates a meal marker.
iGlucose® the iGlucose blood glucose test strip Sample Port Apply a drop of blood or control solution here. The test requires only 0.75µL of blood. Noble Metal Electrodes Electrochemical sensor Indication Symbol Insert strip with indication symbol up and toward meter. Hold Bar Hold here to insert test strip into strip port. View Window Window will turn from yellow to red when blood sample is applied. Electrode Contacts Sensing signal output terminals.
iGlucose® 17 • 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. Do not expose to direct sunlight or heat. • Storage of strips near bleach as well as bleach containing products will affect the results of the iGlucose Test Strips.
iGlucose® • After turning the meter on, the iGlucose® Blood Glucose Meter will remain lit for 90 seconds. After 90 seconds, it will go dark and into “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. meter battery charge Your iGlucose Meter comes with an installed lithium rechargeable battery.
iGlucose® 19 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. • Remove the old battery. • Install the new battery inside the battery compartment so that the small metal contacts on the bottom of the battery touch the small metal pins in the battery compartment.
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. 2. Scroll to the “Date and time” option by using the “ ” or “ ” button and press the “Home” button to select. The “Date and time” menu appears. 3.
iGlucose® 21 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 “ ” button to change the month as needed. Press the “Home” button to select and move to the day. 5. Scroll using the “ ” or “ ” button to change the day as needed. Press the “Home” button. A “Done” confirmation message appears. 6.
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. Press the “Home” button to select. A “Done” confirmation message appears. 5. Scroll to the “Time Format” option by using the “ ” or “ ” button and press the “Home” button to select. 6. Press the “ ” or “ ” button to scroll to the desired time format. Press the “Home” button to select.
iGlucose® 23 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. You select this icon for a blood glucose test done after a meal.
iGlucose® 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).
iGlucose® 25 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. 3. Insert a new disposable lancet firmly into lancing device. 4. Twist off and set aside the protective cover of the disposable lancet. This round piece will be used later to dispose of the used lancet.
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iGlucose® 27 performing a blood glucose test • Wash your hands thoroughly with soap and water and dry well. • Set your meter test mode to “Before Meal” or “After Meal” by turning the meter on (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.
iGlucose® 3a 3b 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. 4a 4b applying a blood sample • Place the lancing device against your fingertip and press the release button as indicated in the drawing below.
iGlucose® 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. An error code will be displayed if the sample size is too small. In this case, repeat the test with a new test strip.
iGlucose® • Touch and hold the blood drop to the edge of sample port until the view window is filled with blood. Please see above drawing. • 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”. • The meter will now count down from 5 to 0 and will display your blood glucose result.
iGlucose® 31 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. • Hold the release button of the lancing device in one hand and pull on the plunger with the other hand to safely eject the used disposable lancet. See drawing below. • Discard the used disposable lancet into a “Sharps” container.
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. Please follow your healthcare professional’s instructions and discard used strips properly.
iGlucose® 33 study results of typical iGlucose users • Like all commercially available blood glucose meters, your iGlucose® Blood Glucose Meter result may vary slightly from your actual blood glucose value. This may be due to slight differences in technique and the natural variation in the test technology. The table below shows the results of a study where 153 typical users used the iGlucose Meter to test their blood glucose level.
iGlucose® caution • Check the expiration date printed on the strip vial every time you use a test strip. 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. • Do not reuse iGlucose Test Strips.
iGlucose® 35 view window appearance Make sure your blood sample covers the whole area of the view window to get an accurate test result. An insufficient blood sample will result in an error message. If this occurs, discard the used strip and repeat the test with a new test strip. Insufficient blood sample Sufficient blood sample understanding test results and messages Blood glucose test results are shown on the iGlucose® Blood Glucose Meter as mg/dL.
iGlucose® If you are experiencing symptoms that are not consistent with your blood glucose test results and you have made sure to follow all instructions in this manual, contact your healthcare professional immediately. 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.
iGlucose® 37 iGlucose® Blood Glucose Monitoring System in the Control solution mode. If the test result is within the Control Solution Range printed on the test strip vial label, the iGlucose Monitoring System passes the quality control test and your iGlucose System is working properly. Control Solution Range: Example of Control Solution Range printed on your test strip vial label.
iGlucose® 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. The Rightest® Control Solution GC550 is good for 3 months after opening the bottle, or until the expiration date printed on the label of the control solution, whichever comes first.
iGlucose® 39 performing a quality control test 1. Press briefly the “ ” button on the device and the Settings menu will appear. 2. Scroll to the “Control Solution Mode” by using the “ ” or “ ” button and press the “Home” button to select. The Control solution screen appears with the message “Control solution testing only, do not test blood”. 3. Take one iGlucose® Blood Glucose Test Strip from the vial and close the vial cap immediately. inserting the test strip 1.
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. 3. The meter goes through an internal check that takes 3 seconds. Wait until a Control Solution drop icon and “Apply a drop of control solution” message appears on the display window.
iGlucose® 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. b. Place a drop of control solution onto the top of the cap. See drawing below. c. Gently touch the sample port of the strip to the control solution on top of the cap. See drawing below.
iGlucose® 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. You can recall and view your Control Solution test results by pressing the “ ” button to select the “Averages” menu. Scroll with the “ ” or “ ” key to the “Previous Readings” and select it with the “Home” button.
iGlucose® 43 caution • The control solution test should be conducted between 59-104°F (15-40°C) and in a location with a relative humidity of 10-90%. • 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.
iGlucose® • Keep the test strip port clean and dry. Clean immediately if the test strip port is stained or is overly exposed to moisture. • Do not touch the tip of the control solution bottle. If the tip is touched, clean with a wet tissue, then with a dry one and pour out 2 drops of control solution. Understanding Control Test Results Your control solution test results should fall within the control solution range printed on the test strip vial label.
iGlucose® 45 If Rightest® Control Solution GC550 results are out of range, your iGlucose® Blood Glucose Monitoring System may not be working properly. Repeat the quality control test. If your control solution results are still out of range, do not use the blood glucose meter to test your blood glucose. Please contact the iGlucose Diabetes 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.
iGlucose® • The average blood glucose reading for the selected period appears. Press the “Home” button to return to the “Averages” menu. Select another item from the menu that you wish to view, or scroll to the “Back” button by using the “ ” or “ ” button and press the ”Home” button to select and exit the “Averages” menu. Please note control solution readings do not count in calculating the averages.
iGlucose® 47 Caring for Your Meter Maintenance Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the carrying case when not in use. If your meter is dropped or damaged, perform a quality control test with the control solution before performing a blood glucose test. Cleaning Meter Clean the outside of the meter with the clean damp cloth or disinfecting towelettes. Do not get the test strip port wet.
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. The disinfecting procedure is necessary to kill pathogens such as HBV on the housing materials of the device.
iGlucose® 49 Please see the following references for further information: -FDA Public Health Notification: Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010). http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm224025.htm - CDC Clinical Reminder: Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010). http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.
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).
iGlucose® 51 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. Stop using the meter and/or lancing device if any of the following occur: ° Thin, silver streaks appear on the screen. ° The screen becomes cracked, soft, dissolved, brittle or swollen.
iGlucose® Troubleshooting If problems remain, please contact the iGlucose® Customer Support Center at 1-844-445-8267, or email us at support@iglucose.com. Problem Possible reason Solution(s) Cannot turn on device No battery. Battery not charged. Battery connection error. Open the battery cover and check that the battery is inserted correctly. If so, remove the batteries, wait for 5 minutes and reinsert the battery as described in the Changing the Battery section. Recharge battery. Replace battery.
iGlucose® 53 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) HI Blood glucose result may be higher than 600 mg/dL. Review proper testing procedure and perform a quality check with control solution. Repeat blood test; if “HI” still appears, call your doctor or seek medical attention immediately. LO Blood glucose result may be lower than 20 mg/dL.
iGlucose® Standby Mode The meter has malfunctioned. Do a Quality Control Test or reinstall the battery to check if the meter works properly. Meter detects an abnormal signal while testing. Repeat the test using a new test strip. Meter senses that strip code may be affected. Remove strip, check it and reinsert. If unsuccessful, discard the strip and use a new one. The applied blood sample volume is insufficient. Discard the used strip and repeat the test using a new test strip.
iGlucose® 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
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 mode Operating Temperature 50-104 0F (10-400C) Operating Relative Humidity 10-90% Operating Altitude Up to 10,000 ft Power Supply Rechargeable battery (3.
iGlucose® 57 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® Blood Glucose Meter that has been altered, misused, tampered with or abused in any way. This warranty applies only to the original purchaser of the iGlucose Blood Glucose Monitoring System. Please complete and return the enclosed warranty card.
iGlucose® Customer Service Please review all of the instructions to make sure you are performing the steps correctly. If you have any questions or concerns, please contact the iGlucose® Customer Support Center at 1-844-4458267, or email us at support@iglucose.com. If you have questions or need assistance outside normal business hours, please contact your healthcare provider.
iGlucose® 59 Log Book Name: Address: Home Phone: Work Phone: Doctor: Doctor’s Phone: Pharmacy: Pharmacy Phone: Insulin/Pills: Log book date From: To: In case of emergency contact: DATE Breakfast Lunch Dinner Bedtime Other Comments M Blood Glucose Insulin/ Medication Blood Glucose Insulin/ Medication Blood Glucose Insulin/ Medication Blood Glucose Insulin/ Medication Blood Glucose Insulin/ Medication T W T F S S
iGlucose® Warranty Card PLACE STAMP HERE Name: Tel: Address: Distributor name and address: Serial No.
iGlucose® 61 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. Or call: Please fill out this card and carry with you at all times.
iGlucose® Manufactured for: SMART METER LLC 201 E. Kennedy Blvd., Suite 880 Tampa, FL 33602 www.iglucose.com.
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