VivaChek Fad Sync Manual
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VivaChek Fad Sync Manual

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Blood Glucose Monitoring System
Dear VivaChek™ Fad Sync System User,
Thank you for choosing the VivaChek™ Fad Sync Blood Glucose Monitoring
System! VivaChek™ Fad Sync Blood Glucose Monitoring System is designed for
easy test of blood glucose and helps you keep blood glucose under control.
Read this User's Manual carefully before you use your meter system. This manual
will help you to get comfortable using the VivaChek™ Fad Sync Blood Glucose
Monitoring System and get reliable test results. Please keep your User's Manual in
a safe place; you may want to refer it in the future.
Thank you again for choosing the VivaChek™ Fad Sync System.
Intended Use and Principle
VivaChek™ Fad Sync Blood Glucose Monitoring System is comprised of the
VivaChek™ Fad Sync Blood Glucose Meter (VGM08) and the VivaChek™ Ino
Blood Glucose Test Strips (VGS01) and VivaChek™ Fad Blood Glucose Test
Strips (VGS02). The VivaChek™ Fad Sync Blood Glucose Monitoring System is
intended to quantitatively measure the glucose concentration in fresh capillary
whole blood samples drawn from the fingertips. It is intended for use by persons
with diabetes at home as an aid to monitor the effectiveness of diabetes control. It
is not intended for neonatal use or for the diagnosis of or screening for diabetes.
This system is intended for self-testing outside the body (in vitro diagnostic use)
and should only be used by a single person and should not be shared.
This meter is not intended for use in healthcare or assisted-use settings such as
hospitals, physician offices, 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. Use of this meter on multiple patients may
lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus
(HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
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Summary of Contents for VivaChek Fad Sync

  • Page 1 Read this User’s Manual carefully before you use your meter system. This manual will help you to get comfortable using the VivaChek™ Fad Sync Blood Glucose Monitoring System and get reliable test results. Please keep your User’s Manual in a safe place;...

  • Page 2: Table Of Contents

    TABLE OF CONTENTS Understanding Your Testing Tools………………………………….. Your Meter System Overview………………………………………….. Your Meter Display………………………………………………………. Important Safety Information……………………………………………… 3 Limitations…………………………………………………………………... 4 Setting Up Your System……………………………………………….. Set the Clock…………………………………………………………….. Set the Date………………………………………………………………. 6 Set the Time……………………………………………………………….. 7 Set the Audio Feature…………………………………………………….. 8 Pairing Your Meter with the iPhone………………………………………...

  • Page 3: Understanding Your Testing Tools

    CHARPTER 1: UNDERSTANDING YOUR TESTING TOOLS Your Meter System Overview The VivaChek™ Fad Sync Blood Glucose Meter and VivaChek™ Ino/Fad Strip...

  • Page 4: Your Meter Display

    All of the segments should be clear and exactly like the picture below. If not, contact VivaChek Customer Support at 800-951-8430 (7 days a week. 9 a.m.-5 p.m. Eastern Time) for help. Please contact your health care professional if you need help outside of these hours.

  • Page 5: Important Safety Information

    The meter failed to sync with the iPhone. Memory Notes: Your VivaChek™ Fad Sync meter is pre-set with beep sound function, the meter will beep when: • turn on the meter. • the test strip is inserted and ready to apply blood or control solution.

  • Page 6: Limitations

    • Use only VivaChek™ Ino/Fad test strip with your VivaChek™ Fad Sync meter. • Use only VivaChek™ Ino/Fad control solution with your VivaChek™ Fad Sync meter and VivaChek™ Ino/Fad strip. • Please contact your physician or diabetes healthcare professional if you determine to make a change on your current medical therapy or diet activity based on test results.
  • Page 7 (with or without ketosis). • The VivaChek™ Fad Sync Blood Glucose Monitoring System should not be used following xylose absorption procedures. • Not for neonatal use. • Not for screening or diagnosis of diabetes mellitus. •...

  • Page 8: Setting Up Your System

    CHAPTER 2: SETTING UP YOUR SYSTEM Before you first time using your meter or if you change your meter batteries, you should check and update your meter settings. 1. Set the Clock Set the clock for either 12 or 24 hour mode Press to adjust it then press and hold to save your choice.

  • Page 9: Set The Time

    The date will now flash. Press to adjust the date, press and hold until the meter beeps to set, then it will shift to the next digit for setting. Repeat the above action until the year setting is completed. Note: Before you first time use your meter system for testing, please adjust the meter settings to set the date and time, ensuring that results stored in the memory are shown with the correct date and time.

  • Page 10: Set The Audio Feature

    The minute will now flash. Press to adjust the minute, press and hold set. Set the Audio Feature to select “On” or “OFF”. Press and hold After you set the time, press set. Now you have completed your meter set up. A symbol of a test strip appears letting you know the meter is ready to test.

  • Page 11: Pairing Your Meter With The Iphone

    Pairing Your Meter with the iPhone Pairing prepares your VivaChek™ Fad Sync Meter and iPhone to communicate with each other. The distance between the meter and iPhone should be within 5 meters. Download the VivaGuard™ app before pairing your meter and iPhone.

  • Page 12: Taking A Test

    Year/Month/Day format. 2022/01/01 indicates 1 January, 2022. Your VivaChek™ Ino/Fad test strips have 6 months shelf life after you first open the test strip vial. Write the discard date on the vial label when you first open it.
  • Page 13 1. Unscrew the lancing device cover from the body of the lancing device. Insert a VivaChek™ sterile lancet into the VivaChek™ lancing device and push it until the lancet comes to a complete stop in the lancing device.

  • Page 14: Getting A Blood Drop And 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 finger will also increase the puncture depth Getting a Blood Drop and Testing 1.

  • Page 15: Discard The Used Test Strip

    4. Immediately touch the tip of the test strip to the drop of blood. The blood pulled into the test strip through the tip. Make sure that the blood sample has been fully filled the check window on the strip tip. Hold the tip of the test strip in the blood drop until the meter beeps.
  • Page 16 • Please contact your physician if you determine to make a change on your current medical therapy based on VivaChek™ Fad Sync test result. Alternative Site Testing The forearm and palm areas have less nerve endings than the fingertip. Because of this, you may find that obtaining blood from these sites is less painful than from the fingertip.
  • Page 17 6. Hold the lancet firmly in the lancing device and twist the safety tab of the lancet until it is loose, then pull the safety tab off the lancet. Save the safety tab for disposing of the used lancet. Screw the clear cap onto the lancing device. Choose a puncture site on the forearm or palm.
  • Page 18 Notes: • Consult your doctor or health care professional to determine if alternative site testing is right for you. • Alternative site testing is not recommended if you have hypoglycemic unawareness (you do not recognize the symptoms of or cannot tell when you have low blood glucose).

  • Page 19: Testing With Control Solution

    You dropped the meter • Your test result does not match with how you feel About the Control Solutions Only use VivaChek™ Ino/Fad Control Solutions (1, 2 or 3) to practice on the • system. • Your meter automatically recognizes the control solution.
  • Page 20 • Close the bottle tightly after use. Performing a Control Test Remove test strip from the test strip vial (or the foil pouch). Tightly close the vial cap immediately after you have removed the test strip. Note: Check the expiration and discard dates of the test strips. Do not use the expired test strip.
  • Page 21 drop. Discard the test strip and start over with a new test strip. Hold it in the drop until the meter beeps, and then you see the meter count down on the screen and followed with your control test result after a beep. Note: The meter will automatically recognize and mark the control result for you.

  • Page 22: Using The Meter Memory

    • Make sure the control solution was mixed well. • Confirm that you are using VivaChek™ Ino/Fad brand control solution. • Make sure that you followed the test procedure correctly. After checking all of the conditions listed above, repeat the control solution test with a new test strip.

  • Page 23: Maintenance And Troubleshooting

    ) appears Caution: • If you use the AC adapter which not provided by VivaChek, be ensure it meets the standard EN 60950-1; • If you use the USB port on your computer to charge the battery, be ensure it...

  • Page 24: Caring For Your Glucose Monitoring System

    Use only Clorox Healthcare Bleach Germicidal Wipes, which has been proven to be safe to use with the VivaChek™ Fad Sync Blood Glucose Meter. Cleaning is part of your normal care and maintenance and should be performed prior to disinfection, but cleaning does not kill germs.
  • Page 25 Step 4: Wait for the surface of meter to be dry. Clorox Healthcare Bleach Germicidal Wipes containing Sodium hypochlorite 0.55%, which has been proven to be safe to use with the VivaChek™ Fad Sync system. Clorox Healthcare Germicidal Bleach Wipes are available by contacting Krasity Medical Supply at 800-537-1394 directly or visiting and purchasing at http://www.walmart.com and http://www.staples.com/.

  • Page 26: Troubleshooting Guide

    Incorrect test strip. Discard the test strip and repeat the test with a new test strip. Make sure that you are using a VivaChek™ Ino /Fad test strip from VivaChek Biotech (Hangzhou) Co., Ltd..
  • Page 27 A test strip was inserted When the charge is completed while meter (about 2 hours when charging connected to a computer an empty battery), remove the or wall outlet. Micro USB cable from the meter, and then take a test. Repeat the test and apply Insufficient sample.

  • Page 28: Symptoms Of High Or Low Blood Glucose

    Symptoms of High or Low Blood Glucose You can better understand your test results by being aware of the symptoms of high or low blood glucose. According to the American Diabetes Association, some of the most common symptoms are: Low blood glucose High blood glucose (Hyperglycemia): (Hypoglycemia):...

  • Page 29: Technical Information

    Bluetooth Version 4.1 (syncing with a iPhone for data and time) The VivaChek™ Fad Sync Blood Glucose monitoring system was tested by XX lay users using capillary blood samples and three VivaChek™ Ino test strip lots. The results were compared to the YSI Model 2300 STAT PLUS Glucose Analyzer, a laboratory instrument.

  • Page 30: Warranty

    Difference range between the true blood glucose level Within Within Within Within VivaChek™ Sync Blood ± 5% ± 10% ± 15% ± 20% Glucose meter result. The percent (and number) of meter results that match true blood...

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