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.
TABLE OF CONTENTS 1. Understanding Your Testing Tools………………………………….. 1 Your Meter System Overview………………………………………….. 1 Your Meter Display………………………………………………………. 2 Important Safety Information……………………………………………… 3 Limitations…………………………………………………………………... 4 2. Setting Up Your System……………………………………………….. 6 Set the Clock…………………………………………………………….. 6 Set the Date………………………………………………………………. 6 Set the Time……………………………………………………………….. 7 Set the Audio Feature……………………………………………………..
CHARPTER 1: UNDERSTANDING YOUR TESTING TOOLS Your Meter System Overview The VivaChek™ Fad Sync Blood Glucose Meter and VivaChek™ Ino/Fad Strip 1
Your Meter Display The picture below shows all the symbols that appear on your meter display. Please make sure the display is working properly before testing. When the meter is off, press and hold to see the complete display. All display segments will appear. If you need more time to check the display, repeat the above operation. 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.
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. • sufficient blood or control solution is pulled into the test strip. • the test is complete. • it is time to perform a test if you set the test alarms. • if any error occurs during operation.
• • • • 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. If the system is used in a manner not specified by the manufacturer, the protection provided by the system can be impaired.
in a hyperosmolar state (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. • Not for use in hypotensive individuals. • Do not use at altitudes above 13123ft (4000 meters) above sea level. Note: • The system is tested to accurately read the measurement of glucose in whole blood within the range of 20 to 600 mg/dL.
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. Start setting the year, month and date. 2. Set the Date The year will now flash. Press to adjust it then press and hold until the meter beeps to set, then it will shift to the next digit for setting.
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. 3. Set the Time The hour will now flash.
The minute will now flash. Press set. to adjust the minute, press and hold to to select “On” or “OFF”. Press and hold to Set the Audio Feature 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.
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. Note: VivaGuard™ App is compatible with iPhone mobile phones with iOS 8.0 or above operating system. WARNING DO NOT pair another person’s meter with your iPhone.
CHAPTER 3: TAKING A TEST Set up your meter correctly and have all the materials you will need ready before you begin testing. This including your VivaChek™ Fad Sync meter, the VivaChek™ Ino test strips and VivaChek™ lancing device with lancets. Preparing the Test Strip 1. Wash and dry your hands well before testing. 2. Remove a test strip from the test strip vial (or the foil pouch). Tightly close the vial cap immediately after you have removed the test strip. 3.
Preparing the Lancing Device For fingertip sampling, adjust the depth penetration to reduce the discomfort. You do not need the clear cap for fingertip sampling. 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. Note: The VivaChek™ lancing device uses ONLY VivaChek™ sterile lancet. 2.
Adjustment: 1 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. Pull the cocking barrel back to set the lancing device. You may hear a click; while the release button changes to orange color to indicate the lancing device is now loaded and ready for obtaining a drop of blood. 2.
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. 5. 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.
Potential Biohazard Dispose of the used test strips as medical waste. Note: 1. The meter and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients! 2. All parts of the kit are considered biohazardous. They can potentially transmit infectious diseases from blood borne pathogens, even after you have performed cleaning and disinfection. Please follow proper precautions when handling your meter and lancing device.
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. 3. Screw the clear cap onto the lancing device. 4. Choose a puncture site on the forearm or palm. Select a soft and fleshy area of the forearm or palm that is clean and dry, away from bone, and free of visible veins and hair.
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). Please consult with your doctor or health care professional if you have a low blood glucose level. • Select a soft, fleshy area of skin that is free from hair, moles and visible veins for alternative site testing.
Source: American Diabetes Association (Standards of Medical Care in Diabetes – 2018. Diabetes Care, January 2018, vol. 41, Supplement 1, S13-S27). Questionable or Inconsistent Results: If your blood glucose result does not match how you feel, please: • Check the expiration date and the discard date of the test strip. Make sure that the test strip vial has not been opened for more than 6 months. • Confirm the temperature in which you are testing is between 41-113°F.
• Close the bottle tightly after use. Performing a Control Test 1. 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. 2. Insert a test strip into the meter in the direction of the arrows. 3. The meter turns on after a beep.
drop. Discard the test strip and start over with a new test strip. 6. 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. Control results are not included in the 7, 14 and 30 day average calculation. Understand Your Control Test Result Compare your control test result with the ranges printed on the test strip vial label.
• 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. 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.
CHARTER 4：MAINTENANCE AND TROUBLESHOOTING Proper maintenance is recommended. Recharging the Battery When the meter needs to be recharged, the Empty Battery symbol ( ) will appear. When the Empty Battery symbol ( ) appears by itself on the screen, the meter cannot be used. You must recharge the battery before using your meter.
Caring for Your Glucose Monitoring System • • • • Store meter in the carrying case provided whenever possible. Wash and dry hands well before handling to keep the meter and test strips free of water and other contaminants. VivaChek™ Fad Sync Blood Glucose Meter is a precision electronic instrument. Please handle it with care. Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, or dirt.
Step 2: Wipe the entire surface including front side, back side, right side and left side of the meter, by a back and forth movement. Step 3: Keep the meter surface wet for at least one minute. Step 4: Wait for the surface of meter to be dry. CloroxTM Healthcare Bleach Germicidal Wipes containing Sodium hypochlorite 0.55%, which has been proven to be safe to use with the VivaChek™ Fad Sync system.
Troubleshooting Guide What You See What It Means What You Should Do Blood or control solution was applied to the test strip before the flashing blood drop appeared on the display Discard the test strip repeat the test with a new strip. Wait until you see flashing blood drop on display before testing. and test the the The meter is sensing a Discard the test strip used or contaminated repeat the test with a new test strip. strip. Wait until you see flashing blood drop on display before testing.
A test strip was inserted while the meter was connected to a computer or wall outlet. Insufficient sample. When the charge is completed (about 2 hours when charging an empty battery), remove the Micro USB cable from the meter, and then take a test. Repeat the test and apply enough sample to fill the test strip check window. The test result is above Wash and dry your hands well 600 mg/dL. and the test site. Repeat the test using a new test strip.
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.
CHAPTER 5: TECHNICAL INFORMATION System Specifications： Feature Specification Measurement Range 20 to 600 mg/dL Test Measured Glucose in fingertip capillary whole blood Sample Fresh capillary whole blood Sample Volume 0.8 µL Test Time 5 seconds Power Source Rechargeable 3.7 Volt Lithium Ion battery Charging Current 100mAh, Battery Type Rechargeable, non-serviceable, 250mAh, 3.
Table 1-Linear Regression Results Slope Y-Intercept Correlation coefficient(R) Number of sample Range tested Table 2-Consumers Accuracy Results The numbers and percentages represented in this table are the number of meter results compared to a laboratory result. Difference range between the true blood glucose level and the VivaChek™ Fad Sync Blood Glucose meter result.
