©2018 VivaChek Biotech(Hangzhou)Co., Ltd.
Blood Glucose Monitoring System Dear VivaChek™ Eco BLE System User, Thank you for choosing the VivaChek™ Eco BLE Blood Glucose Monitoring System! VivaChek™ Eco BLE 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™ Eco BLE Blood Glucose Monitoring System and get reliable test results.
TABLE OF CONTENTS 1. 2. 3. 4. 5. Understanding Your Testing Tools………………………………….. 1 Your Meter System Overview………………………………………….. 1 Your Meter Display………………………………………………………. 2 Important Safety Information……………………………………………… 4 Setting Up Your System……………………………………………….. 5 Set the Date and Time…………………………………………………... 5 Pairing your meter with the Smartphone……………………………….
CHARPTER 1: UNDERSTANDING YOUR TESTING TOOLS Your Meter System Overview The VivaChek™ Eco BLE Blood Glucose Meter and Test Strip 1
Your Meter Display The picture below shows all the symbols that appear on your meter display. Icon What it Means Top left area on the screen indicates date. Top right area on the screen presenting year or time. Date, month. Indicates average value. Indicates low battery and that replacement is necessary. Center area on the display that shows test results or error codes. Indicates the system is ready to test. Control test result.
Notes: Your VivaChek™ Eco BLE Blood Glucose meter is pre-set with beep sound function, the meter will beep when: • set the date and time. • 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. • if any error occurs during operation.
proper operation of the meter. 3. For professional use, the electromagnetic environment should be evaluated prior to operation of this device. Important Safety Information • Always keep the test strips in the original vial. Tightly close the vial immediately after you have removed the test strip. • Do not use the meter if it is dropping into water or splashing water on to it. • Wash and dry your hands well before and after testing. • Test strips and lancets are for single use only.
CHAPTER 2: SETTING UP YOUR SYSTEM Before you first time using your meter or if you change your meter battery, you should check and update your meter settings. Set the Date and Time 1. Enter the Setting Mode and Set the Date When the meter is off, press and hold until the meter beeps to enter the set up mode with the number in the year position will now flash on the display. Press to adjust it then press and hold until the meter beeps to set. Then it will shift to next digit for setting.
2. Set the Time The hour will now flashing. Press to adjust the current hour, press and hold until the meter beeps to set. Then it will shift to next digit for setting. Repeat the above action until the year setting is completed. The minute will now flash. Press the minute, press and hold to adjust to set. You will hear a long beep. Now you have completed your meter set up. A symbol of a test strip appears letting you know the meter is ready to test.
WARNING DO NOT pair another person’s meter with your Smartphone. To pair the Smartphone with your meter, turn your meter on and follow these steps: 1. When you turn on your meter, Bluetooth will automatically turn on. 2. To turn on Bluetooth® on your Smartphone tap the Settings icon on the home screen. 3. Next select Bluetooth and set Bluetooth to ON. Your devices are now searching for each other. 4. Look for a device named BLE- VivaChek. This is your meter. 5.
2. Turn your meter on 3. “Syncing Data” will appear on the app to notify you that the meter is communicating with the app NOTE: The first time you sync, the app will display a Meter Time Difference message. Tap Yes to set the clock in your meter. The date and time will appear on your meter after your first test. NOTE: If you tap No or do not act on the message, the clock in the meter will not be set.
CHAPTER 3: TAKING A TEST Set up your meter correctly and have all the materials you will need ready before you begin testing, including your VivaChek™ Eco BLE Blood Glucose Meter, VivaChek™ Eco Blood Glucose Test Strips and VivaChek™ Lancing Device with VivaChek™ Lancets. VivaChek™ recommend to use VivaChek™ Lancing Device (CE) and VivaChek™ Lancets (CE0197) for blood glucose testing. Preparing the Test Strip 1. Wash and dry your hands well before testing. 2.
1. Unscrew the lancing device cover from the body of the lancing device. Insert a sterile lancet into the VivaChek™ Lancing Device and push it until the lancet comes to a complete stop in the lancing device. 2. Hold the lancet firmly in the lancing device and twist the safety tab of the lancet until it loosens, then pull the safety tab off the lancet. Save the safety tab for disposing used lancet. 3. Carefully screw the cover back onto the lancing device. Avoid contact with the exposed needle.
4 and 5 for calloused or thick skin Note: Greater pressure of the lancing device against the finger will also increase thepuncture 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. Press the lancing device against the side of the finger to be lanced with the cover resting on the finger.
Note: If the blood sample does not fill the check window, do not add a second drop. Discard the test strip and start over with a new test strip. 5. The meter counts down from 5 to 1, then your result appears on the display after a beep. The test result will automatically be stored in the meter memory. Please do not touch the test strip during the countdown as this may result in an error. Note: Remove the used strip meter will turn off automatically. See “Discard used test strip” instruction below.
Reference: 1. ADA Clinical Practice Recommendations, 2014. Warning: • If your blood glucose reading is under 50 mg/dL (2.8 mmol/L) or you see LO (less than 10 mg/dL (0.6 mmol/L)) on the meter display, contact your health care professional as soon as possible. • If your test result is above 250 mg/dL (13.9 mmol/L) or you see HI (greater than 600 mg/dL (33.3 mmol/L)) on the meter display, contact your health care professional as soon as possible.
Press the release button to make sure that the lancet is in the extended position. Slide the ejection button forward to discard the used lancet. Place the lancing device cover back on the lancing device. Potential Biohazard Always dispose of the used lancet properly to prevent injury or contamination to others. Caution: • • • • • • Do not use the lancet if the safety tab is missing or loose when you take the lancet out of the bag. Do not use the lancet if the needle is bent.
Follow Step 1 and 2 of “Preparing the Lancing Device” to insert the lancet and load the lancing device. 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 and palm that is clean and dry, away from bone, and free of visible veins and hair. To bring fresh blood to the surface of the puncture site, massage the puncture site vigorously for a few seconds until you feel it getting warm. 5.
Testing with Control Solution Why Perform Control Tests Performing a control test lets you know that your meter and test strips are working properly to give reliable test results.
3. The meter turns on after a beep. An image of a test strip with a flashing blood drop will appear letting you know the meter is ready to test. 4. Shake the control solution bottle thoroughly. Squeeze the control solution bottle gently and discard the first drop. Squeeze out a second small drop on a clean nonabsorbent surface. Note: Do not apply control solution to the test strip directly from the bottle. 5. Immediately touch the tip of the test strip to the drop of control solution.
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 or on the foil pouch. Notes: If your control test result is out of range: • Check the expiration dates and discard dates of the test strip and control solution.
• the time and date are correct after you change your battery. Control results are not included in the 7, 14 and 30 day average calculation. Viewing Your Test Results When your meter is off, press to turn meter on after a beep, a symbol of strip flashes on the display, press again, the 7 day average will appear in the center of the display with the number of results shown at the top of the display.
CHARTER 4：MAINTENANCE AND TROUBLESHOOTING Proper maintenance is recommended for best results. Changing the Battery Battery should be replaced when the meter continually , or the meter shows then turns off. displays 1． Turn off your meter before changing battery. 2． Press firmly on the battery cover and slide in the direction of the arrow. Note: After you change battery, your meter prompts you to confirm the meter’s time and date settings. All test results are saved in memory.
4． Place new battery under the prongs and into the battery compartment with the “+” side up (Use one 3-volt CR 2032 lithium battery). 5． Slid the battery cover back into place, lining up with the open slots, and close firmly. Warning: Keep battery away from children. Lithium batteryis poisonous. If swallowed, immediately contact your doctor or poison control center. Discard battery according to your local environmental regulations.
The meter is sensing a used or contaminated test strip. Discard the test strip and repeat the test with a new test strip. Wait until you see the flashing blood drop on the display before testing. Incorrect test strip. Discard the test strip and repeat the test with a new test strip. Make sure that you are using a VivaChek™ Eco Blood Glucose Test Strip from VivaChek Laboratories, Inc.. Incorrect sample. Discard the test strip and repeat the test with a new test strip.
Not enough blood or control solution was applied. Discard test strip and repeat the test with a new test strip. Test result is below 10 mg/dL (0.6 mmol/L). Repeat the test using a new test strip. If your result still flashes LO, contact your health care professional as soon as possible. Test result is above 600 mg/dL (33.3 mmol/L). Wash and dry your hands well 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 10 to 600 mg/dL (0.6-33.3 mmol/L) Result calibration Plasma-equivalent Sample Fresh capillary whole blood Sample volume: About 0.5 µL Test time About 5 seconds Power source One (1) CR 2032 3.
Limitations The VivaChek™ Eco BLE Blood Glucose Meter, Test Strips and Control Solution are been designed, tested and proven to work together effectively to provide accurate blood glucose measurements. Do not use components from other brands. • Fresh capillary blood may be collected into test tubes containing sodium heparin, lithium heparin if the blood is used within 10 minutes. Do not use sodium fluoride/oxalate or other anticoagulants or preservatives. • Use only with whole blood.
Index of Symbols These symbols may appear on the packaging and in the instructions for the VivaChek™ Eco BLE Blood Glucose Monitoring System.
Dispose items according to local relevant laws regarding disposal and recycle Keep away from sunlight and heat Use by 6 months from the opening Warranty Please complete the warranty card that came with this product and mail it to your dealer to register your purchase. If the meter fails to work for any reason other than obvious abuse within the first five (5) years from purchase, we will replace it with a new meter free of charge. For your records, also write the purchase date of your product here.
Warranty Card Please complete this warranty card to validate your warranty. Mail it within 30 days of purchase to the local dealer address labeled on the Starter Kit box to process the validation. If the meter does not work for any reason other than obvious abuse in the first 5 years after purchase, we will replace it with a new or equivalent meter free of charge. Date of purchase / / Meter serial number（e.g.
How many times a week do you test your blood glucose? What type of diabetes you have: □Type 1 □Type 2 □Pre-diabetes □ Gestational Suggestion/Comments VivaChek Biotech (Hangzhou) Co.,Ltd. www.vivachek.com ©2018 VivaChek Biotech(Hangzhou)Co., Ltd.
FCC Regulations （15C）This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment.
