2APAPVGM34VivaChek Eco BLE Blood Glucose Meter

©2018 VivaChek Biotech(Hangzhou)Co., Ltd. Number: Effective Date: i 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. 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™ Eco BLE Blood Glucose Monitoring System. Principle and Intended Use The VivaChek™ Eco BLE Blood Glucose Monitoring System (Meter Model: VGM34) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The VivaChek™ Eco BLE Blood Glucose Monitoring System is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed. The meter is calibrated to display plasma-like concentration results. The VivaChek™ Eco BLE Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and health care professionals in clinical setting, as an aid to monitor the effectiveness of diabetes control. The system should not be used for diagnosis of diabetes. ii TABLE OF CONTENTS 1. Understanding Your Testing Tools......................................... 1 Your Meter System Overview.................................................. 1 Your Meter Display................................................................ 2 Important Safety Information...................................................... 4 2. Setting Up Your System........................................................ 5 Set the Date and Time............................................................ 5 Pairing your meter with the Smartphone..................................... 6 Initial syncing of the meter and app............................................. 7 Syncing to send results wirelessly to the app................................. 8 Using your meter without the app........................................... ... 8 3. Taking a Test.......................................................................... 9 Preparing the Test Strip.......................................................... 9 Preparing the Lancing Device.................................................... 10 Getting a Blood Drop and Testing................................................ 11 Discard the Used Test Strip...................................................... 12 Expected Diabetes Control Goal................................................ 12 Removing the Used Lancet...................................................... 13 Alternative Site Testing.............................................................. 14 Testing with Control Solution....................................................... 16 Using the Meter Memory........................................................... 18 4. Maintenance and Troubleshooting.......................................... 20 Changing the Battery.............................................................. 20 Caring for Your Glucose Monitoring System.................................. 21 Troubleshooting Guide.............................................................. 21 Symptoms of High or Low Blood Glucose..................................... 24 5. Technical Information............................................................. 25 System Specifications............................................................... 25 Limitations.............................................................................. 26 Index of Symbols..................................................................... 27 Warranty ............................................................................... 28 1 CHARPTER 1: UNDERSTANDING YOUR TESTING TOOLS Your Meter System Overview The VivaChek™ Eco BLE Blood Glucose Meter and Te s t Strip 2 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. Test results are displayed as mg/dL or mmol/L according to local government regulation. Indicates the temperature is not suitable for testing. Bluetooth The meter failed to sync with the Smartphone. Memory 3 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. Meter Use and Precautions • The meter is pre-set to display blood glucose concentration in either millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL) depending on which unit of measure is standard in your country. This unit of measure cannot be adjusted. • Do not get water or other liquids inside the meter. • Keep the strip port area clean. • Keep your meter dry and avoid exposing it to extremes in temperature or humidity…

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XXXXXXXXXXX VGM34 BLE For in vitro diagnostic use. 888-969-6928 VivaChek Biotech (Hangzhou) Co., Ltd. 1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Economy Development Zone, Yuhang, Hangzhou, 311100, Zhejiang, China FCC ID: 2APAPVGM34

SAR exemption evaluation Applicant VivaChek Biotech (Hangzhou) Co., Ltd. FCC ID 2APAPVGM34 Product VivaChek Eco BLE Blood Glucose Meter Brand VivaChek Model VGM34 Marketing EU Report No. R1904A0157-S1 Issue Date May 21, 2019 Performed by: Yu Wang Approved by: Guangchang Fan TA Technology (Shanghai) Co., Ltd. No.145, Jintang Rd, Tangzhen Industry Park, Pudong Shanghai, China TEL: +86-021-50791141/2/3 FAX: +86-021-50791141/2/3-8000 FCC SAR exemption evaluation Report No: R1904A0157-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-01-008S Page 2 of 2 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Conducted Power Bluetooth (Low Energy) Average Power (dBm) Tune-up Limit (dBm) Ch 0/2402 MHz Ch 19/2440 MHz Ch 39/2480 MHz GFSK -0.70 -1.26 -1.96 1.00 Per KDB 447498 D01, the 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation  The result is rounded to one decimal place for comparison Per KDB 447498 D01, when the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. Band Configuration Frequency (MHz) Distance (mm) MAX Power (dBm) Ratio SAR test exclusion thresholds Evaluation Bluetooth Head 2480 5 1.00 0.053 3 No Note: Based on SAR test exclusion, all values meet the SAR test exclusion thresholds and are exempt from routine RF exposure evaluation.

SAR exemption evaluation Applicant VivaChek Biotech (Hangzhou) Co., Ltd. FCC ID 2APAPVGM34 Product VivaChek Eco BLE Blood Glucose Meter Brand VivaChek Model VGM34 Marketing EU Report No. R1904A0157-S1 Issue Date May 21, 2019 Performed by: Yu Wang Approved by: Guangchang Fan TA Technology (Shanghai) Co., Ltd. No.145, Jintang Rd, Tangzhen Industry Park, Pudong Shanghai, China TEL: +86-021-50791141/2/3 FAX: +86-021-50791141/2/3-8000 FCC SAR exemption evaluation Report No: R1904A0157-S1 TA Technology (Shanghai) Co., Ltd. TA-MB-01-008S Page 2 of 2 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Conducted Power Bluetooth (Low Energy) Average Power (dBm) Tune-up Limit (dBm) Ch 0/2402 MHz Ch 19/2440 MHz Ch 39/2480 MHz GFSK -0.70 -1.26 -1.96 1.00 Per KDB 447498 D01, the 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation  The result is rounded to one decimal place for comparison Per KDB 447498 D01, when the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. Band Configuration Frequency (MHz) Distance (mm) MAX Power (dBm) Ratio SAR test exclusion thresholds Evaluation Bluetooth Head 2480 5 1.00 0.053 3 No Note: Based on SAR test exclusion, all values meet the SAR test exclusion thresholds and are exempt from routine RF exposure evaluation.

FCC RF Test Report Report No: R1904A0157-R1 TA Technology (Shanghai) Co., Ltd. TA-MB-04-005R Page 36 of 36 Thisreportshallnotbereproducedexceptinfull,withoutthewrittenapprovalofTATechnology(Shanghai)Co.,Ltd. A.2 Test Setup 30MHz-1GHz Above 1GHz Picture 2 Radiated Emission Test Setup