2APAPVGM07Blood Glucose Meter

i 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. ii 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.............................................................. 8 Pairing Your Meter with the iPhone............................................. 9 Syncing to send results wirelessly to the app................................. 9 Using Your Meter without App.................................................... 9 3. Taking a Test.......................................................................... 10 Preparing the Test Strip............................................................. 10 Getting a Blood Drop and Testing................................................ 12 Discard the Used Test Strip........................................................ 13 Testing with Control Solution....................................................... 17 Using the Meter Memory........................................................... 20 4. Maintenance and Troubleshooting.......................................... 21 Recharging Batteries.............................................................. 21 Caring for Your Glucose Monitoring System.................................. 22 Cleaning and Disinfection.......................................................... 22 Troubleshooting Guide.............................................................. 24 Symptoms of High or Low Blood Glucose..................................... 26 5. Technical Information............................................................. 27 System Specifications............................................................... 27 Warranty................................................................................ 28 1 CHARPTER 1: UNDERSTANDING YOUR TESTING TOOLS Your Meter System Overview The VivaChek™ Fad Sync Blood Glucose Meter and VivaChek™ Ino/Fad Strip 2 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. Eastern Time) for help. Please contact your health care professional if you need help outside of these hours. Icon What it Means The top right area on the screen indicates the date. The top left area on the screen indicates the time. Indicates empty battery or battery needs to be recharged The center area on the display, this shows the test results or error codes. Indicates the system is ready to test. Control test result. Test results are displayed as mg/dL Bluetooth 3 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. Meter Use and Precautions • The meter is preset to display blood glucose concentration in milligrams per deciliter (mg/dL…

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2APAPVGM07

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FCC ID: 2APAPVGM07

Internal photo FCC ID: 2APAPVGM07 TA Technology (Shanghai) Co., Ltd. Page 1 of 7 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo Internal photo FCC ID: 2APAPVGM07 TA Technology (Shanghai) Co., Ltd. Page 2 of 7 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM07 TA Technology (Shanghai) Co., Ltd. Page 3 of 7 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM07 TA Technology (Shanghai) Co., Ltd. Page 4 of 7 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM07 TA Technology (Shanghai) Co., Ltd. Page 5 of 7 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM07 TA Technology (Shanghai) Co., Ltd. Page 6 of 7 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Internal photo FCC ID: 2APAPVGM07 TA Technology (Shanghai) Co., Ltd. Page 7 of 7 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd.

Prepared by: Wei Liu 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 EMC TEST REPORT Applicant VivaChek Biotech(Hangzhou) Co., Ltd. FCC ID 2APAPVGM07 Product Blood Glucose Meter Model VGM07 Report No. R2111A0973-E1V1 Issue Date March 22, 2022 TA Technology (Shanghai) Co., Ltd. tested the above equipment in accordance with the requirements in FCC Code CFR47 Part15B (2020)/ ANSI C63.4 (2014). The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. EMC Test Report Report No.: R2111A0973-E1V1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-001E Page 2 of 19 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Table of Contents 1 Test Laboratory ............................................................................................................................... 5 1.1 Notes of the Test Report ......................................................................................................... 5 1.2 Test facility .............................................................................................................................. 5 1.3 Testing Location ...................................................................................................................... 5 2 General Description of Equipment under Test ................................................................................ 6 2.1 Applicant and Manufacturer Information.................................................................................. 6 2.2 General information ................................................................................................................. 6 2.3 Applied Standards ................................................................................................................... 7 2.4 Test Mode ................................................................................................................................ 8 3 Test Case Results .......................................................................................................................... 9 3.1 Radiated Emission .................................................................................................................. 9 3.2 Conducted Emission ............................................................................................................. 14 4 Main Test Instruments .................................................................................................................. 17 ANNEX A: The EUT Appearance ......................................................................................................... 18 ANNEX B: Test Setup Photos .............................................................................................................. 19 EMC Test Report Report No.: R2111A0973-E1V1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-001E Page 3 of 19 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Version Revision description Issue Date Rev.0 Initial issue of report. December 31, 2021 Rev.1 Update information in Page 6. March 22, 2022 Note: This revised report (Report No. R2111A0973-E1V1) supersedes and replaces the previously issued report (Report No. R2111A0973-E1). Please discard or destroy the previously issued report and dispose of it accordingly. EMC Test Report Report No.: R2111A0973-E1V1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-001E Page 4 of 19 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Summary of measurement results Number Test Case Clause in FCC Rules Conclusion 1 Radiated Emission FCC Part15.109, ANSI C63.4-2014 PASS 2 Conducted Emission FCC Part15.107, ANSI C63.4-2014 PASS Date of Testing: November 17, 2021 ~ December 20, 2021 Date of Sample Received: November 17, 2021 Note: All indications of Pass/Fail in this report are opinions expressed by TA Technology (Shanghai) Co., Ltd. based on interpretations and/or observations of test results. Measurement Uncertainties were not taken into account and are published for informational purposes only. EMC Test Report Report No.: R2111A0973-E1V1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-001E Page 5 of 19 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. 1 Test Laboratory 1.1 Notes of the Test Report This report shall not be reproduced in full or partial, without the written approval of TA technology (shanghai) co., Ltd. The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. Measurement Uncertainties were not taken into account and are published for informational purposes only. This report is written to support regulatory compliance of the applicable standards stated above. 1.2 Test facility FCC (Designation number: CN1179, Test Firm Registration Number: 446626) TA Technology (Shanghai) Co., Ltd. has been listed on the US Federal Communications Commission list of test facilities recognized to perform measurements. A2LA (Certificate Number: 3857.01) TA Technology (Shanghai) Co., Ltd. has been listed by American Association for Laboratory Accreditation to perform measurement. 1.3 Testing Location Company: TA Technology (Shanghai) Co., Ltd. Address: No.145, Jintang Rd, Tangzhen Industry Park, Pudong Shanghai, China City: Shanghai Post code: 201201 Country: P. R. China Contact: Fan Guangchang Telephone: +86-021-50791141/2/3 Fax: +86-021-50791141/2/3-8000 Website: http://www.ta-shanghai.com E-mail: [email protected] EMC Test Report Report No.: R2111A0973-E1V1 TA Technology (Shanghai) Co., Ltd. TA-MB-06-001E Page 6 of 19 This…

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