2AV24BGM024GlucoSure Link Blood Glucose Monitoring System

GlucoSure Link Blood Glucose Monitoring System 1 Dear GlucoSure Link Owner Thank you for choosing the GlucoSure Link Blood Glucose Monitoring System to help you easily monitoring your blood glucose. We hope it will be of great help in the management of your diabetes. This manual explains how to use your new meter. Before testing, carefully read though this manual and the package inserts the come with: GlucoSure Link blood glucose test strip, Contrex Plus III glucose control solution. Pay particular attention to listed warnings and cautions. Please keep this manual at hand for future reference. Please call us at 1-877-979-5454 between 8:00 am and 5:00 pm EST, Monday through Friday for questions and inquiries. If you have any questions or need assistance outside the operational days and times, please contact your health care provider. GlucoSure Link Blood Glucose Monitoring System 2 Intended Use The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly)It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. IMPORTANT: • Dehydration – Severe dehydration may lead to inaccurate blood glucose test result. If you suspect you are severely dehydrated, contact your healthcare professional immediately. • Hematocrit range – A hematocrit range that is higher than 55% or lower than 30% can cause inaccurate blood glucose test results. • Not intended for use on neonates. • Testing is done outside the body (In Vitro diagnostic use). • Do not use test strips if expiration date has passed. • Use GlucoSure Link Blood Glucose Test Strip within 3 months of opening test strip vial. GlucoSure Link Blood Glucose Monitoring System 3 Important Safety Instructions • 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! • All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. • Users should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips. The link of public health notification and standard practice guideline are: • “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” https://wayback.archive-it.org/7993/20170111013014/http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm224025.htm. • “CDC website on “Infection Prevention during Blood Glucose Monitoring and Insulin Administration.” http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html WARNING • Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.” GlucoSure Link Blood Glucose Monitoring System 4 Limitations • Inaccurate results may occur in ▪ Severely hypotensive individuals ▪ Patients in shock ▪ In a hyperglycemic-hyperosmolar state with or without ketosis • Do not use on critically ill patients. • Do not use on neonates • Do not use the system above 6,562 feet (2,000 meters) in altitude. • Do not use if hematocrit exceeds the acceptable range between 30% to 55% when testing blood glucose. • Severe dehydration (excessive water loss) may cause inaccurate results. • For In Vitro Diagnostic use only. • For Over-the-Counter use only • Perform an Alternative Site Testing (AST) only if your glucose level is not changing rapidly. • For single-patient use only. • Never use AST measurements to calibrate Continuous Glucose Monitors (CGMs). • Never use AST measurements for insulin dosing calculations. GlucoSure Link Blood Glucose Monitoring System 5 Table of Contents Understanding Your New Blood Glucose Kit The GlucoSure Link Meter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 The GlucoSure Link Meter Display Screen .............................10 The GlucoSure Link Blood Glucose Test Strip ..........................12 Contrex Plus III Glucose Control Solution (Required) .....................13 Setting Up Your New System The Setup Screen ................................................14 Setting the Clock ................................................16 Setting the Alarms ................................................19 Setting Beeper Function ...........................................22 Control Solution Testing Performing a Control Solution Test ...................................24 Control Solution Trouble Shooting ....................................29 Testing Your Blood Glucose Preparing Your Lancing Device ......................................32 Important Information on Alternative Site Testing (AST) ...................34 Performing a Blood Glucose Test ....................................36 GlucoSure Link Blood Glucose Monitoring System 6 Understanding Your Blood Glucose Test Results . . . . . . . . . . . . . . . . . . . . . . .41 Viewing Your Meter’s Memory Viewing Stored Reading and 7, 14, 30 Days Average from Memory .........43 Data Transmission Upload Data via Bluetooth ..........................................46 Caring for the Meter Changing the Batteries ............................................51 Cleaning and disinfection procedures for the GlucoSure Link Blood Glucose meter and Apex Lancing Device ..........................................53 Purchase information for Dispatch Hospital Cleaner …

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Test report No. : 4789856090-EP Page : 1 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Product Photos External Photos Test report No. : 4789856090-EP Page : 2 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. : 4789856090-EP Page : 3 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948

Blood Glucose Monitoring System Manufactured by Apex Biotechnology Corp. No. 7, Li Hsin Rd. V, Hsinchu Science Park Hsinchu, Taiwan, R.O.C. E-mail: [email protected] Website: www.apexbio.com TEL: 1-877-979-5454 Monday through Friday from 8am to 5pm EST For In Vitro Diagnostic Use FCC ID: 2AV24BGM024 P/N xxxxxxxxxxx Rev.4/21 GTIN(01): SN(21): 100% 200% Blood Glucose Monitoring System Manufactured by Apex Biotechnology Corp. No. 7, Li Hsin Rd. V, Hsinchu Science Park Hsinchu, Taiwan, R.O.C. E-mail: [email protected] Website: www.apexbio.com TEL: 1-877-979-5454 Monday through Friday from 8am to 5pm EST For In Vitro Diagnostic Use FCC ID: 2AV24BGM024 P/N xxxxxxxxxxx Rev.4/21 GTIN(01): SN(21): Label location

Test report No. : 4789856090-EP Page : 4 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Internal Photos Test report No. : 4789856090-EP Page : 5 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. : 4789856090-EP Page : 6 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. : 4789856090-EP Page : 7 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. : 4789856090-EP Page : 8 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 RF Module Antenna Test report No. : 4789856090-EP Page : 9 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. : 4789856090-EP Page : 10 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. : 4789856090-EP Page : 11 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. : 4789856090-EP Page : 12 of 12 Issued date : May. 14, 2021 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948

Test report No. : 4789856090-US-R1-V0 Page : 1 of 9 Issued date : 2021/5/19 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX) :+886-3-583-7948 Doc No: 17-EM-F0864 / 5.0 Maximum Permissible Exposure Report Product : GlucoSure Link Blood Glucose Monitoring System Model Name : BGM024 FCC ID : 2AV24BGM024 Test Regulation : 47 CFR FCC Part 2.1091 Received Date : 2021/3/23 Issued Date : 2021/5/19 Applicant : Apex Biotechnology Corp. No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. Issued By : Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan The results reported herein have been performed in accordance with the laboratory’s terms of accreditation. This report shall not be reproduced except in full without the written approval of the Laboratory. The results in this report are responsible of the test sample(s) provided by the client only and are not to be used to indicate applicability to other similar products. Test report No. : 4789856090-US-R1-V0 Page : 2 of 9 Issued date : 2021/5/19 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX) :+886-3-583-7948 Doc No: 17-EM-F0864 / 5.0 REVISION HISTORY Original Test Report No.: 4789856090-US-R1-V0 Rev. Test report No. Date Page revised Contents Original 4789856090-US-R1-V0 2021/5/19 - Initial issue Test report No. : 4789856090-US-R1-V0 Page : 3 of 9 Issued date : 2021/5/19 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX) :+886-3-583-7948 Doc No: 17-EM-F0864 / 5.0 Table of Contents 1. Attestation of Test Results ......................................................................................... 4 2. Test Methodology and Reference Procedures ......................................................... 5 3. Facilities and Accreditation ...................................................................................... 5 4. Equipment Under Test .............................................................................................. 6 4.1. Description of EUT .............................................................................................. 6 4.2. Description of Available Antennas ...................................................................... 7 5. Requirement ............................................................................................................... 8 6. Radio Frequency Radiation Exposure Evaluation ................................................. 9 Test report No. : 4789856090-US-R1-V0 Page : 4 of 9 Issued date : 2021/5/19 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX) :+886-3-583-7948 Doc No: 17-EM-F0864 / 5.0 1. Attestation of Test Results APPLICANT: Apex Biotechnology Corp. No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. MANUFACTURER: Apex Biotechnology Corp. No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. EUT DESCRIPTION: GlucoSure Link Blood Glucose Monitoring System BRAND: ApexBio MODEL: BGM024 SAMPLE STAGE: Identical Prototype APPLICABLE STANDARDS STANDARD Test Results 47 CFR FCC PART 2.1091 PASS Underwriters Laboratories Taiwan Co., Ltd. tested the above equipment in accordance with the requirements set forth in the above standards. All indications of Pass/Fail in this report are opinions expressed by Underwriters Laboratories Taiwan Co., Ltd. based on interpretations and/or observations of test results. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. Note: The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. This document may not be altered or revised in any way unless done so by Underwriters Laboratories Taiwan Co., Ltd. and all revisions are duly noted in the revisions section. Any alteration of this document not carried out by Underwriters Laboratories Taiwan Co., Ltd. will constitute fraud and shall nullify the document. This report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, any agency of the Federal Government, or any agency of any government. Prepared By: Approved and Authorized By: Sally Lu Date : 2021/5/19 Waternil Guan Date : 2021/5/19 Project Handler Engineer Test report No. : 4789856090-US-R1-V0 Page : 5 of 9 Issued date : 2021/5/19 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX) :+886-3-583-7948 Doc No: 17-EM-F0864 / 5.0 2. Test Methodology and Reference Procedures The tests documented in this report were performed in accordance with KDB 447498 D01 General RF Exposure Guidance v06. 3. Facilities and Accreditation Test Location Underwriters Laboratories Taiwan Co., Ltd. Address Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Accreditation Certificate Underwriters Laboratories Taiwan Co., Ltd. is accredited by TAF, Laboratory Code 3398. The full scope of accreditation can be viewed at http://accreditation.taftw.org.tw/taf/public/basic/viewApplyI tems.action?unitNo=3398 Test report No. : 4789856090-US-R1-V0 Page : 6 of 9 Issued date : 2021/5/19 FCC ID : 2AV24BGM02…

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Test report No. : 4789856090-US-R0-V0 Page : 1 of 47 Issued date : 2021/5/14 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Doc No: 17-EM-F0876 / 5.0 RADIO TEST REPORT Product : GlucoSure Link Blood Glucose Monitoring System Model Name : BGM024 FCC ID : 2AV24BGM024 Test Regulation : FCC 47 CFR Part 15 Subpart C (Section 15.247) Received Date : 2021/3/23 Test Date : 2021/3/25 ~ 2021/3/30 Issued Date : 2021/5/14 Applicant : Apex Biotechnology Corp. No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. Issued By : Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan The results reported herein have been performed in accordance with the laboratory’s terms of accreditation. This report shall not be reproduced except in full without the written approval of the Laboratory. The results in this report are responsible of the test sample(s) provided by the client only and are not to be used to indicate applicability to other similar products. Test report No. : 4789856090-US-R0-V0 Page : 2 of 47 Issued date : 2021/5/14 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Doc No: 17-EM-F0876 / 5.0 REVISION HISTORY Original Test Report No.: 4789856090-US-R0-V0 Rev. Test report No. Date Page revised Contents Original 4789856090-US-R0-V0 2021/5/14 - Initial issue Test report No. : 4789856090-US-R0-V0 Page : 3 of 47 Issued date : 2021/5/14 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Doc No: 17-EM-F0876 / 5.0 Table of Contents 1. Attestation of Test Results .............................................................................................4 2. Summary of Test Results ...............................................................................................5 3. Test Methodology and Reference Procedures.............................................................6 4. Facilities and Accreditation ...........................................................................................6 5. Measurement Uncertainty .............................................................................................7 6. Equipment under Test ...................................................................................................8 6.1. Description of EUT .............................................................................................. 8 6.2. Channel List ......................................................................................................... 9 6.3. Test Condition ...................................................................................................... 9 6.4. Description of Available Antennas ...................................................................... 9 6.5. Test Mode Applicability and Tested Channel Detail ......................................... 10 6.6. Duty cycle .......................................................................................................... 11 7. Test Equipment ............................................................................................................ 12 8. Description of Test Setup ............................................................................................ 13 9. Test Results ................................................................................................................... 14 9.1. 6dB Bandwidth .................................................................................................. 14 9.2. Conducted Output Power ................................................................................... 17 9.3. Power Spectral Density ...................................................................................... 19 9.4. Conducted Out of Band Emission ...................................................................... 22 9.5. Radiated Spurious Emission .............................................................................. 27 Appendix I Radiated Band Edge Measurement .............................................................. 42 Appendix II Radiated Spurious Emission Measurement ............................................... 46 Test report No. : 4789856090-US-R0-V0 Page : 4 of 47 Issued date : 2021/5/14 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Doc No: 17-EM-F0876 / 5.0 1. Attestation of Test Results APPLICANT: Apex Biotechnology Corp. No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. MANUFACTURER: Apex Biotechnology Corp. No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan, R.O.C. EUT DESCRIPTION: GlucoSure Link Blood Glucose Monitoring System BRAND: ApexBio MODEL: BGM024 SAMPLE STAGE: Identical Prototype DATE of TESTED: 2021/3/25 ~ 2021/3/30 APPLICABLE STANDARDS STANDARD Test Results FCC 47 CFR PART 15 Subpart C (Section 15.247) PASS Underwriters Laboratories Taiwan Co., Ltd. tested the above equipment in accordance with the requirements set forth in the above standards. All indications of Pass/Fail in this report are opinions expressed by Underwriters Laboratories Taiwan 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. The test results show that the equipment tested is c…

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Page : 1 of 3 Issued date : 2021/5/14 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Radiated Spurious Emission Setup Configurations Above 1GHz Page : 2 of 3 Issued date : 2021/5/14 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 30 MHz ~ 1 GHz Page : 3 of 3 Issued date : 2021/5/14 FCC ID : 2AV24BGM024 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone :+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 9 kHz ~ 30 MHz