2AV24MTM309MultiSure GK Link Blood Glucose and Ketone Monitoring System

Blood Glucose and Ketone Monitoring System P/N 650700XXX Rev.3/20 User's Guide For single-patient use APEX BIOTECHNOLOGY CORP. No7, Li Hsin Rd. V, Hsinchu Science Park Hsinchu, Taiwan TEL: 1-877-979-5454 Monday through Friday from 8am to 5pm EST E-mail: [email protected] Website: www.apexbio.com Manufactured by Glu mg/dL PM Link Model : MTM309 MultiSure GK Link Blood Glucose and Ketone Monitoring System 1 Dear MultiSure GK Link Owner Thank you for choosing the MultiSure GK Link Blood Glucose and Ketone Monitoring System to help you easily monitoring your blood glucose and Ketone. 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 through this manual and the package inserts that come with: MultiSure GK blood glucose test strip, MultiSure GK blood ketone test strip, Contrex Plus 4 glucose control solution, and KET-1 ketone 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 US Central Standard Time, 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. MultiSure GK Link Blood Glucose and Ketone Monitoring System 2 Intended Use Your MultiSure GK Link Blood Glucose and Ketone Meter, MultiSure GK blood glucose test strip, and MultiSure GK blood ketone test strip are in vitro diagnostic medical devices to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm, and blood ketone in venous whole blood or capillary whole blood from fingertips. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). They are 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. They are not intended for diagnosis or screening of diabetes and DKA or for neonatal use. Do not alter your treatment on the basis of test results of this meter without previously consulting your doctor or healthcare professional. 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 70% or lower than 10% can cause inaccurate blood glucose test results; A hematocrit range that is higher than 60% or lower than 20% can cause inaccurate blood ketone test results. MultiSure GK Link Blood Glucose and Ketone Monitoring System 3 • 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 MultiSure GK blood glucose test strip within 12 months of opening test strip vial. Use MultiSure GK blood ketone test strip within 3 months of opening test strip vial. 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” (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025. htm • “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/ MultiSure GK Link Blood Glucose and Ketone Monitoring System 4 injectionsafety/Fingerstick-DevicesBGM.html Limitations • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Critically ill patients should not be tested with this device. • No for use on neonates. • Altitude higher than 10,335 feet may cause inaccurate results. • A hematocrit range that is higher than 70% or lower than 10% can cause inaccurate blood glucose test results; A hematocrit range that is higher than 60% or lower than 20% can cause inaccurate blood ketone test results. • Severe dehydration may lead to inaccurate blood glucose/ ketone test result. • For In vitro diagnostic only. • For over the counter use. • Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). • For single-patient use only. • Alternative site measurements should never be used to calibrate continuous glucose monitors (CGMs). • Alternative site measurements should never be used for insulin dosing calculations. MultiSure GK Link Blood Glucose and Ketone Monitoring System 5 • The following drugs do not generally interfere with the MultiSure GK Link system at normal or therapeutic levels However, higher concentrations (listed below) were found to interfere with glucose measurements. • Acetaminophen levels above 10 mg/dL may give falsely high test results. • Tolbutamide levels above 15 mg/dL may cause falsely low test results. • Ibuprofen levels above 40 mg/dL may cause falsely low test results. • Acetylsalicylic acid levels above 40 mg/dL may give falsely low testresults. • Tolazamide levels above 23 mg/dL may cause falsely high test results. • Paralidoxime Iodide (PAM) levels above 50 mg/dL …

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Report No：2030339R-E3032110108 Page: 82 of 95 Attachment 2  EUT External Photograph (1) EUT Photo (2) EUT Photo Report No：2030339R-E3032110108 Page: 83 of 95 (3) EUT Photo (4) EUT Photo Report No：2030339R-E3032110108 Page: 84 of 95 (5) EUT Photo (6) EUT Photo Report No：2030339R-E3032110108 Page: 85 of 95 (7) EUT Photo

Report No：2030339R-E3032110108 Page: 86 of 95 Attachment 3  EUT Internal Photograph (1) EUT Photo (2) EUT Photo Report No：2030339R-E3032110108 Page: 87 of 95 (3) EUT Photo (4) EUT Photo Report No：2030339R-E3032110108 Page: 88 of 95 (5) EUT Photo (6) EUT Photo Report No：2030339R-E3032110108 Page: 89 of 95 (7) EUT Photo (8) EUT Photo Report No：2030339R-E3032110108 Page: 90 of 95 (9) EUT Photo (10) EUT Photo (Antenna) Report No：2030339R-E3032110108 Page: 91 of 95 (11) EUT Photo (12) EUT Photo Report No：2030339R-E3032110108 Page: 92 of 95 (13) EUT Photo (14) EUT Photo Report No：2030339R-E3032110108 Page: 93 of 95 (15) EUT Photo (16) EUT Photo Report No：2030339R-E3032110108 Page: 94 of 95 (17) EUT Photo (18) EUT Photo Report No：2030339R-E3032110108 Page: 95 of 95 (19) EUT Photo

RF Exposure Statement Product Name MultiSure GK Link Blood Glucose and Ketone Monitoring System Model No. MTM309 FCC ID 2AV24MTM309 Device Operation Range Frequency Low (GHz) Frequency High (GHz) 2.402 2.480 1. Standard Applicable According to 1.1307 (b)(1), systems operating under the provisions of this section shall be operated in a manner that ensure that the public is not exposed to radio frequency energy level in excess of the Commission’s guideline. 2. Measurement Result: According to KDB 447498 D01 Mobile Portable RF Exposure v06, Operation frequency = 2402MHz and antenna separation distance = 5mm, SAR Test Exclusion Threshold = 10mW The Device max peak output power = -0.75dBm, Equivalent to 0.8414mW and less than 10 mW The SAR/MPE measurement is not necessary.

Report No：2030339R-E3032110108 Page: 1 of 95 FCC Test Report Product Name ：MultiSure GK Link Blood Glucose and Ketone Monitoring System Trade Name ：ApexBio Model No. ：MTM309 FCC ID. ：2AV24MTM309 Applicant ： Apex Biotechnology Corp. Address ： No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan Date of Receipt：Mar. 12, 2020 Issued Date ：Apr. 15, 2020 Report No. ：2030339R-E3032110108 Report Version ：V1.0 The test results relate only to the samples tested. The test report shall not be reproduced except in full without the written approval of DEKRA Testing and Certification Co., Ltd. Report No：2030339R-E3032110108 Page: 2 of 95 Test Report Certification Issued Date: Apr. 15, 2020 Report No. : 2030339R-E3032110108 Product Name : MultiSure GK Link Blood Glucose and Ketone Monitoring System Applicant : Apex Biotechnology Corp. Address : No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan Manufacturer : Apex Biotechnology Corp. Address : No. 7, Li-Hsin Rd. V, Hsinchu Science Park, Hsinchu, Taiwan Trade Name : ApexBio Model No. : MTM309 FCC ID. : 2AV24MTM309 EUT Test Voltage ： DC 6V (Power by Power Supply) DC 6V (Power by Battery) Testing Voltage ： DC 6V (Power by Power Supply) DC 6V (Power by Battery) Applicable Standard : FCC CFR Title 47 Part 15 Subpart C Section 15.247: 2018 ANSI C63.10: 2013 Laboratory Name : Hsin Chu Laboratory Address : No.372-2, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County 310, Taiwan, R.O.C. TEL: +886-3-582-8001 / FAX: +886-3-582-8958 Test Result : Complied Documented By : ( Carol Tsai / Senior Engineering Adm. Specialist ) Tested By : ( Elwin Lin / Engineer ) Approved By : ( Louis Hsu / Deputy Manager ) Report No：2030339R-E3032110108 Page: 3 of 95 Revision History Report No. Version Description Issued Date 2030339R-E3032110108 V1.0 Initial issue of report Apr. 15, 2020 Report No：2030339R-E3032110108 Page: 4 of 95 TABLE OF CONTENTS Description Page 1. General Information .................................................................................................................. 6 1.1. EUT Description ......................................................................................................... 6 1.2. Test Mode ................................................................................................................... 7 1.3. Tested System Details ................................................................................................ 8 1.4. Configuration of tested System .................................................................................. 8 1.5. EUT Exercise Software .............................................................................................. 9 1.6. Test Facility ............................................................................................................... 10 1.7. List of Test Equipment .............................................................................................. 12 1.8. Duty cycle ................................................................................................................. 14 1.9. Uncertainty ............................................................................................................... 15 2. Conducted Emission .............................................................................................................. 16 2.1. Test Setup................................................................................................................. 16 2.2. Limits ........................................................................................................................ 16 2.3. Test Procedure ......................................................................................................... 16 2.4. Test Specification ...................................................................................................... 16 2.5. Test Result ................................................................................................................ 16 3. Maximum peak conducted output power ................................................................................ 17 3.1. Test Setup................................................................................................................. 17 3.2. Test procedures ........................................................................................................ 17 3.3. Limits ........................................................................................................................ 17 3.4. Test Specification ...................................................................................................... 17 3.5. Test Result ................................................................................................................ 18 4. Radiated Emission ................................................................................................................. 20 4.1. Test Setup................................................................................................................. 20 4.2. Limits ........................................................................................................................ 21 4.3. Test Procedure ......................................................................................................... 22 4.4. Test Specification ...................................................................................................... 22 4.5. Test Result ................................................................................................................ 23 5. RF antenna conducted test .................................................................................................... 4 3 5.1. Test Setup................................................................................................................. 43 5.2. Limits ........................................................................................................................ 43…

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Report No：2030339R-E3032110108 Page: 79 of 95 Attachment 1  Test Setup Photograph <Radiated Emission> Test Mode ： Mode 1: Transmit (Power by Power Supply) (1M) Mode 3: Transmit (Power by Power Supply) (2M) Description： Front View of Radiated Emission Test Setup (Bilog) Description： Back View of Radiated Emission Test Setup (Bilog) Report No：2030339R-E3032110108 Page: 80 of 95 Test Mode ： Mode 2: Transmit (Power by Battery) (1M) Mode 4: Transmit (Power by Battery) (2M) Description： Front View of Radiated Emission Test Setup (Bilog) Description： Back View of Radiated Emission Test Setup (Bilog) Report No：2030339R-E3032110108 Page: 81 of 95 Test Mode ： Mode 1: Transmit (Power by Power Supply) (1M) Mode 3: Transmit (Power by Power Supply) (2M) Description： Front View of Radiated Emission Test Setup (Horn) Description： Back View of Radiated Emission Test Setup (Horn)