2AQBR-D064Self-Monitoring Blood Glucose System

S1 Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly Before using your blood glucose meter 2 Dear EASYMAX ® S1 SMBG System Owner, Thank you for using the EASYMAX ® S1 Self-Monitoring Blood Glucose (SMBG) System. We designed this system to be dependable, easy-to-use, compact, lightweight and portable to help you monitor your blood glucose on a regular basis. Please read this manual thoroughly before you begin testing. This manual provides you and your diabetes care team with important information and step-by-s tep direction to use the EASYMAX ® S1 Self-Monitoring Blood Glucose System. Thanks again for choosing the EASYMAX ® S1 SMBG. Intended Use The EASYMAX ® S1 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood, venous blood and neonate blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternate site testing can be only used during steady-state blood glucose conditions. 3 Important Safety Instructions Lancets and meters are for single use only. A new, sterile lancet should be used one time you perform a test. The lancing device, lancets and meter are NOT to be shared between users or other family members. Do NOT use on multiple individuals. Sharing a lancing device and lancets may transmit blood borne pathogens, such as viral hepatitis. All parts of the kit are considered biohazardous and may transmit infection, even if you have performed cleaning and disinfection. Wash hands thoroughly with soap and water after handling the meter or lancing device. For further information, please see: "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. "CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood borne Pathogens" (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html 4 Standard Accessories The EASYMAX ® S1 Blood Glucose meter and accessories are working together to measure the amount of glucose in your blood. The system includes: Optional Accessories • EASYMAX ® S1 Blood Glucose Meter • EASYMAX ® S1 Glucose Test Strips (10 pcs) • Carrying Case • Alkaline Battery (2 ct.) • Lancets (10 pcs) • Lancing device • AST Lancing Device Cap • User’s Manual • Test Strip Instructions • Self-Test Log Book • EASYMAX ® S1 Level 2 Control Solution • Glucose Control Solution Instructions • Quick Reference Guide • EASYMAX ® S1 Level 3 Control Solution Note: 1. EASYMAX ® S1 Level 2 Control Solution is included with the system. 2. EASYMAX ® S1 Level 3 Control Solution is available. For purchase, please call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). 5 Why is it so important to test blood glucose regularly? Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day. We have made this SMBG system as simple as possible to help you use it regularly. Your meter is easy to use, and you can adjust the lancing device for your comfort. Do you need help? If you have questions or need assistance, please call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). During non-service hours, please contact your healthcare provider. NOTE: Although the EASYMAX ® S1 SMBG System is easy to use, you may need to consult with your healthcare professional (this may be your doctor, pharmacist or diabetes nurse educator) for instructions on how to use the system. Only the correct use of the system will ensure accurate results. 6 Important Information about Your New Meter  EASYMAX ® S1 blood glucose meter is designed and approved for testing fresh capillary whole blood, venous blood and neonate blood samples from your fingertip , palm or forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the body). It should not be used to diagnose or screen for diabetes.  EASYMAX ® S1 blood glucose meter can only be used with EASYMAX ® S1 Blood Glucose Test Strips. Other test strips will give inaccurate results.  Do not disassemble the meter as this may cause damage to the components resulting in incorrect readings. Disassembling the meter will also void the warranty.  Always keep the meter clean and store it in a safe place. Protect the meter from direct sunlight to ensure a longer lifespan.  You should not store the meter and test strips in a car, bathroom, or refrigerator.  Keep the meter, test strips and lancing device away from children and pets.  You should not test critically ill patients with home-use blood glucose meters.  Incorrect results may occur when performing the test. If you believe you are not feeling well, please contact your healthcare professional.  Remove batteries if the meter will not be used for one month or more. 7  It`s not necessary to require servicing, and maintenance while in use.  It`s prohibited to change or modify the glucose device at will. Note:  Consult with your healthcare professional before testing on your fingertip, palm or forearm.  Do not touch the strips with wet hands.  Do not use expired strips (the expiration date is shown on the bottle.)  Do not bend, cut or twist the strips.  Altitude up to 10,000 feet above sea level has no effect on readings.  It should not be used to diagnose or screen for diabetes. 8 Health-Related Information  If you are experiencing dehydration, frequent urination, low blood pressure, shock …

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EPS Bio Technology Corp. Self-Monitoring Blood Glucose System Model : EasyMax S1 EUT External Photos Figure 1 General Appearance (Front View) Figure 2 General Appearance (Back View) EPS Bio Technology Corp. Self-Monitoring Blood Glucose System Model : EasyMax S1 Figure 3 General Appearance (Side View) Figure 4 General Appearance (Side View)

EPS Bio Technology Corp. Self-Monitoring Blood Glucose System Model : EasyMax S1 FCC ID Label Location  Label Placement Location  FCC ID Label Format

EPS Bio Technology Corp. Self-Monitoring Blood Glucose System Model : EasyMax S1 EUT Internal Photos Figure 5 Internal View (Removed Battery Cover) Figure 6 Internal View (Open the Cover) EPS Bio Technology Corp. Self-Monitoring Blood Glucose System Model : EasyMax S1 Figure 7 Internal View (LCD Panel and PCB Board, Back View) Figure 8 Internal View (LCD Panel and PCB Board, Front View) Loop Antenna EPS Bio Technology Corp. Self-Monitoring Blood Glucose System Model : EasyMax S1 Figure 9 Internal View (PCB Board, Front View) NFC Chip

Page 1 of 20 Audix Technology Corp. Tel: +886 2 26099301 No. 53-11, Dingfu, Linkou, Dist., Fax: +886 2 26099303 New Taipei City244, Taiwan File Number: C1M1912309 Report Number: EM-F200036 This test report may be reproduced in full only. The document may only be updated by Audix Technology Corp. personnel. Any changes will be noted in the Document History section of the report. FCC 15.225 13.56MHz Test Report for EPS Bio Technology Corp. NO. 8, R&D RD.III, HSINCHU SCIENCE PARK, HSINCHU, TAIWAN, 30077, R.O.C. Product Name : Self-Monitoring Blood Glucose System Model Name : EasyMax S1 FCC ID : 2AQBR-D064 Prepared by: : AUDIX Technology Corporation, EMC Department TESTING NVLAP LAB CODE 200077-0 The test report is based on a single evaluation of one sample of the above-mentioned products. It does not imply an assessment of the whole production and does not permit the use of the test lab logo. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST or any agency of the U.S. Government. Page 2 of 20 Audix Technology Corp. Tel: +886 2 26099301 No. 53-11, Dingfu, Linkou, Dist., Fax: +886 2 26099303 New Taipei City244, Taiwan File Number: C1M1912309 Report Number: EM-F200036 This test report may be reproduced in full only. The document may only be updated by Audix Technology Corp. personnel. Any changes will be noted in the Document History section of the report. TABLE OF CONTENTS Description Page TEST REPORT CERTIFICATION.................................................................................................... 3 1. REVISION RECORD OF TEST REPORT ............................................................................ 4 2. SUMMARY OF TEST RESULTS ........................................................................................... 5 3. GENERAL INFORMATION ................................................................................................... 6 3.1. Description of Application .............................................................................................................. 6 3.2. Description of EUT ......................................................................................................................... 7 3.3. Antenna Information ....................................................................................................................... 7 3.4. EUT Specifications Assessed in Current Report ............................................................................. 7 3.5. Description of Key Components ..................................................................................................... 7 3.6. Test Configuration ........................................................................................................................... 8 3.7. Tested Supporting System List ........................................................................................................ 8 3.8. Setup Configuration ......................................................................................................................... 9 3.9. Operating Condition of EUT ........................................................................................................... 9 3.10. Description of Test Facility ............................................................................................................. 9 3.11. Measurement Uncertainty ............................................................................................................. 10 4. MEASUREMENT EQUIPMENT LIST ................................................................................ 11 4.1. Radiated Emission Measurement .................................................................................................. 11 4.2. RF Measurement ........................................................................................................................... 11 5. CONDUCTED EMISSION ..................................................................................................... 12 6. RADIATED EMISSION (IN-BAND) .................................................................................... 13 6.1. Block Diagram of Test Setup ........................................................................................................ 13 6.2. Radiated Emission Limits .............................................................................................................. 14 6.3. Test Procedure ............................................................................................................................... 14 6.4. Test Results ................................................................................................................................... 14 7. RADIATED EMISSION (OUT-BAND) ................................................................................ 15 7.1. Block Diagram of Test Setup ........................................................................................................ 15 7.2. Radiated Emission Limits .............................................................................................................. 16 7.4. Test Procedure ............................................................................................................................... 17 7.5. Measurement Result Explanation .................................................................................................. 17 7.6. Test Results ................................................................................................................................... 17 8. 20dB BANDWIDTH ................................................................................................................ 18 8.1. Block Diagram of Test Setup ........................................................................................................ 18 8.2. Specification Limits ..................................................................................…

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APPENDIX B-Page 1 of 3 AUDIX Technology Corp. Tel: +886 2 26099301 No. 53-11, Dingfu, Linkou, Dist., Fax: +886 2 26099303 New Taipei City244, Taiwan File Number: C1M1912309 Report Number: EM-F200036 This test report may be reproduced in full only. The document may only be updated by Audix Technology Corp. personnel. Any changes will be noted in the Document History section of the report. B.1 Radiated Measurement at Chamber Frequency Range 9kHz to 30MHz Zoom in View APPENDIX B-Page 2 of 3 AUDIX Technology Corp. Tel: +886 2 26099301 No. 53-11, Dingfu, Linkou, Dist., Fax: +886 2 26099303 New Taipei City244, Taiwan File Number: C1M1912309 Report Number: EM-F200036 This test report may be reproduced in full only. The document may only be updated by Audix Technology Corp. personnel. Any changes will be noted in the Document History section of the report. Frequency Range 30MHz to 1GHz APPENDIX B-Page 3 of 3 AUDIX Technology Corp. Tel: +886 2 26099301 No. 53-11, Dingfu, Linkou, Dist., Fax: +886 2 26099303 New Taipei City244, Taiwan File Number: C1M1912309 Report Number: EM-F200036 This test report may be reproduced in full only. The document may only be updated by Audix Technology Corp. personnel. Any changes will be noted in the Document History section of the report. B.2 RF Measurement Zoom View