FCC ID: 2AQBR-D064 Self-Monitoring Blood Glucose System

S1 Self-Monitoring Blood Glucose System Users Manual Please read this Users Manual thoroughly Before using your blood glucose meter 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-step 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. 2 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 3 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 Users Manual Test Strip Instructions Self-Test Log Book EASYMAX S1 Level 2 Control Solution Glucose Control Solution Instructions Quick Reference Guide 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 EASYMAX S1 Level 3 Control Solution Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). 4 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. 5 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. 6 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. 7 Health-Related Information If you are experiencing dehydration, frequent urination, low blood pressure, shock or hyperosmolar hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than what your blood glucose really is. If you think you are dehydrated, call your doctor right away. If you have followed the steps in the users manual, but still have symptoms that dont seem to match your test results, contact your Healthcare Professional or physician immediately. If you have questions regarding the use of the meter, 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. Please read your test strip instructions carefully for additional health-related information. 8 Table of Contents Chapter 1: Understanding Your Meter .......................................................................................................11 The EASYMAX S1 Blood Glucose Meter ...........................................................................................11 The EASYMAX S1 Accessories..............................................................................................................13 Installing Batteries.......................................................................................................................................14 Setting the Year and Hour Clock................................................................................................................15 Why Set High Range Limit.........................................................................................................................16 Setting the Date, Time and Glucose Level Alarm.......................................................................................17 Using EASYMAX S1 Blood Glucose Test Strips ...................................................................................18 Chapter 2: Control Solution Testing..............................................................................................................19 Why Run a Control Solution Test ...............................................................................................................19 About the Control Solutions ......................................................................................................................20 Running a Control Solution Test ................................................................................................................21 Understanding Control Solution Test Results ............................................................................................23 Chapter 3: Testing Your Blood Glucose .......................................................................................................25 Using the Lancing Device .........................................................................................................................25 Inserting a Lancet into the Lancing Device ................................................................................................26 Running a Blood Glucose Test with Blood from Your Fingertip .................................................................28 Alternate Site Testing (AST)....30 Running a Blood Glucose Test with Blood from Your Forearm ..........................................................32 9 Running a Blood Glucose Test with Blood from Your Palm ...............................................................33 Discarding Used Lancets ......................................................................................................................34 Understanding Your Test Results - Expected Values......................................................................35 Unusual Test Results..............................................................................................................................35 Comparing Your Meter Result to Lab Results ........................................................................................36 Chapter 4: Meter Memory, Transfer ...........................................................................................................37 Memory, Transferring Test Results ........................................................................................................37 Viewing & Deleting Test Results ............................................................................................................38 Running With Your Smartphone .............................................................................................................39 Chapter 5: Maintenance and Troubleshooting .........................................................................................40 Installing Batteries ..................................................................................................................................40 Cleaning and Disinfecting Your Meter and Lancing Device..............................................................41 Cleaning and Disinfection Frequency.........................................................................................................47 Maintenance and Testing ...........................................................................................................................48 Screen Messages and Troubleshooting .................................................................................................49 Chapter 6: Technical Information ..............................................................................................................55 Specifications .........................................................................................................................................55 Limitations...............................................................................................................................................56 Technical Information .............................................................................................................................58 Device Information .................................................................................................................................57 Warranty ...................................................................................................................................................61 10 Chapter 1: Understanding Your Meter The EasyMax S1 Blood Glucose Meter Display-

Shows results, messages, and results stored in memory. Back/Home Button-

Press to enter memories, adjust setting, and scroll through results. Left Button-

Press to enter 7/14/30/90 memory, adjust setting, and scroll through results. OK Button-

Press to confirm the setting. Test Strip Slot-

Insert test strip here. NFC sensor -

Connect to the smartphone with NFC function. Battery Door-

Flip open the battery door by pushing the tab in the direction of the arrow and pulling the door up. Right Button-

Press to enter memories, adjust setting, and scroll through results. 11 Explanation of Meter Symbols Date

(on the left side) AC

(Before Meal) Unit AM

(Before Noon) Insert strip Temperature Apply Blood Glucose level indicator Glucose Trend Arrow Glucose is rising Time

(on the right side) PC

(After Meal) memory PM

(After Noon ) Result Battery Control solution test Glucose Trend Arrow Glucose is falling 12 Test Strip Bottle Control Solution Bottle The EASYMAX S1 Accessories Blood Glucose Test Strip Electrode Strip Insert Direction Hand Hold Area Reaction area Blood collection area Expiration Date Lancing Device Sliding barrel -

Pull on until it clicks and then release to enable lancing device. Trigger button-

Press the trigger button to activate the lancing device AST Lancing Device Cap-

Use this transparency cap for AST testing Sleeve-

Hand Hold Area Hub-

Unscrew or Recap the Cap. Carrier-

Insert the lancet into the carrier Adjustable tip-

Select the desired penetration depth 13 Inserting Batteries 1. Open the battery door on the back of the meter by pushing the tab in the direction of the arrow. 2. Insert two batteries. The meter will beep to confirm the batteries are inserted correctly. 3. Put the battery door back in place and snap it closed. 14 Setting The Year and Hour Clock Setting the current time and date in your meter is important if you intend to use the meter memory. 1. After inserting batteries, the meter turns on automatically. 2. The last 2-digits of the year flashes at the center of the display. Press Left or Right button to adjust the year and press OK button to confirm the setting. 3. Repeat step 2 to select P, A or 24 mode and then set the time.

(P=PM, A=AM, 24=24hr mode.) NOTE: If the display shows the wrong setting, please press Right and Left buttons together to re-set for 2 seconds. 15 Why Set High Range Limit Your low and high range limits are used by your meter to:

Tell you when a test result is within, below or above the range limits set in the meter. Provide messages that let you know:

When you should treat a low blood glucose result. Your progress staying within your blood glucose range. When you have developed a pattern of blood glucose results below the low limit or above the high limit set in the meter. NOTE:

The low and high range limits you set apply to all glucose test results. This includes tests taken before or after mealtimes, medications and around any other activities that may affect your blood glucose. NOTE: Be sure to talk to your healthcare professional about the low and high range limits that are right for you. When selecting or changing your high limit, you should consider factors such as your lifestyle and diabetes therapy. Never make significant changes to your diabetes care plan without consulting your healthcare professional. 16 Setting The Date, Time and Glucose Level Alarm (High Range Limit) Setting the testing unit and glucose level alarm in your meter is important to review your testing results. high range limit. The flashing field is the one you are currently setting. The flashing field is the one you are currently setting. 4. Repeat step 2 to set the date. the display. The meter is ready to run the test. 5. Repeat step 2 to set the NOTE: The meter is pre-set with a low limit of 70 mg/dL and a high limit of 140 mg/dL. The low limit is fixed. If you need to edit the pre-set high limit, check step 5, page 17. 6. The icon of flashes on 17 Using EASYMAX S1 Blood Glucose Test Strips Use only with EASYMAX S1 Blood Glucose Meters. Run a control solution test every time you open a new box of test strips (See Chapter 2 "Control Solution Testing.") Keep the test strips in their original bottle. After you take a test strip out of the bottle, tightly close the bottle immediately. This keeps the test strips dry. Use the test strip within three minutes after taking it out of the bottle. The strip is for single use only. Do not reuse it. Record the date you open the test strip bottle. Be sure to check the expiration date on the test strip bottle. The test strip is good for three months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first. Store the test strip bottle and your meter in a cool dry place. Store the test strips between 36F - 86F (2C ~30C). Do not freeze. Do not apply blood or control solution to the test strip before you insert it into the meter. Do not touch the test strip with wet hands. Do not bend, cut, or twist the test strips. EASYMAX S1 Self-Monitoring Blood Glucose Test System is a no codesystem and does not require any test strip calibration. 18 Chapter 2: Control Solution Testing Why Run a Control Solution Test We recommend that you run the EASYMAX S1 control solution test because it lets you know that your meter and test strips are working properly to give reliable results. You should run the control solution tests when:

You use the EASYMAX S1 Blood Glucose Meter for the first time. You open a new bottle of test strips. You think the meter or test strips may be working incorrectly. You drop the meter. You have repeated a test and the test results are still lower or higher than expected. You are practicing the test procedure. 19 About The Control Solutions Use with EASYMAX S1 Blood Glucose test strips. Write the date you opened the control solution bottle on the bottle label. The control solutions are good for three months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first. Do not use a control solution that is past the expiration date. Control solutions can stain clothing. If you spill it, wash your clothes with soap and water. Close the bottle tightly after every use. Left over control solution should not be added back into the control bottle. Store control solution at room temperature, between 36F - 86F (2C~30C). Do not freeze. If you would like to purchase EASYMAX S1 level 2 and level 3 Control Solutions, please contact your local dealer. 20 Running a Control Solution Test You need the meter, a test strip, and control solution. 1. Put a test strip into the meter in 2. Wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip of the control solution cap. 4. When the icon of shows, the meter beeps, you have enough control solution for the test. shows itself. the direction of the arrow and the icon of NOTE:

Do not put control solution on top of the test strip. EASYMAX Tag Meter will automatically identify your control solution test, so that results 3. Touch the drop to the collection area at the end of the test strip. from 5 seconds. 5. The meter starts to count down will be NOT included in the memory of blood test. 21 7. The meter will automatically identify the results in control solution mode with icon. 8. Dont remove the test strip yet. Check if the reading falls within the range printed on the test strip bottle. 9. Remove the test strip and throw it away after you have compared the reading to the range printed on the test strip bottle. 22 Understanding Control Solution Test Results The label on your test strip bottle shows the acceptable ranges for the Control Solutions Level 2 and Level 3. The result you get should be inside the acceptable range for the appropriate control solution level. Make sure you compare the result to the correct level of control. When the control solution result is inside the range on the test strip bottle, your test strips and your meter are working properly. If your control solution result is not inside the acceptable range (printed on your test strip bottle), here are some things you can do to solve the problem:

23 Troubleshooting Check Action Was the test strip exposed to open air for a long period of time?

If yes, repeat the control test with properly stored strips. Does test strip cap close tightly? Or was test strip cap left open?

Is the meter functioning well?

Is the control solution expired or contaminated?

If the cap was not tight, or the bottle was left uncapped, open a new bottle of test strips. Do not reuse the strips from the affected bottle. You can use the control solutions to verify the meters functions. If yes, replace with a new control solution to check the performance of SMBG system. Were test strips and control solutions stored in cool, dry places?

If no, repeat the control test with properly stored strips or control solutions. Did you follow the testing steps properly?

If you have followed the steps properly, contact physician. If you continue to have problems please contact at 1-866-994-3345. Customer Support 24 Chapter 3: Testing Your Blood Glucose Using the Lancing Device The best depth setting is the lowest number that draws enough blood for a test. Try different settings to find the one thats right for you. Please do not share your lancing device with anyone. And always use a new, sterile lancet. Lancets are for one time use only. If the meter and lancing device are being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be disinfected prior to use by the second person. For the disinfection instruction, please refer to Chapter 5: Maintenance And Troubleshooting Cleaning and disinfect your meter and supplies. Note:

Used test strips and lancets are considered bio-hazardous waste in accordance with U.S. local regulations and should be handled as if capable of transmitting infection. The users may discuss methods for disposing used test strips and lancets with their doctor. 25 Inserting a Lancet into the Lancing Device You must first load the lancet into the lancing device to get it ready for use. 2. Insert the lancet into the lancing 1. Unscrew the Cap. device firmly then twist off the protective cover. 3. Recap the front cap. NOTE: Lancets are for single use only and a new, sterile lancet should be used each time you perform a test. 26 4. Select the desired penetration depth. 6. Set the lancing device aside until later in the test. 5. Pull on the sliding barrel of the lancing device until it clicks and then release. Now the lancing device is ready. Do not prick your finger until your meter and strip are prepared. NOTE: 1. Select 1-2 for soft or thin skin, 3 for average, and 4-5 for thick or calloused skin. 2. Lancing device and lancets are not to be shared between users. Sharing lancing devices and lancets may transmit blood borne pathogens, such as viral hepatitis. 27 Running A Blood Glucose Test With Blood From Your Fingertip 1. Wash your hands with soap and warm water. Rinse and dry thoroughly. 2. Put a test strip into the meter in the direction of the arrow. The meter turns on. 3. When the blood drop flashes on the display, the meter is ready to obtain a drop of blood from your fingertip. NOTE : When your blood glucose result is displayed after a test, the meter will point a color-coded bar with icon to tell you if your result is within range, below your low limit or above your high limit set in the meter.(See page 18) Blue Bar: Below Range, Green Bar: In Range, Red Bar: Above Range. 28 4. Gently squeeze and/or massage your fingertip until a round drop of blood on your fingertip. 5. Wipe away the first drop with a tissue and use the second drop. Apply blood to the edge of the test strip. Do not apply blood on top of the test strip. Be sure to get enough blood on strip to make it to the confirmation window. Not enough blood on strip to get a test result. 6. Touch the blood drop at the tip of the transparent window of the test strip. Do not put blood on top of the strip. Be sure to get enough blood on the strips reaction zone. Otherwise, an inaccurate reading may result. The meter will beep when enough blood has entered the strips reaction zone. 7. The result will appear on the display after 5 seconds. The glucose trend arrow will show in

. Press or Left & Right button to set or mode and press OK button to confirm the setting. 8. Remove the test strip and the meter turns off automatically. Note: please make sure to apply blood when the blood drop appears on the display. 29 What is the advantage of AST?

You have the option of testing other places on your body besides the fingertip. What is AST?

Besides the fingertip, you can test your palm or forearm. Alternate Site Testing (AST) Understanding Alternate Site Testing Consult your health care professional before you begin using the palm or forearm for testing. Blood glucose test results oS1ained from your palm or forearm may differ significantly from fingertip samples. We strongly recommend that you:

Do AST ONLY in the following intervals:

Do NOT use AST if:

You think your blood glucose is low. You are unaware of hypoglycemia. Your AST results do not match the way you feel. You are testing for hyperglycemia. Your routine glucose results are often fluctuating. If you are pregnant. In a pre-meal or fasting state (more than 2 hours since the last meal). Two hours or more after taking insulin. Two hours or more after exercise. 30 If sick If blood glucose is low After exercising Two hours or less after eating Fingertip test only:

When you have just taken insulin AST Results:

If the blood glucose test result from the alternate site test does not match how you feel, do a After injecting rapid-acting insulin (two hours or less) fingertip test to confirm the result again. Do NOT change your treatment just because of an alternate site result, do a fingertip test to confirm the result. If you often do not notice when your blood glucose is low, do a fingertip test. Caution:

Talk with your healthcare professional before you test palm or forearm. Do NOT ignore symptoms of high or low blood glucose. Fingertip samples are able to show the rapid change of glucose faster than forearm and palm Measurements from alternative site testing should never be used to calibrate a continuous glucose monitor (CGM) or entered into insulin dose calculators for insulin dosing recommendations. samples. 31 Running a Blood Glucose Test with Blood from Your Forearm Please use the clear cap with the lancing device for AST testing Note: 1. Check with your healthcare professional before testing sites other that the fingertip. 1. This graphic shows where the meter cleared for alternate site testing. 3. Press and hold the device with a clear adjustable tip against the forearm. 2. Please do NOT use the first drop of blood sample. 2. Massage the puncture area 4. Press the trigger button to of forearm for a few seconds. activate the lancing device. Hold the device against forearm and increase pressure until the blood sample size is sufficient. 5. Wipe away the first drop with a tissue and use the second drop. 32 Running A Blood Glucose Test With Blood From Your Palm 1. Massage the puncture area of palm for a few seconds. 2. Press and hold the device with a clear adjustable tip against the palm 3. Press the trigger button to activate the lancing device. 4. Hold the device against palm and increase pressure until the blood sample size is sufficient. 33 Discarding Used Lancets 1. Unscrew and remove the cap. 2. Without touching the used lancet, stick the lancet tip into its protective cover. 3. Please discard used disposable lancets according to the recommendations of your healthcare professional. Or discard the used disposable lancet into an appropriate sharps or biohazard container. 4. After discarding, wash hands thoroughly with soap and water. Rinse and dry thoroughly. 34 Understanding Your Test Results Expected Values*

The EASYMAX S1 Blood Glucose test strips are whole-blood referenced and calibrated for easier comparison to lab results. The American Diabetes Association recommends a post-meal glucose level of less than 180 mg/dL and a pre-meal glucose of 70130 mg/dL*. For people with diabetes: please consult with your doctor for the appropriate blood glucose range. Unusual Test Results If your test result does not match the way you feel, please follow these steps:

1. Run a control test, Chapter 2, "Control Solution Testing."

2. Repeat a blood glucose test, Chapter 3, "Testing Your Blood glucose."

3. If your test results still do not reflect the way you feel, call your doctor immediately. Reference: American Diabetes Association. Standards of medical care in diabetes-Table 10. Diabetes care. 2011; Vol. 34, Suppl. 1, S21. Note:

1. Extremely high humidity may affect the test results. A relative humidity greater than 90% may cause inaccurate results. 2. Hematocrit below 0% may cause higher results. Hematocrit above 70% may cause lower results. 35 Comparing Your Meter Result To A Lab Result A common question is how the blood glucose results on your meter compare to the lab results. Your blood glucose can change quickly, especially after eating, taking medication, or exercising. If you test yourself in the morning, then go to the doctors office for a blood glucose test. The results will probably not match, even if you are fasting. This is typically not a problem with your meter, it just means that time has elapsed and your blood glucose has changed. If you want to compare your meter result to the lab result, you must be fasting. Bring your meter to the doctors office, and test yourself by fingertip within five minutes of having blood drawn from your arm by a healthcare professional. Keep in mind that the lab could use different technology than EASYMAX S1 blood glucose meter, and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result. For accuracy and precision data and for important information on limitations, see the instructions that come with your test strips. 36 Chapter 4: Meter Memory, Transfer Memory, Transferring Test Results Your meter stores a maximum of 480 test results with the time and date of the test. You can review them at any time. When the memory is full, the oldest result is dropped as the newest is added, so it is very important to have the correct time and date set in the meter. For further analysis, you can transfer test results to your personal or tablet computer etc. through NFC and then use GlucoManagerTM to check your glucose value. NOTE:

1. Do not change your therapy based on one individual result in memory. 2. The memory is not lost when you replace the battery. You do need to check that the time and date are still correct for future readings. See Section "Setting the time and date" in Chapter 1. 3. Once 880 results are in memory, adding a new result causes the oldest one to be deleted. 37 Viewing & DeletingTest Results 1. Press OK button to turn on the meter. 2. Press Left button to view averages of 30-day in

, and 7/14/30/90 days. 3. Press Right button to view individual test results with 3 different light of glucose level in green, red or blue. 4. To delete a test result, press OK button for more than 3 seconds and display shows "

". Then press OK button to confirm the deletion. 5. Press Right button to keep reviewing the results, or press to go back to testing mode. 38 Running With Your Smartphone The last 40 test results can be transferred to your phone with NFC. To Transfer data, open GlucoManager app as well as the meter can be turned on or off. 1. Open the GlucoManager app of 2. Let you mobile be close to the meter buttons, in order to make transactions of glucose data with GlucoManager. your phone and tap and choose NFC to get ready to scan data. NOTE:

1. Assure your personal smartphone comes with NFC function before you activate the data transmission. While transmitting, make sure the position of NFC from your smartphone tags the button parts of your glucose meter. 2. Make sure you only use a personal smartphone to transmit the data from your personal glucose meter. 3. After transferring all data, the glucose meter shows "data is saved successfully". 39 Chapter 5: Maintenance and Troubleshooting Installing Batteries The meter uses two alkaline 1.5V (AAA) batteries. Batteries will normally last for more than 2000 tests. Other types of 1.5V (AAA) batteries are also acceptable, but the capacity of test times may differ. Install the batteries when you first use the meter or replace with new batteries when the "LP" (low power) message and the low battery symbol appear on the display. The meter will not turn on the first time batteries are installed. Please press and hold power button or insert the test strip to turn your meter on. The meter will turn off automatically. Or you can press and hold power button to turn your meter off. Low battery symbol NOTE:

1. The meter wont delete earlier records after you replace batteries. 2. You should reset the time and date again after you replace the batteries. See Section "Setting 3. CR2032 x 2 batteries are available at most stores. You may take the old batteries with you for the time and date" in Chapter 1. replacement. 4. Remove batteries when you will not be using the meter for one month or more. 40 Cleaning and Disinfecting Your Meter and Lancing Device Choosing the disinfectant The recommended EPA-registered disinfected product is as follow:

PDI Super SANI-CLOTH Germicidal disposable wipe (EPA Reg. No.:9480-4) Super Sani-Cloth germicidal wipe contains active ingredients: n-Alkyl (60% C14, 30%C16, 5%C12, 5%C18) dimethyl benzyl ammonium chlorides and n-Alkyl (68%C12, 32%C14) dimethyl ethylbenzyl ammonium chlorides and they have been shown to be safe for use with the EASYMAX S1 Blood Glucose Meter, but any other disinfectant product with the EPA registration number may be used on this device. Please purchase in retail stores like Walmart and Office Depot. You could also purchase on the PDI website:http://www.pdipdi.com/ or online retail sites like amazon.com, medline.com, and Expression medical supply Inc. http://www.exmed.net/. Cleaning and Disinfection Instruction Please keep the meter and lancing device free of dirt, dust, bloodstain, and water stains. Please follow the following guidelines to clean and disinfect your meter and lancing device. The meter and lancing device have been validated so that they can withstand cleaning for up to 9 times per day. After every use, follow the cleaning instruction to prevent the growth of any microorganism and also to help improving the effectiveness of disinfection. Then follow disinfection instruction once per week which could effectively kill blood borne pathogens, such as viral hepatitis and prevent cross-contamination. If the devices are being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be disinfected prior to use by the second person. 41 Cleaning Instruction: All blood and other body fluids must be thoroughly cleaned from surfaces and objects before disinfection by the germicidal wipe. Open, unfold and use first germicidal wipe to remove heavy soil after every use. Disinfection Instruction: Unfold a clean wipe and thoroughly wet all the surface of the meter, including the strip port and other connection port. Unfold a clean wipe and thoroughly wet all the surface of the lancing device, including cap or AST cap if used. Treated area must remain visibly wet for a full 2 minutes. Let the devices air dry for 0.5 minute. Do disinfection once per week. Do:

Make sure the meter is turned off during cleaning Keep the test strip vials tightly closed when disinfection performing procedures because from the disinfectant may affect the performance of the strip After cleaning or disinfection, please perform the physical appearance and performance check of devices. Do Not:

Get any moisture in the test strip slot. Spray any cleaning solution directly onto the Put the meter under water or liquid. Pour liquid into the meter. cleaning the and disinfection. and fumes meter. the Please follow the instruction on page 43 to 46. 42 1. Meter clearing/disinfection area A B C D E F 2. Lancing device clearing/disinfection area Code Name A B C D E F Strip Slot Front Case Side Case Front Buttons Back Case Battery Cover Code Name A B C D E F G Lancet holder Trigger button Sliding barrel Body Cap Depth adjust ring AST Cap Possibility of contact with blood High High High High High High Possibility of contact with blood High High High High High High High 43 Physical Appearance check of the meter after each cleaning or disinfection Check item Accept Result Is it clear to see through the transparency part, like display?

Are the strip slot and other components free from erosion?

Is the labeling on the meter legible?

Action: If any of the results is No the user should call the Customer Care Service toll-free at Yes Yes Yes 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM) for assistance. Performance check of the meter Steps Check item After each cleaning 1. Press and hold button for 3 sec. 2. Press and release or button. Is meter powered on?

Did the meter beep?

Is the testing result correctly stored in the memory?

Can the result be clearly read?

Accept Result Yes Yes Yes Yes 44 1. Insert test strip 2. Apply Level 2 control solution 3. Remove test strip 4. Press and hold button for 3 sec. 5. Press and release or button. After each disinfection Is the meter powered on?

Any reading?

Is the reading within control range?

Is meter powered off?

Is meter powered on?

Did the meter beep?

Is the testing result correctly stored in the memory?

Can the result be clearly read?

Yes Yes Yes Yes Yes Yes Yes Yes Action: If any of the results is No, stop using the device. Please call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM) for replacement with a new meter. Physical Appearance check of the lancing device after each cleaning or disinfection Check item Are all components free from erosion?

Action: If any of the results is No the user should call the Customer Care Service toll-free at Accept Result Yes 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM) for assistance. 45 Performance check of the Lancing device Step Check item After each cleaning 1. Cap the normal cap to the lancing device. Can the cap be screwed on the lancing device?

2. Pull on the sliding barrel and then release. Can the lancing device click?

3. Press trigger button. Can the lancet be fired?

After each disinfection 1. Install the lancet on the lancet holder. 2. Cap the AST cap to the lancing device. 3. Remove the AST cap. Recap the normal cap to the lancing device. Can the lancet be fixed on the lancet holder?

Can the AST cap be screwed on the lancing device?

Can the cap be screwed on the lancing device?

Can the penetration depth ring be adjusted?

4. Pull on the sliding barrel and then release. Can the lancing device click?

5. Press trigger button. Action: If any of the results is No, please call the Customer Care Service toll-free at 866-994-3345(Eastern Can the lancet be fired?

Standard Time, Mon-Fri 8:00AM~6:00PM) for replacement with a new device. 46 Accept Result Yes Yes Yes Yes Yes Yes Yes Yes Yes Cleaning and Disinfection Frequency The meter and lancing device can sustain 14,000 cleaning cycles and 208 disinfection cycles which represents cleaning 9 times per day and disinfecting (with a pre-clean step) once per week over the 4 year use life of the device. 4 year product life is for properly cleaning and disinfection. After 4 years, the meter must be replaced with a new meter. 47 Maintenance and Testing Your meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong.

(See "Screen Messages" and what to do about them.) To make sure the display is working properly, turn off the meter. Press and hold power button to see the complete display. All the indicators should be clear and look exactly like the picture to the left. If not, 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. 48 Screen Messages and Troubleshooting Never make treatment decisions based on an error message. If you have any concerns, call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). Message What it means?

System error There may be a problem with the meter. What to do?

Replace the batteries first. Refer to pages 15 and 40. If this error message appears again, please contact your local dealer. Volume detector error The volume of blood or control solution is NOT enough. Repeat the test with a new strip. If Err appears again, please contact your local dealer. 49 Message What it means?

Humidified / Used strips The meter has detected a problem with the test strip. What to do?

Repeat the test with a new strip. Refer to pages 28-29 for information on sample application. Memory Error Replace the batteries first. If ERROR 005 appears again, please contact your local dealer. 50 Message What it means?

Test result is higher than 630 mg/dL (35 mmol/L). What to do?

Re-check your glucose level. If the result is HI again, obtain and follow instructions from your healthcare professional without delay. The test result is lower than 20 mg/dL (1.1 mmol/L). This may require immediate treatment according to your healthcare professionals recommendations. Although this message could be due to a test error, it is safer to treat first and then do another test. 51 Message What it means?

The Ht and thermometer icon appears. Temperature is too high, outside the required range of 5C -

45C (41F - 113F). This alerts users that an incorrect result may occur if the test continues. What to do?

Relocate the meter to a location with temperature between 5C - 45C (41F

- 113F). The Lt and thermometer icon appears. Temperature is too low, outside the required range of 5C -

45C (41F - 113F). This alerts users that an incorrect result may occur if the test continues. Relocate the meter to a location with temperature between 5C - 45C (41F

- 113F). 52 Message What it means?

No result in memory The meter doesnt run any test yet. What to do?

You can still perform a blood glucose test and get an accurate test result. Low power The meter batteries do not have enough power to perform a test. Replace the new batteries. 53 Message What it means?

System error There may be a problem with data transfer. What to do?

Repeat the upload. Refer to pages 41. If this error message appears again, please contact your local dealer. 54 Chapter 6: Technical Information Specifications Brand name Range Response time Memory sets Operating condition Storage and transportation condition Blood sample Temp. Relative Humidity Temp. Relative Humidity Hematocrit (Hct) Power Battery life Display dimension Device dimension H W D Weight Principles Software via smartphone EASYMAX S1 Blood Glucose Meter 20~600 mg/dL 5 seconds 880 test results 41F -113F (5C-45C) R.H. 90%

36F -86F (2C -30C) R.H. 90%

0.6 L Fresh blood from fingertip, palm, or forearm 0~70%

CR2032 Battery * 2 ct. Over 2000 tests 39.9 x 35.8 mm 90 x 49 x 12 mm 41grams (without batteries) Electrochemical biosensor technology GlucoManagerTM Diabetes Management 55 Limitations The test strips are used for fresh venous blood and capillary whole blood samples. 1. DO NOT use neonate blood sample. 2. Not to be used for diagnosis or screening of diabetes. 3. Alternate site testing with this system can be used only during steady-state blood glucose conditions. 4. Measurements from alternate site testing should never be used to calibrate a continuous glucose monitor

(CGM) or entered into insulin dose calculators for insulin dosing recommendations. 5. Extreme humidity may affect the results. A relative humidity greater than 90 % may cause incorrect results. 6. The system should be used at a temperature between 50F and 104F (10C and 40C). Outside this range, the system may get incorrect results. 7. DO NOT reuse the test strips. The test strips are for single use only. 8. Hematocrit: The hematocrits between 20% and 60% will not significantly affect the results. Hematocrit below 20% may cause higher results. Hematocrit above 60% may cause lower results. If you do not know your hematocrit level, please consult with your healthcare professional. 9. Altitude up to 10,000 feet above sea level has no effect on readings. 10. The below substances up to the test concentration will not affect the test results. Interfering substance Concentration tested up to (mg/dL) Gentisic Acid Ascorbic Acid Ibuprophen Methyldopa Sodium Salicylate Tetracycline 6 4 50 2 50 1.5 56 Tolbutamide Galactose Maltose Manose Sucrose Xylitol Glipizide Bilirubin Cholesterol Creatinine Triglycerides Fructose 100 20 20 10 50 200 8 25 500 30 1000 30 11. Interference was observed with the substances below at the concentrations listed. Interfering substance Interference observed at (mg/dL) Acetaminophen Dopamine L-Dopa Xylose Uric Acid 8 5.2 4 8 15.9 57 Technical Information Near-field communicationNFC Wireless Technology Wireless Technology This device complies with United States Federal Communication Commission (FCC) standards. The device complies with FCC Part 15 Rules. Operation of the device is subject to the following conditions:

1. This device may not cause harmful interference and 2. must accept any interference received, including interference that may cause undesired operation. Compliance with these guidelines means that under normal, daily circumstances, the device should not affect the operation of other devices. In addition, the device should operate normally in the presence of other devices. Changes or modifications to the device not expressly approved by EPS Bio Technology Corporation could void the users authority to operate the device. 58 operation. Electromagnetic Compatibility This meter meets the electromagnetic immunity requirements as per EN ISO15197. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. In addition, the meter meets the electromagnetic emission requirements as per EN 60601-1-2. The meters electromagnetic mission is thus low. Interference from the meter to other electrically-driven equipment is not anticipated. The device complies with Part 15 of the FCC Rules. Operation is subjective to the following two conditions:

1. This device may not cause harmful interference and 2. This device must accept any interference received, including interference that may cause undesired This equipment complies with FCC and IC radiation exposure limits set forth for an uncontrolled environment. This equipment is in direct contact with the body of the user under normal operating condition. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. NOTE:

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this product does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. 59 lncrease the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Changes or modifications not expressly approved by the party responsible for compliance (i.e. the manufacturer) could void the users authority to operate the equipment. CAUTION:

To assure continued FCC compliance:

1. Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the equipment. 2. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator & your body. 60 Device Information EASYMAX S1 SMBG System, EASYMAX S1 Blood Glucose Test Strips, EASYMAX S1 Blood Glucose Meter, EASYMAX S1 Level 2 Control Solution, EASYMAX S1 Level 3 Control Solution Reference:

* American Diabetes Association. Standards of medical care in diabetes-Table 10 Diabetes care. 2011; Vol. 34, Suppl. 1, S21. Manufacturer:

EPS BIO TECHNOLOGY CORP. No.8, R&D RD. III, Hsinchu Science Park, Hsinchu, Taiwan 30077 TEL+886-3-6686868 FAX+886-3-6686866 E-mailinfo@epsbio.com.tw Warranty EPS warrants the original purchaser for a period of 4 years from the date of purchase. This means during the warranty period if the Self-Monitoring Blood Glucose System does not work for any reason (other than obvious abuse), EPS will replace it with a new system or an equivalent product free of charge. Websitehttp://www.epsbio.com 61 Please read EASYMAX S1 Users Manual before operation. If you have any questions and/or need assistance, please contact us as follows:

Within the USA, call toll-free: 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). During non-service hours, please contact your healthcare provider. Outside the USA, call your authorized representative or write to:

Customer Service E-mail: info@epsbio.com.tw Lancing Device Meets the requirements of MDD 93/42/EEC Manufacturer:

STERILANCE MEDICAL (SUZHOU) INC. No. 32 Xinlian RD. Pingjiang Suzhou P.R. China 215031 TEL0086 (512) 67217661 Lancet Meets the requirements of MDD 93/42/EEC Manufacturer:

SAE HAN MEDICAL CORP.

# 700-113 PUB GOT-DONG, IL SAN-GU, GOYANG-CITY, KYUNGGI-DO, KOREA TEL82-31-923-4330 P/N: 71800580A_0129A_01 FAX0086 (512) 67217663 E-mailguopings@xinda-medical.com FAX82-31-923-4331 E-mailsaehan@saehanmed.com 62

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

Authority to Act as Agent Date: February 4, 2020 American Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 To Whom It May Concern:

AUDIX Technology Corporation is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. We also declare that the information provided to the FCC is true and correct to the best of our knowledge (47 CFR 2.911(d)) and we have been informed of the grantee responsibilities (47 CFR 2.909) with regard to certified equipment. Thank you, Agency Agreement Expiration Date: February 04, 2021 By: HP su 0 HP Su

(Signature') (Print name) Title: Product Manager On behalf of: EPS Bio Technology Corp.

(Company Name) Telephone: +886 3 6686866

'_ Must be signed by applicant contact given for applicant on the FCC site. or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead. 053019 12

Request for Confidentiality Date: February 4, 2020 Subject: Confidentiality Request for: FCC ID: 2AQBR-D064 Pursuant to FCC 47 CFR 0.457(d) and 0.459 and IC RSP-100, Section 9.4, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit Short Term M Permanent Block Diagrams Short Term External Photos Short Term Permanent *? Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Parts List & Placement/BOM Short Term Permanent Tune-Up Procedure Short Term M Permanent Schematics Short Term Test Setup Photos Short Term Permanent * Users Manual EPS Bio Technology Corp. has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of __*__ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public before the requested period has expired. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications:

IC currently only distinguishes Permanent Confidentiality exhibits as shown above. Short Term confidentiality is not considered applicable to IC applications. Sincerely, Be Ho P. Su pro HP Su

(Product Manager *) (Print name)

- The asterisked items (*) require further information to be provided to ACB before permanent confidentiality will beextended to these exhibits. Please refer to FCC KDB 726920 and the specific Document link for DO1 found at:

https://apps.fec.gov Joetef/kdb/forms/l TSSearchResultPage.cfin2switch=P&id=41731 and review section II, 3) regarding specific information that must accompany these requests.

+ -Please refer to http://aebcert.com/documents/misc-docs/Memo-Short-Term-Vs-Standard-Con fidentiality.pd! for complete details. 4. Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead. 053019 12