FCC ID: WSX-IGM-1007A Blood Glucose Monitoring System

Blood Glucose Monitoring System Dear GluNEO M3 blood glucose monitoring system Owner, Thank you for choosing the GluNEO M3 Blood Glucose Monitoring System. This manual contains everything you need to know about your new glucometer and how it works. Please take a moment to read the instructions carefully. We understand that self-testing of blood glucose level provides a way to control your diabetes and may give you peace of mind by testing regularly. GluNEO M3 has been developed to provide you with a fast and accurate reading in a convenient and simple process. Our goal for the GluNEO M3 Blood Glucose Monitoring System is to provide you with the best quality healthcare products coupled with superior customer service. Always consult with your healthcare professional, before making any changes to your diabetes management. The GluNEO M3 Blood Glucose Monitoring System is for in-vitro diagnostic use only. Customer Service is available 24 hours a day, 7 days a week, and 365 days a year. Please call customer support center in your local area. Important information The GluNEO M3 Blood Glucose Monitoring System is intended for use outside the body (in-vitro diagnostic use only). It should be used only for testing blood glucose with fresh whole blood samples(Capillary and/

or venous). It should not be used for the diagnosis of diabetes. Consult with your physician or diabetic healthcare professional about daily management of your diabetes and proper use of the glucometer. Please pay close attention when handling blood. Improper procedures may cause serious hazards to your health. The GluNEO M3 Blood Glucose Monitoring System contains small parts, which could be a choking hazard for children if swallowed.

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Test principle GluNEO M3 blood glucose test strip is the bio-sensor which is composed of the FAD-dependent Glucose Dehydrogenase(enzyme). FAD-GDH(enzyme) quantitatively reacts with the glucose in the whole blood and the mediator. Glucose in the whole blood sample reacts with the reagent of the test strip and generates an electrical. The amount of current, which is related with glucose concentration, is measured by the current, for which the method is called amperometry. have taken cleaning and disinfection measures. WARNING All parts of the kit are considered bio-hazardous and can potentially transmit infectious diseases, even after you Always use a new, sterile lancet. Lancets are for single use only. Avoid getting hand lotions, oil, dirt or debris in and/or on the lancets and reusable lancing device. Please refer to page 29 for cleaning and disinfecting GluNEO M3 Blood Glucose Monitoring System. Do not change your medication based on the GluNEO M3 meter test results without contacting your physician or healthcare professional first. Do not assemble or disassemble the blood glucose test meter. Keep out of direct sunlight. CAUTION Please keep your monitoring system out of reach of children. Make sure it does not come in contact with water and moisture. Avoid getting dirt and moisture. Close supervision is necessary when equipment is used by, on, or near children, handicapped persons or invalids. Do not place the equipment in liquid, nor put it where it could fall into liquid. If the equipment becomes wet, Do not use accessories which are not supplied or recommended by the manufacturer. Do not place anything on top of the equipment. unplug it before touching it. NOTE:

Blood Glucose Monitoring System may also be called as Blood Glucose Test Meter, the Meter, Test Meter in this Blood Glucose Test Strip may also be called as the Test Strip, Strip, for which they equal meaning to each other. manual, for which they have equal meaning to each other.

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Table of contents Learning the System Intended use GluNEO M3 kit contents GluNEO M3 meter GluNEO M3 meter display GluNEO M3 test strip Before Testing Setting your meter Auto-coding function Performing a glucose control solution test Performing your test Testing blood - preparation Performing a blood test with your finger tip Test Strip ejector function Reviewing your results Reviewing your blood glucose Reviewing your averages Deleting test results Alternate site test Lancing and sampling from an alternate site area Lancing device clear tip is used for alternate site testing Caring for your GluNEO M3 system Cleaning your meter and maintenance Storage of your GluNEO M3 system Bluetooth Function Transferring your result data Battery installation Disposing Trouble-shooting Inconsistent or unexpected test results Warranty Specifications Symbol reference

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5 6 7 8 9 10 12 13 - 16 16 - 17 18 - 21 22 23 23 24 25 - 27 27 - 28 29 30 - 31 32-33 34 35 36 37 - 38 39 40 41 42 Learning the system Intended use The GluNEO M3 test meter is used with GluNEO M3 test strip for the measurement of glucose in fresh whole blood samples(Capillary and/or venous). It should not be used for the diagnosis or screening of diabetes or for the testing of new born babies. GluNEO M3 Blood Glucose Monitoring System is intended for use outside the body only (in-vitro diagnostic use). GluNEO M3 Blood Glucose Monitoring System is for self-testing by people with diabetes and by healthcare professionals. Recorded results make it easier for your doctor to access your metabolic control. However, the self-testing should not take the place of overall diabetes management assessment from your doctor. CAUTION Do not use system for any other purpose than blood glucose test. Cholesterol concentrations > 500 mg/dL or triglyceride concentrations > 3,000 mg/dL may produce elevated reading. Icodextrin does not interfere with GluNEO M3 test strips. Do not use during or soon after xylose absorption testing. Xylose in the blood will cause interference. Before using any product, please read all instructions. Consult with your physician or diabetic healthcare professional about daily management of your diabetes and proper use of the glucometer. If you have any questions about the GluNEO M3 product, please contact your local representative. NOTE:

Before using GluNEO M3 system, read all instructions in this manual, and practice for accurate and safe test. You should have commentary recommendation from your diabetes care professional for the proper use of the meter and daily management of your diabetes. If you think your blood glucose results are too low or too high, or if the results are doubtful, please contact your doctor. If your blood glucose result is unusually low or high, or you do not feel the result is correct, repeat the test again with a new test strip. If the results are still inconsistent, please consult with your physician before making any decision in controlling your diabetes.

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GluNEO M3 kit contents 3 1. GluNEO M3 Meter 2. GluNEO M3 Test strip(optional) 3. Reusable Lancing Device(optional) 4. Lancets(optional) 5. Instructions for use 6. Warranty Registration Card 7. Carrying Case 8. Patient Logbook 9. 2EA 3V Coin Battery (CR2032) Your GluNEO M3 Blood Glucose Monitoring System has been sealed to protect the contents. If you find your seal has been broken, please return it to the place of purchase.

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GluNEO M3 meter Data Port:

Send Stored data to the PC Display Screen:

Displays your test results, symbols, and messages. Up/Down Arrow Buttons:

Scroll up or down to adjust settings or retrieve memory. Power/Enter Button:

Power the meter on/off, prompts memory data and acts as an "Enter"

button during setup and after tests. Test Strip Ejector:

Releases and discards test strip. Test Strip Port:

Insert the GluNEO M3 test strip Battery Cover Serial Number Synthetic clothes, carpets, etc., may cause damaging static discharge in a dry environment. CAUTION Do not use GluNEO M3 glucose test meter in a dry environment, especially if synthetic materials are present. Do not use GluNEO M3 glucose test meter near cellular or cordless telephones, walkie-talkies, garage door openers, radio transmitters, or other electrical equipment that are sources of electromagnetic radiation, as these may interfere with the proper operation of the glucose test meter.

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GluNEO M3 meter display Low Battery Warning Before Having a Meal After Having a Meal Pasting Blood Drop Symbol for Test Memory Mode Setting Mode Bluetooth Function Average Test Result Warning Measurement Unit Date Time Test Strip Code Alarm Control Solution

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GluNEO M3 test strip Target to apply blood Confirmation window Contact Bar results. GluNEO M3 test strips and vial away after the expiry date. Store the GluNEO M3 test strip vials in a cool, dry place. Keep out of direct sunlight. Do not freeze. Store test strips in their original vial only. Do not mix the test strips in new vials or in any other container. Immediately replace the vial cap and close tightly after removing any test strips from the vial. CAUTION Make a note of the expiry date, which is six month from the date you first open a new vial of test strips. Throw Do not use the test strips after the expiration date printed on the package or vial, since it may cause inaccurate GluNEO M3 test strips should be single use only. DO NOT RE-USE. Do not test at temperatures below 10C(50F) or above 40C(104F). Do not test in the condition that humidity is below 10% or above 90%. Do not bend, cut, or alter the test strip. Avoid getting dirt, food, and water on the test strip with wet hands. Avoid getting dirt, food, and water on the color-coding label (backside of test strip) Refer to additional information in the GluNEO M3 test strip package. Use only GluNEO M3 test strip with your GluNEO M3 meter. Before testing WARNING To reduce the chance of infection:

Lancing device and lancets should NOT be shared with others. Always use a new lancet and a new blood glucose test strip. Practice using the lancing device and become accustomed with its use. Wash your hands in warm and clean running water using soap before testing. Avoid getting hand lotion, oils, dirt or debris on the lancets or on the lancing device. Dry your hands completely before testing. Lancets and blood glucose test strips should be single use only.

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Setting your meter The GluNEO M3 Meter has a wide variety of functions to choose. The setup mode you can turn activity/meal flags, set the date/time, designate three unique averages, and set up to five daily alarms. Power On Press for 3 seconds at least. User Activity Option After pressing and releasing either or buttons to turn the User Activity Option on/off, push button. Year After pressing and releasing either or buttons to set the year, button. push Date / Time After pressing and releasing either or buttons to set the date and time, respectively push button. Test Unit After pressing and releasing either or buttons to set the test unit(mg/dL or mmol/L), push button. Number of days for average After pressing and releasing either or buttons to set the number of days for average calculation (3 different settings possible), push button.

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Alarm on/off After pressing and releasing either or buttons to turn the alarm on/off, push button. Alarm time After pressing and releasing either or buttons to set the alarm button. hour and minute, push Alarm After programming the number of desired alarms (5 alarms button. possible),push CAUTION VERY IMPORTANT: Set the right test unit. Your GluNEO M3 Meter is pre-set to mg/dL as test unit. A wrong test unit will lead to wrong test result display. Please consult your healthcare professional if youre not sure which test unit to use. Without setting the date properly, the average glucose level and the results in memory will not show proper values. It is recommended to set the glucose test meter before use and also when new batteries are installed. You cannot test your blood glucose in the setting mode. To turn the meter off during the setup, press for at least 3 seconds.

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Auto-coding function 1. GluNEO M3 has automatic code recognition function (e.g.125) 2. It recognizes the code number automatically. This is a very convenient function preventing the inconvenience of setting the code number on the glucose test meter every time. Check the code on the vial to see if the codes match each other M3

:

125

:

:

:

CAUTION Do not bend the glucose test strip to prevent the automatic code recognition failure. If the code recognition label is damaged, code recognition may fail. Please check the code number on the LCD window together with the code number on the glucose test strip vial to see if code numbers match each other.

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Performing a glucose control solution test GluNEO M3 control solution contains a known amount of glucose that reacts with GluNEO M3 test strip. By comparing your control solution test results with the expected range printed on the test strip vial, you are able to check that the meter and test strips are working properly, and that you are performing the test correctly. It is very important that you perform routine checking to ensure accurate results. The Glucose control solution should be used

- Before using a new box of test strips.

- Whenever you suspect the blood glucose test meter or blood glucose test strip is not functioning properly.

- If your blood glucose test results are not consistent with your symptoms, or if you think results are not accurate.

- If you have dropped the blood glucose test meter.

- For quality control in the point of care usage.

- For teaching or learning the system.

- When using the meter for blood glucose tests after any disinfection procedure. 1. Firmly insert the test strip into the meter test port. Insert deeply in direction of arrow on test strip. Please do not insert the glucose test strip upside down. 2. When you insert the glucose test strip into the glucose test meter, the power automatically adjusts the meter accordingly. 3. Press and release either the or button, then, Control Solution bottle icon will appear. Then, press (

). M3

:

125

:

:

:

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4. Check the expiration date before performing a control solution test. Do not use if expired. Please note the expiration date marked on the control solution bottle. 5. Gently shake the control solution before use. 6. Discard the 1st drop of control solution. This will eliminate any residue. Place a drop of control solution liquid on a clean, dry surface (e.g. the lid of the test strip vial) 7. Dip the test strip into the control solution liquid. Results will appear in 5 seconds. Compare the result to the range printed on the test strip vial. Result should fall within that range. control solutions made by other manufacturers. CAUTION Control solutions is for in-vitro diagnostic use only. This means that it is only used for testing outside the body. Control solution is exclusively made for the GluNEO M3 Blood Glucose Monitoring System. Do not use other brand Check the expiration date on the vial. Do not use, if expired. Once opened, use it for the next three months only. Record the discard date on the control solution bottle. Discard Do not swallow. This is NOT for human or animal consumption. The control solution bottle icon contains letter C, so as not to be confused with the medication bottle. This will allow you to understand differences between a control solution test and an actual blood test. after three months.

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For example only If you are using the normal control solution, according to this particular vial of strips, your meter should show a number between 80 and 120. L: 35-65 N : 80-120 H : 225-345 Please note that the control values shown in the picture are not control ranges. It is recommended that glucose control solution is stored at room temperature 20~25C (68~77F) before testing. NOTE Check the expiration date before performing a glucose control solution test. Do not use if it expired. Once opened, the control solution expires after 6 months. If your control solution test falls out of range, please follow the next steps before contacting customer support:

- Check the expiration dates on all the products you are using. Be sure you are using GluNEO M3 Control Solution.

- Try another control solution test. If this test falls out of range, try another control solution test with a new unopened bottle of test strips. If you continue to get control soulution test results that fall outside the range, do not perform a glucose test. Please call customer support in your local area.

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Follow-up action 1. Check your meter and test strips with the glucose control solution. 2. Perform your test again. CAUTION If your glucose control solution falls out of range, do not perform a glucose test and please contact your local representative. The glucose control solutions measurement range has nothing to do with individuals blood glucose level, as its own purpose is to check the status of test strip and meter. Discard the used control solution and test strips carefully, according to the local regulation. Performing your test Testing blood - preparation Lancing device is a convenient medical tool for collecting capillary blood samples for glucose monitoring or other tests which require one or two drops of blood. Being a more advanced lancing device, it provides ultimate safety and comfort for obtaining blood samples. An adjustable tip offers 5 different strength levels of skin penetration for individual users comfort, while a lancet ejector enables the safe disposal of the used lancet. As an added bonus, this also comes with a transparent tip for AST (Alternative Site Testing). If the lancing device is to be used by another person, the unit must use a new tip or properly disinfected CAUTION Never use a lancet that has been used by someone else. This could lead to contamination. Do not leave the lancet in the device after use. A new lancet must only be placed into the lancing device directly before testing. Always dispose of the used lancet in a biohazard garbage container. This device has many small parts and could be a choking hazard for children if swallowed. In the case of hospital use, hospitals need to observe their own infection control protocols in order to avoid any contamination.

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Components Ejection System Lancet Holder Clear Tip Depth Indicator/

Adjustable Tip Release Button Sliding Barrel Using the clear tip (AST) 1. Place the lancing device and lancet on the skin in the chosen area, press and hold it continuously for a few seconds, then push the release button to take a blood sample. 2. Watch through the clear tip until a sufficient blood sample is taken. If there is not enough blood, gently massage the area until a sufficient sample is collected. Storage Products must be stored at room temperature protected from sunlight or moisture. Cleaning and disinfection

- Clean and wipe the outer part of lancing device once a week at the minimum with a soft cloth dampened with mild soap and water. Wash the adjustable tip and clear tip, once a week with mild soap.

- DO NOT immerse the lancing device in water or liquid. Warranty Lancing device has a 2-year warranty from the date of purchase. A malfunctioning device should be returned to the following address

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Performing a blood test with your fingertip Step 1 1. Firmly insert the test strip into the meter test port in the direction of arrow on test strip. Please do not insert the glucose test strip upside down. 2. When you insert the glucose test strip into the glucose test meter, the power automatically turns on with the code. Make sure the code number matches on the test strip bottle (e.g. 125). GluNEO M3 automatically recognizes the test strip code number and adjusts the meter accordingly. M3

:

125

:

:

:

3. A blinking blood drop symbol will appear at the top of the screen, which indicates that the meter is ready for testing. If the code is not displayed after for a while, pull the glucose test strip out of the port, and re-start the procedure from the beginning. If the code on the LCD display window as well as on the glucose test strip vial does not match, try another new glucose test strip. If the mismatch persists, please contact your local representative for assistance. CAUTION Avoid testing under direct sunlight, for a more accurate test result. If you apply your blood sample too early, Er5 message will appear on LCD. Please refer to Page 35.

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Step 2 To obtain a suitable blood samples Before obtaining a blood sample, wash your hands with warm, clean water and soap. Dry hands completely before testing. WARNING All parts of the kit are considered biohazardous and can potentially transmit infectious disease, even after you have Avoid getting hands lotion, oil, dirt or debris in or on the lancets (single use only) and the lancing device. Wash your hands thoroughly with soap and clean water after handling the meter, lancing device and/or test strip. conducted cleaning and disinfection measures. 1. Unscrew the lancing device tip. 2. Insert a sterile lancet into the lancing device. 3. Twist the protective cover off. Do not discard. 4. Put the lancing tip back and twist it tightly. 5. To adjust the depth setting:

Use strength level 1-2 for soft skin, 3 for average skin, 4-5 for thick or calloused skin. 6. Pull the end of the lancet device back. 3 3 3 1 2 3 4 5 3 1 2 3 4 5 3 1 5 1 2 3 4 5 3 3 1 5 1 2 3 4 5 3 1 5 1 2 3 4 5 3 3 1 5 1 2 3 4 5 3 3 3 3 5 5 1 3 1 3 3 3

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3 7. To prick your finger, push the center button. CAUTION Do not share reusable lancing device with anyone including other family members. If the blood smears or runs, do not use such blood sample. Dry the area and gently squeeze another drop or puncture a new area of the finger. Step 3 Correct Completely Filled Incorrect Poorly filled GluNEO M3 Test Meter only requires 0.9 ul sample volume. Stick the edge of the test strip to the drop of blood. The blood will automatically be drawn into the test strip channel. When your sample blood is enough, your meter will automatically count down. Apply your blood to the glucose test strip and do not take off your finger until you get the beep sound. The test will automatically start. Please respect recommended quantity of blood sample. Too much blood may cause malfunction of your meter by contaminating it. CAUTION Apply your blood to the glucose test strip and do not take off your finger until you get the beep sound, The test will If the countdown does not start, do not add more blood to the glucose test strip. Discard the glucose test strip and re-start testing. If you do not conduct the test within 3 minutes, the glucose test meter will automatically power off to save battery life. In this case, test procedure should start again from the beginning. You may get an inaccurate result if the blood sample is not completely filled. automatically start

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Step 4 After the beeping sound, test will begin automatically, and your results will appear in 5 seconds. It should begin counting down from 5 to 1 second on the LCD display window. LCD window will display the result of your blood glucose level, temperature and time. If you selected to use the User Activity option during set up, press and release or button to select the activity ( ) that correlates with your result, then press and release the power button

. If you do not select to use User Activity option during set up, press the power button

. Record the result value in your logbook. When glucose test strip is removed, glucose test meter turns off automatically. CAUTION If the test result is out of the test range, HI/Lo message will be shown on the LCD window. Safely discard used glucose test strips and lancets in the proper place, according to the local regulation.

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Test strip ejector function Disposing of your test strip 1. Once the test is complete, push the test strip forward to remove the test strip from the meter. 2. Used test strips may be considered biohazardous waste in your area. Be sure to contact your local representative for proper disposal. Disposing of your lancet 1. Push the needle into the protective cover. 2. Pull the lancet out and discard accordingly. If you push the ejector button forward too much, it may be part of the failure. CAUTION Do not give strong impact to blood glucose test meter. Please follow the waste disposal regulations on the used lancets and strips imposed by your local authorities.

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Reviewing your results The GluNEO M3 meter stores up to 1,000 test results in its built-in memory, along with the average glucose level for the number of days, which you had preset the glucose test meter to calculate. Reviewing your blood glucose button. The most recent result appears first. Note the time and day of your blood Press and release glucose result. Press and release the button and your previous result will appear on the display Reviewing your averages Press and release the button, and your average result will be displayed. Average Test Result Test Unit Test Result Amount Average Test Result Days

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Deleting test results Deleting individual test result To delete any individual test result in the memory, press or button for will start blinking. After the third beep sound, 3 seconds. Then displayed you may hear that the test result has been deleted. Deleting all the test results To delete all test results in the memory press and button for 3 seconds. will start blinking. After the third beep sound you Then displayed may hear that the test results have been deleted.

, CAUTION Deleted test results cannot be recovered. Please be careful in deleting the test results.

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Alternative site test Dorsal Hand Ventral Palm Fingertips GluNEO M3 blood glucose monitoring system gives you the ability to obtain a blood sample for testing your blood glucose from different areas of your body. The figure shown above displays the areas where you can test using your GluNEO M3 meter. You may test your blood glucose from your palm (ventral palm or dorsal hand), or fingertips. IMPORTANT It is recommended that alternative site testing be used when glucoses are stable: before meals and before bedtime. However, when glucoses are changing, blood from the fingertip may show these changes sooner than blood from other body areas. LIMITATION 1. Alternative site testing results should never be used to calibrate continuous glucose monitoring systems. 2. Alternative sampling results should never be used in insulin dosing calculations.

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Lancing and sampling from an alternative site area Sampling from your ventral palm or dorsal hand allows you to use your fingertips less often. You may find that obtaining a blood sample from an alternative site is less painful than using a fingertip. Getting a blood sample from your forearm or palm is different than getting a sample from your fingertip. Ventral palm/Dorsal hand Choose a fleshy area on the palm, below your thumb or pinky finger. Select a spot without any visible veins and away from any deep lines. This may cause your blood sample to smear. IMPORTANT We recommend that you test on your fingertips if you are testing for hypoglycemia (low blood glucose) or if you are suffering from hyperglycemia unawareness. To ensure accurate results when lancing your palm (ventral palm or dorsal hand), clean the test site with soap and water. Make sure there is no cream or lotion on the test site. Thoroughly dry your hands and test site. WARNING To reduce the chances of getting infection: never share a lancet or lancing device with anyone.

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Lancing device clear tip is used for alternate site testing Lance the test site with the lancing device 1. Remove the lancing tip by twisting off. 3 2. Insert lancet and replace with the clear tip. 1 2 3 4 5 1 3 3 3 5 3 1 2 3 4 5 1 5 1 2 3 4 5 3 3 5 1 3 3 3. To bring fresh blood to the surface of the test site, rub the test site vigorously for a few seconds until you feel it getting warm. Applying heat may be helpful. 4. Adjust clear tip to the highest setting. Hold the clear tip down against a fleshy area on the alternative site. Press the release button. Do not lift up. 5. Continue to hold the lancing device and gradually increase pressure for several seconds.

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3 3 6. While holding the lancing device on your test site, look through the clear tip until a round drop of blood appears. 7. Lift the lancing device straight up; be careful not to smear the blood on your testing site. 8. Stick the edge of the test strip to the drop of blood. Blood will automatically be drawn up. REMEMBER Consult with your healthcare professional before using alternate site testing. Choose a different puncture site each time you test. Repeated punctures in the same spot may cause soreness and calluses. If bruising occurs at an alternate site or you have difficulty getting a sample, consider sampling from a fingertip instead. You may want to review the choice of sites with your healthcare professional. Do not share reusable lancing device with anyone including other family members. CAUTION Do not test on your Alternative Site Test when You think you blood glucose is rapidly falling. For example within two hours of exercise, rapid-action insulin injection, or an insulin pump bolus. Testing with a fingertip sample may identify hypoglycemia or an insulin reaction sooner than testing with a palm sample.

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Caring for your GluNEO M3 system Cleaning your meter and maintenance Blood glucose test meter :

Your blood glucose test meter does not require special maintenance or cleaning. Avoid getting dirt, dust, blood, glucose control solution, or liquids on the blood glucose test meter, the test port, or data port. Your blood glucose test meters operation temperature is 10~40C(50~104F). It is recommended that you store the blood glucose test meter in the portable pouch after each use. A cloth dampened with water and mild detergent can be used to wipe down the outer part of the blood glucose test meter. Your GluNEO M3 blood glucose test meter is a precision instrument. Please handle it with care. Lancing device :

Clean the lancing device and tips with soap and tepid water. To disinfect the lancing device, prepare a disinfectant solution household bleach and water in 1(bleach) : 9(water) ratio. Dampen a cloth with this solution and wipe the lancing device thoroughly. Soak only the tip for at least 30 minutes in the disinfectant solution. Do not soak the lancing device in liquid. Rinse the lancing device and tip with water, and dry thoroughly. 1. For detailed instructions concerning GluNEO M3 blood glucose test strips, refer to the blood glucose test strip package inserted and found in the blood glucose test strip box. 2. Please store the GluNEO M3 blood glucose monitoring system in a cool and dry area, out of reach of children. Do not freeze. For a more accurate test result, avoid testing under direct sunlight. 3. Do not soak the blood glucose test meter or blood glucose test strips in water or liquid. 4. Do not subject the meter or blood glucose test strips to excessive heat. 5. Use your meter according to the instructions in the manual. 6. If you need to purchase the lancing device, lancets or blood glucose test strips, contact your local representative. 7. Discard the used lancets carefully, to prevent any infection.

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Storage of your GluNEO M3 system To prevent the meter and test strips from getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use Meter storage Storage condition: 2~30C or 36~86F (Temperature) Always store and transport the meter in its original storage case. Avoid dropping and strong impact. Avoid direct sunlight and humidity. Test strip storage Storage condition: 2~30C or 36~86F (Temperature) Store your test strips in their original vial only. Do not store the test strips in other containers. Store test strip packages in a cool and dry place. Keep away from direct sunlight and heat. Do not freeze. After removing a test strip from the vial, immediately close it tightly. Record the discarded date (date vial opened, 6 months) on the test strip label. Do not use if it is expired(2 years) after manufacturing. Touch the test strip with clean and dry hands. Do not use if 6 months have been passed, since the opening of the vial cap for test strips. Control solution storage Storage condition: Store in a cool, dry place at between 2 ~ 30C or 46~86F (Temperature) After use, close cap tightly. Make sure the control solution bottle is tightly closed Record the discarded date (date vial opened, 6 months) on the control solution on the bottle. Do not use if expiry date has passed. It expires 24 months after manufacturing date. It expires 6 months after opening the vial cap.

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GluNEO M3 test strips and vial away after the discard date. Store the GluNEO M3 test strip vials in a cool, dry place. Keep out of direct sunlight. Do not freeze. Store test strips in their original vial only. Do not mix the test strips in new vials or in any other container. Immediately replace the vial cap and close tightly after removing any test strips from the vial. CAUTION Make a note of the discard date, which is six months from the date you first open a new vial of test strips. Throw Do not use the test strips after the expiration date printed on the package or vial, since it may cause inaccurate Do not test at temperatures below 10C(50F) or above 40C(104F). Do not test with humidity below 10% or above 90%. Do not bend, cut, or alter the test strip. Avoid getting dirt, food, and water on the test strip with wet hands. Avoid getting dirt, food, and water on the color-coding label (backside of test strip) results. Transferring your result data You can transfer test results from the GluNEO M3 meter to a computer. You will need to download the software from the following web site

(http://www.osanghc.com) and purchase the computer cable from your local representative. This is sold separately.

* Please use the exclusive USB cable provided by OSANG Healthcare.

[User]

[PC]

[Cable]

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Bluetooth Function Meter stores glucose test result data and can transmit it to wireless device such as a Smart phone (android or iOS) and Tablet PC via Bluetooth wireless technology. Step1. Ensure you have completed one or more tests on your Meter and your Bluetooth is switched ON on your mobile device. Step2. Go to your app store on your mobile device (you can find your app store at google play or the apple app store), and search for the GluNEO M3 App. Download and launch the app and fill in all details required. Step3. Once your app is ready to use, select Connect Device on the app on your mobile device. From the drop down list shown on your mobile device, select the meter that you are using. Step4. Ensure your meter is switched off, then press the left arrow button pointing upwards above the Bluetooth symbol on your meter for 3 seconds until you hear the sound of a beep. A flashing p for pairing will appear on your screen. This indicates your meter is transferring Bluetooth signals to your mobile device. When reconnecting to a mobile device that has already been paired, simply press the left arrow button to enter data transfer mode. Step5. Press OK to the alert appearing on the app on your mobile device. A flashing C for confirmed will now appear on your meter to show that the pairing between your meter and your mobile device has been successful. Step6. Your meter will now transfer all glucose test result data to your app. When this has been completed, your meter will automatically switch to sleep mode.

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NOTE

-When ejecting the test strip, this will automatically activate the Bluetooth on your meter. If you wish to transmit your results to your app on your mobile device, open your app and follow the instructions above. If you do not wish to transmit your results to your app at this time, simply press the middle OFF button your meter will enter sleep mode and your results can be transmitted to your app another time.

-Activate at the Bluetooth function at a close distance

-Do not turn off the App whilst transmitting data via Bluetooth from your meter.

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Battery installation The low battery icon battery power is running low, which is an indication that a new battery are needed. will appear in the upper left corner of the LCD display to alert you when the Your GluNEO M3 blood glucose test meter uses only two 3V lithium batteries (CR2032), which are included. When replacing the batteries, only CR2032 or equivalent lithium battery should be used. Follow-up action 1. Check your meter with the glucose control solution 2. Perform your test again. 3. If you are experiencing symptoms that are not consistent with your blood glucose test results, call your healthcare professional. NOTE Make sure your date and time are correct after changing your battery. Please recycle or dispose of used batteries using your local battery collection systems and in compliance with your Caution risk of explosion if battery is replaced by an incorrect type. local environmental laws and regulations.

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Dispose of meter and batteries Dispose of meter:

The meter must be disposed of according to the local regulations concerning the disposal of electrical and electronic equipment. The Waste Electrical and Electronic Equipment(WEEE) regulation implement provisions of the European Parliament and Council Directive 2012/19/EU aimed to reducing the amount of EEE waste going for final disposal. The manufacturer, has specific instructions for the recovery of the meter. Please contact your distributor. Dispose of batteries :

Please recycle or dispose of used batteries using your local battery collection systems and in compliance with your local environmental laws and regulations. Batteries contain chemicals that, if released, may affect the environment and human health. The crossed-

out wheeled-bin symbol indicates the need for the separate collection for batteries. Disposing of your blood glucose test strips and lancets Discard your blood glucose test strip Once the test is complete, push forward the discard knob to remove the blood glucose test strip from the GluNEO M3 Blood glucose test meter. Disposing of your lancet Dispose of used Blood glucose test strip in a sealed container with your household waste in accordance with local regulations 1. Push the needle into the protective cover. 2. Pull the lancet out and discard accordingly.

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Trouble-shooting The following chart may help you identify certain problems, but may not solve all the problems that could occur. Contact your authorized representative or customer support center of OSANG Healthcare Co.,Ltd., if the problem continues. Message What it means Action required Problem with the blood glucose test meter Place the battery again, and set the blood glucose test meter. If the problem persists, please contact your authorized representative or customer support at OSANG Healthcare Co., Ltd. Caused by either used or wet blood glucose test strip Please insert a new glucose test strip and perform your test again. Caused by less bloodor irregular blood fill Please insert a new glucose test strip and apply the blood sample completely and regularly. Caused by reagent damage in the test strip Please insert a new glucose test strip and perform your test again.

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Trouble-shooting Message What it means Action required Blood sample is placed on the test strip before the display for the blinking blood icon(

) Wait for the meter to display the blinking

) before applying your blood blood icon(

sample. Caused by color bar contamination or foreign test strip Please insert a new glucose test strip and perform your test again. If blinking with Sun, avoid the direct sunlight and re-test. Contact your local representative or customer support at OSANG Healthcare Co, Ltd., if the problem persists. The ambient temperature is less than 10C (50F) Place the meter at a temperature between 10

~ 40C (50 ~ 104F) for more than 30 minutes or more and test again. The ambient temperature is over 40C

(104F) Place the meter at a temperature between 10

~ 40C (50 ~ 104F) for more than 30 minutes or longer, and then test again. Test result is lower than 20 mg/dL(1.1mmol/L) You may have a very low blood glucose level. Treat this condition immediately according to your doctor's recommendations. Perform a control solution test to check the accuracy of your test strip.

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Trouble-shooting Message What it means Test result is higher than 600 mg/dL(33.3mmol/L) Action required Check the accuracy of your blood glucose test strip by performing a glucose control solution test. If the test results in a normal reading, re-test your blood sample two or three times. If "Hi" persists, consult with your doctor immediately. There are no reading stored in the meter Low Battery Change the battery and if the problem persists, contact your local representative or customer support at OSANG Healthcare Co., Ltd. The glucose test meter is not powered ON Glucose test meter does not start after being applied blood sample. Results are inconsistent Battery is dead, or there is a problem with the meter Insufficient amount of blood. Change the battery and if the problem persists, contact your local representative or customer support at OSANG Healthcare Co., Ltd. Please insert a new test strip and perform your test again. There may be a problem with the glucose test strip Please insert a new test strip and perform your test again.

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Inconsistent or unexpected test results If you continue to get unexpected results, check your system with control solution. If you experience symptoms that are not consistent with your glucose results, review and follow all the instructions in this manual. Do not ignore symptoms or make significant changes to your diabetes control program by informing healthcare professional of your symptoms and/or concerns. CAUTION Low Glucose Results: If your result is lower than 60mg/dL, it may mean hypoglycemia (low blood glucose). This may require immediate treatment, according to your healthcare professionals recommendations. Although this result could be due to a test error, it is safer to treat first and you may test another. High Glucose Results: if your test result is higher than 180 mg/dL, it may mean hyperglycemia (high blood glucose). If you are uncertain about your test results, consider re-testing. Your health care professional will help you to decide how you need to act. If the meter displays HI all the time, please re-check your blood glucose. If the HI continues, please consult with your healthcare professional immediately. FCC Compliance Statement This device complies with part 15 of the FCC Rules. Operation is subject 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 operation. Caution: Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 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 equipment 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.

-Increase 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. RED Compliance Statement This product is CE marked according to the provision of the RED (2014/53/EU). Hereby OSANG Healthcare Co., Ltd. declares that this product is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU

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Warranty Manufacturers warranty OSANG Healthcare Co.,Ltd. warrants to the original purchaser that this instrument will be free from defects in workmanship for 3 years from the date of original purchase. Limitations of warranty This warranty is subject to the following exceptions and limitations. 1. OSANG Healthcare Co.,Ltd. shall not be required to replace any units which are damaged or malfunctioning due to abuse, accidents, alteration, neglect, misuse, maintenance by someone other than OSANG Healthcare Co.,Ltd. or failure to operate, in accordance with the instructions. 2. OSANG Healthcare Co.,Ltd. reserves the right to make changes in design without obligation to incorporate such changes into previously manufactured instruments. 3. OSANG Healthcare Co.,Ltd. has no knowledge of the performance of the instrument when the test strip is altered or modified in any manner. For warranty service Purchaser must contact the customer service department of OSANG Healthcare Co.,Ltd. by calling +82-31-

460-0300, for assistance and/or instructions for obtaining service of this instrument. Alternatively, you are requested to contact your place of purchase in your country for initial warranty request. Service information OSANG Healthcare Co.,Ltd. has trained specialists to help you 24 hours a day, 7 days a week, and 365 days a year. IMPORTANT NOTICE Please confirm with the OSANG Healthcare Co.,Ltd. representative before returning your meter for any reason. You will be given the information needed to get your problem handled correctly and efficiently. Keep your meter, test strip and control solution with you, when you call.

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Specifications Sample Type Sample Volume Test Range Reading Time Calibration Hematocrit Altitude Fresh Capillary and/or venous whole blood 0.9ul 20~600mg/dL (1.1~33.3mmol/L) 5 seconds Plasma equivalent 15 ~ 65%

3048 meter Up to (10,000 feet) Operating Temperature 10 ~ 40C (50 ~ 104F), indoor use only Operating Humidity Storage Temperature Display Type 10~90% RH Store 2~30C(36~86F)and no direct sunlight. Do not Freeze LCD Dimension(WxHxD) 89 x 51 x 17 (mm) Weight Power Source Data Communication Battery life 481g (Including batteries) 3V (Coin Battery, CR2032 X 2EA) USB to Serial / Bluetooth One year after purchasing

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Symbol reference Symbol Description Consult Instructions for use Use By date This product fulfills the requirements of Directive 98/79/EC on in vitro Diagnostic medical device Caution, consult accompanying documents In vitro diagnostic medical device Batch Code Do not re-use Serial number Date of manufacture Manufacturer Keep away from sunlight Waste electrical and electronic equipment Symbol Temperature limitation Catalogue number Self-testing Used Authorisd representative in the European community Waste batteries and accumulators

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MEMO

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OSANG Healthcare Co.,Ltd. 132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, Korea (14040) www.osanghc.com Obelis S.A Bd. General Wahis 53, 1030 Brussels, Belgium Tel : +(32)2.732.59.54 / Fax : +(32)2.732.60.03 E-mail : mail@obelis.net INFM003K IMC01610 Rev. 2019-04-02

OSANG Healthcare Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, South Korea TEL: +82-31-460-0360, FAX: +82-31-460-0402 http://www.osanghc.com/

July 10, 2019 Federal Communications Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD21046 TO WHOM IT MAY CONCERN ATTESTATION:

We, the undersigned, would like to declare that the composite portion categorized as Class B digital device has been authorized under the Suppliers Declaration of Conformity procedures. FCC ID Number Product WSX-IGM-1007A Description (Model) Blood Glucose Monitoring System(IGM-1007A) Sincerely, Dae Sup Shin/ R&D/Chief researcher

OSANG Healthcare Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, South Korea TEL: +82-31-460-0360, FAX: +82-31-460-0402 http://www.osanghc.com/

July 10, 2019 Federal Communications Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD21046 RE: LETTER OF AGENT AUTHORIZATION We, the undersigned, hereby authorize SK TECH Co., Ltd.(Mr. Jongsoo, Yoon) to act on our behalf in all matters relating to application for equipment authorization. We also hereby certify that no party to the application authorized hereunder is subject to the denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C.853(a). APPLICANT/AGENT CERTIFICATION AND AGREEMENT:

All of the statements herein and the exhibits attached hereto, are true and correct to the best of my knowledge and belief. In accepting a Grant of Equipment Authorization issued by the TCB, under the authority of the FCC, as a result of the representations made in this application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID specified in this application, (2) compliance statement labeling pursuant to the applicable rules, and (3) compliance of the equipment with the applicable technical rules. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. Authorizing an agent to sign this application, is done solely at the applicants discretion:

however, the applicant remains responsible for all statements in this application. Sincerely, Dae Sup Shin/ R&D/Chief researcher

OSANG Healthcare Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, South Korea TEL: +82-31-460-0360, FAX: +82-31-460-0402 http://www.osanghc.com/

July 10, 2019 Federal Communications Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD21046 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commission's Rules (47 C.F.R) and Section 552(b)(4) of the Freedom of Information Act, OSANG Healthcare Co., Ltd. requests confidentiality for the following products:

Product description Blood Glucose Monitoring System, model IGM-1007A FCC ID WSX-IGM-1007A The requested Permanent and Short-Term Confidential exhibits art listed as follows:

PERMANENT CONFIDENTIAL LIST Exhibit Description 1 Block Diagram PERMANENT 2 Operational Description 3 Schematics No other items submitted as part of the equipment authorization filing process are deemed confidential. The above exhibits contain OSANG Healthcare Co., Ltd. trade secrets and proprietary information that could be of benefit to our competitors regarding the design of our products. This material is not customarily available to the general public and we request that it be withheld from public inspection. Sincerely, pe Dae Sup Shin/ R&D/Chief researcher

OSANG Healthcare Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, South Korea TEL: +82-31-460-0360, FAX: +82-31-460-0402 http://www.osanghc.com/

July 18, 2019 Federal Communications Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD21046 TO WHOM IT MAY CONCERN We, the undersigned, would like to declare that according to the FCC rules the label would be permanently fixed on the device by sale. FCC ID Number Product Description (Model) WSX-IGM-1007A Blood Glucose Monitoring System(IGM-1007A)

Sincerely, wer fy Dae Sup Shin/ R&D/Chief researcher

SK Tech Co., Ltd. Photographs of EUT External view - Front External view - Rear SK Tech Co., Ltd. External view - Right External view - Left SK Tech Co., Ltd. External view - Top External view - Bottom

ID Label Location & Sample LABEL LOCATION: Label will be attached to the Rear of the product LABEL Drawing:

SK Tech Co., Ltd. Photographs of EUT Cover opened Battery Cover opened SK Tech Co., Ltd. Main board - Front Main board - Rear SK Tech Co., Ltd. LCD - Front LCD - Rear SK Tech Co., Ltd. BUZZER - Front BUZZER - Rear