FCC ID: AYY0000003 GlucoLeader Enhance 2 Blood Glucose Monitoring System

GlucoLeader Enhance Blood Glucose Monitoring System 2 Set Mem Enhance 3K-02-XXXXXX V3 Please read this User Guide before using your GlucoLeader Enhance 2 Blood Glucose Meter. If you have any questions or enquiries, please contact us or your local distributor. INTRODUCTION Thank you for selecting GlucoLeader Enhance Blood Glucose Monitoring Sys-

tem. This system was produced in close association with diabetes healthcare professionals, most importantly, people with diabetes. ABOUT GlucoLeader Enhance SYSTEM Intended Use The GlucoLeader Enhance Blood Glucose Monitoring System (The Gluco-

Leader Enhance 2 System) is designed to quantitatively measure the concen-

tration of glucose in capillary and venous whole blood by people with diabetes or by healthcare professionals for monitoring blood glucose at home or in health-

care facilities. The device is indicated for professional use and over-the-counter sales. The GlucoLeader Enhance 2 System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body

(in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. About the System The GlucoLeader Enhance 2 System are designed to pursuit the accuracy in blood glucose monitoring to provide you with easy and comfortable testing. The system requires 0.8L of blood sample and 5 seconds for the test to complete. The GlucoLeader Enhance 2 System consists of 1) GlucoLeader Enhance 2 Blood Glucose Meter 2) GlucoLeader Enhance 2 Lancing Device 3) GlucoLeader Enhance 2 Blood Glucose Test Strips (Optional) 4) GlucoLeader Enhance 2 Control Solution. (Optional) 5) GlucoLeader Enhance 2 Check Strip (Optional) These products are intended to be used together to get accurate blood glucose test results. Do not use other test strips or glucose control solutions with your meter. Important Information The GlucoLeader Enhance 2 System is intended for in vitro diagnostic use with capillary and venous whole blood or for testing newborn infant (neonatal testing). The system should not be used for diagnosis of diabetes. Caution ing medical practitioner. 1. The user should not take any medical relevant decision without first consult-

2. Call your doctor immediately if you experience symptoms that are not consistent with your blood glucose test results. 3. Severe dehydration or excessive water loss may cause false, high results. Call your doctor right away if you suspect suffering from dehydration. 4.A sample with large amount of reducing substances such as Acetaminophen(>10mg/dL), Cholesterol(>500mg/dL), Bilirubin(>10mg/dL), Glutathione(>23mg/dL) and Uric Acid(>5mg/dL) may cause the result slightly higher than the actual glucose level. 5. A red blood cell count (hematocrit) that is either very high (over 70%) or very low (under 10%) can cause false result. 6. High altitudes above than 2,750 meter (8,800 feet) may affect the test results. 7. Temperatures outside the range of 8C to 44C (46.6F to 111.2F) may affect the test results. 8. Do not modify this meter. 9. Do not perform maintenance and servicing when using the meter. 10. Remove the battery if the meter will not be used for a long time. Limitations:

1.For single-patient use only. 2.For self-testing. 3.For over the counter use. 4.The patient is an intended operator. NOTE: PLEASE MAKE SURE THAT ALL PRODUCTS LISTED ON THE CONTENTS OF THE BOX ARE CONTAINED IN THE PACKAGE BEFORE USING THIS SYSTEM. IF YOU FIND ANY IMPERFECTION IN OUR PROD-

UCTS, PLEASE RETURN THE WHOLE SYSTEM TO THE PLACE OF PUR-

CHASE. BLOOD GLUCOSE METER Study this diagram and become familiar with all the parts of your GlucoLeader Enhance 2 Blood Glucose Meter. 4 1 3 Set Mem Enhance 2 7 6 5 GlucoLeaderTM Blood Glucose Monitoring System Enhance 2 In vitro diagnostic medical device for self testing Battery: CR2032, 3V HMD BioMedical Inc. No.181 Minsheng St., Xinpu Township, Hsinchu County, Taiwan (R.O.C.) FIA Biomed GmbH Rheiner Strasse 172, D-48282 Emsdetten, Germany 3 L

X X X X X X V 1

. 4 BR20000000001 8 1. DISPLAY: The large, easy to read display shows the test results, messages, blood glucose results stored in memory, time and date. 2. Mem BUTTON: Press Mem button to enter memory mode to recall the information stored in meters memory. 3. Set BUTTON: Press Set button to enter date and time setting. 4. STRIP SLOT: Holds a GlucoLeader Enhance 2 Blood Glucose Test Strip or Check Strip in place when you perform blood glucose test or perform check test. 5. BATTERY COMPARTMENT: Holds one 3V Lithium battery. The battery is not yet installed into meter when new purchasing. Before using the meter, please install the battery first. 6. Meter SN Label: The label shows the meter serial number and FCC ID. 7. EJECTION BUTTON: For a easy ejection of the test strip. 8. DATA PORT: Allows you to transfer the information stored in the meters memory to a smartphone to view, analyze. (The smart cable should be pur-

chased separately.) FCC Regulations:

15.19(a)(3):

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. 15.105(b):

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 resi-

dential 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 in-

terference 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. Exposure to Radio Frequency Radiation Exposure to Radio Frequency Radiation This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meet FCC radio frequency(RF) Exposure Guide-

lines. This equipment must not be co-located or operating in conjunction with any other antenna or transmitter. METER LCD WINDOW 1. TEST RESULT 2. DATE: Month/date. 3. DAY AVG: Appears when the meter is in the memory mode while recalling 7/14/21/28 day test averages. 4. TIME: The meter is programmed for a 24 hour period format. 5. BATTERY SYMBOL: Appears when battery is low. SYMBOL: When the result is over 320mg/dL(17.7 mmol/L) or 6. below 70mg/dL (3.9 mmol/L), the symbols will appear and beeping alarms the patients of abnormal glucose level. 7. mg/dL mmol/L: The meter has two units of measurement (mg/dL or mmol/L) to choose from. 8. modes - BEFORE MEAL TEST (AC and GLUCOSE CONTROL SOLUTION TEST (QC SYMBOL: The test can be adjust and stored into 3 types of test

), AFTER MEAL TEST (PC

appears to indicate memory mode when reading previous results. 9. 10. CODE:Code appears to indicate code NO. when ready to test. 11. THERMOMETER SYMBOL: Appears when ambient temperature is above or below the acceptable range needed for testing. 12. STRIP SYMBOL: Appears when the test strip is inserted and meter is ready for blood testing. GlucoLeader Enhance 2 BLOOD GLUCOSE TEST STRIP 3 1 1. Aperture: It absorbs the blood from either side of the test strip. 2. Blood Reaction Zone: It must be filled with blood entirely. 3. Meter Contact: The value of the test result will be transmitted from blood Re-

1 2 3 3 1 action Zone into the meter through this Meter Contact. twice once NOTE 1 NOTE 2 once twice NOTE 1: NEVER APPLY BLOOD SAMPLE TWICE IN THE SAME STRIP. PLEASE REPEAT THE TEST USING A NEW TEST STRIP WITH A LARGER BLOOD DROP. NOTE 2: IF THE AMOUNT OF BLOOD APPLIED WAS TOO SMALL, AN ER-

ROR CODE E42 WILL APPEARS WHICH SHOWS THE BLOOD IS NOT ENOUGH. PLEASE DO NOT ADD BLOOD IN THE SAME STRIP. PLEASE REVIEW THE ERROR CODE TABLE AND PROBLEM SOLVING GUIDE SEC-

TION. 1. GlucoLeader System measures the amount of glucose in capillary and ve-

nous whole blood. Blood can be applied to the front of the test strip and is automatically drawn to the test strip through capillary and venous action. IMPORTANT TEST STRIP INFORMATION 2. GlucoLeader Blood Glucose Test Strips are intended for in vitro diagnostic use with capillary and venous whole blood or GlucoLeader Glucose Control Solution. Results will not be accurate if used with plasma or serum samples. 3. Do not use test strips beyond the expiration date indicated on the strip 4. Use test strips within 90 days after first opening the vial cap. Record the dis-

card date on the vial when you open a new vial of test strips. 5. Blood Glucose Test Strip can be damaged by heat and light. Keep them sealed in the original vial. 6. 7 .

+2C

(35.6F)

+30C

(86F) Store test strip in the original container within the range of 50F to 104F(10C to 40C). Do not refrigerate. Do not use damaged test strips in any way. Use test strip im-

mediately after taking it out from the vial or foil packet; replace the vial cap and close it tightly. 8. Do not transfer test strips to a new vial. Always carry test strips in their origi-

vial label. nal vial. 9. Do not place in direct heat or sunlight. 10. Do not carry loose test strips in your carrying case. 11. Test strips are for single use only. GlucoLeader GLUCOSE CONTROL SOLUTION

(OPTIONAL) GlucoLeader Glucose Control Solution is used to check if the GlucoLeader Enhance 2 Blood Glucose Meter and Test Strip are working correctly as a system. It can be used in two ways:

1. To practice the test procedure 2. To make sure that the GlucoLeader Enhance 2 Blood Glucose Meter and Test Strips are working together properly. IMPORTANT INFORMATION 1. Do not use glucose control solution beyond the expiration date indicated on the bottle label. 2. The discard date for glucose control solution is 90 days after first opening. Record the discard date on the bottle when you open a new bottle of glucose control solution. 3. Store the glucose control solution closed at temperatures between 10C (50F) and 30C (86F). PERFORM CONTROL TEST 1. Insert a new test strip into the strip slot, the meter will activate. 2. The last code number will appear on the screen. Compare the code number shown on the screen against the code number on the test strip vial. If the two numbers match, you may begin test, otherwise consult Section CODING YOUR METER of this user guide to code your meter first. 3. Gently shake the glucose control solution and apply a drop to the aperture of strip. Make sure that the glucose control solution has saturated the blood re-

action zone. 4. Test result will show up in 5 seconds. The result should correspond to the range printed on the label of strip vial used. NOTE: REPEAT TEST IF THE RESULT FALLS OUTSIDE THE CONTROL RANGE. IF YOU CONTINUE TO GET THE RESULT FALLING OUTSIDE THE CONTROL RANGE, YOUR METER AND STRIP MAY NOT BE WORKING PROPERLY. DO NOT USE THE SYSTEM TO TEST YOUR BLOOD UNTIL YOU GET A TEST RESULT FALLS WITHIN THE CONTROL RANGE. CON-

SULT YOUR LOCAL DISTRIBUTOR FOR HELP. GlucoLeader Enhance 2 CHECK STRIP(OPTIONAL) The GlucoLeader Enhance 2 Check Strip can be used in 2 ways:

1.To check that the meter is operating properly. Use when performing quality control check on your meter. 2.To delete all test memories. How to check meter by check strip Step 1: Insert the check strip into strip slot with label side up as above. Step 2: You should obtain an OK reading within 10 seconds, which means your meter is working properly. Step 3: Remove the check strip to exit. Meter will automatically turn off. NOTE: IF YOU DO NOT GET OK READING BUT APPEAR OTHER ERROR MESSAGE, TURN OFF THE METER BY REMOVE CHECK STRIP FROM THE METER. THEN REPEAT THE TEST. IF THE SECOND RESULT PERSISTS, CONSULT YOUR LOCAL DISTRIBUTOR FOR HELP. HOW TO DELETE MEMORY 1. Insert check strip into strip slot with label side up. 2. After OK displayed, press Mem button until flashing dEL shows up with a beep sound. 3. Press and hold the Set button until you hear a beep sound, Meter will display OK before turning off and all the memory has been deleted successfully. 4. Remove the check strip from the meter. SETTING METER PARAMETERS SETTING TIME & DATE When you first time installing the battery into the meter or when replacing a bat-

tery, the meter will automatically enter to the setting mode. Please set correct time and date before you begin testing. How to set time and date 1. Press Set button for 2 seconds to turn on the meter. The meter will enter to the setting mode automatically. 2. At the beep sound, the year 12 will flash(It mean 2012). Press Set button to select the desired month. 3. Press Mem button to confirm and shift to the next setting. 4. Repeat above steps to set the day, hour and minute by Set & Mem buttons. After minute is set, the meter will display OK before turning off. NOTE: WHILE SETTING THE TIME AND DATE, YOU CAN EXIT THE SET-

TING MODE ANYTIME BY PRESS Mem BUTTON FOR 3 SECONDS. PREPARE FOR BLOOD SAMPLING ADJUSTABLE LANCING DEVICE 1. Depth Adjustment Cap 2. Depth Selector 3. Lancet Holder 4. Cocking Control 5. Release Button 6. Ejection Button 1. Protective cap LANCET Important Information 1. Lancet is for single use only. 2. Keep lancing device and lancets clean. 3. Be cautious when removing the used lancet from the device and when disposing the used lancet. 4. The lancing device and lancets are in conformity with MDD 93/42/EEC. Refer to product labels for contact information of manufacturer and CE marking. SET LANCING DEVICE 1. Remove the depth adjustment cap. Insert a lancet into the lancet holder and push down until it is fully seated 2. Twist off the protective cap until it separates from the lancet. 3. Replace the depth adjustment cap and set the puncture depth to the desired number. NOTE: The shorter the scale the shallower the puncture. 4. Pull back the cocking control until it makes a click, press release button for penetration. If it does not click, the device may have been cocked when the lancet was inserted. Please contact local distributor. 10 Automatic power off 3 minutes Test strip may be damaged. Perform the test with new test strip. 11 Power supply One 3-volt lithium battery (type CR 2032) CODING YOUR METER Before you use your meter for the first time and every time you open a new box of test strips, you need to set the meter to match the strips. This is called cod-

ing. 1. Insert the test strip into the strip slot, the meter will activate. The last code number will appear on the screen. 2. Compare the code number shown on the me-

ter display against the code number on the test strip vial. If the two numbers match you may begin blood testing. Otherwise continue to the next step. 3. Press Mem button until you hear the sound of buzzer and the code value flashes, press Set or Mem button to obtain the code number indi-

cated on the new test strip vial. E n h a n c e S e t M e m FIG 2 05 05 S e t M e m M e m E n h a n c e 4. Upon obtaining the right code number, wait to flash 3 times to validate the change. When the symbol flashes, you are ready to perform a NOTE: THE NEW SETTING CODE NUMBER IS ALSO DISPLAYED ON THE SCREEN. test. PERFORMING BLOOD TEST 1. Wash your hands in warm, soapy water. Rinse and dry completely. 2. Remove new test strip from vial. Be sure to tightly replace vial cap after removing test strips. Insert test strip immediately into strip slot as illustrated. The meter turns on auto-

matically. 3. Check the code number on the meter matches the number is on the pouch, and also the indi-

vidually wrapped strip. If the 2 numbers match, you may begin blood testing. Otherwise refer to previous section to code your meter first. 4. When the symbol flashes, you are ready to perform a test. 5. Hold the prepared lancing device firmly against the side of your finger. Press the release but-

ton. Gently massage your finger to obtain the required blood volume. To perform the test, you need only 0.8uL of blood sample resting on your finger. 6. Apply the blood sample to the right or left ap-

erture of test strip in a way that comfortable for you. Make sure that the blood drop has saturated the test confirmation window. When blood is applied to the strip, a line moves on the screen until measurement is completed. 7. Test result will show up in 5 seconds. If a count down number not appear, an error code E42 will appears which shows the blood is not enough. Please do not add blood in the same strip. Please review the error code table and problem solving guide section. Before remov-

ing strip from the meter, you can press Set button to set the test as BEFORE MEAL TEST

), or

(AC a CONTROL SOLUTION TEST (QC

). If not setting, the default of the meter is BEFORE MEAL TEST (AC

), or AFTER MEAL TEST (PC

). Set Mem Mem Enhance 05 05 Set Mem Enhance Set Mem Enhance 8.1 8.2 to PC 8. If the test is been done in 2 hours after meal, press Set button to change the setting from AC

(8.1). If the test is a glucose control solution test, press Set button again to to QC (8.2). change the setting from PC NOTE: IF A TEST IS SET AS QC

, THE RESULT WILL NOT BE CALCULATE INTO AVERAGES. 9. After setting complete, remove the strip from meter and discard the used strip and lancet safely in a puncture resistant container. 10. The meter has risk indicator function. If is displayed, your blood glucose result may be higher than 17.7 mmol/L or 320 mg/dL. If is displayed, your blood glucose result may be lower than 3.9 mmol/L or 70 mg/dL. Set Mem Enhance Set Mem Enhance Set Mem Enhance 11. The testing range of the meter is from 10 to 600 mg/dL (0.6 to 33.3 mmol/L). If HI is displayed, your blood glucose result may be higher than 33.3 mmol/L or 600 mg/dL. If LO is displayed, your blood glucose result may be lower than 0.6 mmol/L or 10 mg/dL. UNDERSTANDING YOUR TEST RESULT Expected values for people without diabetes:

Time of Day Expected Range, Non-diabetes Source: American Diabetes, Association Position State-

ment, Diabetes Care Vol.37

(Suppl.1) P.S16 (2014). Less than 100 mg/dL Less than 140 mg/dL Before Meal After Meal For diabetes patients, please consult your healthcare professional to find out your target blood glucose value. If your blood glucose result seems unusually high or low, or inconsistent with your previous results, check the following:

1. Does the code number on the test strip vial match the code number on the 2. Was the blood sample applied to the test strip immediately after the strip meter?

was removed from the vial?

3. Was the size of the blood sample sufficient?

4. Was the test strip vial cap tightly sealed?

5. Was the test strip used before the expiration date?

6. Were the test strips stored away from extreme temperatures or from areas of high humidity?

7. Then run a quality control check with your GlucoLeader Glucose Control Solution and a new test strip. If the control test result is within the acceptable range, review testing procedure and repeat your blood glucose test with a new test strip. If your blood glucose value is still inconsistent with your previ-

ous results, contact your doctor immediately for help.

-test results. Press the Set button continuously to MEMORY RECALL The GlucoLeader Enhance 2 Blood Glucose Meter can automatically store up to 800 results and auto-calculate your average results of 7-, 14-, 21-, 28- days on both AC and PC. When recalling the results, each single result appears from the latest to the ear-

liest with time and date. To recall Results Stored in Memory 1. Turn meter on by pressing Mem button till you hear a beep sound. The first result displayed on the screen is your latest test result. 12 represents the 12th recorded of the overall results on this meter. 2. By pressing Mem button, you will see your test record from the most recent to the oldest. 3. Pressing the Set button to view the average results. 03 represents within the past 7 days there were 3 AC view the average results sequentially for 7, 14, 21 and 28 days. 4. Please press the Mem button for 2 seconds to EXIT or put it aside for 3 minutes for auto shutdown. NOTE: ANYTIME IN MEMORY MODE, YOU CAN PRESS Mem BUTTON UN-

TIL YOU HEAR THE BEEP TO EXIT AND TURN OFF THE METER. DATA DOWNLOAD You may download test results to your smartphone, you need to have smart cable and GlucoLeader Enhance 2 Health2Sync diabetes management App. The smart cable should be purchased separately. The GlucoLeader Enhance 2 Health2Sync diabetes Management APP is a free iOS and Android apps listed on the Apple App Store and Google Play. Please search Health2Sync to down-

load the App:

Health2Sync provides innovative diabetes care & analytics service to help dia-

betics and care provider manage diabetes effectively. Through Smart Cable and Health2Sync App, diabetics can easily manage their blood sugar and relevant data, and obtain personalized reminders. Care provider can be connected to their patients through Health2Sync web platform. If you have inquiry, please contact with your local distributor for more information. SPECIFICATIONS 1 Blood volume 2 Sample type 3 Test time 4 Measuring range 5 Test strip storage conditions 35.6F to 86F (2C to 30C), 10%-90%

0.8 micro liters capillary and venous 5 seconds 10~600 mg/dL (0.6~33.3 mmol/L) humidity

-13F to 158F (-25C to 70C), 10% -90%

humidity 6 Meter storage conditions 7 System operating conditions 46.4F to 111.2F (8C to 44C), 10% - 90%

8 Transportation conditions 9 Memory capacity humidity 35.6F to 86F (2C to 30C), 10%-90%

humidity 800 blood glucose results 12 Display 13 Dimensions 14 Weight 15 Test Results Average 16 Construction LCD 97 60 16.5mm (LWH) Approx.55.2g 7,14,21,28-days AC / PC average Hand-held The GlucoLeader Enhance 2 Meter is suit-

able for continuous conditions Refer to the control solution package insert 17 Meter type 18 Control solution storage TAKING CARE OF YOUR METER REPLACING THE BATTERY The GlucoLeader Enhance 2 Blood Glucose Meter comes with a battery (not yet be installed when new purchasing). Please install your battery before starting. Battery life will vary depending on usage, so always keep a spare on hand. The battery should last about 12 months when testing 3 times a day. When the battery symbol appears on the meter display, battery is getting low. You will still be able to test with low battery, but you should replace it as soon as possible. When battery symbol appears flashing on the display, the meter will no longer give results and you must replace the battery immediately. TO REPLACE THE BATTERY 1. Make sure the meter is turned off. 2. Let the front of meter rest in the palm of your hand. 3. Slide battery compartment door open. 4. Remove the old battery and insert the new 3 -volt Lithium battery into the bat-

tery compartment. Be sure to align the plus (+) and minus (-) signs correctly. 5. Slide battery compartment door closed. Check to see that your meter is work-

ing. If it fails to turn on, the battery may have been inserted incorrectly. Re-

move the battery and reinsert it correctly. NOTE: EVERY TIME WHEN YOU REPLACE THE BATTERY, THE METER WILL TURN ON AUTOMATICALLY AND ENTER TO THE TIME/DATE SET-

TING. PLEASE SET CORRECT TIME AND DATE BEFORE TESTING. CLEANING Clean the outside of the meter with a soft cloth, slightly dampened with water. Do not get moisture into the strip slot and data port. STORAGE AND HANDLING Keep your meter free of dust or water. Protect it from extreme temperature and humidity. DISPLAY MESSAGES AND PROBLEM-SOLVING GUIDE When any of the following messages appears, there is a problem with your GlucoLeader Enhance 2 Blood Glucose Meter or the way in which you are performing a test. These messages will help you to identify certain problems. If error messages appear that are not listed on the following pages, contact with your local distributor for help. DISPLAY DESCRIPTION ACTION TO TAKE Display check. If some parts of the display are not working,contact your local distributor for help. Test strip is used or test was not performed correctly. Maybe:

1.The amount of blood applied was too small. Please repeat the test using a new test strip with a larger blood drop. 2.Defective test strip 3.Defective meter Maybe:

1. Battery is dead. 2. Wrong strip was inserted. 3. Meter is defective. Maybe:

1. Blood sample is not sufficient. 2. Meter is defective. Wait for the blood sign appear before applying blood.Perform the test with a new test strip and follow the test procedure correctly.If problem persists, contact Customer Care. Wait for the blood sign appear before applying blood.Perform the test with a new test strip and follow the test procedure correctly.If problem persists, contact Customer Care. You have to:

1. Replace battery. 2. Insert the test strip correctly. 3. Contact us for help. You have to:

1. Repeat test with sufficient sample. 2. Perform Meter Check by inserting check strip. No responses when strip is inserted into the meter. No responses when blood sample is applied to the strip. NOTE : IF THERE IS ANY ERROR MESSAGE DISPLAYED BUT NOT LISTED HERE, OR YOUR METER SHUT DOWN FOR NO REASON, YOU CAN RESET THE METER BY REPLACE THE BATTERY. PERFORMANCE EVALUATIONS PRECISION Tests were carried by trained technicians in the laboratory setting. The venous whole blood from one subject was adjusted to 6 different levels. Strips out of a single lot were tested. The results are shown in the following table. Level No. of tests 1 2 3 4 5 6 100 100 100 100 100 100 YSI Mean

(mg/dL ) 31.4 87.4 143.4 225.1 348.3 481.6 Strip Mean

(mg/dL) 25.1 80.4 147.3 221.9 349.7 478 With Run SD(mg/dL) or CV.(%) 1.5(mg/dL) 2.8(mg/dL) 3.5%

2.6%

4.7%

3.6%

ACCURACY 600 samples at glucose concentration 46~576 mg/dL were tested at hospital by healthcare professionals. Fresh capillary finger whole blood samples were tested with the GlucoLeader Enhance 2 System; plasma samples from the subjects were tested with YSI Model 2300 Glucose Analyzer as reference. The results are shown in the following table. Glucose concentration < 100 mg/dL(5.6mmol/L) Within 5mg/dL

(0.28mmol/L) 85/172 (49.4%) Within 10mg/dL

(0.56mmol/L) 139/172 (80.8%) Within 15mg/dL

(0.84mmol/L) 171/172 (99.4%) Glucose concentration 100 mg/dL(5.6mmol/L ) Within 5%

242/448(54%) Within 10%

363/448 (81%) Within 15%

437/448(97.5%) Within 15mg/dL or 15%

(Within 0.84mmol/L or 15%) 608/620 (98.1%) Blood glucose result may be higher than 600 mg/dL or 33.3 mmol/L. If you find the result is doubtful and hard to believe, review proper testing procedure and perform a quality check with glucose control solution. Repeat blood test, if HI still appears, call your doctor immediately. Blood glucose result may be lower than 10 mg/dL or 0.6 mmol/L. If you find the result is doubtful and hard to believe, review proper testing procedure and perform a quality check with glucose control solution. Repeat test, if LO still appears, call your doctor immediately. Blood glucose result is higher than 320 mg/dL or 17.7 mmol/

L. Blood glucose result is lower than 70 mg/dL or 3.9 mmol/L. still appears, call your If you find the result is doubtful and hard to be-

lieve, review proper testing procedure and perform a quality check with glucose control solution. Repeat blood test, if doctor immediately. If you find the result is doubtful and hard to believe, review proper testing procedure and perform a quality check with glucose control so-

lution. Repeat test, if still appears, please eat a candy and call your doctor immediately. Temperature is above or below the operating range of test strips. The result you have obtained may not be accurate. Move to an area with temperature between 8C to 44C (46.4F - 111.2F). Do not artificially heat or cool the meter. Battery is low. Change battery immediately. User performance 100 samples at glucose concentration 76~339 mg/dL were tested at hospital by lay user. 94.7% within 0,83 mmol/L (15 mg/dL) of the medical labora-

tory values at glucose concentrations below 5,55 mmol/L (100 mg/dL), and 100% within 15% of the medical laboratory values at glucose concentra-

tions at or above 5,55 mmol/L (100 mg/dL). Batch code Caution Keep away from sunlight Temperature limitation / Store at Do not reuse Biological risks Please consult instructions for use In vitro diagnostic medical device. Use by /Expiry date Manufacturer Serial number Authorised representative in the European community This product fulfills the requirement of directive 98/79/EC in vitro diagnostic medical device The symbol indicating seperate collectionfor electrical and electronic equipment consists of the crossed-out wheeled bin. When the end-user wishes to discard this product, it must be sent to seperate collection facilities for recovery and recycling. By separating this product from other household-type waste, the volume of waste sent to incinerators or land-fills will be reduced and natural resources will thus be conserved. HMD BioMedical Inc. No.181 Minsheng St.,Xinpu Township, Hsinchu County, Taiwan (R.O.C.) Tel: +886-3-5895000 FIA Biomed GmbH Rheiner Strasse 172, D-48282 Emsdetten, Germany 3K-02-XXXXXX V4

HMD BioMedical Inc. GlucoLeader Enhance 2 Blood Glucose Monitoring System Model No. : P5B Label Location Label Placement Location Label Placement Location Label Format

Technical Compliance Statement FCC and ISED Test Report Ref. File No.: C1M1911123 For the following information Product Model Number Applicant Manufacturer Rules and Standards 47 CFR FCC Part 15 Subpart B and GlucoLeader Enhance 2 Blood Glucose Monitoring System P5B HMD BioMedical Inc. HMD BioMedical Inc. ICES-003 Issue 6: 2016

(Class B Limit) We hereby certify that the above product has been tested by us and complied with above FCC and ICES official limits. The test was performed according to the pro-

cedures ANSI C63.4-2014.The equipment might be marketed in US or Canada in accordance with the rules of 47 CFR FCC Part 2 and ISED regulations. The test data and results are issued on the test report EM-F190482. Signature ____________________________ Alex Deng/Deputy Manager Date: 2019. 12. 05 Test Laboratory:

AUDIX Technology Corporation, EMC Department NVLAP Lab. Code: 200077-0 FCC OET Designation: TW1004 & TW1090 Web Site: www.audixtech.com The statement is based on a single evaluation of one sample of the above-mentioned products. It does not imply an assessment of the whole production and does not permit the use of the test lab logo.

Authority to Act as Agent Date: January 10, 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. Thank you, Agency Agreement Expiration Date: January 10, 2020

{ 4 N r b) v | | Alex Nobida

(Signature) (Print name) Product Manager On behalf of: HMD BioMedical Inc.

(Company Name) Telephone: +886-(0)-3-5895-000 #6200

Request for Confidentiality Date: January 10, 2020 Federal Communications Commission Authorization and Evaluation Division Subject: Confidentiality Request regarding Application for certification of FCC ID: AYY0000003 Gentlemen:

Pursuant to Section 0.457 and 0.459 of the Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below:

Functional Block Diagram

@ Operational Description (theory of operation)

@ Schematic Diagram The above materials contain trade secrets and proprietary information not customarily released to the pub i closure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Alex Nobida Product Manager HMD BioMedical Inc.