FCC ID: RPJ01GM100-1 Blood Glucose Meter

TABLE OF CONTENTS CHAPTER 1 Understanding the Product Intended Use 04 Precautions 04 Principles of the Use 04 Product Details 05 Separately Purchased Items 06 Packaging Details 06 Separately Purchased Items 07 CHAPTER 2 Precautions General Precautions 07 Cradle 09 Touch Screen 09 Camera 09 Waste Disposal 09 CHAPTER 3 How to Use STANDARD GlucoNavii Elite Blood Glucose Meter Activating Equipment 10 Blood Glucose Measurement 15 Understanding the Measurement Results 20 2 T A B L E O F C O N T E N T S CHAPTER 4 Other Tests and Functions Control Solution Test 21 A. Why a Control Solution Test is Necessary 21 B. When to use a Control Solution 21 C. Precautions in using a Control Solution 21 D. Measurements 22 External Quality Control 26 Linearity Test 29 Cradle Functions and LED Display 32 Test Results 33 Other Settings 37 A. Elite Manager Communication Settings 37 B. Elite Manager Settings Information 38 C. Cradle Settings 39 D. System Settings 40 E. Device Information 42 CHAPTER 5 Storage and Handling Cleaning the Product 43 Precautions when Storing 43 CHAPTER 6 Error and Corrective Measures 44 CHAPTER 7 Technical Information STANDARD GlucoNavii Elite Meter 45 STANDARD GlucoNavii Elite Cradle 46 STANDARD GlucoNavii Elite Test Strip 46 CHAPTER 8 References 47 3 CHAPTER 1 Understanding the Product Intended Use STANDARD GlucoNavii Elite Blood Glucose Meter is an in vitro diagnostic medical device for Blood Glucose management. It is a system for monitoring glucose in capillary or venous whole blood. STANDARD GlucoNavii Elite Blood Glucose Meter can be used in conjunction with a designated program to measure blood glucose and transmit and manage data to Electronic Medical Records (EMR) to diagnose glucose metabolism disorders of patients in hospitals. This product is designed for professionals. Precautions For accurate measurement, be familiar with the instructions in this use instructions. Then use the meter.

(1) Use fresh capillary or venous blood. (Incorrect results can be obtained when using contaminated capillary blood.)

(2) STANDARD GlucoNavii Elite Blood Glucose Meter must be used only with STANDARD GlucoNavii Elite Blood Glucose Test Strip, STANDARD GlucoNavii Control Solution and STANDARD GlucoNavii Linearity Solution.

(3) When performing a control solution test, the range of the control solution may be different for each test strip Lot, so the user should check the range of the control solution that matches the Lot number of the test strip before proceeding with the test. To see the range of the control solution, please refer to the values in Elite Manager or the test strip bottle. Be sure to check the expiration date and appearance condition before using the test strip. If you use an expired or damaged test strip, inaccurate results may appear.

(4) Use this product only by a trained professional. Principles of the Use STANDARD GlucoNavii Elite Blood Glucose Test Strip is designed with an electrode that measures glucose levels. Glucose in the blood sample mixes with reagent on the test strip that cause a small electric current. The amount of current that is created depends on how much glucose is in the blood. STANDARD GlucoNavii Elite Blood Glucose Meter measures the current that is created and converts the measurement to the amount of glucose that is in the blood. The blood glucose result is displayed on the meters LCD display. By touching a drop of blood to the tip of the test strip, the strips reaction chamber automatically draws the blood into the strip through capillary action. When the chamber is full, the meter start to measure the blood glucose level. It is a simple and practical system for the daily monitoring of your blood glucose level. 4 Product Details

(1) STANDARDTM GlucoNavii Elite Blood Glucose Meter Fixation Hole Test Strip Slot Strip Ejector Camera Power Button C-Type USB Port C H A P T E R 1 i U n d e r s t a n d n g t h e P r o d u c t

- Test Strip Slot : Insert test strip.

- Strip Ejector : Use when removing the inserted test strip.

- Fixation Hole : Fixation hole to prevent separation between the instrument and the measuring part

- Power Button : Use the button on the right to turn the product on and off .

- C-type USB Port : Connect a C-Type USB cable to charge the device

- Camera : Used to scan barcodes of a test strip bottle, patients, etc.

(2) Cradle C-Type Connection Port LAN Connection Port Status LED Charging Port

- Status LED: The device status can be checked via the display LED.

- C-Type Connection Port : BT pairing between the device and cradle to transfer data to PC.

- Charging Port : Connect the charger to the cradle to turn the cradle on, and dock the device to the cradle to charge.

- LAN Connection Port : Connects to the PC to send and receive data 5 Packing Details Meter: Meter, Quick manual Cradle: Cradle Accessory: Strip, Control Solution, Linearity Solution , USB Cable, Adapter Separately Purchased Items The below items are purchased separately from the STANDARD GlucoNavii Elite Blood Glucose Meter.

- STANDARD GlucoNavii Elite Blood Glucose Test Strip

- STANDARD GlucoNavii Control Solution

- STANDARD GlucoNavii Linearity Solution 6 C H A P T E R 2 P r e c a u t i o n s CHAPTER 2 Precautions 1. General Precautions

(1) Read the instructions in this user manual before use for an accurate measurement.

(2) This product is a professional Blood Glucose Monitoring System.

(3) STANDARD GlucoNavii Elite Blood Glucose Meter should be used only with STANDARD GlucoNavii Elite Blood Glucose Test Strip, STANDARD GlucoNavii Control Solution and STANDARD GlucoNavii Linearity Solution.

(4) STANDARD GlucoNavii Elite Blood Glucose Meter is available for use only with capillary or venous whole blood (useable anticoagulants: Heparin, EDTA). However, if venous blood is used, it should be done under the guidance of a medical professional.

(5) Be sure to check the strip bottle before using the test strip for the first time. If there is damage to the bottle cap or the bottle, or if the bottle cap is not closed properly, please stop using the product. If a damaged test strip is used, you may get inaccurate results. If the result continuously deviates from normal values, use STANDARD GlucoNavii Control Solution to check the Blood Glucose Meter and Test Strip.

(6)

(7) If all instructions in the user manual were followed properly and the problem persists, contact the person in charge of or the respective distributor.

(8) The test strip is for single use only. Do not reuse.

(9) Discard the used test strip carefully.

(10) If you insert a test strip by a strong power, it is easily to bend. Therefore, insert a test strip in the meter gently until it will go no further.

(11) The amount of blood sample required for testing is 0.5l. If the applied blood is insufficient, accurate measurement results cannot be obtained. Discard the test strips applied with insufficient blood.

(12) Do not apply the blood to other sites except the reaction chamber of the test strip.

(13) Do not use a test strip that has passed their expiration date or has expired 6 months from opening. Discard the expired test strips.

(14) The test strip is sensitive to humidity. Therefore, be sure to store the test strip in the designated bottle and immediately close the bottle cap when removing the test strip.

(15) Keep the test strip in a cool, dry place (2-32C). Avoid direct sunlight or heat and do not freeze the test strip.

(16) Do not expose the test strip to heat or moisture. Test Strip stored outside the specified temperature or humidity range (e.g., toilet, kitchen, laundry room, car, garage, etc.) can result in inaccurate results.

(17) Be careful not to get dust, food, or liquid on all areas of the test strip. Handle the test strip with clean, dry hands.

(18) Failing to follow the precautions may result in inaccurate results.

(19) Extreme Hematocrit (HCT) ratio can affect the measurement result. If the Hematocrit ratio is greater than 70%, the result may be lower than its actual value.

(20) Avoid touching the reaction chamber of the test strip.

(21) Wash your hands with soap and water then dry it completely before collecting the blood. 7

(22) To prevent infections, wipe your hand with an alcohol swab and dry it completely before collecting blood.

(23) Interferences: Elevated levels of the following substances may affect measurement results Interference Concentration Interference Concentration Acetaminophen

> 6mg/dL Ascorbic acid( Vt.C )

> 4mg/dL Bilirubin

> 40mg/dL Ibuprofen Levodopa Maltose

> 50mg/dL

> 4mg/dL

> 60mg/dL Total Cholesterol

> 250mg/dL Methyl-DOPA

> 2mg/dL Creatinine Dopamine EDTA

> 30mg/dL

> 5mg/dL Salicylate

> 20mg/dL Tolazamide

> 9mg/dL

> 0.1mg/dL Tolbutamide

> 64mg/dL Galactose

> 60mg/dL Triglycerides

> 1800g/dL Gentisic Acid

> 1.8mg/dL Glutatione

> 9.2mg/dL Uric Acid Xylose

> 9mg/dL

> 60mg/dL Hemoglobin

> 200mg/dL Pralidoxime Iodide

> 38mg/dL Heparin

> 3000U/L Icodextrin

>1100mg/dL Precautions when measuring

- Do not shake or move the meter during the measurement process.

- Measurements should be made in an 8~45C environment.

- Do not use the analyzer near strong electromagnetic radiation sources, as strong electromagnetic fields can damage the function of the meter.

- Store in a flat, dry environment and avoid direct sunlight.

- Extremely strong lights can interfere with the test results. Stay away from strong lights when measuring.

- Do not drop the meter as it may get damaged.

- Do not disassemble the meter.

- Do not put the meter in water or any cleaning solutions.

- If an error message appears repeatedly, stop using the product. 8 C H A P T E R 2 P r e c a u t i o n s 2. Cradle

- Install the cradle out of patient's reach. The cradle is not intended for use in an open space with patients.

- Connect the Cradle to an approved rated 5Vd.c./2A or high current power adapter that complies with LPS requirement with the same connector jack size. Be careful, as there is a possibility of an electric shock. 3. Touch Screen

- When touching a screen, please use your hand to touch. If you touch the screen with a pointed or sharp object (such as a nib), damage to the screen may cause. 4. Camera

- The camera is for scanning barcodes and QR codes. It cannot be used for any other purposes.

- Be careful not to give impact to the camera lens. If the lens is broken or cracked, scanning may not work. 5. Waste Disposal

- STANDARD GlucoNavii Elite Blood Glucose Meter or its accessories must be treated as a potential biological hazardous waste. Removal of contamination (eg. cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal. Dispose of the system or its accessories in accordance with local regulations. 6. Electromechanical Safety 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. 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. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with RF exposure requirement. This device complies with RF exposure requirement. Cradle(FCC ID: RPJ01GMC100-1) should be installed and operated with minimum 20 cm between the radiator and your body. 9 CHAPTER 3 How to Use STANDARD GlucoNavii Elite Blood Glucose Meter 1. Activating Equipment Fixation Hole

(1) Press and hold the power button at the right side of the equipment to turn the device on. Test Strip Slot Strip Ejector Camera Power Button Power Button

(2) Connect cradle and meter through Bluetooth. C-Type USB Port 10 C H A P T E R 3 H o w t o U s e S T A N D A R D G u c o N a v i i l E l l l i t e B o o d G u c o s e M e t e r

(3) Select the communication method with Elite Manager. You can choose between cradle or Wifi connection. After selecting the option, set the address of Elite Manager to register. A. USB: Connects to the PC through the USB port of the cradle which then connects to the hospital network. B. DHCP: Connect the router or Internet line through the cradle's LAN port to automatically assign an IP address and connect to the hospital network. C. IP: Connect the router or Internet line through the LAN port of the cradle, but manually enter IP information to assign an IP and connect to the hospital network. D. Wifi: Connect the Elite meter to Wifi to connect to the hospital network. 11

(4) When using cradle connection, dock the meter to the cradle. If you use Wi-Fi connection, you do not need to dock the meter to the cradle.

(5) Connect to Elite Manager and change the current registering device to Registered in the Meter Management Settings, then the meter is fi nally registered and available for use. 12 C H A P T E R 3 H o w t o U s e S T A N D A R D G u c o N a v i i l E l l l i t e B o o d G u c o s e M e t e r 1-1. Data Communication A. BT Communication (Meter Cradle Elite Manager server)

(1) BT connection between the meter and cradle when registering the device for the fi rst time

(2) Data transmission when the meter is docked on the cradle (USB, LAN communication) B. Wi-Fi Communication (Meter Elite Manager server)

(1) Connects to Wi-Fi used by the hospital when registering the device for the fi rst time

(2) Checks data communication by connecting with Elite Manager server

(3) Data transmission via Wifi upon completion of the data communication check 1-2. Login

(1) In the ID fi eld of the user login screen, manually enter the user number with the on-screen keyboard or press the barcode button and activate the camera to scan the users barcode.

(2) Once the barcode scan is complete, the user is logged in to the home screen. 13 1-3. Home Screen NO. Function Logout Press to log out Measure Glucose Press to proceed with blood glucose measurement. Control Solution Press to proceed with control solution test for quality control. Emergency can use this menu to measure glucose without any patient or strip If you need to measure blood glucose in an emergency situation, you information. However, the result will not be saved. Home You can move to the home screen. Test Results Setting Test results can be checked in this menu. Results that were not transmitted are indicated by a number in a red circle. In this menu, there are other functions such as device settings, external quality control, and linearity test. 1 2 3 4 5 6 7 14 C H A P T E R 3 H o w t o U s e S T A N D A R D G u c o N a v i i l E l l l i t e B o o d G u c o s e M e t e r 2. Blood Glucose Measurement 2-1. Blood Glucose Measurement

(1) When logged in, select the Measure Glucose button on the screen and the screen will move to the Patient ID Scan screen. You may scan the patients ID or press the Enter Manually button to enter the information manually.

(2) Enter the patient number in the Patient ID fi eld or select the barcode button to activate the camera and scan the patient barcode.

(3) Enter the Lot number in the Strip Lot fi eld or select the barcode button to activate the camera and scan the barcode at the side of the test strip bottle. Since the test paper LOT or control LOT used at the time of the previous login is recorded, you can enter the recorded LOT by tapping it. 15

(4) When the patient ID and test strip Lot number are entered, select the 'Con rm' button to proceed to the next step.

(5) Insert the electrode side of the test strip to the meter as shown on the meters screen, and collect the patient's blood at the edge of the test strip.

(6) The result will be displayed in 5 seconds. 16

(7) Press the Con rm button to return to the home screen. If you press the Memo button, a pop-up is created, where you can enter a memo. C H A P T E R 3 H o w t o U s e S T A N D A R D G u c o N a v i i l E l l l i t e B o o d G u c o s e M e t e r Glucose Measurement test results can be checked in the Test Results tab of the menu bar. 17 2.2 Emergency Measurement

(1) Select the Emergency button in the home screen.

(2) Insert the electrode side of the test strip to the meter as shown on the meters screen, and collect the patient's blood at the edge of the test strip. 18

(3) The result will be displayed in 5 seconds.

* When using the Emergency menu, the results will not be saved. C H A P T E R 3 H o w t o U s e S T A N D A R D G u c o N a v i i l E l l l i t e B o o d G u c o s e M e t e r 19 3. Understanding the Measurement Results Normal Blood Glucose Levels Fasting blood glucose values in adults without diabetes is 70~99mg/dL. Normal blood glucose range two hours after a meal is below 140mg/dL. When the Measurement Range is out of the Normal Range Was the size of the blood sample sufficient to fill the reaction chamber?

Was the test strip bottle cap tightly sealed?

Was the test strip used before the expiration date?

Were the test strips stored at extreme temperatures such as a car during very cold or hot weather?

Were the test strips stored in areas of high humidity such as kitchen or bathroom?

1. 2. 3. 4. 5. Test Result Range The meter reads blood glucose results at 10-600 mg/dL. If Hi is displayed, blood glucose result may be higher than 600 mg/dL. If Lo is displayed, blood glucose result may be lower than 10 mg/dL. 20 C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s CHAPTER 4 Other Tests and Functions Control Solution Test A. Why a Control Solution Test is Necessary Control solution test allows you to verify that the measurement meter and test strip are functioning correctly, and that the user has measurement in the correct way. Periodically checking your equipment using a simple control solution test is critical to getting accurate results. B. When to Use a Control Solution If you leave the cap off the container of test strips. Before using your meter for the first time. When you open a new container of test strips. If you drop the meter. Whenever your result does not agree with the way you feel. If you have repeated a test, and the blood glucose result is still lower or higher than expected. When you want to check the performance of the meter and test strip. C. Precautions in Using a Control Solution Only use STANDARD GlucoNavii Control Solution for Quality Control. The control solution is for use outside the body (in vitro use). Test the control solution in an 18~30C (64~86F) environment. Do not swallow or inject the control solution. Do not put the control solution in your eyes. Make sure to check the expiration date before use and to write down the date of its first opening. Do not use a control solution that is expired or that has passed 3 months from its opening. Keep the control solution away from children. Shake the control solution well and discard the first drop before using. 21 D. Measurements

(1) Select the Control Solution button in the home screen and choose the level you wish to proceed with. C H A P T E R 4

(2) The screen will move to Control Lot Scan screen. You may scan the Control Lot or press the Enter Manually button to enter the information manually. Enter the Lot number of STANDARD GlucoNavii Control Solution - Level 2 in the Control Lot fi eld or select the barcode button to activate the camera and scan the barcode at the side of STANDARD GlucoNavii Control Solution - Level 2. 22

(3) Enter the test strip Lot number in the Strip Lot fi eld or select the barcode button to activate the camera and scan the barcode at the side of the test strip bottle.

(4) When the Control Lot and Strip Lot are entered, press the Confi rm button to move to the next step.

(5) Insert the electrode side of the test strip to the meter as shown on the meters screen. Drop STANDARD GlucoNavii Control Solution - Level 2 to a fl at surface and collect the solution by touching the edge of the test strip to the drop. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s 23

(6) Check the result in 5 seconds.

(6-1) If the result is within range, select the Confi rm button to proceed to the next step. If the result is out of range, select the Retry button and re-test from step (2). C H A P T E R 4

* If the result is continuously out of range, please contact the person in charge in the hospital or the supplier of the product. 24

(7) For STANDARD GlucoNavii Control Solution - Level 3 test, proceed in the same manner as the above Level 2 test. Control Solution test results can be checked in the Test Results tab of the menu bar. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s The control solution range printed on the test strip bottle is for STANDARD GlucoNavii Control Solution only. It is not a recommended range for your blood glucose level. Control Range Level 2 Level 3 90-140 mg/dL 170-240 mg/dL

[This is an example. Refer to the ranges on your test strip bottle.]

QC Lock If a control solution test is not performed for a specifi c time or for a certain period of time, there are restrictions on the patient's blood glucose measurement. This setting can be changed in Elite Manager's Meter Management>Preset Management. For accurate results, please conduct the control solution tests regularly. 25 External Quality Control External quality control is a test conducted by an external quality control association, to check the accuracy between hospitals on an external standard by preparing a control sample twice a year on for the registered hospitals.

(1) After user login, select the Settings tab (cogwheel) on the menu bar of the home screen to enter the settings screen. C H A P T E R 4

(2) Select 'External QC' from the Settings menu to enter then select Level 1.

(3) Manually enter the Lot number of the Level 1 External Control Solution in the Control Lot fi eld and the test strip Lot number in the Strip Lot fi eld or select the barcode button to activate the camera and scan the barcode. 26

(4) When the Control Lot and Strip Lot are entered, press the Con rm button to move to the next step.

(5) Insert the electrode side of the test strip to the meter as shown on the meters screen. Drop the Level 1 Control Solution to a fl at surface and collect the solution by touching the edge of the test strip to the drop. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s

(6) The result will be displayed in 5 seconds. After checking the result, select the Con rm button to move to the next step. 27

(7) For Level 2 and Level 3, proceed in the same manner as the above Level 1 test.

(8) The test is completed when all Level 1, 2, 3 tests are completed. External Quality Control test results can be checked in the Test Results tab of the menu bar. C H A P T E R 4 28 Linearity Test Linearity Test is a test to verify the exact performance of the test strip by testing it with a diff erent concentration material. The test method is the same as the control solution test, but the test strip barcode must be scanned fi rst and then repeatedly tested at least 6 substances twice.

(1) After user login, select the Settings tab (cogwheel) on the menu bar of the home screen to enter the settings screen. Select the 'Linearity Test' button. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s

(2) In the Linearity Test screen, select the TEST START button.

- For linearity tests, at least 2 tests per level should be conducted for the results to be saved. Complete all the tests from Level 1 to Level 6 once the test has begun. Test level and measurement can be changed in the DM of the equipment main server. 29

(3) Select Level-1 to move to the next step.

(4) Manually enter the Lot number of the Level 1 Linearity Solution in the Control Lot fi eld and the test strip Lot number in the Strip Lot fi eld or select the barcode button to activate the camera and scan the barcode. C H A P T E R 4 O t h e r T e s t s a n d M a n a g e m e n t F u n c t i o n s

(5) When the Control Lot and Test Strip Lot are entered, press the Confi rm button to move to the next step.

(6) Insert the electrode side of the test strip to the meter as shown on the meters screen. Drop the Level 1 Linearity Solution to a fl at surface and collect the solution by touching the edge of the test strip to the drop. 30

(7) The result will be displayed in 5 seconds. After checking the result, press the Con rm button and repeat (6) for the set amount of tests.

(8) After proceeding with (7), select the Confi rm button to move to the next step.

(9) For Level 2 to Level 6, proceed in the same manner as the above Level 1 test.

(10) The test is completed when all tests from Level 1 to 6 are completed. Linearity test results can be checked in the Test Results tab of the menu bar. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s 31 Cradle Functions and LED display After connecting the charger to the cradle, dock the measurement meter to the cradle to charge it. C H A P T E R 4 O t h e r T e s t s a n d M a n a g e m e n t F u n c t i o n s

(1) Connect Charger (Power ON): Green LED blinks 3 times.

(2) Stand-by Mode: If the meter is not docked on the cradle, it enters a standby mode and there will be no color indication on the LED.

(3) Charging Mode: A Red LED will light up when charging begins, and a Green LED will light up when charging is complete.

(4) Cradle-Meter BT pairing: If there are any test results that have not been transmitted to the server, it will start transmitting the data to Elite Manager server. When data transmission is complete, the LED will return to charging mode. Please do not remove the meter from the cradle while data transmission is in process. A. When charging: Red and Orange LED will blink in order until pairing and data transmission are complete. B. When fully charged: Green and Orange LED will blink in order until pairing and data transmission are complete.

(5) Error : A Red LED will keep blinking if there are any errors or if charging is not working. 32 Test Results

(1) Checking the Test Results A. In the Home Screen, select the 'Test Results tab located at the center of the menu bar. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s 33 B. You can check patient result, control solution result, external degree management result in the 'result list'. All measurement results measurement with that equipment are recorded, sorted by recent measurement. 34

(2) Search : Patient Test Results A. For patient test results, you can search with the patients ID number using the Search Button at the upper right corner. In the search bar, you can either manually enter the patient ID or select the barcode button to activate the camera and scan the patient ID. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s B. When a Patient ID is searched, all test results of the patient will be displayed. 35 C. If you select one of the test results, you can check the details of the test result and any memo that was saved along with the test result. 36 Other Settings After user login, select the Settings tab (cogwheel) from the menu bar on the home screen to enter the settings screen. On the Settings screen, you can check Elite Manager communication settings, Elite Manager Settings Information, Cradle Settings, System Settings, and Device Information. A. Elite Manager Communication Settings In Elite Manager Communication Settings, you can set the cable or wireless data transmission options for the device. (See Chapter 3, Equipment Activation for details) C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s 37 B. Elite Manager Settings Information

(1) In Elite Manager Settings Information, you can check the information set in Elite Manager. You can check and change the settings in Elite Manager's Meter Management > Pre-Settings.

(2) If Lock if no QC is implemented and QC upon test strip change is being used, conduct the QC tests in accordance with the settings as glucose tests may be restricted if needed QC tests are not conducted. C H A P T E R 4 38 C. Cradle Settings

(1) In Cradle Settings you can check and modify the information of the connected cradle.

(2) Select the Change Cradle button and fi nd your device. You can change the connection to a new cradle by pairing it with a cradle from the searched device list. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s 39 D. System Information In System Information, you can change the time format, language, and measurement unit. C H A P T E R 4 O t h e r T e s t s a n d M a n a g e m e n t F u n c t i o n s

(1) Time Format In Time Format, you can choose to display the time in 12H or 24H format. 40

(2) Language In Language, you can choose the system language to be used. You may choose from Korean or English. C H A P T E R 4 O t h e r T e s t s a n d F u n c t i o n s

(3) Measurement Unit In the Measurement Unit, you can choose to use mg/dL or mmol/L depending on the measurement units used in your location. 41 E. Device Information

(1) In Device Information, you can check the basic information of the device being used, such as Device Name, Serial Number, Software Version, Meter Module Version, Cradle Version, etc. C H A P T E R 4 42 CHAPTER 5 Storage and Handling C H A P T E R 5 S t o r a g e a n d H a n d l i n g Cleaning the Product

(1) If foreign substances such as blood or dust get into the test strip slot, it may cause malfunction.

(2) If necessary, wipe the meter with an alcohol swab or soft cloth moistened with water. Use the product once the water or alcohol has been completely dried.

(3) Do not use any other substances that are not provided or recommended as there is a risk of product damage.

(4) Maintenance of the device is necessary for accurate measurement and transmission of results. Check the device regularly for any anomalies, and if there is any foreign substance, wipe it off immediately. Precautions when Storing

(1) Prevent dust from entering the test strip slot.

(2) Keep away from the humid environment.

(3) Keep away from direct sunlight and strong heat.

(4) Store in a cool and dry place. Do not refrigerate.

(5) Keep away from the reach of children.

(6) Check whether the exterior of the test strip is damaged before use, and do not use if there are any damages.

(7) Always store the test strip in the test strip bottle. Be careful not to leave the bottle cap open when storing. (For further details, refer to the user manual of the test strip.) 43 CHAPTER 6 Error and Corrective Measures No. Error Message Corrective Measures 1 2 3 4 5 6 7 8 9 Unregistered user. Occurs when logging in with a user number that is not registered. Please contact the management

(person in charge) to register the employee number. Insufficient blood(solution) sample. Insufficient blood(solution) sample was collected. Discard the used test strip and measure again using a new test strip. Apply a sufficient amount of blood(solution) sample into the reaction chamber of the test strip. Invalid test strip. Unregistered strip. The test strip inserted is damaged, or an incompatible test strip is used. After confirming that a proper test strip is used, test again using the strip. The barcode of the test strip bottle is not registered. Please check the Lot number of the test strip and try again with another test strip. If the error message continue, contact the management. Test strip has expired. The test strip has passed its expiration date. Please use a new test strip. Conduct quality control test. The temperature of the meter is higher or lower than the operating range. Leave the meter between 8~45C for 30 minutes and let the meter return to its operating temperature. Do not intentionally heat or cool the meter in the process. Conduct quality control test. The meter has passed its set periodic quality control test period. Please conduct a quality control test to be able to use the glucose measurement function. Control solution has expired. The control solution used has passed its expiration date. Please use a new control solution Invalid control solution. The barcode of the control solution is not registered. Please use a new solution. If the error message continues, contact the management. 10 Linearity solution has expired The linearity solution used has passed its expiration date. Please use a new linearity solution. 11 Device synchronization The device synchronization was not successful. failed.

(1) Cable Make sure the cradle and device are properly docked. If it is properly docked, check the connection between the LAN or USB cable at the back of the cradle and the PC or router.

(2) Wifi Check the Wi-Fi status of the device. If no problems are found, contact the management. 44 C H A P T E R 7 T e c h n i c a l I n f o r m a t i o n CHAPTER 7 Technical Information 1. STANDARD GlucoNavii Elite Blood Glucose Meter Meter Size LCD Size Weight 80 (W) x 16.2 (D) x 150 (H) mm 62.1 (W) x 110.2 (H) mm 170g Measurement Range 10 - 600mg/dL Correction Method Plasma correction Sample Type Sample Volume Measurement Time Capillaries and venous blood Minimum 0.5 5 seconds Measurement Method Glucose Dehydrogenase Biosensor Hematocrit Measurement Unit Display Screen Operation Button Memory Capacity 0~70%

mg/dL or mmol/L LCD Touch screen 5000 cases each for patient, control solution, linearity, and external quality control 8 GB (Storage capacity of 4 GB) Communication function BT / Wifi / LAN / USB BT Version RF Range Bluetooth 5.0(LE) 2402~2480 MHz Maximum Output Power

-5.55dBm Storage Conditions

-20C~50C / 10%~93% RH Operating Conditions 8~45 / 10%~93% RH Altitude Max 2000m (80~106 kPa) Power Consumption Protection against electric shock

- 5 Vd.c., 1.0 A (for C-type USB cable and Cradle charging)

- 3.7 Vd.c., 1700 mAh (for Lithium Polymer battery pack)

- Class II (for Cradle charging)

- Internally powered (for Lithium Polymer battery pack) Degree of protection against electric shock Not applied parts 2. STANDARD GlucoNavii Elite Cradle Size Weight IP Classification 142.8 (W) x 101 (D) x 100.8 (H) mm 200g IPX0 Power Supply C-Type USB or Charging Adapter Input Out 5Vdc, 1.5A (for C-Type USB cable and adatper) 5Vdc, 1.0A [wireless charging for meter]

45 3. STANDARD GlucoNavii Elite Test Strip PERFORMANCE CHARACTERISTIC All performance characteristic of STANDARD GlucoNavii Elite BGMS shall be evaluated with a series of measurements within a short interval of time in accordance with EN ISO 15197:2015. Precision The acceptable criteria are within standard deviation(STD) 4mg/dL at the below 100mg/dL(5.55mmol/L), and coefficient of variation(CV) 5% at the above 100mg/dL(5.55mmol/L). 1) Repeatability Precision Range Number of samples REF. (mg/dL) AVG (mg/dL) STD (mg/dL) CV (%) 30 - 50 mg/dL 51 - 110 mg/dL 111 - 150 mg/dL 151 - 250 mg/dL 251 - 400 mg/dL 300 300 300 300 300 2) Intermediate Precision 42.8 100.0 138.3 237.0 343.0 Number of samples AVG. (mg/dL) STD CV (%) Level 1 300 55.9 3.3 5.9 42.6 100.4 122.9 222.9 311.3 Level 2 300 138.1 4.3 3.1 3.3 3.2 5.0 7.4 9.7 7.9 3.1 4.1 3.3 3.1 Level 3 300 222.9 8.3 3.7 System Accuracy The accuracy of STANDARD GlucoNavii Elite blood glucose monitoring system was assessed by comparing blood glucose results obtained by patients with results by using YSI Model 2300/2700 STAT Plus glucose analyzer(reference), a laboratory instrument. The acceptable criteria for system accuracy is following;

95% of the measured glucose values shall fall within either 15mg/dL(0,83mmol/L) of the average measured values of the reference measurement procedure at glucose concentrations <100mg/

dL(5,55mmol/L) or within 15% at glucose concentrations 100mg/dL(5,55mmol/L). 1. Capillary Blood 1) Below 100mg/dL(5.55mmol/L) Within 5mg/dL

(within0.28mmol/L) Within 10mg/dL

(within0.56mmol/L) Within 15mg/dL

(within0.83mmol/L) 50.6% (91/180) 98.5% (163/180) 100% (180/180) 2) Above 100mg/dL(5.55mmol/L) Within 5%

43.6% (183/420) Within 10%

81.0% (340/420) Within 15%

99.0% (416/420) 3) Between 33.4 mg/dL and 466.7 mg/dL Within 15mg/dL or 15%

99.3% (596/600) Influence quantities The acceptable criteria for influence quantities are following;

Below 100mg/dL(5.55 mmol/L), the average difference between the test sample and the control sample is within 10mg/dL(0.55 mmol/L) Over 100mg/dL(5.55 mmol/L), the average difference between the test sample and the control sample is within 10%

1. Packed cell volume: STANDARD GlucoNavii Elite BGMS is performed according to EN ISO 15197:2015, 6.4.3 Packed cell volume evaluation. The suitable for STANDARD GlucoNavii Elite BGMS is 0-70%. 46 2. Interference testing: STANDARD GlucoNavii Elite BGMS is performed according to EN ISO 15197:2015, 6.4.4 Interference testing. Followings interference materials may affect test results. Acetaminophen

> 6 mg/dL Ascorbic acid( Vt.C )

> 4 mg/dL Bilirubin

> 40 mg/dL Ibuprofen Levodopa Maltose

> 50 mg/dL

> 4 mg/dL

> 300 mg/dL Total Cholesterol

> 250 mg/dL Methyl-DOPA

> 2 mg/dL Creatinine Dopamine EDTA Galactose Gentisic Acid Glutatione

> 30 mg/dL

> 5 mg/dL

> 0.1 mg/dL

> 60 mg/dL

> 1.8 mg/dL

> 9.2 mg/dL Sodium Salicylate

> 20 mg/dL Tolazamide Tolbutamide Triglyceride Uric Acid Xylose

> 9 mg/dL

> 64 mg/dL

> 1800 mg/dL

> 9 mg/dL

> 60 mg/dL Hemoglobin

> 200 mg/dL Pralidoxime Iodide

> 38 mg/dL Heparin

> 3000 U/L Icodextrin

> 1100mg/dL C H A P T E R 7 T e c h n i c a l I n f o r m a t i o n 47 CHAPTER 8 References 1. American Diabetes Association: Diabetes Care, 2015;38(Suppl. 1): S8-S16 2. Stedman, TL. Stedmans Medical Dictionary, 27th Edition, 1999, p.2082 3. Ellen T. Chen, James H. Nichols, Show-Hong Duh, Glen Hortin, MD: Diabetes Technology &

Therapeutics, Performance Evaluation of Blood Glucose Monitoring meter, Oct 2003, Vol. 5, No. 5: 749 -768 48 Symbols and Abbreviations The symbols and abbreviations given below are shown in the user manual, label, and external package. Symbol Description Manufacturer C H A P T E R 8 R e f e r e n c e s In vitro diagnostic medical device Consult instructions for Use Reference number Date of manufacture Serial number (S/N) Reference The measuring instrument can be easily damaged, so handle it with care. Batch code It must be disposed of separately from other general waste. This product fulfills the requirements of Directive 98/79/EC on in vitro Diagnostic medical device. This product complies with part 15 of the FCC Rules. The meter should be maintained in a dry condition. Precautions DC Power 49 01GM100-1 FCC ID: RPJ01GM100-1 SD BIOSENSOR, Inc. Headoffice SD Biosensor, Inc. 01GMC100-1 FCC ID: RPJ01GMC100-1 Head oce C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA Manufacturing site 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA Tel : +82-31-300-0400 Fax : +82-31-300-0499 www.sdbiosensor.com C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA www.sdbiosensor.com Authorized Representative MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St. Ingbert Germany Phone : +49 6894 581020, Fax : +49 6894 581021 ML21GNEENR1 Issue date : 2023.01 50

SAMPLE LABEL & LOCATION FCC ID: RPJ01GM100-1 LABELLING REQUIREMENTS The Label shown shall be permanently affixed at a conspicuous location on the device and be readily visible to the user at the time of purchase SAMPLE LABEL LOCATION

- The FCC label shown is representative of the label that will appear on the radio when in production. Other information may also be included on this label.

Certification designating a U.S. Agent for service of process:

As required by section 2.911(d)(7), the applicant must designate a contact located in the United States for purposes of acting as the applicants agent for service of process, regardless of whether the applicant is a domestic or foreign entity. An applicant located in the United States may designate itself as the agent for service of process. In either scenario, the designation of the U.S. agent for service of process should be provided as an attachment to the equipment authorization application. The applicant must provide a written certification, which must:

i. Be signed by both the applicant and designated agent for service of process, if the agent is different from the applicant. ii. Acknowledge the applicants consent and the designated agents obligation to accept service of process. iii. Provide a physical U.S. address and email for the designated agent. iv. Acknowledge the applicants acceptance to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Unofficial information provided by FCC personnel on February 14, 2023, via the monthly call with the TCB Council:

The Agent for Process of Service:

cannot be a TCB or affiliated with a TCB (e.g. could not be a person who works for a TCB or a company that owns or is owned by the TCB) cannot be a [FCC recognised] Lab or affiliated with a test lab (e.g. could not be a person who works for a Lab or a company that owns or is owned by the Lab) Agent can be Individual Entity or a Company Entity Agent Entity must be located in US, US address/phone Entity acting as Agent must have FRN (best practice, put FRN on Agent Letter) Agent letter does not have to be FCC ID specific, can be general Agent for Grantee For devices being marketed or for which marketing has ceased for less than 1 year, if the Agent for Process of Service changes, then for every TC Number the TCB must request the FCC to put application into Audit Mode and Agent Letter needs to be updated (superseded). NOTE: The U.S. Agent for Service of Process should not be confused with the authorized agent used for signing the 731 form, other cover letters within the application, and/or the agent who may interface with the TCB. U.S. Agent Designation for Service of Process ATTENTION:

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA REGARDING: FCC Certification Section 2.911(d)(7) Information Designated U.S. Agent Company Name: Approve-IT, Inc. Contact Name: Nathan Grinager Street Address: 8011 34th Ave South, Suite 342 City/Province/Zip: Bloomington, MN 55425 Telephone No: 651-247-1678 Email: team@approve-it.net FRN #: 0027533835 This letter is to confirm that we (the Designated U.S. Agent) have accepted the responsibility to act as the Designated U.S. Agent for Service of Process as required by section 47 CFR 2.911(d)(7) on behalf of the Applicant noted below. U.S. Agent Signature:

Date: June 26, 2023 Signed by (Printed Name/Title): Nathan Grinager / Co-President

*This letter is valid indefinitely for all applications submitted within the period of 06/26/2023 06/26/2028. The Applicant confirms its explicit consent and acknowledges that they must maintain an agent for no less than one year after terminating all marketing and importation OR the conclusion of any Commission-related proceeding involving the equipment. The applicant further acknowledges their responsibility to inform the FCC whenever the Designated U.S. Agent information above changes. Applicant Company name: SD Biosensor, Inc. Grantee Code: RPJ Contact Name: Hyo-Lim, Park Street Address: C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu Suwon-si, Gyeonggi-do 16690 REPUBLIC OF KOREA City/Province/Zip: Suwon-si, Gyeonggi-do 16690 Telephone No: +82-31-300-0421 Email : hlpark@sdbiosensor.com Applicant Signature:

Date: 06/26/2023 Signed by (Printed Name/Title): Hyo-Lim, Park . Senor Manager

SD Biosensor, Inc. C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do South Korea 443-813 FederalCommunicationsCommission AuthorizationandEvaluationDivision 7435OaklandMillsRoad Columbia,MD21046 USA Date:08012023 Ref:AttestationStatementsPart2.911(d)(5)(i)Filing FCCID:RPJ01GM1001 SDBiosensor,Inc.certifiesthattheequipmentforwhichauthorizationissoughtisnotcovered equipmentprohibitedfromreceivinganequipmentauthorizationpursuanttosection2.903oftheFCC rules. Sincerely, HyolimPark Rev 1/26/2023 SD Biosensor, Inc. C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do South Korea 443-813 FederalCommunicationsCommission AuthorizationandEvaluationDivision 7435OaklandMillsRoad Columbia,MD21046 USA Date:08012023 Ref:AttestationStatementsPart2.911(d)(5)(ii)Filing FCCID:RPJ01GM1001 SDBiosensor,Inc.certifiesthat,asofthedateofthefilingoftheapplication,theapplicantisnot identifiedontheCoveredList(asaspecificallynamedentityoranyofitssubsidiariesoraffiliates)asan entityproducingcoveredequipment. Sincerely, HyolimPark Rev 1/26/2023

SD Biosensor, Inc. C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do South Korea 443-813 Date: 07/28/2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Letter of Authorization We, the undersigned, hereby authorize Geunki Son of Dt&C Co., Ltd. to act on our behalf in all manners relating to application for equipment authorization for FCC ID: RPJ01GM100-1 including signing of all documents relating to these matters. Any and all acts carried out by Geunki Son of Dt&C Co., Ltd. on our behalf shall have the same affect as acts of our own. This authorization is valid until further written notice from SD Biosensor, Inc.. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Sincerely, Contact Name: Hyolim Park Title: Senior Manager

SD Biosensor, Inc. C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do South Korea 443-813 Date: 07/28/2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA FCC ID: RPJ01GM100-1 To Whom It may Concern:

Request of Confidentiality Pursuant to Sections 0.457 and 0.459 of the Commission`s Rules(CFR 47), and Section 552 (b) (4) of the Freedom of Information Act, SD Biosensor, Inc. hereby requests confidentiality and treatment of certain information accompanying this application. The materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. We are also hereby request Short-Term Confidentiality for 180 days after the grant as outlined in Public Notice DA 04-1705. This provision will give SD Biosensor, Inc. temporary confidentiality of commercially sensitive information prior to product release. The requested permanent and Short-Term Confidential exhibits are listed as follows:

PERMANENT & SHORT-TERM CONFIDENTIAL LIST PERMANENT SHORT-TERM Description Exhibit 1 2 3 4 5 6 7 8 9 Block Diagram Schematics Part Lists Operation Description NA Internal Photos External Photos Test-Setup Photos User Manual The Applicant understands that pursuant to Rule 0.457, disclosure of this application and all accompanying documentations, where applicable, will not be public before the date of the Grant for this application. Sincerely, Contact Name: Hyolim Park Title: Senior Manager