0168 FCC ID : RPJ01GM14 0123 Link™0.3 NFC Link0.3 Mentor tor NFC NF NFC Link™0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Dear SD GlucoNavii® Link0.3 NFC System Owner; Thank you for choosing SD GlucoNavii® Link0.3 NFC Blood Glucose Monitoring System. Your new SD GlucoNavii® Link0.3 NFC Blood Glucose Monitoring System is an important tool that can help you better manage your diabetes. Important steps for using the System are inside this guide. Please read it carefully. If you have questions, we are here to help. Please contact SD Biosensor, Inc.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM TABLE OF CONTENTS TABLE OF CONTENTS Chapter 1 : Understanding Your New System 1. Before You Start Testing 2. Special Information for Healthcare Providers and Caregivers 3. Indication for Use 4. Product Description and the Principle of the use 5. The Complete SD GlucoNavii® Link0.3 NFC Blood Glucose Monitoring System 6. SD GlucoNavii® Link0.3 NFC Meter 7. SD GlucoNavii® Link0.3 NFC 8. SD GlucoNavii® Link0.3 NFC Accessories 9.
Chapter 4 : Using NFC function 1. Information on NFC function 2. Information on Caution for NFC 3. Using NFC function 4. How to use GlucoNavii App 5. How to use GlucoNavii DMS for PC 40 40 40 41 42 43 Chapter 5 : Using the Meter Memory 1. Searching Test Results 2. Downloading results to a computer 45 46 50 Chapter 6 : Maintenance and Troubleshooting 1. Performing a SD Glucose check strip 2. Cleaning the meter 3. Maintenance, Testing and Transportation 4. Cleaning the Lancing Device 5.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 1 : Understanding Your New System The SD GlucoNavii® Link0.3 NFC Blood Glucose Monitoring System 1. Before You Start Testing Understanding Your New System About the meter and test strips t Carefully read and follow the instructions in the User Instruction Guide and Package Inserts for the test strips and SD Glucose control solution.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t t CAUTION t t Keep the meter and testing supplies away from small children. The battery door, test strips, lancets, protective disks, and control solution cap are choking hazards. Do not eat the test strips. Do not swallow or inject SD Glucose control solution, or use control solutions for any purpose.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t healthcare professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your healthcare professional. Consult your physician to determine if it is appropriate for your child to be taught how to use the meter system or any other medical products. 2.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM cause a small electric current. The amount of current that is created depends on how much glucose is in the blood. SD GlucoNavii® Link0.3 NFC 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 meter’s LCD display. By touching a drop of blood to the tip of the SD GlucoNavii® Link0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 6. SD GlucoNavii® Link0.3 NFC Meter NFC Display Shows blood glucose result, messages, and glucose result stored in memory. ON/OFF Button Press to turn meter ON or OFF. Link0.3 Arrow Buttons Use for meter setup and review of memory moving to the right and left. Understanding Your New System Test Strip Slot Insert test strip here. Data port Cominucate test results with a personal computer.
SD GlucoNavii® Link0.
Understanding Your New System SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Indicates the average result Test strip Tell you when to apply the sample and indicates if you select whole blood for blood reference type Indicates a control solution test result Indicates alarm setting Indicates hypo warning Indicates S/W communication 10 nuGsWUZGumj|GluYWXZW[X^YUGGGXW YWXZTW[TX^GGG㝘䟸G\aXYa[Y
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 2) Blood Stand-by Display If a test strip is inserted into the meter in either Strip Standby Display or turning off, the below will be displayed automatically to show the appropriate test result after applying blood sample. And if you pull off the test strip, it will return to Strip Stand-by Display. In this Blood Standby Display, the ON/OFF button doesn’t act. But if you need to check the meter or the test strip, you may use a control solution.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 7. SD GlucoNavii® Link0.3 Test Strip SD GlucoNavii® Link0.3 NFC System measures the amount of glucose in whole blood. Blood is applied in the Yellow Window (TOP EDGE) of SD GlucoNavii® Link0.3 Test Strip and is automatically drawn into the reaction cell where the reaction takes place. Understanding Your New System (Top Edge) 12 nuGsWUZGumj|GluYWXZW[X^YUGGGXY YWXZTW[TX^GGG㝘䟸G\aXYa[Y
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 8. SD GlucoNavii® Link0.3 NFC Accessories Lancet SD Glucose check strip Electrode Check Strip Arming Knob Release Button SD GlucoNavii® control solution NFC Reader/Writer Arming Knob Understanding Your New System 1 2 Lancing Device Cap & Comfort dial with puncture depth selection 13 nuGsWUZGumj|GluYWXZW[X^YUGGGXZ YWXZTW[TX^GGG㝘䟸G\aXYa[Z
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 9. Changing the Battery Inserting and replacing the Battery Your meter is shipped with one 3V battery type CR2032 that needs to be inserted before testing. The battery that comes with your meter can be found in the mesh pocket of your carrying case. Battery life will vary depending on usage, so always keep a spare on hand.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM STEP-2: Insert the 3V battery (type CR2032) into the compartment with “+” side facing you. STEP-4: Push the ON/OFF button or insert a strip to start testing. NOTE After inserting or replacing the battery, confirm that the time and date are set correctly. If they are not, use the ON/OFF and left/right buttons to reset the meter before testing. See the “10. Meter Set up”. Understanding Your New System STEP-3: Snap battery cover back in place.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 10. Meter Set up STEP-1 : Setting the Audible Beep 1. In Strip Stand-by Display, if you press the ON/OFF button during 3 seconds, the display for setting the beep will appear, the first step of the setting mode. Link0.3 Understanding Your New System [ During 3 sec. ] 2. Set the beep mode on or off by pressing either the left or the right button and then selecting the preferred feature by pressing the ON/OFF button.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM STEP-2: Setting the Hypo warning NOTE t You can set the meter to let you know when your result indicates a possible low blood glucose (hypoglycemia). You can also select what blood glucose level you want this indicator to have 60, 70, 80 mg/dL(3.3, 3.9, 4.4 mmol/L). If your results are lower than selected hypo result, the candy symbol will appear on LCD with a ‘beep’ sound. It is very important to manage your hypoglycemia. 1.
Understanding Your New System SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM NOTE Your new meter comes with a preset time and date. You may need to change the time to your time zone. Having the right time and date in your meter is important if you use the meter memory. It also helps your healthcare team interpret your results. STEP-3: Setting the date and time [ Date Setting ] 1. The third step of setting mode is the Date & Time setting.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM [ Left or right button ] Link0.3 [ ON/OFF button ] 2. Next will appear the setting display for month and day format. The meter can display the month and day in either a Month-Day (m-d) format or a Day-Month (dm) format. Set the preferred format on the display by pressing either the left or the right button and select by pressing the ON/OFF button. 3.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM [ Time Setting ] 1. Next will appear the display for setting the 12 or 24 Hour clock format. The meter can display the time in either the 12h format or the 24h format. Set the preferred format on the display by pressing either the left or the right button and select by pressing the ON/OFF button. Understanding Your New System Link0.3 [ Left or right button ] 2. Link0.3 [ ON/OFF button ] Next will appear the setting display for time format.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM STEP-4: Post-meal alarm You can use the meter’s post-meal alarm function to remind you to test your blood glucose after meal. After day and time setting, the display for setting the post-meal alarm will appear the fourth of setting mode. 2. Set the post-meal alarm mode ‘2h’ or ‘off’ by pressing either the left or the right button and then select the preferred feature by pressing the ON/OFF button. Link0.3 [ Left or right button ] Link0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t t NOTE Understanding Your New System t If you select the post-meal alarm ‘2h’ feature and test with pre-meal mark, the ‘clock symbol’ will appear on result display and the ‘beep’ sound will be made in 2 hours to remind you to test your blood glucose after meal for 1mimute.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM STEP-5: Setting the alarm You can use the meter’s alarm function to remind you to test your blood glucose. After Post-meal alarm setting the display for setting the alarm will appear, the fifth of setting mode. 2. Set the first alarm on or off by pressing either the left or the right button and then select the preferred feature by pressing the ON/OFF button. Link0.3 [ Left or right button ] t t NOTE Link0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. If you select the alarm on feature in first alarm mode, the clock will blink. Set the correct time and minute you want to set an alarm on the display by pressing either the left or the right button and then select the preferred feature by pressing the ON/OFF button. Link0.3 [ Left or right button ] Understanding Your New System NOTE Link0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 2. Set the data review function by pressing the left or right button for selecting the preferred feature. Understanding Your New System STEP-6: DATA REVIEW SETTING This function is to review the latest test result when inserting the strip into the meter. You can check your latest test result before testing. 1. After alarm setting, display the Data review setting mode. Link0.3 Link0.3 Link0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. If you finish data review setting mode, next appear at the strip-stand by display. 11. Using SD GlucoNavii® Link0.3 Test Strips Understanding Your New System [ Important Test Strip Information ] t SD GlucoNavii® Link0.3 blood glucose test strip should be used with SD GlucoNavii® Link0.3 NFC meter. Using other glucose test strip can cause inaccurate the result or ‘E-1’ error message.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Write the opening date on the container label when you first open it. Discard remaining SD GlucoNavii® Link0.3 Test Strips after the discard date. (6 months after first opening from the container.) t SD GlucoNavii® Link0.3 Test Strips are for single use only. Never reuse a test strip that has had either blood or control solution applied to it. t Avoid getting dirt, food or liquids on the test strip.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 2 : Control Solution Test Why you do control solution test ; t SD Glucose control solution is used to check that the meter and the test strips are working together as a system and that you are performing the test correctly. t It is very important that you do this simple check routinely to make sure you get an accurate result. Control Solution Test When you do control solution test ; t You open a new box test strips.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Shake the container, discard the first drop of control solution, and wipe off the tip to ensure a proper sample and an accurate result. Store SD Glucose control solution tightly closed at temperatures between 8-30°C (46-86°F). Do Not refrigerate. t t t CAUTION t Do not swallow SD Glucose control solution; it is not for human consumption. Do not apply SD Glucose control solution to the skin or eyes as it may cause irritation. 1.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM STEP-1: 1) Remove a new test strip from container. Be sure to tightly replace container cap after removing test strip. 2) Insert a test strip (yellow window printed ‘Link0.3’ facing up) into test strip slot. The meter turns on automatically. Link0.3 STEP-2: 1) Press the left button for 3 seconds to check the testing system using a control solution in Blood Stand-by Display. If you don’t want a control solution test, press the left button again.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3) 4) The control solution result appears on the screen in just 5 seconds. Compare control solution result with the range printed on the test strip container. If the results are not within the control range printed on the test strip container, then the meter and strips may not be working properly. Repeat the control solution test. NFC mg/ dL mmo l/L Link0.3 5) Remove the used test strip for control solution from the meter and discard it.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Control Solution Test 2. Troubleshooting Control Solution Test Check Action Did you do the test in control solution mode? Did you see “control solution container icon” on the screen with the result? If not, do the test again. Insert a test strip; Press the left button for 3 seconds in Blood Standby Display to display a control solution container icon.
Check Action Did you insert test strip firmly into meter? Make sure test strip is inserted into the test strip slot until it will go on further. Did you follow the procedure correctly? Read again “Chapter 2 : Control Solution Test” (pages 28-33) and retest. Were test strips stored correctly? (at 2-32°C, 36-90°F) Was the bottle cap replaced immediately after removing a test strip? If not, retest with a new container of test strips.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 3 : Testing Your Blood Glucose 1. Getting a Drop of Blood 1) 2) Wash your hands in warm, soapy water. Rinse well and dry completely. Warming fingers can increase blood flow. Turn the lancet insert cap counterclockwise to remove it, insert the lancet into the lancing device holder and push down firmly until it is fully seated. Twist the lancet protective disk until it separates from the lancet.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 4) After cocking the lancing device back, hold the lancing device firmly against the side of finger and then press the release button. 2 CAUTION t A lancet should only be used once. Do not share used lancets with another person. To prevent possible infection, a used lancet should not be touched by another person. Used lancets in the regular trash can be dangerous.