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.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 2. Performing a Blood Glucose Test NOTE 1) 2) Always wash hands with warm, soapy water. Rinse and dry them before testing. Remove a new test strip from container. Be sure to tightly replace container cap after removing test strip. Make sure the meter turn off. And then, insert the test strip into the meter. Testing Your Blood Sugar Link0.3 3) When the blood drop symbol flashes (Blood Stand-by Display), you are ready to perform a test.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 8) 9) The blood will be drawn into the strip automatically. If beeper is turned on, meter will beep to let you know the test is beginning. When blood is applied to the strip, start the test. After 5 seconds, the test result appears on the screen. You can set the pre-meal or post-meal test if you want. The symbol indicating pre-meal( ) or post-meal( ) appears on the screen. Choose what you want by pressing the left or right button.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. Understanding Test Results Your test results 1. After 5 seconds testing time from applying a blood into strip, you will receive a normal result, 10mg/dL to 600mg/dL. CAUTION Testing Your Blood Sugar 2. If you perform the pre-meal test while the postmeal alarm setting is on, then the post-meal mark will appear automatically on your LCD when you test within following period: from 30min to 130min after your Pre-meal test.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Normal Blood Glucose Readings The normal fasting blood glucose range for an adult without diabetes is 74 - 106 mg/dL.2 Two hours after meals, the blood glucose range for an adult without diabetes is less than 140 mg/dL.1 t 'BTUJOH UP NH E- t IPVST BGUFS NFBMT NH E- What This Means For You Frequent blood glucose testing is the best means to track how well you are doing with your diabetes management.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Chapter 4: Using NFC function 1. Information on NFC function NFC(Near field communication) is a set of standards for smartphones and similar devices to establish radio communication with each other by touching them together or bringing them into close proximit. This function is comfortable for test results back-up at PC or smartphones. So, you can easily monitor your blood glucose results. SD GlucoNavii® Link0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. Using NFC function 1) 2) Check the location of NFC at your smartphone. If you tap SD GlucoNavii® Link0.3 NFC to your smartphone, two kinds of action are happened. First, start GlucoNavii App., seconds, upload the glucose results stored in SD GlucoNavii® Link0.3 NFC meter to smartphone. 3) After finishing the communication, check that the test results are transferred well in your smartphone or PC.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 4. How to use GlucoNavii App 1) Download & Install t Search ‘GlucoNavii’ in Google Play at your smartphone. You can search other keyword that are ‘SD Biosensor’. t Install GlucoNavii App. in your smartphone. NFC enabled smartphone with Android OS v.2.3.1 or higher. Check the list in http://www.nfcworld.com/nfc-data/ android/. NOTE t 2) Check the NFC function at your smartphone. If it is the ‘Off’ setting, turn NFC function ‘On’.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 5. How to use GlucoNavii DMS for PC 1) 2) 3) 4) NOTE Download the software at www.sdbiosensor.com. And then, start the software. Turn the meter off. If not, you cannot start NFC function. Tap the meter with NFC Reader/Writer plugged with PC. And then, start the communication. After finishing the communication, you can look the log book(test results) or graph. More information on App or software for PC, refer to each manual.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Using NFC function NOTE This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 5 : Using the Meter Memory Using the Meter Memory The meter automatically stores about 300 glucose results, letting your review them in order from the most recent to the oldest. If you have set the time/date feature, the time and date of the results are also displayed. If the memory is full and a new result is added, the meter deletes the oldest result.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 1. Searching Test Results 1) In Strip Stand-by Display, press the left arrow button to review in sequence from the most recent test result to the last test results stored in memory. Link0.3 [ Left button ] Using the Meter Memory [Normal result] [Pre-meal result] [Post-meal result] 46 nuGsWUZGumj|GluYWXZW[X^YUGGG[] YWXZTW[TX^GGG㝘䟸G\aXZaXY
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM [Control Solution result] If there aren’t the stored test results, the following display appears for 1 second, and then the meter will display Strip Stand-by Display automatically. Using the Meter Memory 2) 47 nuGsWUZGumj|GluYWXZW[X^YUGGG[^ YWXZTW[TX^GGG㝘䟸G\aXZaXZ
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3) In Strip Stand-by Display, press the right arrow button to review three kinds of 7,14 and 30 day averages of test result stored in memory in sequence. (normal, pre-meal and post-meal state) You can also review the number of results at each average in the right bottom of the LCD window. If you press the right arrow button once more after displaying the 30 day average(with post-meal mark), the 7-day average result appear again.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM NOTE If there aren’t any stored 7, 14 and 30-day average of test results, following display will appear on the LCD. You cannot search the stored test results and average of results in the meter, if a test strip is inserted in the meter, Blood Stand-by Display. After removing the test strip from the meter, you can search the test results and average of results stored in memory by pressing the left or the right button.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 2. Downloading results to a computer You can use your meter with GlucoNavii DMS to store your records and to help you spot patterns for planning meals, exercise, and medication. GlucoNavii DMS puts information downloaded from the meter into charts, diagrams and graphs. 1) 2) Using the Meter Memory NOTE Obtain the GlucoNavii DMS and NFC Reader/Writer. Install the software on a personal computer. Please refer to Software Product Manual.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 6 : Maintenance and Troubleshooting 1. Performing Check strip Test When you do the check strip test? t When you want to easily check the performance of the meter. t Before using your meter for the first time. t Whenever your result does not agree with the level you feel. t If you have repeated a test and the blood glucose result is still lower or higher than expected. Check Strip test does not replace Control Solution test.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. The check result appears on the screen in 5 seconds. ‘OK’ message appears on the screen if there isn’t any problem for the meter. If not, ‘EEE’ message appears on the screen. [ ‘OK’ Message ] [ ‘EEE’ Message ] Maintenance and Troubleshooting 2. Cleaning the meter Caring for SD GlucoNavii® Link0.3 NFC meter is easy. Just keep it free of dust.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. Maintenance, Testing and Transportation Precautions for Maintenance, Testing and Transportation 1) Meter t Keep the test strip slot free of dust. t Protect the internal meter from humidity. t The carrying case is designed to let you store a variety of supplies you may need and helps to protect your meter. t If you keep the meter with the battery inserted, then keep it in a low humidity environment.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Maintenance and Troubleshooting 3) Lancet and Lancing device t The needle of lancet is sharp, keep the lancet away from children. t Keep the lancet and lancing device dry and do not store in direct sunlight, or high heat and humidity locations. t A lancet should not use for the other intended use except sampling blood. t A lancet is for single use only. Do not reuse. t A lancet provided with SD GlucoNavii® Link0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 5. Screen Messages and Troubleshooting Message Description t The meter turns on normally. [Blood Stand-by Display] t The meter is ready for a drop of blood. Maintenance and Troubleshooting [Strip Stand-by Display] t The meter is ready for you to insert a test strip. 55 nuGsWUZGumj|GluYWXZW[X^YUGGG\\ YWXZTW[TX^GGG㝘䟸G\aXZaX[
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM The meter shows the test result. Maintenance and Troubleshooting t 56 nuGsWUZGumj|GluYWXZW[X^YUGGG\] YWXZTW[TX^GGG㝘䟸G\aXZaX[
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t The meter shows three kinds of average of results. [Normal Results Average] [Post-meal Results Average] Maintenance and Troubleshooting [Pre-meal Results Average] 57 nuGsWUZGumj|GluYWXZW[X^YUGGG\^ YWXZTW[TX^GGG㝘䟸G\aXZaX[
Maintenance and Troubleshooting SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t The meter shows the saved results of blood glucose. t The meter is ready for a drop of control solution. 58 nuGsWUZGumj|GluYWXZW[X^YUGGG\_ YWXZTW[TX^GGG㝘䟸G\aXZaX[
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t t [Low battery] At this time, battery is getting low but you can still perform about 50 tests. Replace the battery soon. See Chapter 1 “9. Changing the Battery”. [Replace battery] Battery power is low. Replace the battery immediately. See Chapter 1 “9. Changing the Battery”. If you press the ON/OFF button after discharging of the battery, the battery icon will flash and then after ten seconds the meter will turn off automatically.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t Maintenance and Troubleshooting t t [Lo message] Blood glucose may be lower than the measuring range of the system. See chapter 3 “4. Understanding Test Results”. [Internal Error Message for a meter] Turn off a meter. Then turn on the meter again. If there is still error message, please contact SD Biosensor, Inc. TEL: +82-31-300-0400. [Strip Error] Defective test strip or the test strip is damaged or inserted improperly.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t t [Blood Sample Error] An insufficient amount of blood was applied. Discard this test strip and test again using new test strip and a larger sample, making sure blood is placed to the narrow channel in the top edge of the test strip. See Chapter 3 “2. Performing a Blood Glucose Test”. [Temperature Error] If the environmental temperature is above or below the operating range of a meter, a thermometer icon will appear on the display.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 6. Warnings, Precautions and Limitations t t t Maintenance and Troubleshooting t t t Never make significant changes to your diabetes control program or ignore physical symptom without consulting with your healthcare professional. Severe dehydration (excessive water loss) may cause false low results. If you believe you are suffering from dehydration, consult your healthcare professional right away.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t t Maintenance and Troubleshooting t Do not use during or soon after xylose absorption testing. Xylose in the blood will cause an interference. SD GlucoNavii® Link0.3 NFC System is not designed to be a substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes. Do not use SD GlucoNavii® Link0.3 NFC meter to test neonates. It has not been validated for neonatal use.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 7 : Product Technical Information 1. System Specifications Result Range 10 - 600 mg/dL, (0.6 - 33.3 mmol/L) Calibration Plasma-equivalent Sample Fresh capillary whole blood Sample Size 0.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Memory 300 blood glucose tests Function - Hypo warning : 60, 70, 80 mg/dL(3.3, 3.9, 4.4 mmol/L) - Pre-meal and post-meal mark - Alarm setting (up to 4 times) - Post-meal Alarm - 7-, 14- and 30-day Averages of the following results 1)Normal Results 2)Pre-meal Results 3)Post-meal Results - Automatic shutoff Operation Temperature 10 - 45°C (48 - 113°F) Hematocrit 20 - 60% Altitude Up to 12,388 feet.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 1 : Information for Healthcare Professionals Product Technical Information Healthcare professionals : Follow the infection control procedures appropriate for your facility. Decisions about whether to recommend alternative site testing (AST) should take into account the motivation and knowledge level of the patient and his or her ability to understand the considerations relative to diabetes and AST.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 2 : Symbol The following list describes all symbols used on SD GlucoNavii® Link0.3 NFC Blood glucose monitoring (BGM) system. Symbol Description Caution, consult accompanying documents Battery type used in this meter Crossed out wheeled bin: To discard it separately from other household waste In-vitro diagnostic medical device: This system is intended to use outside the body (in vitro diagnostic use). Serial number for this meter.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Symbol Description Lot No. or Batch Code To indicate the lot number for this system Expiry date: This system should be used by the given date.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 3 : References 1. 2. Product Technical Information 3. American Diabetes Association, Clinical Practice Recommendation Guidelines 2003, Diabetes care, Vol. 26. Supplement 1. p.22 Stedman, TL. Stedman’s Medical Dictionary, 27th Edition, 1999, p. 2082. Ellen T. Chen, James H. Nichols, Show-Hong Duh, Glen Hortin, MD: Diabetes Technology & Therapeutics, Performance Evaluation of Blood Glucose Monitoring Devices, Oct 2003, Vol. 5, No.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Return You must contact SD Biosensor Customer Service at +8231-300-0400 before returning your meter. You will be instructed how to return the meter to SD Biosensor, Inc. Returned meters without this authorization will not be accepted. Product Technical Information This device complies with Part 15 of the FCC Rules.
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Manufactured by SD BIOSENSOR, Inc. C-4th&5th Floor Digital Empire Building 980-3, Yeongtong-dong, Yeongtong-gu, Suwon-si, Kyonggi-do, Korea Product Technical Information EC-Representative 71 nuGsWUZGumj|GluYWXZW[X^YUGGG^X YWXZTW[TX^GGG㝘䟸G\aXZaX]
SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Product Technical Information MEMO 72 nuGsWUZGumj|GluYWXZW[X^YUGGG^Y YWXZTW[TX^GGG㝘䟸G\aXZaX]