SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM 1 1 2 2 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® Voice N 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 VOICE N 38 3) When the blood drop symbol flashes (Blood Stand-by Display), you are ready to perform a test.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM 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. 8) When blood is applied to the strip, start the test. After 5 seconds, the test result appears on the screen. 9) 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM 3. Understanding Test Results Testing Your Blood Sugar 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. 40 2. If your blood glucose is above 600 mg/dL, you will receive a “HI” and is below 10 mg/dL, you will receive “Lo”. In these cases, repeat the test with new test strip. If this message show again, contact your healthcare professional immediately. 3.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM CAUTION If you set the post-meal mark after the test, you will receive a result with post-meal mark. ( ) 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. Normal Blood Glucose Readings The normal fasting blood glucose range for an adult without diabetes is 74 - 106 mg/dL.
SD GlucoNavii® Voice N 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM t If the distance between the meter and a smartphone(or SD NFC reader writer) is far(about over 2cm/0.06ft), NFC function is not operated. 3. Using NFC function? 2) 3) 4) NOTE After testing or you want to test result back-up, turn the meter off. Check the location of Voice N at your smartphone. If you tap SD GlucoNavii® Voice N to your Smart phone, two kinds of action are happened. First, start App. Seconds, Upload Data. (If App.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM 4. How to use GlucoNaviiApp 1) Download & Install t Search ‘GlucoNavii’ in Google Play at your smartphone. You can search other keyword that are ‘SD Biosensor’ or ‘NFC glucose meter’. t Install GlucoNavii App. in your phone. NFC enabled smart-phone 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 smart-phone.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM 5. How to use SD NFC Software 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 SD 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM Using NFC function NOTE 46 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 5 : Using the Meter Memory Using the Meter Memory The meter automatically stores about 500 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® Voice N 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.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM 2) After the result with date and time display for 1 second, the date will change into the appropriate memory number automatically. 3) 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.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM 4) 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® Voice N 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM 2. Downloading results to a computer You can use your meter with SD NFC Software to store your records and to help you spot patterns for planning meals, exercise, and medication. SD NFC Management Software puts information downloaded from the meter into charts, diagrams and graphs. 1) 2) Using the Meter Memory NOTE 52 Obtain the SD NFC Software and SD NFC R/W. Install the software on a personal computer. Please refer to Software Product Manual.
SD GlucoNavii® Voice N 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® Voice N 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 54 Caring for SD GlucoNavii® Voice N meter is easy. Just keep it free of dust. If you need to clean it, follow these guideline carefully to help you get the best performance possible.
SD GlucoNavii® Voice N 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® Voice N 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.
SD GlucoNavii® Voice N 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. t The meter is ready for a drop of blood with pre-meal mark. Maintenance and Troubleshooting [Strip Stand-by Display] t The meter is ready for you to insert a test strip.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM t The meter is ready for a drop of blood with post-meal mark. t The meter shows the test result. t The meter shows three kinds of average of results.
SD GlucoNavii® Voice N 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.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM t Maintenance and Troubleshooting t 60 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”.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM t Maintenance and Troubleshooting t 62 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”.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM t t t 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. Extremes in hematocrit may affect test results. Hematocrit levels greater than 70% may cause falsely low readings.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM t t t t Maintenance and Troubleshooting t 64 Do not use during or soon after xylose absorption testing. Xylose in the blood will cause an interference. SD GlucoNavii® Voice N 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® Voice N meter to test neonates. It has not been validated for neonatal use.
SD GlucoNavii® Voice N 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 or venous whole blood Sample Size 0.5 microliter Test Time 5 seconds Glucose Dehydrogenase Biosensor Two replaceable 1.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM Memory 500 blood glucose tests Function - Hypo warning : 60, 70, 80 mg/dL(3.3, 3.9, 4.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM Annex 1 : Information for Healthcare Professionals 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM Annex 2 : Symbol The following list describes all symbols used on SD GlucoNavii® Voice N Blood glucose monitoring (BGM) system. Symbol Description Caution, consult accompanying documents Consult instructions for use Product Technical Information In-vitro diagnostic medical device: This system is intended to use outside the body (in vitro diagnostic use). 68 Serial number for this meter.
SD GlucoNavii® Voice N 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. To indicate the temperature limitations in which the transport package has to be kept and handled Catalogue number: To indicate the catalogue number for this system To indicate the manufacturer 6 To use for 6 months after first opening the container.
SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEM Annex 3 : References 1. 2. Product Technical Information 3. 70 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® Voice N 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® Voice N BLOOD GLUCOSE MONITORING SYSTEM Manufactured by SD BIOSENSOR, Inc.
Voice N FCC ID : RPJ01GM51 0168 0123
