Blood Glucose Gluucose M Mobile Monitoring System User Instruction Guide
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Dear SD GlucoNavii® NFC System Owner; Thank you for choosing SD GlucoNavii® NFC Blood Glucose Monitoring System. Your new SD GlucoNavii® 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® NFC BLOOD GLUCOSE MONITORING SYSTEM TABLE OF CONTENTS TABLE OF CONTENTS 2 4 4 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® NFC Blood Glucose Monitoring System 6. SD GlucoNavii® NFC Meter 7. SD GlucoNavii® NFC Test Strips 8. SD GlucoNavii® NFC Accessories 9. Changing the Battery 10. Meter Set up 11.
Chapter 4 : Using NFC function 1. Information on NFC function 2. Information on Caution for NFC 3. Using NFC function 4. How to use GlucoNaviiApp 5. How to use SD NFC Software 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® NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 1 : Understanding Your New System The SD GlucoNavii® 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 GlucoNavii® control solution. It is very important to follow the instructions in order to prevent an incorrect result or improper treatment.
SD GlucoNavii® 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 GlucoNavii® control solution, or use control solutions for any purpose.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM t Guide, call your 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® NFC BLOOD GLUCOSE MONITORING SYSTEM 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. SD GlucoNavii® 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.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 6. SD GlucoNavii® 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. 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. (If you have software) Battery Cover Remove cover to change battery.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Indicates Measurement time Indicates during the meter setting Indicates beep setting Warns when the battery is low or must be replaced Indicates if environmental temperature is exceeded during testing Indicates post-meal or pre-meal Testing date Indicates a test result stored in memory Unit of test result Test result and nfc message Understanding Your New System Display 9
Understanding Your New System SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 10 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
SD GlucoNavii® 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® NFC BLOOD GLUCOSE MONITORING SYSTEM 7. SD GlucoNavii® NFC Test Strip SD GlucoNavii® NFC System measures the amount of glucose in whole blood. Blood is applied in the Yellow Window (TOP EDGE) of SD GlucoNavii® NFC Test Strip and is automatically drawn into the reaction cell where the reaction takes place.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 8.
SD GlucoNavii® 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® 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® 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. Understanding Your New System [ During 3 sec. ] 16 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® 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® NFC BLOOD GLUCOSE MONITORING SYSTEM 18 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® NFC BLOOD GLUCOSE MONITORING SYSTEM [ 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. Set the correct month or day on the display by pressing either the left or the right button and select by pressing the ON/OFF button.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Understanding Your New 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. 20 [ Left or right button ] 2. [ ON/OFF button ] Next will appear the setting display for time format.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 1. 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.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM t t NOTE Understanding Your New System t 22 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® NFC BLOOD GLUCOSE MONITORING SYSTEM 1. 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. [ Left or right button ] t t NOTE [ ON/OFF button ] If you select the alarm off feature, next will appear the Strip Stand-by Display.
SD GlucoNavii® 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.
SD GlucoNavii® 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.
SD GlucoNavii® 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® NFC Test Strips Understanding Your New System [ Important Test Strip Information ] 26 t SD GlucoNavii® NFC blood glucose test strip should be used with SD GlucoNavii® NFC meter. Using other glucose test strip can cause inaccurate the result or ‘E-1’ error message.
t Write the opening date on the container label when you first open it. Discard remaining SD GlucoNavii® NFC Test Strips after the discard date. (6 months after first opening from the container) t SD GlucoNavii® NFC 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. With clean, dry hands, you may touch the test strip anywhere on its surface.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 2 : Control Solution Test Why you do control solution test ; t SD GlucoNavii® 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® NFC BLOOD GLUCOSE MONITORING SYSTEM t 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 GlucoNavii® control solution tightly closed at temperatures between 8-30°C (46-86°F). Do Not refrigerate. t t CAUTION t Do not swallow SD GlucoNavii® control solution; it is not for human consumption. Do not apply SD GlucoNavii® control solution to the skin or eyes as it may cause irritation. 1.
SD GlucoNavii® 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 ‘ ’ facing up) into test strip slot. The meter turns on automatically. NFC Control Solution Test STEP-2: 1) Press the left button for 3 seconds to check the testing system using a control solution in Blood Stand-by Display.
SD GlucoNavii® 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 5) Remove the used test strip for control solution from the meter and discard it.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Control Solution Test 2. Troubleshooting Control Solution Test 32 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® 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® NFC 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® 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 NFC 36 3) When the blood drop symbol flashes (Blood Stand-by Display), you are ready to perform a test.
SD GlucoNavii® NFC 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® NFC 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. 38 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® NFC 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® 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® NFC BLOOD GLUCOSE MONITORING SYSTEM 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 NFC at your smartphone. If you tap SD GlucoNavii® NFC to your Smart phone, two kinds of action are happened. First, start App. Seconds, Upload Data. (If App. is already running, please, wait a minute.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 4. How to use GlucoNaviiApp 1) Download & Install t Search ‘GlucoNavii’ in Google Play at your celphone. 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. If it is the ‘Off’ setting, turn NFC function ‘On’.
SD GlucoNavii® NFC 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® NFC BLOOD GLUCOSE MONITORING SYSTEM Using NFC function NOTE 44 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® NFC 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® 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.
SD GlucoNavii® NFC 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® NFC 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® 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® NFC 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 50 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® 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® 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 52 Caring for SD GlucoNavii® NFC 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® 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® 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.
SD GlucoNavii® 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. 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.
Maintenance and Troubleshooting SD GlucoNavii® NFC 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® 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.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM t Maintenance and Troubleshooting t 58 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® NFC 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. Discard this test strip and test again using new test strip.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM t Maintenance and Troubleshooting t 60 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® NFC 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® NFC BLOOD GLUCOSE MONITORING SYSTEM t t t t Maintenance and Troubleshooting t 62 Do not use during or soon after xylose absorption testing. Xylose in the blood will cause an interference. SD GlucoNavii® 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® NFC meter to test neonates. It has not been validated for neonatal use.
SD GlucoNavii® 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 or venous whole blood Sample Size 0.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Memory 500 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 Product Technical Information - Meter 64 Operation Temperature 8 - 45°C (46 - 113°F) Hematocrit 0 - 70% Altitude Up to 11,549 feet.
SD GlucoNavii® NFC 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® NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 2 : Symbol The following list describes all symbols used on SD GlucoNavii® NFC Blood glucose monitoring (BGM) system.
SD GlucoNavii® 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. 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® NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 3 : References 1. 2. Product Technical Information 3. 68 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® 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® NFC BLOOD GLUCOSE MONITORING SYSTEM Manufactured by SD BIOSENSOR, Inc.
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Product Technical Information MEMO 71
SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Product Technical Information MEMO 72
For further information on 01GM40/01GC40 series FCC ID : RPJ01GM40 Floor Digital Empire Building 980-3, 0168 C-4th&5th Yeongtong-dong, Yeongtong-gu, Suwon-si, Kyonggi-do, Korea 0123 TEL : +82-31-300-0400 FA X : +82-31-300-0499 - /'$ &/3 *TTVF %BUF please p lease contact on a your BIOSENSOR, SSD DB IOSENSOR, Inc. Inc.
