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SD GlucoNavii® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM Dear SD GlucoNavii® Mentor NFC System Owner; Thank you for choosing SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System. Your new SD GlucoNavii® Mentor 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® Mentor 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® Mentor NFC Blood Glucose Monitoring System 6. SD GlucoNavii® Mentor NFC Meter 7. SD GlucoNavii® Mentor NFC Test Strips 8. SD GlucoNavii® Mentor 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® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 1 : Understanding Your New System The SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM is created depends on how much glucose is in the blood. SD GlucoNavii® Mentor 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® Mentor test strip, the strip’s reaction chamber automatically draws the blood into the strip through capillary action.
SD GlucoNavii® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM 6. SD GlucoNavii® Mentor 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. Mentor 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® Mentor 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 nuGtGumj|GYWXZW[X]ZUGGG` YWXZTW[
Understanding Your New System SD GlucoNavii® Mentor 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 nuGtGumj|GYWXZW[X]ZUGGGXW YWXZTW[TX]GGG㝘䟸G\a\_a[Y
SD GlucoNavii® Mentor 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® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM 7. SD GlucoNavii® Mentor Test Strip SD GlucoNavii® Mentor NFC System measures the amount of glucose in whole blood. Blood is applied in the Yellow Window (TOP EDGE) of SD GlucoNavii® Mentor Test Strip and is automatically drawn into the reaction cell where the reaction takes place. Understanding Your New System (Top Edge) 12 nuGtGumj|GYWXZW[X]ZUGGGXY YWXZTW[TX]GGG㝘䟸G\a\_a[Y
SD GlucoNavii® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM 8. SD GlucoNavii® Mentor 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 nuGtGumj|GYWXZW[X]ZUGGGXZ YWXZTW[TX]GGG㝘䟸G\a\_a[Z
SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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. ] 2. Set the beep mode on or off b y pressing either the left or the right button and then selecting the preferred feature by pressing the ON/OFF button.
SD GlucoNavii® Mentor 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® Mentor 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® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM Ment Mentor [ 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® Mentor 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 Ment Mentor [ Left or right button ] 2. [ ON/OFF button ] Next will appear the setting display for time format.
SD GlucoNavii® Mentor 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.
SD GlucoNavii® Mentor 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® Mentor 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.
SD GlucoNavii® Mentor 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® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM If you finish alarm setting, next appear at the stripstand by display. Understanding Your New System NOTE 25 nuGtGumj|GYWXZW[X]ZUGGGY\ YWXZTW[TX]GGG㝘䟸G\a\_a\Z
SD GlucoNavii® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM 11. Using SD GlucoNavii® Mentor NFC Test Strips Understanding Your New System [ Important Test Strip Information ] t SD GlucoNavii® Mentor NFC blood glucose test strip should be used with SD GlucoNavii® Mentor NFC meter. Using other glucose test strip can cause inaccurate the result or ‘E-1’ error message. t After removing a test strip from the container, replace the container cap immediately and close it tightly.
SD GlucoNavii® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM 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. t Do not bend, cut, or alter SD GlucoNavii® Mentor Test Strip in any way. Understanding Your New System CAUTION Do not swallow test strips. The test strip container may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.
SD GlucoNavii® Mentor 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® Mentor 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 Glucose control solution tightly closed at temperatures between 8-30°C (46-86°F). Do Not refrigerate. 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® Mentor 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 ‘Mentor’ facing up) into test strip slot. The meter turns on automatically. NFC Mentor 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® Mentor 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 Mentor 5) Remove the used test strip for control solution from the meter and discard it.
SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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® Mentor 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. NFC Testing Your Blood Sugar Mentor 3) When the blood drop symbol flashes (Blood Stand-by Display), you are ready to perform a test.
SD GlucoNavii® Mentor 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. 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. If you press the On/Off button, no select any features.
SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM 3. Using NFC function 1) 2) Check the location of NFC at your smartphone. If you tap SD GlucoNavii® Mentor NFC to your smartphone, two kinds of action are happened. First, start GlucoNavii App., seconds, upload the glucose results stored in SD GlucoNavii® Mentor NFC meter to smartphone. 3) After finishing the communication, check that the test NOTE More information on App or software for PC, refer to each manual.
SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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® Mentor 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® Mentor 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. Mentor [ Left button ] Using the Meter Memory [Normal result] [Pre-meal result] [Post-meal result] 46 nuGtGumj|GYWXZW[X]ZUGGG[] YWXZTW[TX]GGG㝘䟸G\a\_a\_
SD GlucoNavii® Mentor 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 nuGtGumj|GYWXZW[X]ZUGGG[^ YWXZTW[TX]GGG㝘䟸G\a\_a\_
SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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® Mentor 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® Mentor 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® Mentor NFC meter is easy. Just keep it free of dust.
SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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 nuGtGumj|GYWXZW[X]ZUGGG\\ YWXZTW[TX]GGG㝘䟸G\a\_a\`
SD GlucoNavii® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM The meter shows the test result. Maintenance and Troubleshooting t 56 nuGtGumj|GYWXZW[X]ZUGGG\] YWXZTW[TX]GGG㝘䟸G\a\_a\`
SD GlucoNavii® Mentor 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 nuGtGumj|GYWXZW[X]ZUGGG\^ YWXZTW[TX]GGG㝘䟸G\a\_a\`
Maintenance and Troubleshooting SD GlucoNavii® Mentor 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 nuGtGumj|GYWXZW[X]ZUGGG\_ YWXZTW[TX]GGG㝘䟸G\a\`aWW
SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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® Mentor 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® Mentor 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® Mentor 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® Mentor NFC meter to test neonates. It has not been validated for neonatal use.
SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 2 : Symbol The following list describes all symbols used on SD GlucoNavii® Mentor 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® Mentor 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® Mentor 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® Mentor 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® Mentor 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 nuGtGumj|GYWXZW[X]ZUGGG^X YWXZTW[TX]GGG㝘䟸G\a\`aWX
SD GlucoNavii® Mentor NFC BLOOD GLUCOSE MONITORING SYSTEM Product Technical Information MEMO 72 nuGtGumj|GYWXZW[X]ZUGGG^Y YWXZTW[TX]GGG㝘䟸G\a\`aWX
FCC ID-RPJ01GM24 0168 0123 L21MVN1ENR0 Issue date: 2013.