SD Biosensor SD GlucoNavii NFC User Instruction Manual
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SD Biosensor SD GlucoNavii NFC User Instruction Manual

Blood glucose mobile monitoring system
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Summary of Contents for SD Biosensor SD GlucoNavii NFC

  • Page 1 Blood Glucose Blood ucose Mobile Monitoring System User Instruction Guide...
  • Page 2 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. Tel : +82-31-300-0400 Fax : +82-31-300-0499 website : www.sdbiosensor.com We offer assistance 24 hours a day, 365 days a year in many languages.

  • Page 3: Table Of Contents

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM TABLE OF CONTENTS Chapter 1 : Understanding Your New System Before You Start Testing Special Information for Healthcare Providers and Caregivers Indication for Use Product Description and the Principle of the use The Complete SD GlucoNavii® NFC Blood Glucose Monitoring System SD GlucoNavii®...
  • Page 4 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Chapter 4 : Using NFC function Information on NFC function Information on Caution for NFC Using NFC function How to use GlucoNaviiApp How to use SD NFC Software for PC Chapter 5 : Using the Meter Memory Searching Test Results Downloading results to a computer Chapter 6 : Maintenance and Troubleshooting...

  • Page 5: Chapter 1 : Understanding Your New System

    If you see any damage to the container cap or if anything prevents the cap from closing properly, do not use the test strips. Contact SD Biosensor, Inc. Damaged test strips can cause inaccurate results, which could lead to improper treatment.
  • Page 6 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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. CAUTION Do not eat the test strips. Do not swallow or inject SD GlucoNavii® control solution, or use control solutions for any purpose.

  • Page 7: Special Information For Healthcare Providers And Caregivers

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.

  • Page 8: Glucose Monitoring System

    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.

  • Page 9: Sd Gluconavii® Nfc Meter

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 6. SD GlucoNavii® NFC Meter 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.
  • Page 10 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Display Indicates Indicates during the meter Measurement time setting Warns when the Indicates beep battery is low or must be setting replaced Indicates if environmental Indicates post-meal or temperature is pre-meal exceeded during testing Indicates a test result stored Testing date...
  • Page 11 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Indicates the Test strip average result Tell you when to apply the sample and indicates if you Indicates a control select whole blood solution test result for blood reference type Indicates alarm Indicates hypo warning setting Indicates S/W communication...
  • Page 12 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 1) Strip Stand-by Display After turning on the meter, the below will be displayed automatically to show the test strip icon flashing. In this Strip Stand-by Display, it’s able to enter setting mode of the meter or search the test results.

  • Page 13: Sd Gluconavii® Nfc Test Strips

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.

  • Page 14: Sd Gluconavii® Nfc Accessories

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 8. SD GlucoNavii® NFC Accessories Lancet SD Glucose check strip Electrode Arming Knob Lancing Device Cap & Comfort dial with puncture depth selection Release Arming Button Knob SD GlucoNavii® control solution SD NFC Reader/Writer...

  • Page 15: Changing The Battery

    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.
  • Page 16 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM STEP-2: Insert the 3V battery (type CR2032) into the compartment with “+” side facing you. STEP-3: Snap battery cover back in place. STEP-4: Push the ON/OFF button or insert a strip to start testing.

  • Page 17: Meter Set Up

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 10. Meter Set up STEP-1 : Setting the Audible Beep 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. [ During 3 sec.
  • Page 18 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM STEP-2: Setting the Hypo warning 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).
  • Page 19 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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. NOTE It also helps your healthcare team interpret your results.
  • Page 20 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM [ Left or right [ ON/OFF button ] button ] 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 (d- m) format.
  • Page 21 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM [ Time Setting ] 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.
  • Page 22 SD GlucoNavii® 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. Set the post-meal alarm mode ‘2h’...
  • Page 23 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.
  • Page 24 SD GlucoNavii® 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. 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.
  • Page 25 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.
  • Page 26 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING 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. After alarm setting, display the Data review setting mode. Set the data review function by pressing the left or right button for selecting the preferred feature.

  • Page 27: Using Sd Gluconavii® Nfc Test Strips

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM If you finish data review setting mode, next appear at the strip-stand by display. 11. Using SD GlucoNavii® NFC Test Strips [ Important Test Strip Information ] SD GlucoNavii® NFC blood glucose test strip should be used with SD GlucoNavii®...
  • Page 28 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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) 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.

  • Page 29: Chapter 2 : Control Solution Test

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 2 : Control Solution Test Why you do control solution test ; 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.

  • Page 30: Performing A Control Solution Test

    SD GlucoNavii® 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 GlucoNavii® control solution tightly closed at temperatures between 8-30°C (46-86°F). Do Not refrigerate.
  • Page 31 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM STEP-1: Remove a new test strip from container. Be sure to tightly replace container cap after removing test strip. Insert a test strip (yellow window printed ‘ ’ facing up) into test strip slot. The meter turns on automatically. STEP-2: Press the left button for 3 seconds to check the testing system using a control solution in Blood Stand-by...
  • Page 32 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.

  • Page 33: Troubleshooting Control Solution Test

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 2. Troubleshooting Control Solution Test Check Action Did you do the test in If not, do the test again. Insert a control solution mode? test strip; Press the left button Did you see “control for 3 seconds in Blood Stand- solution container icon”...
  • Page 34 Repeat the test. If you get the Is the control result same results, do not use your outside the acceptable meter and test strip until you range(printed on your solve the problem. If you still test strip container)? have problem, call SD Biosensor, Inc. at +82-31-300-0400.

  • Page 35: Chapter 3 : Testing Your Blood Glucose

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 3 : Testing Your Blood Glucose 1. Getting a Drop of Blood 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.
  • Page 36 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM After cocking the lancing device back, hold the lancing device firmly against the side of finger and then press the release button. 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.

  • Page 37: Performing A Blood Glucose Test

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 2. Performing a Blood Glucose Test Always wash hands with warm, soapy water. Rinse and dry them before testing. NOTE Remove a new test strip from container. Be sure to tightly replace container cap after removing test strip. Make sure the meter turn off.
  • Page 38 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. When blood is applied to the strip, start the test. After 5 seconds, the test result appears on the screen.

  • Page 39: Understanding Test Results

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 3. Understanding Test Results Your test results After 5 seconds testing time from applying a blood into strip, you will receive a normal result, 10mg/dL to 600mg/dL. If your blood glucose is above 600 mg/dL, you will receive a “HI”...
  • Page 40 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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 post- meal alarm setting is on, then the post-meal mark will appear automatically on your LCD when CAUTION you test within following period: from 30min to...

  • Page 41: Chapter 4: Using Nfc Function

    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.

  • Page 42: Using Nfc Function

    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? 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®...

  • Page 43: How To Use Gluconaviiapp

    Download & Install Search ‘GlucoNavii’ in Google Play at your celphone. You can search other keyword that are ‘SD Biosensor’ or ‘NFC glucose meter’ . Install GlucoNavii App. in your phone. NFC enabled smart-phone with Android OS v.2.3.1 or higher.

  • Page 44: How To Use Sd Nfc Software For Pc

    SD NFC Software for PC , please email to (SD_Dev@sdbiosensor.com). European Union Directive Conformance Statement Hereby, SD Biosensor declares that SD GlucoNavii(R) NFC blood glucose meter is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.
  • Page 45 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.

  • Page 46: Chapter 5 : Using The Meter Memory

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 5 : 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.

  • Page 47: Searching Test Results

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 1. Searching Test Results 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. [ Left button ] [Normal result] [Pre-meal result] [Post-meal result]...
  • Page 48 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM [Control Solution result] After the result with date and time display for 1 second, the date will change into the appropriate memory number automatically. 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.
  • Page 49 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.
  • Page 50 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.

  • Page 51: Downloading Results To A Computer

    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.

  • Page 52: Chapter 6 : Maintenance And Troubleshooting

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 6 : Maintenance and Troubleshooting 1. Performing Check strip Test When you do the check strip test? When you want to easily check the performance of the meter. Before using your meter for the first time. Whenever your result does not agree with the level you feel.

  • Page 53: Cleaning The Meter

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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’ [ ‘EEE’...

  • Page 54: Maintenance, Testing And Transportation

    Do not modify the meter, such as resembling or remodeling, NFC function is not operated well. If any function is not perated, please contact SD Biosensor, Inc. 2) Test strip The test strip is sensitive to humidity, keep it in a dry and cool environment, and do not store in direct sunlight.

  • Page 55: Cleaning The Lancing Device

    But if at all possible, use the lancing device manufactured by SD Biosensor, Inc. Before using, check a packaging condition, if there is any problem, you should not use it.

  • Page 56: Screen Messages And Troubleshooting

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 5. Screen Messages and Troubleshooting Message Description The meter turns on normally. [Strip Stand-by Display] The meter is ready for you to insert a test strip. [Blood Stand-by Display] The meter is ready for a drop of blood.
  • Page 57 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM The meter is ready for a drop of blood with post-meal mark. The meter shows the test result. The meter shows three kinds of average of results. [Normal Results Average] [Pre-meal Results Average] 56 56 56...
  • Page 58 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM [Post-meal Results Average] The meter shows the saved results of blood glucose. The meter is ready for a drop of control solution. 57 57 57...
  • Page 59 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM [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.
  • Page 60 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM [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.
  • Page 61 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM [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.

  • Page 62: Warnings, Precautions And Limitations

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 6. Warnings, Precautions and Limitations 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.
  • Page 63 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM 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.

  • Page 64: Chapter 7 : Product Technical Information

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 7 : Product Technical Information 1. System Specifications 10 - 600 mg/dL, Result Range (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 Assay Glucose Dehydrogenase Biosensor...
  • Page 65 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Memory 500 blood glucose tests - 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 Function - 7-, 14- and 30-day Averages of the following results 1)Normal Results 2)Pre-meal Results...

  • Page 66: Annex 1 : Information For Healthcare Professionals

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 1 : Information for Healthcare Professionals 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.

  • Page 67: Annex 2 : Symbol

    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. Symbol Description Caution, consult accompanying documents Battery type used in this meter Crossed out wheeled bin: To discard it separately from other household waste Consult instructions for use In-vitro diagnostic medical device:...
  • Page 68 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...

  • Page 69: Annex 3 : References

    SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 3 : References 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 &...
  • Page 70 Return You must contact SD Biosensor Customer Service at +82- 31-300-0400 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. This device complies with Part 15 of the FCC Rules.
  • Page 71 SD GlucoNavii® 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 EC-Representative 70 70 70...
  • Page 72 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM MEMO 71 71 71...
  • Page 73 SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM MEMO 72 72 72...
  • Page 74 For further information on further information on please contact your contact your SD BIOSENSOR, Inc. Representative FCC ID : RPJ01GM40 0168 0123...

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