SD Biosensor 01GM24 NFC Blood Glucose Monitor User Manual Link manual part2

SD Biosensor, Inc. NFC Blood Glucose Monitor Link manual part2

Link manual part2

35Testing Your Blood Sugar 35SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 4) After cocking the lancing device back, hold the lancing device rmly against the side of nger and then press the release button.1212t 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. t Used lancets in the regular trash can be dangerous. We recommend that you throw out the used lancets in sharps containers or test strip vials. Please be sure to save the cap so that the lancets cannot spill out of the container into the trash.CAUTIONnuGsWUZGumj|GluYWXZW[X^YUGGGZ\ YWXZTW[TX^GGG㝘䟸G\aXZaW`
36Testing Your Blood Sugar 36SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 2. Performing a Blood Glucose Test1) Remove a new test strip from container. Be sure to tightly replace container cap after removing test strip.2) Make sure the meter turn o. And then, insert the test strip into the meter. 3) When the blood drop symbol ashes (Blood Stand-by Display), you are ready to perform a test. 4) Let your arm hang down at your side to allow blood to ow to your ngertips. Grasp your nger just below the joint closest to the ngertip. 5) Obtain a drop of blood sample using the lancet and lancing device. 6) Hold your nger to the tip of the strip until the yellow window is completely lled with blood. Do not place the blood drop on top of the strip. Always wash hands with warm, soapy water. Rinse and dry them before testing. NOTELink0.3nuGsWUZGumj|GluYWXZW[X^YUGGGZ] YWXZTW[TX^GGG㝘䟸G\aXZaW`
37Testing Your Blood Sugar 37SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 7) 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. If you press the On/O button, no select any features. 10) When the test is done, pull out the used test strip and discard it. t Remove the inserted lancet from the lancing device and dispose the used lancet with care. t Always use fresh capillary or venous whole blood for tests.t If you want to use NFC function, refer to ‘Chapter 4. Using the NFC function’ on page 40~44 . NOTEnuGsWUZGumj|GluYWXZW[X^YUGGGZ^ YWXZTW[TX^GGG㝘䟸G\aXZaXW
38Testing Your Blood Sugar 38SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. Understanding Test ResultsYour test results1. After 5 seconds testing time from applying a blood into strip, you will receive a normal result, 10mg/dL to 600mg/dL.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. 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 you test within following period: from 30min to 130min after your Pre-meal test. CAUTIONnuGsWUZGumj|GluYWXZW[X^YUGGGZ_ YWXZTW[TX^GGG㝘䟸G\aXZaXW
39Testing Your Blood Sugar 39SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Normal Blood Glucose Readings The normal fasting blood glucose range for an adult without diabetes is 74 - 106 mg/dL.2 Two hours after meals, the blood glucose range for an adult without diabetes is less than 140 mg/dL.1 t 'BTUJOHUPNHE-t IPVSTBGUFSNFBMTNHE-What This Means For You Frequent blood glucose testing is the best means to track how well you are doing with your diabetes management. It helps you track the eects of medications, diet, exercise, and stress management. Blood glucose test results can also tell you if your diabetes is changing. This may alert you to adjust your treatment plan. Always consult your healthcare professional before making any adjustments. Frequency of Testing Work with your healthcare professional to decide when and how often to test. This will depend on such things as age, type of diabetes, and medications. It is important to make testing part of your daily routine. nuGsWUZGumj|GluYWXZW[X^YUGGGZ` YWXZTW[TX^GGG㝘䟸G\aXZaXW
4040Using NFC function 40SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Chapter 4: Using NFC function1. Information on NFC functionNFC(Near eld communication) is a set of standards for smartphones and similar devices to establish radio communication with each other by touching them together or bringing them into close proximit.This function is comfortable for test results back-up at PC or smartphones. So, you can easily monitor your blood glucose results.SD GlucoNavii® Link0.3 NFC follows “Felica” standard which include ISO/IEC 18092.2. Information on Caution for NFCt Check your smatphone or PC OS version. For PC, It is available for Windows XP, Windows VISTA, Windows 7 and need to NFC Reader/Writer purchased separately.t For smartphone, It is available for only smartphones with Android OS v.2.3.1 or higher. Check the list in www.nfcworld. com/nfc-data/android/.t Before using this function, check the meter turn o. If turn the meter on, you cannot use NFC function.t Check the location of chip for NFC in your smartphone. It is dierent by manufacturer. For more information, refer to manufacturer website of your smartphone.t SD NFC software for PC is able to download at www.sdbiosensor.com . t If the distance between the meter and a smartphone(or NFC Reader/Writer) is far(about over 2cm/0.06ft), NFC function is not operated.nuGsWUZGumj|GluYWXZW[X^YUGGG[W YWXZTW[TX^GGG㝘䟸G\aXZaXW
4141Using NFC function41SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. Using NFC function1) Check the location of NFC at your smartphone.2) If you tap SD GlucoNavii® Link0.3 NFC to your smartphone, two kinds of action are happened. First, start GlucoNavii App., seconds, upload the glucose results stored in SD GlucoNavii® Link0.3 NFC meter to smartphone. 3) After nishing the communication, check that the test results are transferred well in your smartphone or PC.More information on App or software for PC, refer to each manual. NOTEnuGsWUZGumj|GluYWXZW[X^YUGGG[X YWXZTW[TX^GGG㝘䟸G\aXZaXX
4242Using NFC function 42SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 4. How to use GlucoNavii App1) Download & Installt Search ‘GlucoNavii’ in Google Play at your smartphone. You can search other keyword that are ‘SD Biosensor’.t Install GlucoNavii App. in your smartphone.t Check the NFC function at your smartphone. If it is the ‘O’ setting, turn NFC function ‘On’.2) Communicate with SD GlucoNavii® Link0.3 NFC meter t If you tap SD GlucoNavii® Link0.3 NFC meter to your smart-phone, two kinds of action will be happened. First, if App. is not turning it on, start App. Seconds, if App. is already running, please, wait a minute to upload test results. 3) Utilize GlucoNavii App (1) Start App. (2) If you need to upload new data, just tap SD GlucoNavii Link0.3 NFC meter to your smartphone.Please remember the points of contact for both devices.NOTENFC enabled smartphone with Android OS v.2.3.1 or higher. Check the list in http://www.nfcworld.com/nfc-data/android/.NOTEnuGsWUZGumj|GluYWXZW[X^YUGGG[Y YWXZTW[TX^GGG㝘䟸G\aXZaXX
4343Using NFC function43SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 5. How to use GlucoNavii DMS for PC1) Download the software at www.sdbiosensor.com. And then, start the software.2) Turn the meter o. If not, you cannot start NFC function.3) Tap the meter with NFC Reader/Writer plugged with PC. And then, start the communication.4) After nishing the communication, you can look the log book(test results) or graph.If you have any question or queries about GlucoNavii App.or GlucoNavii DMS for PC, please email to (SD_Dev@sdbiosensor.com). More information on App or software for PC, refer to each manual. NOTEEuropean Union Directive Conformance StatementHereby, SD Biosensor declares that SD GlucoNavii® Link0.3 NFC blood glucose meter is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. You can view your product’s Declaration of Conformity(DoC) to Derictives 1995/5/EC(R&TTE) Directive at www.sdbiosensor.com.NOTEWARNING: Changes or modications made to this equipment not expressly approved by SD Biosensor, Inc. for compliance could void the user’s authority to operate the equipment.CAUTIONnuGsWUZGumj|GluYWXZW[X^YUGGG[Z YWXZTW[TX^GGG㝘䟸G\aXZaXX
4444Using NFC function 44SD GlucoNavii® Link0.3 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. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or more of the following measures:t Reorient or relocate the receiving antenna.t Increase the separation between the equipment and receiver.t Connect the equipment into an outlet on a circuit dierent.t from that to which the receiver is connected.t Consult the dealer or an experienced radio/TV technician for help.NOTEnuGsWUZGumj|GluYWXZW[X^YUGGG[[ YWXZTW[TX^GGG㝘䟸G\aXZaXX
4545Using the Meter Memory45SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 5 : Using the Meter MemoryThe 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. The meter also calculates three kinds of 7, 14 and 30-day averages of test results stored in memory, 1)normal, 2)pre-meal and 3)post-meal state averages. You do not need to set the time and date for the meter to give you average calculations. HI/Lo result (results outside of the meter’s reading range) and results with control solution symbol are not included in averages. nuGsWUZGumj|GluYWXZW[X^YUGGG[\ YWXZTW[TX^GGG㝘䟸G\aXZaXX
4646Using the Meter Memory46SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 1. Searching Test Results1) 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.[Normal result][Pre-meal result][Post-meal result][ Left button ]Link0.3nuGsWUZGumj|GluYWXZW[X^YUGGG[] YWXZTW[TX^GGG㝘䟸G\aXZaXY
4747Using the Meter Memory47SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM [Control Solution result]2) 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. nuGsWUZGumj|GluYWXZW[X^YUGGG[^ YWXZTW[TX^GGG㝘䟸G\aXZaXZ
4848Using the Meter Memory48SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3) In Strip Stand-by Display, press the right arrow button to review three kinds of 7,14 and 30 day averages of test result stored in memory in sequence. (normal, pre-meal and post-meal state) You can also review the number of results at each average in the right bottom of the LCD window. If you press the right arrow button once more after displaying the 30 day average(with post-meal mark), the 7-day average result appear again. [Post-meal average][ Normal average ][Pre-meal average]nuGsWUZGumj|GluYWXZW[X^YUGGG[_ YWXZTW[TX^GGG㝘䟸G\aXZaXZ
4949Using the Meter Memory49SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 4) 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.NOTEnuGsWUZGumj|GluYWXZW[X^YUGGG[` YWXZTW[TX^GGG㝘䟸G\aXZaXZ
5050Using the Meter Memory50SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 2. Downloading results to a computerYou 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) Obtain the GlucoNavii DMS and NFC Reader/Writer.2) Install the software on a personal computer. Please refer to Software Product Manual.t While the meter is connected to the PC, it is unable to perform a blood glucose test.t For downloading GlucoNavii DMS and Software Product manual(both are free of charge), please visit www.sdbiosensor.com.t For ordering NFC Reader/Writer, please contact our representative.t For more information,please refer to Software Product Manual. If the cable port got ESD while downloading data, time delay, a few seconds, may be happened. After a while, the meter retransmit data automatically. NOTEnuGsWUZGumj|GluYWXZW[X^YUGGG\W YWXZTW[TX^GGG㝘䟸G\aXZaXZ
515151Maintenance and Troubleshooting51SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 6 : Maintenance and Troubleshooting 1. Performing Check strip TestWhen 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 rst 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. How to Use the check strip1. Insert SD Glucose Check strip (facing up ‘Check strip’ printed in arming knob) into test strip slot. The meter turns on automatically. 2. If the check strip is inserted properly, the meter will start the check.Check Strip test does not replace Control Solution test.CAUTIONLink0.3Check StripCheck StripnuGsWUZGumj|GluYWXZW[X^YUGGG\X YWXZTW[TX^GGG㝘䟸G\aXZaXZ
525252Maintenance and Troubleshooting52SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. The check result appears on the screen in 5 seconds. ‘OK’ message appears on the screen if there isn’t any problem for the meter. If not, ‘EEE’ message appears on the screen.2. Cleaning the meterCaring for SD GlucoNavii® Link0.3 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. To prevent malfunction of the meter, keep the test strip port free of blood, moisture, dirt, or dust. Use a lint-free cloth dampened with water to clean meter. Thoroughly wring out cloth before use. Do not use an abrasive cloth or antiseptic solution, as these may damage the display screen.[ ‘OK’ Message ][ ‘EEE’ Message ]nuGsWUZGumj|GluYWXZW[X^YUGGG\Y YWXZTW[TX^GGG㝘䟸G\aXZaXZ
535353Maintenance and Troubleshooting53SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3. Maintenance, Testing and TransportationThe meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. If you drop the meter or think it is not giving accurate results, make sure that your test strips and control solution haven’t expired, and then run a control solution test.Precautions for Maintenance, Testing and Transportation1) Metert 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. t 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 stript The test strip is sensitive to humidity, keep it in a dry and cool environment, and do not store in direct sunlight.t After pulling out the test strip from its container, close a container cap of the test strip immediately.t The test strip container closes tightly and can protect the test strips, so you should keep the unused test strips in the container in which they came.nuGsWUZGumj|GluYWXZW[X^YUGGG\Z YWXZTW[TX^GGG㝘䟸G\aXZaXZ
545454Maintenance and Troubleshooting54SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 3) Lancet and Lancing devicet The needle of lancet is sharp, keep the lancet away from children. t Keep the lancet and lancing device dry and do not store in direct sunlight, or high heat and humidity locations.t A lancet should not use for the other intended use except sampling blood.t A lancet is for single use only. Do not reuse.t A lancet provided with SD GlucoNavii® Link0.3 NFC Blood glucose meter is able to use every lancing devices manufactured by other company. But if at all possible, use the lancing device manufactured by SD Biosensor, Inc.t Before using, check a packaging condition, if there is any problem, you should not use it.t If a lancet protective disk is loosed or needle of a lancet is exposed, you should not use it.t To reduce the chance of infection for the used lancet, discard it.4) Control solutiont Keep SD Glucose control solution in 8-30°C (46-86°F) environment.t Do not refrigerate or freeze.t Do not use SD Glucose control solution that has passed the expiration date.t SD Glucose control solution can be used for 3 months after opening the container. Write the opened date on the container when you rst opened.t No reconstitution or dilution is necessary.t Wipe the container tip clean and reseal the container tightly after each use.4. Cleaning the Lancing DeviceClean the outside of SD lancing device regularly with 70% isopropyl (rubbing) alcohol. Do not place the entire device under water. Do not use bleach. At least once a week, disinfect the cap after cleaning by placing it in 70% rubbing alcohol for 10 minutes. Allow the cap to air-dry after disinfecting.nuGsWUZGumj|GluYWXZW[X^YUGGG\[ YWXZTW[TX^GGG㝘䟸G\aXZaXZ
555555Maintenance and Troubleshooting55SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 5. Screen Messages and TroubleshootingMessage Descriptiont The meter turns on normally. [Strip Stand-by Display]t The meter is ready for you to insert a test strip.[Blood Stand-by Display]t The meter is ready for a drop of blood.nuGsWUZGumj|GluYWXZW[X^YUGGG\\ YWXZTW[TX^GGG㝘䟸G\aXZaX[
565656Maintenance and Troubleshooting56SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t The meter shows the test result.nuGsWUZGumj|GluYWXZW[X^YUGGG\] YWXZTW[TX^GGG㝘䟸G\aXZaX[
575757Maintenance and Troubleshooting57SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM [Normal Results Average][Pre-meal Results Average][Post-meal Results Average]t The meter shows three kinds of average of results.nuGsWUZGumj|GluYWXZW[X^YUGGG\^ YWXZTW[TX^GGG㝘䟸G\aXZaX[
585858Maintenance and Troubleshooting58SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t The meter shows the saved results of blood glucose.t The meter is ready for a drop of control solution. nuGsWUZGumj|GluYWXZW[X^YUGGG\_ YWXZTW[TX^GGG㝘䟸G\aXZaX[
595959Maintenance and Troubleshooting59SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM [Low battery]t 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]t 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 ash and then after ten seconds the meter will turn o automatically.[HI message]t Blood glucose may be higher than the measuring range of the system. See chapter 3 “4. Understanding Test Results”.nuGsWUZGumj|GluYWXZW[X^YUGGG\` YWXZTW[TX^GGG㝘䟸G\aXZaX\
606060Maintenance and Troubleshooting60SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM [Lo message]t 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]t Turn o 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]t Defective test strip or the test strip is damaged or inserted improperly. Discard this test strip and test again using new test strip. See Chapter 3 “2. Performing a Blood Glucose Test”. nuGsWUZGumj|GluYWXZW[X^YUGGG]W YWXZTW[TX^GGG㝘䟸G\aXZaX\
616161Maintenance and Troubleshooting61SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM [Blood Sample Error]t An insucient 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]t If the environmental temperature is above or below the operating range of a meter, a thermometer icon will appear on the display. Move to an area between 8-45°C (46-113°F), wait for 30 minutes, and perform a test. Do not articially heat or cool the meter. See Chapter 6. “Product Technical Information”.[Communication Error]t The communication between meter and computer is failed. Connect again between meter and PC.nuGsWUZGumj|GluYWXZW[X^YUGGG]X YWXZTW[TX^GGG㝘䟸G\aXZaX\
626262Maintenance and Troubleshooting62SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 6. Warnings, Precautions and Limitationst Never make signicant changes to your diabetes control program or ignore physical symptom without consulting with your healthcare professional. t Severe dehydration (excessive water loss) may cause false low results. If you believe you are suering from dehydration, consult your healthcare professional right away. t Extremes in hematocrit may aect test results.Hematocrit levels less than 20% may cause falsely high readings. Hematocrit levels greater than 60% may cause falsely low readings. t Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with blood glucose meters. t Normal endogenous (within body) natural levels of uric acid, ascorbic acid (vitamin C), bilirubin, triglycerides, and hemoglobin do not interfere with your blood glucose results obtained.t Interferences : The following compounds, elevated levels of ascorbic acid, uric acid, acetaminophen, total bilirubin, triglycerides may aect results.Compound LimitationAscorbic acid > 4 mg/dLUric acid> 9 mg/dLAcetaminophen> 6 mg/dLTotal bilirubin> 40 mg/dLTriglycerides> 1026 mg/dLnuGsWUZGumj|GluYWXZW[X^YUGGG]Y YWXZTW[TX^GGG㝘䟸G\aXZaX\
636363Maintenance and Troubleshooting63SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM t Do not use during or soon after xylose absorption testing. Xylose in the blood will cause an interference.t SD GlucoNavii® Link0.3 NFC System is not designed to be a substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes. t Do not use SD GlucoNavii® Link0.3 NFC meter to test neonates. It has not been validated for neonatal use. nuGsWUZGumj|GluYWXZW[X^YUGGG]Z YWXZTW[TX^GGG㝘䟸G\aXZaX\
646464Product Technical Information64SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM CHAPTER 7 : Product Technical Information1. System SpecicationsResult Range 10 - 600 mg/dL,(0.6 - 33.3 mmol/L) Calibration Plasma-equivalentSample Fresh capillary whole blood Sample Size 0.3 microliter Test Time 5 seconds Assay Method Glucose Oxidase Biosensor ON/OFF Source One replaceable 3 V Lithium Battery type CR2032 Battery Life Around 1,000 tests Glucose Unit mg/dL , mmol/LDisplay LCD (Customized)Controls3 ButtonsSize48 mm × 90 mm × 15 mmWeight50g (with battery)Automatic Shuto t 1 minutes after last user action without inserting test strip into the meter t 3 minutes after last user action when inserting test strip into the meter nuGsWUZGumj|GluYWXZW[X^YUGGG][ YWXZTW[TX^GGG㝘䟸G\aXZaX\
656565Product Technical Information65SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM - System- Test strip OperationTemperature 10 - 45°C (48 - 113°F)Hematocrit 20 - 60%AltitudeUp to 12,388 feet. (3,776 meters) StorageTemperature 2°C – 32°C (36°F – 90°F)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 shutonuGsWUZGumj|GluYWXZW[X^YUGGG]\ YWXZTW[TX^GGG㝘䟸G\aXZaX\
666666Product Technical Information66SD GlucoNavii® Link0.3 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. If you are considering recommending AST for your patients, you need to understand that there is a potential for a signicant dierence between ngertip and alternative site blood glucose test results. The dierence in capillary bed concentration and blood perfusion throughout the body can lead to sample site-to-site dierences in glucose results. These physiological eects vary between individuals and can vary within a single individual based upon his or her behavior and relative physical condition. Our studies involving AST of adults with diabetes show that most persons will nd their glucose level changes more quickly in the ngers’ blood than the alternative sites’ blood. This is especially important when glucose levels are falling or rising rapidly. If your patient is used to making treatment decisions based upon ngertip readings, he or she should consider the delay or lag-time, aecting the reading obtained from an alternative site.Healthcare professionals : Follow the infection control procedures appropriate for your facility.nuGsWUZGumj|GluYWXZW[X^YUGGG]] YWXZTW[TX^GGG㝘䟸G\aXZaX\
676767Product Technical Information67SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 2 : Symbol The following list describes all symbols used on SD GlucoNavii® Link0.3 NFC Blood glucose monitoring (BGM) system.Symbol DescriptionCaution, consult accompanyingdocumentsBattery type used in this meterCrossed out wheeled bin: To discard it separately from other household wasteConsult instructions for useIn-vitro diagnostic medical device:This system is intended to use outside the body (in vitro diagnostic use).Serial number for this meter.Date of manufacture :To indicate the date of manufacture for this meternuGsWUZGumj|GluYWXZW[X^YUGGG]^ YWXZTW[TX^GGG㝘䟸G\aXZaX\
686868Product Technical Information68SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Symbol DescriptionLot No. or Batch CodeTo indicate the lot number for thissystemExpiry date:This system should be used by thegiven date.To indicate the temperaturelimitations in which the transportpackage has to be kept and handledCatalogue number:To indicate the catalogue number for this systemTo indicate the manufacturer$POUBJOT4VóDJFOUGPSO5FTUTTo use for 6 months after rst opening the container.DO NOT REUSE:To warn the user of a piece ofequipment that it is for single useonly and that it must not therefore be used more than once6nuGsWUZGumj|GluYWXZW[X^YUGGG]_ YWXZTW[TX^GGG㝘䟸G\aXZaX\
696969Product Technical Information69SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Annex 3 : References1. American Diabetes Association, Clinical Practice Recommendation Guidelines 2003, Diabetes care, Vol. 26. Supplement 1. p.22 2. Stedman, TL. Stedman’s Medical Dictionary, 27th Edition, 1999, p. 2082. 3. 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. 5 : 749 -768nuGsWUZGumj|GluYWXZW[X^YUGGG]` YWXZTW[TX^GGG㝘䟸G\aXZaX]
707070Product Technical Information70SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM 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. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.nuGsWUZGumj|GluYWXZW[X^YUGGG^W YWXZTW[TX^GGG㝘䟸G\aXZaX]
717171Product Technical Information71SD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM Manufactured by SD BIOSENSOR, Inc. C-4th&5th Floor Digital Empire Building 980-3, Yeongtong-dong, Yeongtong-gu, Suwon-si, Kyonggi-do, Korea EC-Representative nuGsWUZGumj|GluYWXZW[X^YUGGG^X YWXZTW[TX^GGG㝘䟸G\aXZaX]
727272Product Technical Information72MEMOSD GlucoNavii® Link0.3 NFC BLOOD GLUCOSE MONITORING SYSTEM nuGsWUZGumj|GluYWXZW[X^YUGGG^Y YWXZTW[TX^GGG㝘䟸G\aXZaX]

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