SD Biosensor 01GM51 SD GlucoNavii Voice N Blood Glucose Meter User Manual pt2

SD Biosensor, Inc. SD GlucoNavii Voice N Blood Glucose Meter pt2

Contents

User Manual pt2

37SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMTesting Your Blood Sugar 3712124)  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.CAUTION
38SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMTesting Your Blood Sugar 382. 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. NOTEVOICE N
39SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMTesting Your Blood Sugar 397)  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  42~46 . NOTE
40SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMTesting Your Blood Sugar 403. 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. 3.  If you set the pre-meal mark after the test, you will receive a result with pre-meal mark. (       )
41SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMTesting Your Blood Sugar 414.  If you set the post-meal mark after the  test, you will receive a result with post-meal mark. (        ) 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. 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. CAUTION
4242SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing NFC function 42Chapter 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® Voice N  follows “Felica” standard which include ISO/IEC 18092.2. Information on Caution for Voice Nt Check your smatphone or PC OS version.            For PC, It is available for Windows XP, Windows                VISTA, Windows 7 and need to SD NFC reader             writer purchased separately.  For Smartphone, It  is available for only smartphones with Android OS v.2.3.1 or higher. Check the list in http://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 .
4343SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing NFC function43t If  the  distance  between  the  meter  and  a  smartphone(or SD  NFC reader  writer)  is    far(about  over 2cm/0.06ft),  NFC function is not operated.3. Using NFC function?1)  After testing or you want to test result back-up, turn the meter o.2)  Check the location of Voice N at your smartphone.3)  If  you  tap  SD  GlucoNavii®  Voice  N    to  your  Smart phone,  two  kinds  of  action  are  happened.  First,  start App. Seconds, Upload Data. (If App. is already running, please, wait a minute.)4)  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. NOTE
4444SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing NFC function 444. How to use GlucoNaviiApp1)  Download & Installt Search ‘GlucoNavii’ in  Google Play at  your smart-phone. You can search other keyword that are ‘SD Biosensor’ or  ‘NFC glucose meter’.t Install GlucoNavii App. in your phone.t Check the NFC function at your smart-phone. If it is the ‘O’ setting, turn NFC function ‘On’.2)  Communicate with SD GlucoNavii® Voice N t Please power o SD GlucoNavii® Voice N  meter. t If you tap SD GlucoNavii® Voice N  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 GlucoNaviiApp       (1) Start App.       (2) If you need to upload new data, just tap              GlucoNavii® Voice N to your smart-phone.Please remember the points of contact for both devices.NOTENFC enabled smart-phone with Android OS v.2.3.1 or higher. Check the list in http://www.nfcworld.com/nfc-data/ android/. NOTE
4545SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing NFC function455. How to use SD NFC Software 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 SD 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 SDGlucoNaviiApp, or SD NFC Software 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® Voice N 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.CAUTION
4646SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing NFC function 46This 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.NOTE
4747SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing the Meter Memory47CHAPTER 5 : Using the Meter MemoryThe 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. 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.
4848SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing the Meter Memory481. 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]
4949SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing the Meter Memory49[Control Solution result]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. 2)  After the result with date and time display for 1 second, the date will change into the appropriate memory number automatically.
5050SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing the Meter Memory504)  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]
5151SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing the Meter Memory515)  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.NOTE
5252SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMUsing the Meter Memory522. Downloading results to a computerYou 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)  Obtain the SD NFC Software and SD NFC R/W.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 SD NFC Software and Software Product manual(both are free of charge), please visit  www.sdbiosensor.com.t For ordering SD 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. NOTE
535353SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting53CHAPTER 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.CAUTIONVOICE NCheck StripCheck Strip
545454SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting543.  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® Voice N meter is easy. Just keep it free of dust. If you need to clean it, follow these guideline carefully to help you get the best performance possible. 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 ]
555555SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting553.  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.
565656SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting563)   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® Voice  N    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  GlucoNavii®  control  solution  in  8-30°C  (46-86°F) environment.t Do not refrigerate or freeze.t Do not  use SD  GlucoNavii®  control solution  that has passed the expiration date.t SD  GlucoNavii®  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.
575757SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting575.  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.t The meter is ready for a drop of blood with pre-meal mark.
585858SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting58t 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.[Normal Results Average][Pre-meal Results Average]
595959SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting59t The meter shows the saved results of blood glucose.t The meter is ready for a drop of control solution. [Post-meal Results Average]
606060SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting60[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”.
616161SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting61[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”.
626262SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting62[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 7. “Product Technical Information”.[Communication Error]t The communication between meter and computer is failed. Connect again between meter and PC.
636363SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting636.    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 greater than  70% 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> 1800 mg/dL
646464SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMMaintenance and Troubleshooting64t Do  not  use  during  or  soon  after  xylose  absorption testing. Xylose in the blood will cause an interference.t SD GlucoNavii® Voice N  System is not designed to be a substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes. t Do  not  use  SD  GlucoNavii®  Voice  N    meter  to  test neonates. It has not been validated for neonatal use. t Preservatives:  When  using  the  venous  blood  foe sample,  blood  may  be  collected  by  healthcare professional into test tubes the anticoagulants(EDTA, lithium heparin or sodium heparin). Do not use other anticoagulants or preservatives.t Peritoneal  dialysis  solution:  Icodextrin  does  not interfere with SD GlucoNavii® Voice N  test strip.
656565SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMProduct Technical Information65CHAPTER 7 : Product Technical Information1. System SpecicationsResult Range  10 - 600 mg/dL,(0.6 - 33.3 mmol/L) Calibration Plasma-equivalentSample  Fresh capillary or venous  whole blood Sample Size  0.5 microliter Test Time  5 seconds Assay Method  Glucose Dehydrogenase Biosensor ON/OFF Source Two replaceable 1.5V Alkaline Batteries type AAABattery Life  Around 1,000 tests Glucose Unit  mg/dL , mmol/LDisplay LCD (Customized)Controls3 ButtonsSize52 mm x 95 mm x 19 mmWeight150g (with batteries)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
666666SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMProduct Technical Information66- Meter- Test strip OperationTemperature 8 - 45°C (46 - 113°F)Hematocrit 0 - 70%AltitudeUp to 11,549 feet. (3,520 meters) StorageTemperature 2 – 32°C (36 – 90°F)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 shuto- Voice announce (3 Language)
676767SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMProduct Technical Information67Annex 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
686868SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMProduct Technical Information68Annex 2 : Symbol The  following  list  describes  all  symbols  used  on  SD GlucoNavii®  Voice  N    Blood  glucose  monitoring  (BGM) system.Symbol DescriptionCaution, consult accompanyingdocumentsConsult 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 meter
696969SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMProduct Technical Information69Symbol 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 once6
707070SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMProduct Technical Information70Annex 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 -768
717171SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMProduct Technical Information71Return 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.
727272SD GlucoNavii® Voice N BLOOD GLUCOSE MONITORING SYSTEMProduct Technical Information72Manufactured by                       SD BIOSENSOR, Inc. C-4th&5th Floor Digital Empire Building 980-3, Yeongtong-dong, Yeongtong-gu, Suwon-si, Kyonggi-do, Korea EC-Representative
Voice NFCC ID : RPJ01GM5101680123

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