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SD Biosensor SD GlucoNavii NFC, User Instruction Manual

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SD Biosensor SD GlucoNavii NFC User Instruction Manual Download Page 69

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SD GlucoNavii® NFC BLOOD GLUCOSE MONITORING SYSTEM

P

roduc

t T

echnical 

Inf

orma

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Annex 3 : References

1.  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

Summary of Contents for SD GlucoNavii NFC

Page 1: ...BloodGlucose MobileMonitoring System BloodGlu M ucose User Instruction Guide...

Page 2: ...can also visit www sdbiosensor com for diabetes management tools and product demonstrations Please refer to the instructions with following symbols in this User Instruction Guide To identify conditio...

Page 3: ...Blood Glucose Monitoring System 6 SD GlucoNavii NFC Meter 7 SD GlucoNavii NFC Test Strips 8 SD GlucoNavii NFC Accessories 9 Changing the Battery 10 Meter Set up 11 Using SD GlucoNavii NFC Test Strips...

Page 4: ...ults 2 Downloading results to a computer Chapter 6 Maintenance and Troubleshooting 1 Performing a SD Glucose check strip 2 Cleaning the meter 3 Maintenance Testing and Transportation 4 Cleaning the La...

Page 5: ...lood samples for example blood from your fingertip palm upper arm or forearm or fresh venous blood t Only use SD GlucoNavii NFC test strips Other test strips will give inaccurate results or E 1 error...

Page 6: ...glycemia low blood glucose This may require immediate treatment according to your healthcare professional s recommenda tions Although this result could be due to a test error it is safer to treat firs...

Page 7: ...is higher than 70 can cause false results 3 Indication for use Purpose of the devices Your new SD GlucoNavii NFC meter and accessories work together to measure the amount of glucose sugar in your bloo...

Page 8: ...s reaction chamber automatically draws the blood into the strip through capillary action When the chamber is full SD GlucoNavii NFC meter start to measure the blood glucose level It is a simple and pr...

Page 9: ...ii NFC Meter Arrow Buttons Use for meter setup and review of memory moving to the right and left ON OFF Button Press to turn meter ON or OFF Test Strip Slot Insert test strip here Battery Cover Remove...

Page 10: ...icates 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 me...

Page 11: ...ur New 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 Indica...

Page 12: ...f a test strip is inserted into the meter in either Strip Stand by Display or turning off the below will be displayed automatically to show the appropriate test result after applying blood sample And...

Page 13: ...ystem 7 SD GlucoNavii NFC Test Strip SD GlucoNavii NFC System measures the amount of glucose in whole blood Blood is applied in the Yellow Window TOP EDGE of SD GlucoNavii NFC Test Strip and is automa...

Page 14: ...ding Your New System SD GlucoNavii control solution SD NFC Reader Writer 8 SD GlucoNavii NFC Accessories 1 2 Lancing Device Cap Comfort dial with puncture depth selection Arming Knob Release Button Ch...

Page 15: ...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 The meter saves battery power by automatically turning off af...

Page 16: ...tment 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 After inserting or replacing the battery confirm that the time and d...

Page 17: ...e display for setting the beep will appear the first step of the setting mode 2 Set the beep mode on or off by pressing either the left or the right button and then selecting the preferred feature by...

Page 18: ...4 mmol L by pressing either the left or the right button and then selecting the preferred feature by pressing the ON OFF button t You can set the meter to let you know when your result indicates a po...

Page 19: ...ng Date Time will appear the third step of the setting mode Set the correct year by pressing either the left or the right button and then select the correct year by pressing the ON OFF button Your new...

Page 20: ...ay format The meter can display the month and day in either a Month Day m d format or a Day Month d m format Set the preferred format on the display by pressing either the left or the right button and...

Page 21: ...er 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 2 Next will appear the setting disp...

Page 22: ...to remind you to test your blood glucose after meal 1 After day and time setting the display for setting the post meal alarm will appear the fourth of setting mode 2 Set the post meal alarm mode 2h or...

Page 23: ...2 hours to remind you to test your blood glucose after meal for 1mimute t If you perform the pre meal test while the post meal alarm setting is on then the post meal mark will appear automatically on...

Page 24: ...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...

Page 25: ...the right button and then select the preferred feature by pressing the ON OFF button 4 If you finish setting the first alarm next will appear the second alarm setting mode Set the alarm with the same...

Page 26: ...G This function is to review the latest test result when inserting the strip into the meter You can check your latest test result before testing 1 After alarm setting display the Data review setting m...

Page 27: ...e the test strip within three minutes after you take it out of the container t Store test strip containers in a cool dry place at 2 32 C 36 90 F Keep away from direct sunlight and heat Do not refriger...

Page 28: ...i NFC Test Strips are for single use only Never reuse a test strip that has had either blood or control solution applied to it t Avoid getting dirt food or liquids on the test strip With clean dry han...

Page 29: ...rip container open or you think your test strips have been damaged t Your test strips were stored in extreme temperatures and or humidity t You want to check the meter and test strips t You dropped th...

Page 30: ...label For more information how to obtain SD GlucoNavii control solution call at 82 31 300 0400 t Do not swallow SD GlucoNavii control solution it is not for human consumption t Do not apply SD GlucoNa...

Page 31: ...ng system using a control solution in Blood Stand by Display If you don t want a control solution test press the left button again 2 Shake the control solution container and discard the first drop of...

Page 32: ...meter and strips may not be working properly Repeat the control solution test 5 Remove the used test strip for control solution from the meter and discard it mg d L mmo l L NFC NOTE The control solut...

Page 33: ...ol solution container icon Have the test strips and or control solution expired Make sure that test strips and control solutions are not past expiration date This date is shown the container bottle Ma...

Page 34: ...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 Is the meter damaged Does it show a...

Page 35: ...nto the lancing device holder and push down firmly until it is fully seated Twist the lancet protective disk until it separates from the lancet 3 Replace the cap and turn it clockwise until it is snug...

Page 36: ...2 1 2 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 t Used lancets in the regula...

Page 37: ...drop symbol flashes Blood Stand by Display you are ready to perform a test 4 Let your arm hang down at your side to allow blood to flow to your fingertips Grasp your finger just below the joint closes...

Page 38: ...thepre mealorpost mealtestifyouwant 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...

Page 39: ...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 wi...

Page 40: ...abetes management It helps you track the effects 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 adju...

Page 41: ...EC 18092 2 Information on Caution for NFC t Check your smatphone or PC OS version For PC It is available forWindows XP Windows VISTA Windows 7 and need to SD NFC reader writer purchased separately For...

Page 42: ...back up turn the meter off 2 Check the location of NFC at your smartphone 3 If you tap SD GlucoNavii NFC to your Smart phone two kinds of action are happened First start App Seconds Upload Data If Ap...

Page 43: ...Communicate with SD GlucoNavii NFC t Please power off SD GlucoNavii NFC meter t If you tap SD GlucoNavii NFC to your smart phone two kinds of action will be happened First if App is not turning it on...

Page 44: ...viiApp 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 NOTE EuropeanUnionDirectiveConformanceStatement Hereby SD Biosen...

Page 45: ...use 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...

Page 46: ...d 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 r...

Page 47: ...ng the Meter Memory 46 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...

Page 48: ...tion 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 t...

Page 49: ...ay 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...

Page 50: ...ts 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...

Page 51: ...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 downloa...

Page 52: ...he 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 How to Use the check strip...

Page 53: ...er Caring for SD GlucoNavii NFC meter is easy Just keep it free of dust If you need to clean it follow these guideline carefully to help you get the best performance possible To prevent malfunction of...

Page 54: ...e 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 the...

Page 55: ...ctive 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 solution t Keep SD GlucoNavii control solution...

Page 56: ...55 5 Screen Messages and Troubleshooting Message Description t 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 mete...

Page 57: ...ITORING SYSTEM Maintenance and Troubleshooting 56 t The meter is ready for a drop of blood with post meal mark t The meter shows the test result t The meter shows three kinds of average of results Nor...

Page 58: ...GlucoNavii NFC BLOOD GLUCOSE MONITORING SYSTEM Maintenance and Troubleshooting 57 t The meter shows the saved results of blood glucose t The meter is ready for a drop of control solution Post meal Res...

Page 59: ...pter 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 batter...

Page 60: ...Understanding Test Results Internal Error Message for a meter t 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...

Page 61: ...p 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 a...

Page 62: ...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 wi...

Page 63: ...atory equipment and should not be used for the diagnosis of diabetes t DonotuseSDGlucoNavii NFC metertotestneonates It has not been validated for neonatal use t Preservatives When using the venous blo...

Page 64: ...Sample Size 0 5 microliter Test Time 5 seconds Assay Method Glucose Dehydrogenase Biosensor ON OFF Source One replaceable 3 V Lithium Battery type CR2032 Battery Life Around 1 000 tests Glucose Unit m...

Page 65: ...Altitude Up to 11 549 feet 3 520 meters Storage Temperature 2 C 32 C 36 F 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...

Page 66: ...ation and blood perfusion throughout the body can lead to sample site to site differences in glucose results These physiological effects vary between individuals and can vary within a single individua...

Page 67: ...tem 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 I...

Page 68: ...en date To indicate the temperature limitations in which the transport package has to be kept and handled Catalogue number To indicate the catalogue number for this system To indicate the manufacturer...

Page 69: ...ion 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...

Page 70: ...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...

Page 71: ...i NFC BLOOD GLUCOSE MONITORING SYSTEM Product Technical Information 70 Manufactured by SD BIOSENSOR Inc C 4th 5th Floor Digital Empire Building 980 3 Yeongtong dong Yeongtong gu Suwon si Kyonggi do Ko...

Page 72: ...71 71 71 SD GlucoNavii NFC BLOOD GLUCOSE MONITORING SYSTEM Product Technical Information 71 MEMO...

Page 73: ...72 72 72 SD GlucoNavii NFC BLOOD GLUCOSE MONITORING SYSTEM Product Technical Information 72 MEMO...

Page 74: ...your S S SD D D B B B BI I I IO O O OS SE EN NS SO OR R I In nc c R R Re ep p pr r r re e e es s s se e en n nt ta at ti iv ve e 01GM40 01GC40 series FCC ID RPJ01GM40 0168 0123 3 TTVF BUF TEL 82 31 30...

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