SD Biosensor SD GlucoNavii Voice N, User Instruction Manual

Page 1: ...Voice N Voice N ...

Page 2: ...uages You 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 conditions or practices that could result in damage to equipment or other property To provide an additional useful information Before using any product to test your blood glucose read all instruction...

Page 3: ...lood Glucose Monitoring System 6 SD GlucoNavii Voice N Meter 7 SD GlucoNavii Voice N Test Strips 8 SD GlucoNavii Voice N Accessories 9 Changing the Battery 10 Meter Set up 11 Using SD GlucoNavii Voice N Test Strips Chapter 2 Control Solution Test 1 Performing a Control Solution Test 2 Troubleshooting Control Solution Test Chapter 3 Testing Your Blood Sugar 1 Getting a Drop of Blood 2 Performing a ...

Page 4: ...Results 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 Lancing Device 5 Screen Messages and Troubleshooting 6 Warnings Precautions and Limitations Chapter 7 Product Technical Information 1 System Specifications Annex 1 Information for Healthcare Professi...

Page 5: ...ood samples for example blood from your fingertip palm upper arm or forearm or fresh venous blood t Only use SD GlucoNavii Voice N test strips Other test strips will give inaccurate results or E 1 error message t Do not use the SD GlucoNavii Voice N blood glucose monitoring system for testing of serum or plasma or arterial blood t Inspect the container of test strips before using them for the firs...

Page 6: ...ypoglycemia 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 first and then repeat the test t High glucose results If your test result is greater than 180 mg dL or is shown as HI it may mean hyperglycemia high blood glucose If you do not have symptoms first repe...

Page 7: ...gher than 70 can cause false results 3 Indication for use Purpose of the devices Your new SD GlucoNavii Voice N meter and accessories work together to measure the amount of glucose sugar in your blood Your SD GlucoNavii Voice N blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood or fresh venous blood Testing is done outside the body in vitro diagnosti...

Page 8: ... reaction chamber automatically draws the blood into the strip through capillary action When the chamber is full SD GlucoNavii Voice N meter start to measure the blood glucose level It is a simple and practical system for the daily monitoring of your blood glucose level 5 The Complete GlucoNavii Voice N BGMS The system includes t SD GlucoNavii Voice N Meter t SD GlucoNavii Voice N Test strips t SD...

Page 9: ...Navii Voice N 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 cover to change battery Location of NFC function Tap a smartphone or SD NFC R W for communication Data port Cominucate test results with a personal computer If you have software ...

Page 10: ...icates during the meter setting Indicates sound level Warns when the batteries are low or must be replaced Indicates if environmental temperature is exceeded during testing Indicates post meal or pre meal Testing date Indicates a test result stored in memory Unit of test result Test result and Voice N message Display ...

Page 11: ...he average result Test strip Tell you when to apply the sample and indicates if you select whole blood for blood reference type Indicates a control solution test result Indicates alarm setting Indicates hypo warning Indicates S W communication Indicates time setting Indicates voice language setting ...

Page 12: ...erted 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 if you pull off the test strip it will return to Strip Stand by Display In this Blood Stand by Display the ON OFF button doesn t act But if you need to check the meter or the test strip you may use a control solution Then...

Page 13: ...em 7 SD GlucoNavii Voice N Test Strip SD GlucoNavii Voice N System measures the amount of glucose in whole blood Blood is applied in the Yellow Window TOP EDGE of SD GlucoNavii Voice N Test Strip and is automatically drawn into the reaction cell where the reaction takes place Top Edge ...

Page 14: ...ing Your New System SD GlucoNavii control solution SD Voice N Reader Writer 8 SD GlucoNavii Voice N Accessories 1 2 Lancing Device Cap Comfort dial with puncture depth selection Arming Knob Release Button Check Strip Lancet SD Glucose check strip Electrode Arming Knob ...

Page 15: ...ith your meter can be found in the mesh pocket of your carrying case Batteries life will vary depending on usage so always keep a spare on hand The meter saves batteries power by automatically turning off after 1 minute without inserting a test strip or 3 minutes with a test strip from non use If the meter does automatically shut off all tests in memory are saved STEP 1 Push the recessed plastic t...

Page 16: ...o their polarity follow the directions on the case STEP 3 Snap battery cover back in place STEP 4 Push the ON OFF button or insert a strip to start testing 1 5V AA 1 5V AA After inserting or replacing the battery confirm that the time and date are set correctly If they are not use the ON OFF and left right buttons to reset the meter before testing See the 10 Meter Set up NOTE ...

Page 17: ...up STEP 1 Setting the sound level 1 In strip stand by mode with sound icon if you press the ON OFF button the display for setting the sound level will be appeared Set the sound level by pressing the left or right button Right button ON OFF button Left button L R button L R button L R button L R button ...

Page 18: ...ning will be appeared t Set the OFF or 60 70 80 mg dL by pressing the left or right button NOTE ON OFF button Right button Left button L R button L R button L R button L R button Your new meter comes with a preset time and date You may need to change the time to your time zone Having the right time and date in your meter is important if you use the meter memory It also helps your healthcare team i...

Page 19: ...mode with hypo set icon if you press the right button the display for setting the date time will be appeared And when you press the ON OFF button year digit will be appeared Set the correct year by pressing the left or right button and then go to time setting by pressing the ON OFF button ON OFF button ON OFF button Right button Left button Right button ...

Page 20: ...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 select by pressing the ON OFF button 3 Set the correct month or day on the display by pressing either the left or the right button and select by pressing the ON OFF button ON OFF button Left or right button ...

Page 21: ...ither 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 display for time format Set the correct hour and minute on the display by pressing either the left or the right button and select the correct time by pressing the ON OFF button ON OFF button Left or ri...

Page 22: ...your blood glucose after meal 1 In strip stand by mode with time set icon if you press the right button the display for setting the post meal alarm set icon will be appeared And when you press the left or right button 2h or OFF will be appeared Select the preferred feature by pressing the ON OFF button ON OFF button ON OFF button Right button Right button Left button Right button ...

Page 23: ... 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 t If you mark the new test result with a pre meal mark the old alarm setting will be ignored and only the new setting will sound in 2 hours NOTE 2 Set the post meal alarm mode 2h or off by pressing e...

Page 24: ... your blood glucose 1 In strip stand by mode with post meal alarm set icon if you press the right button the display for alarm set icon will be appeared And when you press the left or right button On or OFF will be appeared Select the preferred feature by pressing the ON OFF button ON OFF button ON OFF button Right button Right button Left button Right button Right button ...

Page 25: ...et the alarm up to four times a day at any time you want NOTE 2 Set the first alarm on or off by pressing either the left or the right button and then select the preferred feature by pressing the ON OFF button ON OFF button Left or right button 3 If you select the alarm on feature in first alarm mode the clock will blink Set the correct time and minute you want to set an alarm on the display by pr...

Page 26: ...ode with the same way as above 2 3 STEP 6 SETTING THE LANGUAGE 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 In strip stand by mode with alarm set icon if you press the right button the display for language set icon will be appeared And when you pres s the left or right button On or OFF will be appea...

Page 27: ...26 SD GlucoNavii Voice N BLOOD GLUCOSE MONITORING SYSTEM Understanding Your New System ON OFF button ON OFF button Right button Right button Left button Right button Right button Right button ...

Page 28: ...s 3 different languages per each country Language numbers are as follows t L 1 English t L 2 Spanish t L 3 French t L 4 German t L 5 Russian t L 6 Portuguese t L 7 Hindustani t L 8 Chinese t L 9 Japanese t L10 Korean 3 After selecting a language announce level figure will be displayed By pressing the left or right button br or FUL namely brief or full level can be selected ...

Page 29: ...te test strips t Do not expose strips to heat moisture or humidity Temperatures outside the required range as well as moisture and humidity e g bathroom kitchen laundry room car or garage can damage your test strips and lead to inaccurate results t Store test strips in their original container only to avoid damage or contamination Do not transfer test strips to any other storage device and do not ...

Page 30: ...on the test strip With clean dry hands you may touch the test strip anywhere on its surface t Do not bend cut or alter SD GlucoNavii Voice NTest Strip in any way Do not swallow test strips The test strip container may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation CAUTION ...

Page 31: ...st strip 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 the meter t Your test result does not agree with how you feel t You want to check if you are testing correctly Before you begin t Use only SD GlucoNavii control solution t Check the expiration date...

Page 32: ...ip 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 GlucoNavii control solution to the skin or eyes as it may cause irritation CAUTION A set of Level M and H control solutions is available for purchase To order control solutions talk to your pharmacist or ...

Page 33: ... testing system using a control solution in Blood Stand by Display If you don t want a control solution test press the left button again 2 Shake the control solution container and discard the first drop of solution Gently squeeze the container to form one small drop Bring the drop to the edge of the strip and allow the strip to automatically draw the control solution into the yellow window When co...

Page 34: ...the 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 dL mm ol L VOICE N NOTE The control solution range printed on the test strip container is for SD GlucoNavii Control Solution only It is not a recommended range for your blood glucose level This is an example Refer to the ranges on your...

Page 35: ...ontrol 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 Make sure the expiration date of both a test strip and a control solution test strip 6 months control solution 3months Were control solutions at room temperature 18 30 C 64 86 F when used If not ret...

Page 36: ...st 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 an error message If yes contact SD Biosensor Inc at 82 31 300 0400 Is the control result outside the acceptable range printed on your test strip container Repeat the test If you get the same results do n...

Page 37: ... into the lancing device holder and push down firmly until it is fully seated Twist the lancet protective disk until it separates from the lancet 3 Replace the cap and turn it clockwise until it is snug Adjust the puncture depth setting by turning the comfort dial The dial has 1 to 5 steps and the higher the step number the stronger the blood sampling pressure on the puncture site The comport tip ...