FORA V10 BLOOD GLUCOSE MONITORING SYSTEM English

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FORA V10BLOOD GLUCOSEMONITORING SYSTEMEnglish311-4244100-016Version 5.0 2010/07

Thank you for choosingV10BLOOD GLUCOSEMONITORING SYSTEMDear FORA V10 System Owner:This product can assist you in monitoring your blood glucose level.Please visit our website www.foracare.com/usa to view other updated instructions or product information.This manual contains important information you must know aboutthe system. Please read it thoroughly and carefully.The most unique feature of this system is its speaking function,which is an audible aid for users, especially those with visualimpairment.Another unique feature of this system is its no code function, whichmeans that there is no need to calibrate your meter. You just simply insert the test strip into the meter and begin the test.For other questions regarding this system, please contact our customer service team at 1-888-307-8188, 1-866-469-2632. You canalso visit www.foracare.com/usa for helpful information.2

IMPORTANT SAFETY INSTRUCTIONSREAD THIS BEFORE USEThe following basic safety precautions should always be taken.1. Close supervision is necessary when the device is used by, on,or near children, handicapped persons or invalids.2. Use the device only for the intended use described in thismanual.3. Do not use accessories which are not supplied by the manufacturer.4. Do not let the device or its cord come into contact with surfacesthat are hot to the touch.5. Do not use the device near aerosol sprays, or where oxygen isbeing administered.6. Do not use device if it is not working properly, or if it had sufferedany damages.7. Read all instructions thoroughly and practice the test before usingthe product to test your blood glucose. Do all quality controlchecks as directed and consult with a diabetes healthcareprofessional.KEEP THESE INSTRUCTIONS3

TABLE OF CONTENTSIMPORTANT INFORMATIONABOUT ALTERNATIVE SITE TESTING (AST)INTRODUCTION TO THE SYSTEM060709Intended Use09Principle of Measurement09Contents of the System10Appearance and Key Function of the Meter11Meter Display12Speaking Function13Test Strip14BEFORE USE15Battery Replacement15Setting the Meter and Deleting the Memory17BEFORE TESTING BLOOD SUGAR20Control Test20Important Control Solution Test Information21Performing a Control Solution TestTESTING BLOOD SUGAR2225Test Procedure26Expected Test ResultsCOMPARING METER AND LABORATORY RESULTSUSING THE METER MEMORY323334Viewing Results on the Meter34Viewing Results on a Personal Computer374

TAKING CARE OF YOUR METER AND TEST STRIPS38Cleaning38StorageTROUBLESHOOTING GUIDE3840Risk Message41Error Message42Operational problemSPECIFICATIONS43455

IMPORTANT INFORMATIONSevere dehydration and excessive water loss may cause readingswhich are lower than actual values. If you believe you are sufferingfrom severe dehydration, consult a healthcare professionalimmediately.If your blood glucose results are lower or higher than usual, andyou do not have symptoms of illness, first repeat the test. If youhave symptoms or continue to get results higher or lower thanusual, follow the treatment advice of your healthcare professional.Use only capillary whole blood sample to test your blood glucose.Using other substances will cause wrong results.If you are experiencing symptoms that are inconsistent with yourblood glucose test results and you have followed all instructionsdescribed in this owner’s manual, call your healthcare professional.Inaccurate results may occur in severely hypotensive individualsor patients in shock. Readings which are lower than actual valuesmay occur for individuals experiencing a hyperglycemic-hyperosmolarstate, with or without ketosis.Please refer to your test strip package insert for additional importantinformation.6

Alternative Site Testing (AST)Important: AST results serve as references only.Please consult your healthcare professional before you begin AST.What is AST?Alternative site testing (AST) refers towhen individuals check their blood glucose levels using areas of the body otherthan the fingertip. This system allowsAST at the palm, the forearm, the upperarm, the calf or the thigh with results asreliable as those obtained from fingertiptesting.What’s the advantage?Fingertips feel pain more readily because they are full of nerve endings(receptors). Since nerve endings are not so condensed at otherbody sites, tests performed there will be less painful.When to use AST?Food, medication, illness, stress and exercise can affect bloodglucose levels.Capillary blood at the fingertip reflects these changes faster thancapillary blood at other sites. Therefore, when testing blood glucoseduring or immediately after a meal or physical exercise, results fromAST and fingertip may be significantly different.7

We strongly recommend you do AST in the following intervals: In a pre-meal or fasting state (more than 2 hours since the last meal). Two hours or more after taking insulin. Two hours or more after exercise.Do NOT use AST if: You think your blood glucose is low. You are unaware of hypoglycemia. You are testing for hyperglycemia. Your AST results do not correspond with the way you feel. Your routine glucose results are often fluctuating.How to increase the accuracy?Stimulating blood perfusion by rubbing the puncture site prior toblood extraction has a significant influence on the glucose valueobtained. Blood from a site that has not been rubbed exhibits ameasurably different glucose concentration than blood from the finger.When the puncture site is rubbed prior to blood extraction, thedifference is markedly reduced.Please follow suggestions below before puncturing the skin: Rub the puncture site approximately 20 seconds before penetration. Use a clear cap (included in the kit) while setting the lancing device.8

INTRODUCTION TO THE SYSTEMIntended UseThe system is intended for use outside the body (in vitro diagnosticuse). It should be used only for testing glucose (sugar) and onlywith fresh capillary whole blood samples (from the finger, the palm,the forearm, the upper arm, the calf and the thigh). The systemis intended for use in the home and in clinical settings. It shouldnot be used for the diagnosis of diabetes or for the testing of newborns.AST in this system can be used only during steady-state bloodglucose conditions described in the section of “About AlternativeSite Testing (AST).”Principle of MeasurementThe test is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. Themeter measures the current and displays the corresponding bloodglucose level. The strength of the current produced by the reactiondepends on the amount of glucose in the blood sample.9

Contents of the SystemThe system consists of three main products: the blood glucose meter,test strips, and a control solution. These products have been designed,tested, and proven to work together as a system to produce accurateblood glucose test results. Use only the FORA V10 test strips andFORA brand control solution with the blood glucose meter.Your system includes:1212334564567871 meterOwner’s manualWarranty cardQuick start user guideDaily log bookProtective storage caseBatteries10 Strips8PLEASE NOTE1. If your system was opened prior to use or it did not contain all the partslisted above, please return your system to the place of purchase.2. Control solutions, lancing device, and lancets are optional. They are notincluded in the standard kit. Please contact the Customer Care Line at1-888-307-8188, 1-866-469-2632 or place of purchase for availability.3. Only use the FORA V10 Blood Glucose Test Strip with this meter foraccurate measurement results.10

Appearance and Key Function of the Meter1425312345TEST SLOT is where you insert the test strip. The meter will turnon automatically after insertion.LCD SCREEN guides you through the test using symbols andsimple messages.MAIN BUTTON located in front of the meter with "M" on it, isused to turn on the meter, enter the memory mode and controlsteps of setting.SET BUTTON (in the back) located in the battery compartment,is used to set up the meter.DATA PORT located at the side, is for cable connection.11

Meter Display17289341011512613141TEST STRIP SYMBOLAppears when the meter is turnedon.2BLOOD DROP SYMBOLFlashes when it is ready to applythe sample.3TEMPERATURE SYMBOLAppears when ambient temperature is outside operatingtemperature.46DATETIMEVOICE SYMBOLIndicates speaking function is on/off.8LOW BATTERY SYMBOLAppears when the battery power islow.9TEST RESULT AREADisplays glucose results.1011UNIT OF MEASUREMENTKETONE WARNINGAppears when the test result is equalor higher than 240mg/dL(13.3mmol/L).CTL SYMBOLAppears when doing acontrol test and indicatesthat the result won’t bestored in the memory.5712DAY AVERAGEIndicates that the displayed test resultis an average.13FACE SYMBOLAppears when memory deletioncompleted.14MEMORY SYMBOLAppears when you review the memory.12

Speaking FunctionFORA V10 “speaks” aloud step by step instructions to guide youthrough the process of blood glucose testing. The following tabletells you when and what the meter “speaks”.WHEN does the meter speak?WHAT does the meter speak?When you insert the strip intothe meter.Thank you for using this product.Please relax during measurement.When room temperature is outside op- Room temperature out of range,erating range, which is 50-104ºF(10unable to measure.40ºC).When the meter is ready to test.Please apply blood into the strip.(symbol appears on display)When the test is completed. (resultappears on display)The blood glucose is (number) milligramper deciliter.When the test result is outsidemeasurement range, which is 20-600mg/dL(1.1-33.3 mmol/L).The blood glucose out of range,unable to measure.13

Test Strip1FrontAbsorbent HoleApply a drop of blood here.The blood will beautomatically absorbed.Back2Confirmation WindowThis is where you confirm ifenough blood has beenapplied to the absorbenthole in the strip.3The front side of thetest strip should faceup when insertingthe test strip.Test Strip HandleHold this part to insert thetest strip into the slot.4Contact BarsInsert this end of the teststrip into the meter. Pushit in firmly until it will go nofurther.ATTENTION:Test results might be wrong if the contactbar is not fully inserted into the test slot.NOTEThe FORA V10 monitor should only be used with FORA V10 Test Strips.Using other test strips with this meter can produce inaccurate results.14

BEFORE USEBattery ReplacementYour meter comes with two 1.5V AAA alkaline batteries. Themeter will alert you when the power is low by displaying twodifferent messages:1. With battery exhausted symbolappears on the display: the meter is functionaland the result remains accurate, but batteryshould be replaced.2.With battery exhausted symbol , lowand E-b symbols on the display: the batteriescan not provide enough power for a test. Youmust replace the batteries immediately.PLEASE NOTE1. Replacing the batteries does not affect the meter’s memory (previoustest results stored in memory). The time and date settings may need tobe updated.2. Batteries might leak chemicals if not used for a long time. Remove thebatteries if you are not going to use the device for an extended period(i.e. 3 months or more).15

To replace the battery, make sure that the meter is turned off.STEP 1STEP 2STEP 3STEP 1STEP 2STEP 3Press the buckle onRemove old batteriesClose the batterythe battery cover andand replace them withcover.lift it up to removetwo 1.5V AAA alkalinecover.batteries.WARNINGAs with all small batteries, these batteries should be kept away fromsmall children. If they are swallowed, promptly see a doctor for help.16

Setting the Meter and Deleting the MemoryYour meter comes with the time, date, memory deletion, voice volume and language preset. If you need to change the time or replacethe batteries, you may have to enter the setting mode and reset.Please set the time, date, memory deletion, voice volume andlanguage according to the following steps.To set the time, you must first enter the setting mode. Start withthe meter off. Then press the set button located in the batterycompartment. The meter is now in the setting mode.STEP 1 Set the YearThe year appears first, with the number flashing.Press and release the M button to advance oneyear. To move faster, hold the M button down.With the correct year on the display, press the setbutton and the date will appear on the display withthe month flashing.STEP 2 Set the MonthPress and release the M button until the correctmonth appears. To move faster, hold the Mbutton down. With the correct month on the display press the set button and the date will startflashing.17

STEP 3 Set the DatePress and release the M button until the correctdate appears. To move faster, hold the M buttondown. With the correct date on the display, pressthe set button and the time will appear on thedisplay with the hour flashing.STEP 4 Set the HourPress and release the M button to advance onehour. To move faster, hold the M button down.With the correct hour on the display press theset button and the minute will start flashing.STEP 5 Set the MinutesPress and release the M button to advance oneminute. To move faster, hold the M button down.With the correct minute on the display, press the setbutton and the memory deletion will start flashing.STEP 6 Delete Memory“dEL” and flashing “ ” symbol appearon the display. If you didn't want to delete memory, press the set button againto skip this step. If you’d like todelete ALL memory, press M button.Both “dEL” and “ ” will flash. Pressthe M button again to delete all memory.The meter then displays " ", which meansthat the memory has been deleted.18

NOTE1. The time, date, memory deletion, voice volume and language can ONLY bechanged in the setting mode. Therefore, while performing a blood glucose,these parameters cannot be changed.2. Your meter displays 7-, 14-, 21-, 28-, 60- and 90-day averages which you canaccess from the meter memory. These averages are calculated from resultsobtained during the 7-, 14-, 21-, 28-, 60-and 90-days preceding the currentdate and time settings. When the date and time are changed, the 7-, 14-, 21-,28-, 60- and 90-day averages may change as well.3. If the meter is at the setting mode, and if there is no button pressed for 3 minutes, the meter will turn off automatically.STEP 7 Select Speaking FunctionThe meter displays “VOL”, “ ” and flashing number. Press M button to select speaking volumefrom 0 to 7. Then press the set button to proceedto the next step.Number 0 indicates that the speaking function is turned off. “ ”will not display on LCD during testing. Numbers 1 to 7 indicatesspeaking volume from low to high. At this time “ ” will be displayed on LCD during test.STEP 8 Select LanguageL1 (English) or L2 (Spanish) and “ ” displayon LCD. Press the M button to select one of thetwo languages.After the set-up is complete, press the set button to turn off the meter. “OFF” will be displayedbefore shut down.Congratulations! You have finished all settings now!19

Control TestFORA control solution contains a known amount of glucose that reacts withtest strips. By comparing your control solution test results with the expectedrange printed on the test strip vial label, you can ensure that the meter andthe test strips are working together as a system and that you are performingthe test correctly. It is very important that you do this simple check routinelyto make sure your results are accurate.How often should the control solution test be performed? When you use this system to test your blood for the first time, practice theprocedure using control solution. When you can do three tests in a row thatare within the expected range, you are ready to test your blood. To routinely check the meter and test strips, perform a single test for eachlevel of control solution at least once a week.When should the control solution test be performed? When you first get your meter. When you begin using a new vial of test strips. Whenever you suspect that the meter or test strips are not working properly. When your blood glucose test results are inconsistent with how you feel, orwhen you think your results are inaccurate. When your test strips are exposed to extreme environmental conditions(See section TAKING CARE OF YOUR METER & STRIP ). When you want to practice running the test. If you drop the meter.20

Important Control Solution Test Information Use only FORA control solutions. Check the expiration date on thecontrol solution vial. Do not use if expired. Control solution, meter, and test strips should be at roomtemperature, 68-77 F (20-25 C), before testing. Shake the vial before use. Discard the first drop of control solution.After squeezing, wipe off the dispenser tip to avoid contamination.The above tips ensure you to get a clean sample and an accurateresult. Use only 3 months after the first opening date. Record the discarddate (date opened plus 90 days) on the control solution vial. Discard the vial after 90 days. Store the control solution with lid tightly closed at temperatures36-86 F (2-30 C). Do not freeze.PLEASE NOTEThe control solution range is printed on FORA test strip vial. Only useFORA control solution with FORA test strips. It is used to evaluate themeter and test strip performance. It is not a recommended range for yourblood glucose level.21

Performing a Control Solution TestSTEP 1 Insert Test StripFully insert the test strip, with the contact bars end first facing upinto test slot. The meter will turn on automatically. “CH” and “” will appear first, followed by a flashing “ ”symbol.STEP 2 Press the M ButtonAfter the symbol appears on display,press the M button so that “CTL” appears.With the “CTL” sign on the display, themeter will not store your test result inmemory. If you decide not to perform acontrol solution test, press the M buttonagain and the “CTL” sign will disappear.PLEASE NOTE1. Contact bars must be inserted all the way into the meter or you mayreceive an inaccurate test result.2. Every time you perform a control solution test, you must enter into the“CTL” test mode so that the test result will not be stored in the metermemory. Failure to do so will cause confusion between the blood glucose test result and the control solution test result in system memory.22

STEP 3 Obtain Control SolutionShake the control solution vial well.Remove the cap from the controlsolution bottle and place it on a flatsurface. Squeeze the vial, discard thefirst drop, and wipe off the dispenser tipto prevent contamination. Squeeze thevial again to produce another drop andplace this drop on the top of cap.STEP 4 Apply Control SolutionHold the meter up to meet the absorbenthole of the test strip and the drop willbe automatically absorbed. Once theconfirmation window is completely filled,the meter will start counting down.To avoid contaminating the control solution with the contents ofthe test strip, you will have to place a drop of control solution ona clean surface. Do not directly apply control solution to a teststrip.23

STEP 5 Result Appears in 7 SecondsAfter counting down to 0, the controlsolution test result will appear. Compare the result with the range printedon the test strip vial. The resultshould fall within this range.Normal109 165Out-of-range resultsIf test results fall outside the printed range, check the “OperationalProblem” section in troubleshooting guide and repeat the test. Ifyour results continue to be out-of-range, the system may not beworking properly. Do NOT test your blood. Please contact Customer Care Line at 1-888-307-8188, 1-866-469-2632 for help.24

TESTING YOUR BLOOD SUGARBe sure to read this section and the test strip package insert included in the test strip box carefully before testing. Make sure youhave all items needed to test:A. Blood glucose meterB. Test stripC.Lancing deviceD.Sterile lancetE. Cl

The FORA V10 monitor should only be used with FORA V10 Test Strips. Using other test strips with this meter can produce inaccurate results. Absorbent Hole Apply a drop of blood here. The blood will be automatically absorbed. Confirmation Window This is where you confirm if enough blood has

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