Untitled - Menarini Diagnostics
Contents
1. MT IE NE MARE RA E ANNE 46 This product may become infectious in the course of use Discard the product accordance with local SPECIFICATIONS Eo PO VL ET OR EVO E 46 regulations for biohazardous waste CHEMISTRY MEA UREME Ne oe A ED Sie 46 47 INSTRUC HON MOB 48 gs WARNING WARRANTY 90 K Blood samples and blood products are potential sources of hepatitis and other infectious agents Handle all blood products with care Wear gloves when performing measurements on another person Items that are used to measure glucose e g test strips lancets and alcohol swabs must be disposed of in accordance to local regulations to avoid risk to anyone GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 SYMBOLS The following are symbols that are used in this manual on insert sheets and on the GlucoMen LX blood glucose meter Manufacturer Attention read user manual before use Serial number Direct Current Voltage jt P Catalogue number LOT Batch code K Store at z Use by CONT SELF TESTING Blood glucose meter 1 V n GlucoMen LX 38973 09 07 Contents of Set This product fulfills the requirements of the Directive 98 79 EC on in vitro diagnostic medical devices In Vitro Diagnostic Medical Device In vitro device for self testing Blood glucose meter Biohazard This meter could be potentially contaminated2. Appears when not displayed on meter call Meter is turned on for Setup and A Menarini Diagnostics for assistance T TNT Memory Review UK 0800 243667 D f th A Menarini Diagnostics if the meter needs to be repaired replaced et Ireland 1800 709903 Blood Drop Symbol meter is ready to ac Apply a blood sample to the test strip cept blood Refer to how to run a blood sample Countdown screen 4 second countdown No action reguired as meter calculates the blood glucose test result A blood glucose test result in mmol L No action reguired Result is automatically stored into memory GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 DISPLAYS MEANINGS ACTIONS DISPLAYS MEANINGS ACTIONS Display What it Means What to Do What it Means What to Do Ca Your blood glucose reading is higher Retest your blood glucose immediately The average of all blood glucose test re No action required than 33 3 mmol L You may have high If your reading is still Hl you should treat sults taken in the last 24 hours blood sugar yourself as advised by your healthcare professional and or contact your health care professional immediately No test results in the last 24 hours No action required Your blood glucose reading is lower than Retest your blood glucose immediately 1 1 mmol L You may have low blood If your reading is still LO treat as pre sugar scribed by your healthcare professional and
3. below it will be replaced with a new meter or a substantial eguivalent free of charge Limitations on Warranty This warranty is subject to the following exceptions and limitations 1 This warranty is applicable only to the original purchaser 2 This warranty does not apply to units which malfunction or are damaged due to obvious abuse misuse alteration neglect unauthorized maintenance or failure to operate meter in accordance with instructions 3 We have no knowledge of the performance of the GlucoMen LX blood glucose meter when used with test strips other than GlucoMen LX Sensor test strips Therefore we make no warranty as to the performance of the GlucoMen LX blood glucose meter when used with any test strips other than GlucoMen LX Sensor test strips 4 There is no other express warranty for this product The option of replacement described above is the warrantor s only obligation under this warranty For warranty service The original purchaser must contact A Menarini Diagnostics UK 0800 243667 Ireland 1800 709903 Privacy Policy A Menarini Diagnostics is committed to using your personal information responsibly and in compliance with the law You have our pledge that we will not share or sell your personal information with marketers or third parties The information you voluntarily share with us will be used to help us serve you better in the future GlucoMen LX 38973 09 07 GlucoMen LX 3
4. nU 24 To be used by people with diabetes mellitus at home as an aid to measure the effectiveness of diabetes OBTAINING AND APPLYING A BLOOD SAMPLE FROM FOREARM OR PALM 27 control It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not Ca LIMITATIONS AND CONSIDERATIONS FOREARM AND PALM TESTING 29 intended for use on neonates It can also be used by healthcare professionals YOUR TEST 8 The GlucoMen LX blood glucose meter is intended for use outside the body in vitro diagnostic use REVIEW TEST RESULTS IN MEMORY J 33 It should only be used with GlucoMen LX Sensor test strips and GlucoMen LX Control solution DATA REVIEW IN MEMORY LU t should be used for testing glucose sugar and only with fresh capillary whole blood samples DATA MANAGEMENT SOFTWARE uU t should NOT be stored in the refrigerator or in the car nu d idcq 36 BATTERY CHECK ebu sundae 36 WARNING BATTERY uuu The GlucoMen LX blood glucose meter contains small parts Keep the meter out of reach of small CLEANING AND CARE uuu children and pets If you have hypoglycaemia unawareness a blood glucose meter is critical to your care DISPLAYS MEANINGS ACTIONS 111 1 LLL 39 Since any meter may fail break or be misplaced you should always have a backup meter APPENDIX 2
5. 0800 243667 Ireland 1800 709903 GlucoMen LX 38973 09 07 IMPORTANT INFORMATION CONTENTS For correct use refer to GlucoMen LX sensor instructions for use INTENDED USE ines Before you begin using your new blood glucose meter please read all of the instructions provided in SYMBOLS 8 C3 this User Manual INTRODUCTION E Your meter uses a CR2450 3 volt coin cell battery To begin using your meter you need to install the METER COMPONENTS LLL 9 enclosed battery See Battery Replacement page 35 to install a new battery METER DISPLAY iru 10 Perform all quality control checks recommended your User Manual THE GLUCOMEN LX BLOOD GLUCOSE METER gg Consult with your diabetes healthcare professional and follow his her guidance for your blood glucose OVER VIE oe cst 11 monitoring routine NINECOSEIIIIS 12 These recommendations apply to all blood glucose monitors and are supported by the American ENVIRONMENTAL CONDITIONS LL 12 Association of Diabetes Educators AADE the American Diabetes Association ADA the US Food zie cARIOIC and Drug Administration FDA and the Advanced Medical Technology Association AdvMed REASONS TO CHECK FOR LOW BLOOD GLUCOSE 2 13 IMPORTANT HEALTH RELATED INFORMATION eme e e esee is 1
6. be handled with care Dropping rough handling etc may damage the meter If the meter is not to be used for an extended period of time remove the batteries to eliminate the risk of battery leakage Also protect the meter from moisture prolonged direct sunlight and extreme temperatures Overview To perform a test the operator simply inserts a test strip waits for the blood drop symbol to appear on the screen brings the test strip to the drop of blood and obtains a glucose test result in 4 seconds The test result is automatically stored into the meter s memory The operator can recall delete and review test data stored in the meter including the average result GlucoMen LX 38973 09 07 INTRODUCTION Kit Contents GlucoMen LX blood glucose meter e Battery CR2450 3V User Manual Warranty Card Depending on the version your Set may include additional items Please refer to the box label for the list of contents of your Set Environmental conditions e The storage temperature range for the meter 25 C to 46 C 13 F to 115 F The storage temperature range for the Test Strips 4 to 30 C 39 2 F to 86 F The meter operational temperature range 5 C to 45 C 41 F to 113 F The relative humidity range 10 to 90 non condensing GlucoMen LX 38973 09 07 INTRODUCTION Before Testing Ca Before testing and to ensure accurate glucose results wash your hands and the
7. due to the blood samples used Significant additions or changes from previous user manual revision Contents sufficient for n tests INTRODUCTION Meter Components Test Strip Goes Here LCD Display cau m am a 1112111 L 4 Mem mg dL Avg mmol L 86 56 8858 Left Arrow Button Right Arrow Button Mode Button GlucoMen LX blood glucose meter GlucoMen LX 38973 09 07 INTRODUCTION Meter Display When you turn the GlucoMen LX blood glucose meter on the all segments display appears briefly This tells you that all the display segments are working properly Control Low Battery Marked Test Indicator Results Glucose Test Results Memory Result mg dL Mem mg dL Results rop Indicator A Avg meli T moll or PM Average Test 9 58 9898 Indicator Results Date Day Hour Minute GlucoMen LX meter Screen GlucoMen LX 38973 09 07 INTRODUCTION The GlucoMen LX blood glucose meter The meter is a hand held testing device that measures glucose sugar in capillary blood The test strip is touched to a drop of blood to initiate the test process A simple one step process provides a blood glucose result Test results are available in 4 seconds There is memory for one user s set of test results 400 The meter is powered by a battery that can perform approximately 1000 tests CAUTION The meter should
8. forward 3 months and write that date on the label of the control solution vial Discard any remaining solution after the date you have written on the vial e Store the control solution tightly closed at room temperature below 30 C 86 F Do not refrigerate or freeze e Shake the control solution well before using Caution The GlucoMen LX Control solution range printed on the test strip vial is for control solution only It is used to test the performance of the meter and test strip It is not a recommended range for your blood glucose level If your control solution test results continue to fall outside the range printed on the test strip vial The GlucoMen LX blood glucose meter may not be working properly Do not use the meter to test your blood Call A Menarini Diagnostics for assistance UK 0800 243667 Ireland 1800 709903 GlucoMen LX 38973 09 07 RUNNING CONTROL SOLUTION Testing a Quality Control Solution 1 Insert a test strip into the meter If meter was off the screen displays all segments for 2 seconds then the blinking blood drop symbol appears NOTE If the strip is removed before you start the test the screen goes blank 2 Press the left right 9 F buttons to move between unmarked sample or marked control sample CTL select control NOTE It is important to select control solution test so the test result does not appear to be one of your blood glucose test results NOTE If a
9. in the highlighted areas as shown drop NOTE Thick hair at the sample site may cause the blood drop to smear 1b Select the Palm Heel or Palm Side test site in the highlighted areas as shown 2 Attach the clear cap to the lancing device Press and hold the lancing device FIRMLY against the Forearm or Palm 3 Continue to hold FIRMLY and press the release button to lance the area GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 TESTING A BLOOD SAMPLE TESTING A BLOOD SAMPLE Limitations and Considerations Forearm and Palm Testing Ca Some patients test their blood glucose at sites other than the finger because it is generally less painful 4 Continue to hold the device pressing FIRMLY until a proper blood drop forms The clear cap allows you to see the blood drop 5 Apply blood drop to the edge of the test strip The blood is drawn into the test strip Hold the meter to the blood drop until you hear a short beep or see the meter begin to count down NOTE Results from the forearm may be different from fingertip results when glucose levels are changing rapidly e g after a meal after taking insulin or during or after exercise Only use finger or palm testing during NOTE these times The blood in the strip should look similar to the red blood you are accustomed _ The GlucoMen LX reduces the of blood glucose monitoring significantly by requiring only 0 3 uL of to seeing when you test your fin
10. is inserted the meter immediately switches to test mode minutes when download connector inserted Upon exiting test mode the meter screen goes blank and does not return to Data review mode Battery low icon is displayed in every mode except setup 4 Once battery level goes below the threshold that triggers the low battery warning it continues to give the warning until the meter becomes unusable due to low battery 5 The meter responds to the pressing and the holding of keys Left Right amp buttons The Left Right button moves forward backward through a series of stored test result screens or increments of value Hold down the Left Right button to speed up screen change process MODE W button When the MODE button is pressed for less than 1 5 seconds to advance to the next function the meter advances to the next screen immediately when the button is pressed While the meter is in sleep mode OFF pressing the MODE button for less than 1 5 seconds wakes up the meter and enters data review mode While the meter is in sleep mode OFF pressing the MODE button for longer than 3 seconds wakes up the meter and enters setup mode C2 GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 WARRANTY Your GlucoMen LX blood glucose meter is warranted to be free of material and workmanship defects for life If at any time your GlucoMen LX blood glucose meter does not work for any reason other than as described
11. store near heat or moisture e Store the test strips in their original vial only After removing a test strip from the vial immediately replace the vial cap and close tightly Donotuseteststrips beyondthe expiration date printed onthe package asthis may cause inaccurate results GlucoMen LX 38973 09 07 INTRODUCTION Test strips should only be stored for 9 months after opening the vial When first opening a new vial of test strips count forward 9 months and write that date on the vial Discard any remaining test strips after the date you have written on the vial Do not tamper with the test strip WARNING The test strip vial contains small parts Keep the test strip vial away from children and pets Lancing Device The diagram below shows the components of the Lancing Device Depth Adjustment Force Adjustment Release Button GlucoMen LX 38973 09 07 SETTING THE TIME DATE AND BEEPER SETTING THE TIME DATE AND BEEPER Having the correct time and date of each blood glucose test result helps you and your healthcare This brings the meter display to the first setup screen time professional track changes in your therapy It is important to set the correct time and date so you have ca records of when you tested If you do not set the time and date all blood glucose monitoring results will Modes Screen Display be marked and will not be included in averages Hour Flashing 14 00 Minu
12. 3 Notes Cautions and Warnings ERO TE RLP O O 14 IMPORTANT GLUCOMEN LX SENSOR TEST STRIP INFORMATION 1 74 NOTES LANCING DEVICE Provide helpful operating information SETTING THE TIME DATE AND BEEPER CAUTIONS RUNNING CONTROL SOLUTION ooo 0 0 0 0 0 0 9 0 0 0 0 9 O 6 0 9 0 0 9 0 0 8 0 0 0 8 9 O 0 0 0 0 9 0 6 9 O 0 0 0 O 9 0 0 0 0 0 9 0 O 9 0 0 9 0 6 0 6 Provide information that is important for instrument protection WARNINGS 9 6 6 0 9 9 0 6 0 0 9 6 0 0 0 9 6 9 c 0 0 Provide information that is important for user protection or about risk of inaccurate results TESTING A OUALITY CONTROL SOLUTION RUNNING A TEST 0 0 6 9 0 0 6 8 9 0 6 9 9 6 0 9 0 0 6 0 0 9 9 6 6 9 0 9 9 8 0 6 o 9 9 0 9 0 0 9 0 0 9 o 9 8 0 o 9 O 9 6 9 6 6 8 9 0 0 0 0 0 9 0 0 0 9 0 0 6 6 0 6 0 6 9 6 6 6 6 6 6 GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 CONTENTS INTENDED USE TESTING BLOOD SAMPLE ooo
13. 8973 09 07 NA A MENARINI diagnostics
14. UK User Manual Read this user manual carefully before you start testing A MENARINI diagnostics MENARINI HELPLINE Menarini Helpline UK 0800 243667 Ireland 1800 709903 Email glucomenlx menarinidiag co uk The GlucoMen LX blood glucose meter is an in vitro diagnostic medical device intended for blood glucose self testing The product conforms to the reguirements of the Directive 98 79 EC on in vitro diagnostic medical devices Date of issue September 2007 GlucoMen 38973 09 07 THANK YOU A Menarini Diagnostics thanks you for choosing the GlucoMen LX blood glucose meter This User Manual contains important information on the meter and how it works Please read it carefully before us ing your new meter The GlucoMen LX blood glucose meter is designed to be convenient and easy to use It gives accurate results in just 4 seconds using a very small blood sample This small sample allows you to use a thinner lancet because not as much blood is needed to do a blood sugar test The meter also has memory that stores your blood sugar test results to help you and your healthcare professional manage your diabetes care Before you get started it is important to complete the Warranty Registration Card included in your kit and return it back to A Menarini Diagnostics Doing this will help us better serve your needs If you need to contact us please call A Menarini Diagnostics for assistance UK
15. Your test strips are for personal use only DO NOT share with others Use only fresh capillary whole blood DO NOT USE SERUM OR PLASMA There is no effect on blood glucose values for altitudes up to 3000 meters 10000 feet above sea level Refer to the User Manual for operating temperature range for the meter Extremes in humidity higher than 90 and lower than 10 may affect results The GlucoMen LX Sensor test strips are calibrated against plasma The anticoagulant sodium heparin may be used EDTA is not recommended for use with GlucoMen LX Sensor test strips Interferences from elevated levels of Acetaminophen Tolazamide Uric Acid Bilirubin Ephedrine and Methyldopa may affect results Test results may be falsely low if the patient is severely dehydrated Critically ill patients should not be tested with home blood glucose meters GlucoMen LX 38973 09 07 APPENDIX APPENDIX Instructional Notes While the meter is awake ON pressing the MODE button for longer than 1 5 seconds manually turns off the meter sleep mode Ca 1 If in setup mode when the test strip is inserted the meter saves all the values entered up to that point 6 With no activity time out occurs after the following times and immediately switches to test mode Upon exiting test mode the meter screen goes blank and does 1 minute for all screens not return to setup mode 2 minutes during test mode 2 in Data Review mode when the test strip
16. ger If the sample looks clear pink or light in blood sample color retest with a fingertip sample CAUTION 6 The blood glucose test result is displayed and stored The test is Always seek the advice of your doctor or healthcare professional before choosing to use forearm and complete palm sites Bruising may occur with forearm and palm testing NOTE If you get an error message when testing on your forearm or palm or do not get a blood glucose reading after multiple attempts test on your finger and call A Menarini Diagnostics for assistance UK 0800 243667 Ireland 1800 709903 THIS NUMBER IS NOT FOR EMERGENCY OR MEDICAL INFORMATION GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 TESTING A BLOOD SAMPLE YOUR TEST RESULT Do not use forearm testing Your blood glucose test result is displayed on the meter For at least 2 hours after you have eaten or injected insulin f you have recently exercised e f you think that your blood glucose is low un e Ifyou think that your blood glucose may be changing rapidly e g after a meal after taking insulin or during 25 0 8 after exercise f you are not aware of symptoms when your blood glucose is low hypoglycaemic f your forearm test results do not match the way you feel retest using your finger or palm high blood sugar Retest your blood glucose immediately using new test strip If your reading is still high you s
17. he meter immediately switches to test mode To review test results that are stored in memory start with the meter in the off position The meter is in the off position when the screen is completely blank To turn off the meter hold the Mode W7 button down until the screen goes blank then release the button 1 With the meter off press the Mode W button The most recent test result should display If there are NO results in memory the screen displays 3 dashes 2 Press the Left Right B button to view all the data in memory The Left arrow goes back in time and the Right arrow goes forward in time All results including control results marked results and unmarked results can be viewed 3 At the end of reviewing individual test results the screen displays End Mem NOTE For data averaging HI results gt 33 3 mmol L and LO results lt 1 1 mmol L are not considered GlucoMen LX 38973 09 07 25 mmol L 050 448 DATA REVIEW IN MEMORY 4 To review 1 day 7 day 14 day and 30 day average results press the Mode VW button 5 If there are less than 2 test results in memory the screen displays 000 if no results the screen displays 63 50 be pita mmol L Im mmol L nem mmol L mmol L dry TORY M dRS 30 udis mmol L 30 Od RY Avg mmol L real mmol L Il mmol L dry TORY M dRS 6 After reviewing the 30 day average press the Mode VW button to shut off the
18. hould treat yourself as advised by your healthcare professional Consider NOT using forearm testing if you i and or contact your healthcare professional immediately Are ill Are under extra stress 0510 98 Routinely have widely fluctuating blood glucose values that are often low hypoglycaemic If your test result is lower than 1 1 mmol L the meter displays LO You may have a low Values from the palm sample were shown to be equivalent to values from the finger samples blood sugar Retest your blood glucose immediately using a new test strip n If your reading is still low you should treat yourself as advised by your healthcare L LJ professional and or contact your healthcare professional immediately If you receive an Error Message see page 38 of this user manual displays meaning 251 Mug actions GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 YOUR TEST RESULT NOTE Test results greater than 13 3 mmol L may mean high blood sugar hyperglycaemia Test results lower than 3 3 mmol L may mean low blood sugar hypoglycaemia If you obtain results in these ranges retest your blood glucose If your reading is still in these ranges you should treat yourself as advised by your healthcare professional and or contact your healthcare professional immediately GlucoMen LX 38973 09 07 REVIEW TEST RESULTS IN MEMORY NOTE If a test strip is inserted while in the Data Review mode t
19. it Means Not enough blood sample e Sample applied after meter automatically turned off Meter may not be working properly Test strip may be damaged GlucoMen LX 38973 09 07 What to Do Repeat the test with a new test strip again After 3 attempts call A Menarini Diagnostics for assistance UK 0800 243667 Ireland 1800 709903 APPENDIX Specifications Test Measured Glucose Methodology Blood Glucose Glucose oxidase biosensor Glucose Test Results mmol L Plasma values Sample type Fresh Capillary Whole Blood Glucose Test range 1 1 to 33 3 mmol L Length of Test 4 seconds Test Strip Volumes 0 3 uL Battery Life nominal 1000 Tests Low Battery Life About 20 Tests Data Output Port Serial USB Operating Ranges Temperature 5 to 45 C 41 to 113 F Operating Ranges Humidity 10 to 90 relative humidity Weight 15g Size 96 x 51 x 20 mm Meter data storage 400 Results Chemistry Measurement Glucose test imprecision Refer to GlucoMen LX Sensor insert GlucoMen LX 38973 09 07 APPENDIX Limitations The GlucoMen LX Sensor test strips give accurate results when the following limitations are observed The test strips should not be used to diagnose diabetes or to test newborns Each test strip is for single use only Do not reuse Use a new sterile GlucoMen LX Sensor Test Strip each time you test
20. meter or press no buttons and the meter will turn off automatically after 30 seconds NOTE When the meter memory is full 400 test results each new test result stored in memory will remove the oldest test result stored in memory GlucoMen LX 38973 09 07 DATA MANAGEMENT SOFTWARE Glucose results stored in the GlucoMen LX meter s memory can be also downloaded using a dedicated cable and filed by using Dialogue software These are supplied separately The Dialogue software minimum reguirements are shown on the software packaging For further information on these products or ordering information call the Menarini Helpline UK 0800 243667 Ireland 1800 709903 GlucoMen LX 38973 09 07 BASIC UPKEEP Battery Check The meter is powered by a single coin cell battery CR2450 3V The first time you see the battery icon in the upper right corner of the screen and the blood drop at the lower left corner of the screen the meter has sufficient charge for 20 more tests Continue with testing as usual the battery indicator will remain on screen Please contact the Menarini Helpline immediately on 0800 243 667 for a free replacement battery 68 mmol L 050 MMB After 20 more tests have been performed there will be insufficient battery charge to continue testing and the meter will no longer operate until the battery is replaced The battery icon will only appear when a strip is inserted and the ic
21. on will disappear when the strip is removed If you have forgotten to order a new battery when the battery icon first displayed please call Menarini Helpline on 0800 243 667 for a free replacement battery Battery low GlucoMen LX 38973 09 07 BASIC UPKEEP Battery Replacement Replace the battery as follows 1 Remove the battery cover on the back of the meter 2 Remove the battery and replace with a new one with the side facing towards you 3 Replace the cover NOTE After the battery is replaced the meter displays the all segments screen Then the meter displays the time set up Reset to the current time and date If needed go to page 16 in this guide to review set up GlucoMen LX 38973 09 07 BASIC UPKEEP DISPLAYS MEANINGS ACTIONS Cleaning and Care Displays Meanings Actions Ca The exterior of the GlucoMen LX blood glucose meter should only be cleaned with alcohol wipes swabs This section addresses the messages that appear on your displays what they mean and what action you Keep liquids from entering the test strip port or the Left Right Arrow buttons and the Mode button need to take Displa What it Means What to Do CAUTION PUE DO NOT attempt to open the meter to make any repairs Your warranty and all claims will be void System Check Verifies that all segments No action required If all segments are Only authorized service person may repair the meter are working
22. or contact your healthcare profes The average of all blood glucose test re No action required sional immediately sults taken in the last 7 days A blood glucose test result in mmol L No action required b stored in the meter s memory with date Mer me No test results in the last 7 days No action required End of Setup or Memory Review No action required The average of all blood glucose test re No action required sults taken in the last 14 days GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 What it Means No test results in the last 14 days DISPLAYS MEANINGS ACTIONS What to Do No action required The average of all blood glucose test re sults taken in the last 30 days No action required No test results in the last 30 days No action required There are NO results in memory Battery is getting low but you can still perform a test Battery will appear on all screens GlucoMen LX 38973 09 07 No action required We suggest that you replace the bat tery immediately There is only enough power to perform 20 tests DISPLAYS MEANINGS ACTIONS What it Means What to Do Ca A control solution test result No action required A marked sample test result No action required Software Error Call A Menarini Diagnostics for assistance UK 0800 243667 Ireland 1800 709903 System Hardware Error Call A Mena
23. p starting from Step 1 3 Wash hands with soap and warm water then dry thoroughly NOTE Cleaning of the puncture site is important 4 Holding hand downward massage finger with thumb toward tip to stimulate blood flow GlucoMen LX 38973 09 07 TESTING A BLOOD SAMPLE 5 Usethelancing device loadedwith anewlancet to puncturethefinger See lancing device instructions for use 6 Gently sgueeze your finger to help form a drop of blood 7 Touch the end of the test strip to the blood drop until the test strip is full and the on screen countdown timer begins Beeper sounds if enabled NOTE The Blood Drop symbol flashes on and off repeatedly until sufficient blood has been added to the test strip 8 A countdown on screen appears while test is in progress Glucose result is available on screen in 4 seconds 9 The result is automatically stored into memory 10 Press the Left Right EB buttons to move between marked V or unmarked results Marked results are not included in the average test results Hl LO and Control results are not included in the average 11 Press the Mode VW button to save the Marking Status Marked V or Unmarked 12 If test result is above 33 3 mmol L the screen displays Hl test result cannot be stored If test result is below 1 1 mmol L the screen displays LO test result cannot be stored GlucoMen LX 38973 09 07 TESTING A BLOOD SAMPLE NOTE The meter will
24. rini Diagnostics for assistance UK 0800 243667 Ireland 1800 709903 Operating temperature GlucoMen LX 38973 09 07 Meter is outside the required testing temperature range of 5 to 45 C 41 to 113 F Move the meter to a warmer or cooler area as appropriate and wait a few minutes DISPLAYS MEANINGS ACTIONS Display What it Means Used Strip Error Used or damaged strip What to Do Retest with a new strip Blood Sample Error Incorrect application of blood sample or control solution onto the test strip or the test strip may be damaged Review your sampling technigue The blood sample guantity may be incorrect or hematocrit may be out of the allowed range for glucose measurement No test results in the last 30 days No action required Meter does not turn on after inserting a test strip Battery is dead Battery is installed incorrectly or there is no battery in the meter Test strip is inserted upside down or not completely in Replace the battery Check thatthe battery is correctly installed with the signfacing you Insert the test strip correctly with the GlucoMen name and white tip facing upandout Call A Menarini Diagnostics for assistance UK 0800 243667 Ireland 1800 709903 GlucoMen LX 38973 09 07 DISPLAYS MEANINGS ACTIONS Display Meter does not begin test countdown after applying blood sample What
25. tains a fixed amount of glucose Use this control solution to test that your meter is working properly with the test strip e Use this solution to practice or to check that you are following the correct testing procedure without using your own blood e f the meter reading is within the control solution s acceptable range the meter is working properly Performing a Control Solution Test The control solution test confirms that your meter and test strips are working correctly A control solution test is similar to a blood glucose test except you use GlucoMen LX Control solution and not a blood sample You should run a control solution test When you first get your meter Each time you open and begin using a new vial of test strips f you leave the test strip vial cap open for any length of time e f the meter is dropped damaged or exposed to liquids e f you think your test results are not accurate or if your test results are not consistent with how you feel To check the performance of the meter and test strips GlucoMen LX 38973 09 07 RUNNING CONTROL SOLUTION Important Information for Control Solution Use only the GlucoMen LX Control solution for the test Check the expiration date on the control solution vial Do not use control solution past the expiration date or you may get inaccurate results e Store only for months after first opening When you open a new vial of control solution count
26. tes Flashing 14 55 enn Your GlucoMen LX blood glucose meter offers a beeper function that is preset On This tells you when Day Flashing 28 12 2006 enough blood is applied to the test strip when test is completed and prompts you through other steps in Month Flashing 28 12 2006 using your meter Year Flashing 28 12 2006 Sample Marking ON or OFF ON NOTE Remember to adjust time and date settings as needed to match the local time or daylight savings Beep ON or OFF ON time and after you replace the battery Once you have completed a blood glucose or control solution test END End of Setup Mode END the last result will appear the next time your meter is turned on The date and time displayed is the date and time of your previous blood sugar or control solution test result not the current date and time 1 Press the MODE VW button for longer than 3 seconds The meter if in SLEEP v ct 2 Repeatedly press the MODE VW button to find the MODE you want to change Mode wakes up displays all segments for 3 seconds and enters the SETUP Mode 3 Press the left right arrow XB buttons to choose a new setting for that MODE 4 Mem mg dL Avg mmol L 9998 0859 4 Press the MODE VW button to select the new settings or to skip to the next MODE GlucoMen LX 38973 09 07 GlucoMen LX 38973 09 07 RUNNING CONTROL SOLUTION Control Solution Control solution is a liguid that con
27. test is not performed within 2 minutes from the insertion of the test strip the screen goes blank To perform a test take out then replace the test strip starting from Step 1 3 Shake the control solution vial Discard a drop before use Sgueeze a drop of control solution onto a clean hard dry surface e g control cap 4 Pick up the meter with test strip inserted and touch the test strip to the control solution drop NOTE Control solution should be applied to a clean hard and dry surface GlucoMen LX 38973 09 07 RUNNING CONTROL SOLUTION NOTE The on screen Control Symbol flashes on and off repeatedly until sufficient control solution has been added to the test strip Beeper sounds if enabled 5 glucose quality control test result is available on screen in 4 seconds The display does a countdown from 4 to 1 6 Compare the result on the display with the range printed on the test strip vial If the result falls within the range your meter and test strips are working correcily 7 The result is automatically stored into memory 8 If test result is above 33 3 mmol L the screen displays Hl test result cannot be stored If test result is below 1 1 mmol L the screen displays LO test result cannot be stored GlucoMen LX 38973 09 07 RUNNING CONTROL SOLUTION Out of range results may be caused by the following e An error in performing the control test Retest and follow the instructions caref
28. testing site then thoroughly dry these areas The GlucoMen LX blood glucose meter can test your blood glucose on the fingers forearm or palm The sample size is just 0 3 uL of blood Reasons to Check for Low Blood Glucose You have symptoms such as weakness sweating nervousness headache or confusion You took insulin but have delayed eating Your doctor or healthcare professional advises you to do so Important Health Related Information If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in the User Manual call your doctor or healthcare professional GlucoMen LX 38973 09 07 INTRODUCTION Test Strips The GlucoMen LX Sensor test strips are designed for use with your GlucoMen LX blood glucose meter only Use each test strip only once then discard DO NOT reapply blood to the test strip e Requires a very small blood volume 0 3 pL Automatically draws blood into the test area of the strip e Can be handled with clean dry hands without affecting glucose readings Insert This End lx Apply Blood Drop Into meter to Front Edge Important GlucoMen LX Test Strip Information Use only GlucoMen LX Sensor test strips when testing Remove the test strip from the vial only when ready to test Store the test strip package a cool dry place below 30 C 86 F Do not refrigerate or freeze Do not
29. time out after 2 minutes of non use or if the strip is removed The keys are disabled until a strip is inserted Results and marking status are saved if the meter times out the strip is removed or the meter is turned off NOTE You must apply the sample to the GlucoMen LX Sensor test strip while the blood drop symbol is flashing in the display If the meter turns off before sample application remove the GlucoMen LX Sensor test strip and insert again NOTE If blood is not applied within 2 minutes the meter will go into sleep mode to conserve the battery life NOTE Lancets are for one time use only Use a new sterile lancet each time you test Test different areas on your fingertips to avoid developing calluses Remove the used lancet from the lancing device Follow your local disposal regulations where applicable WARNING Your lancing device is for your personal use only DO NOT share with others Sharing the lancing device or lancets can transmit very serious infections To avoid accidental fingersticks injuries do not store used lancets in the device after testing or arm the lancing device with a new sterile lancet unless ready to use GlucoMen LX 38973 09 07 TESTING A BLOOD SAMPLE TESTING A BLOOD SAMPLE NOTE Obtaining and Applying a Blood Sample from Forearm or Palm C3 Do not press the blood glucose sensor directly against the skin Touch the test strip gently to the blood Ta Select the Forearm test site
30. ully e The control solution may have expired or have been contaminated Check the expiration date on the control solution vial Control solution is good for only 3 months after opening Make sure the control solution vial is closed when not in use Expired test strip Check the expiration date on the test strip vial he test strip may have been damaged This can be caused by extreme temperature or by leaving the test strip vial cap open Retest using a new test strip Meter malfunction The meter may not be working properly NOTE If the control solution test result is outside the range is either higher or lower your meter or test strip may not be working properly Repeat the process using a new test strip Do not use the meter until test results fall within the appropriate range If the problem continues call A Menarini Diagnostics for assistance UK 0800 243667 Ireland 1800 709903 GlucoMen LX 38973 09 07 RUNNING A TEST 1 Insert a test strip into the meter If the meter was switched off the screen displays all segments for 2 seconds Ca NOTE If the strip is removed before you start the test the screen goes blank Insert this End Apply Blood 9 Into meter Drop Here 2 After 3 seconds the blinking blood drop symbol appears NOTE If a test is not performed within 2 minutes from the insertion of the test strip the screen goes blank To perform a test take out then replace the test stri
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