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User Manual - Giuseppe Di Grande

1. GlucoMen LX PLUS meter GlucoMen LX PLUS 42338 09 10 3 INTRODUCTION uK When you turn the GlucoMen LX PLUS meter on the all segments display appears briefly This tells you that all the display segments are working properly ies aii fo Lelu Ket Ct EE Low Battery Indicator Test Results Blood or Control Drop ml Menor ugm ays meron Markers Alarm Pre Meal _ A DX anc BV g Post Meal Exercise and Mark B 8 8 B B BA or AM or PM Indicator Date Day t t Hour Minute GlucoMen LX PLUS meter screen Note with no activity time out occurs after the following times 7 minute for all screens 2 minutes during test mode 3 minutes when the download cable is inserted GlucoMen LX PLUS 42338 09 10 UK 3 INTRODUCTION 3 3 Navigation Buttons The meter responds to the pressing and the holding of the following keys Left Right B7 d buttons Left Right amp 7 8 buttons move forward backward through a series of stored test result screens or increments of value Press the Left Right 7 8 buttons to choose a new setting for time date and beeper see below how to enter the SETUP Mode Hold down the Left Right B7 Xd buttons to speed up screen change process Mode 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 immediat
2. Note if a sensor is inserted while in the DATA REVIEW Mode the meter immediately switches to TEST Mode Upon exiting TEST Mode the meter goes blank and does not return to DATA REVIEW Mode Note when the meter memory is full 400 test results each new test result stored in memory will remove the oldest one Note for data averaging only glucose results are averaged The averaging function equalises HI results to 33 3 mmol L and LO results to 1 1 mmol L 9 GLUCOLOG DATA MANAGEMENT SOFTWARE uK Glucose and B ketone results stored in the GlucoMen LX PLUS meter s memory can be also downloaded from the audio jack port using a dedicated cable as shown in the figure below and filed by using GlucoLog Both cable and software are supplied separately GlucoLog minimum requirements are shown on the software packaging For further information on these products or ordering information call the Menarini Helpline UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 GlucoMen LX PLUS 42338 09 10 UK 10 BASIC UPKEEP 10 1 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 Ket c Glu
3. Display What it Means What to Do Kot A blood B ketone test result in mmol L No action required i Result is automatically stored into iw memory m25 eye Glu Your blood glucose reading is higher H than 33 3 mmol L You may have high blood sugar Retest your blood glucose immediately a using a new sensor If your reading is mese still high you should treat yourself as Kot Your blood B ketone reading is higher advised by your healthcare professional H than 8 0 mmol L and or contact your healthcare professional immediately 025 24am ou Your blood glucose reading is lower than Retest your blood glucose immediately A g 1 1 mmol L You may have low blood If your reading is still LO treat yourself sugar as prescribed by your healthcare professional and or contact your eiil healthcare professional immediately 11 DISPLAYS MEANINGS ACTIONS E GlucoMen LX PLUS 42338 09 10 UK 11 DISPLAYS MEANINGS ACTIONS Display What it Means What to Do Ket Your blood ketone reading is lower than No action required L n 0 1 mmol L 025 24am ou A blood glucose test result in mmo L No action required Gh stored in the meter s memory with date Petar time 025 1255 Ket A blood B ketone test result in mmol L No action required HH stored in the meter s memory with date a time 825 ee End of SETUP Mode or DATA REVIEW No action required E n d Mode ou The average of a
4. The system operational temperature range 5 to 45 C 41 to 113 F The relative humidity range 10 to 90 non condensing The meter complies with applicable EMC electromagnetic emission requirements However do not use the meter near cellular or cordless telephone walkie talkies garage door openers radio transmitters or any other electrical or electronical equipment that are sources of electromagnetic radiation as these may interfere with the operation of the meter GlucoMen LX PLUS 42338 09 10 UK 3 INTRODUCTION 3 7 Before Testing Before testing and to ensure accurate glucose or B ketone results wash your hands and the testing site then thoroughly dry these areas The GlucoMen LX PLUS meter can test your blood glucose on the fingers forearm or palm B ketone can be assayed using capillary blood from the fingers only The blood sample size is just 0 3 uL Glu or 0 8 uL Ket 3 8 Reasons to Check for Low Blood Glucose e 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 3 9 Reasons to Check for B Ketone Your blood glucose levels are persistently higher than 13 9 mmol L Your breath has a fruity odour Your stomach is upset and or painful loss of appetite You are ill with nausea and or vomit You feel increasingly thirsty and urinate more frequently than usual
5. b Select the desired marking by pressing the Mode button while the icon is displaying and flashing Note the meter does NOT automatically save the marking status if the one minute time out occurs or the glucose sensor is removed c Once the pre meal marker is selected the pre meal marker stops flashing and the alarm icon displays and flashes d Toggle the alarm ON or OFF by pressing either the Left Right amp 7 d buttons e Then press the Mode button to select the alarm ON or OFF Note if the alarm is enabled the alarm icon stops flashing and the user has the option to set the post meal test reminder alarm to alert the user 2 5 hours 150 1 minutes later Note you can view the status ON OFF of the post meal test reminder alarm in the 1 day average screen GlucoMen LX PLUS 42338 09 10 SETTING THE TIME DATE MARKERS AND BEEPER f The post meal test reminder screen sounds 20 sets of alarm beeps independent of setup beep ON OFF and displays the marked pre meal result stored in non volatile memory the flashing alarm and the flashing blood drop g Press any button while the alarm is sounding to silence the alarm Note hold down the Mode button for greater than gt 1 5 seconds after the alarm has stopped to turn the meter OFF h Inserting a sensor during the alarm after the alarm has stopped or after the alarm has been manually silenced enables a glucose test to be run If no action is taken the met
6. LX sensor or GlucoMen LX B Ketone sensor may not be working properly do not use the sensors to test your blood Call A Menarini Diagnostics for assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 Warning the GlucoMen LX Glu Ket control range printed on the GlucoMen LX sensor vial is for glucose control solution only It is used to test the performance of both meter and sensors It is not a recommended range for your blood glucose level Similarly the GlucoMen LX Glu Ket control range printed on the GlucoMen LX B Ketone sensor foil pouch is for B ketone control solution only It is used to verify the performance of both meter and sensors It does not represent a recommended range for your blood B ketone concentration GlucoMen LX PLUS 42338 09 10 6 GLUCOSE TESTING uK 6 1 Running a Glucose Control Solution Test a Insert a GlucoMen LX sensor into the GlucoMen LX PLUS meter If meter was off the screen displays all segments for 2 seconds then the blinking blood drop symbol and Glu appear b Press the Left Right B7 a buttons to move between unmarked sample or marked control sample CTL select control c Shake the GlucoMen LX Glu Ket control vial Discard a drop before use Squeeze a drop of control solution onto a clean hard dry surface e g control cap d Pick up the meter with sensor inserted and touch the control solution drop with the sensor e T
7. UK MENARINI HELPLINE Menarini Helpline UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 This number is not for emergency or medical information Email glucomen menarinidiag co uk The GlucoMen LX PLUS is an in vitro diagnostic medical device intended for blood glucose and B ketone self testing The product conforms to the requirements of the Directive 98 79 EC on in vitro diagnostic medical devices Date of issue September 2010 GlucoMen LX PLUS 42338 09 10 THANK YOU A Menarini Diagnostics thanks you for choosing GlucoMen LX PLUS This User Manual contains important information on the system and how it works Please read it carefully before using your new system for blood glucose and B ketone self testing The GlucoMen LX PLUS is designed to be convenient and easy to use It gives accurate results in just 4 seconds for glucose or 10 seconds for ketone 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 or B ketone test The meter also has a memory that stores your blood test results to help you and your healthcare professional manage your diabetes including diabetic ketoacidosis DKA 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
8. g The blood glucose test result is displayed and stored The test is complete Note thick hair at the sample site may cause the blood drop to smear Warning the blood in the sensor should look similar to the red blood you are accustomed to seeing when you test your finger If the sample looks clear pink or light in colour retest with a fingertip sample 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 6 4 Forearm and Palm Testing Limitations and Considerations 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 In contrast the glucose results obtained testing blood samples from the palm were shown to be equivalent to those obtained using finger samples under all testing conditions Only use finger or palm testing when the glycemic levels are expect to change rapidly Do not use forearm testing For a blood B ketone test For at least 2 hours after you have eaten or injected insulin GlucoMen LX PLUS 42338 09 10 UK 6 GLUCOSE TESTING You have a concern about hypoglycaemia insulin reactions e You are doing risky activities driving a car working with machines If you have recently exercised If you think that your blood glucose may be changing rapi
9. After 3 seconds the blinking blood drop symbol appears with Glu displaying Insert this end into meter c Holding hand downward massage finger with thumb toward tip to stimulate blood flow d Use the lancing device loaded with a new lancet to puncture the finger see lancing device instructions for use Ba i e Gently squeeze your finger to help form a drop of blood f Touch the end of the GlucoMen LX sensor to the blood drop until the sensor is full and the on screen countdown timer begins beeper sounds if enabled g A countdown on screen appears while test is in progress Glucose result is available on screen in 4 seconds GlucoMen LX PLUS 42338 09 10 Apply blood drop to front edge UK 6 GLUCOSE TESTING h The result is automatically stored into memory i Press the Left Right B7 8 buttons to move between marked or unmarked results Press the Mode button to save the Marking Status Marked v or Unmarked Note if test result is above 33 3 mmol L the screen displays HI if test result is below 1 1 mmol L the screen displays LO Warning excessive squeezing should be avoided as hemolysis may lead to inaccurate results 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 needle stick injuries do not store used
10. Ket A mmol L 25 IHE After 20 more tests have been performed battery charge will be insufficient to continue testing and the meter will no longer operate until the battery is replaced The battery icon will appear when a sensor is inserted and the icon will disappear when the sensor is removed The battery icon is also displayed in DATA REVIEW Mode Battery low Note battery low icon is displayed in every mode except SETUP Mode Note 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 GlucoMen LX PLUS 42338 09 10 a 10 BASIC UPKEEP E 10 2 Battery Replacement Replace the battery as follows a Remove the battery cover on the back of the meter b Remove the battery and replace with a new one with the side facing up c Put the cover back on 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 Paragraph 4 at page 20 in this guide to review setting the time date markers and beeper Dispose of used batteries according to your local environmental regulations Note do not use rechargeable batteries Warning keep all batteries out of reach of children 10 3 Cleaning and Care The exterior of the GlucoMen L
11. hold the Mode x button down until the screen goes blank then release the button a With the meter OFF press the Mode button The most recent test result should display If there are NO results in memory the screen displays 3 dashes b Press the Left Right amp 7 d buttons to view all the data in memory The Left B7 button goes back in time and the Right button goes forward in time All results including control results marked results and unmarked results can be viewed c At the end of reviewing individual test results the screen displays End Mem d To review 1 day 7 day 14 day and 30 day average results glucose only press the Mode button e If there are less than 2 test results in memory the screen displays 000 If no results the screen displays 3 dashes f After reviewing the 30 day average press the Mode button to shut off the meter or press no buttons and the meter will turn off automatically after 30 seconds Mem mmol L Ket rm Ly Mem mmol L eS 2 58 End GlucoMen LX PLUS 42338 09 10 UK 6J Mem Avg mmol L idA9 a Mem Avg mmol L TAY Be Mem Avg mmol L 4dAY ou Mem Avg mmol L JU dAY Glu 000 Mem Avg mmol L day Glu 000 Mem Avg mmol L TdAY Glu 000 Mem Avg mmol L H dAY Glu 000 Mem Avg mmol L 30dAY
12. displays all segments for 2 seconds After 3 seconds the blinking blood drop symbol appears with Ket displaying j Apply blood drop to front edge Insert this end Lx into meter c Holding hand downward massage finger with thumb toward tip to stimulate blood flow 1 ON d Use the lancing device loaded with a new lancet to puncture the finger see lancing A 2 device instructions for use Ca RY A e Squeeze the finger to form a drop of blood 3 GlucoMen LX PLUS 42338 09 10 Ss 7 B KETONE TESTING f Touch the end of the GlucoMen LX 8 Ketone sensor to the blood drop until the sensor is full and the on screen countdown timer begins beeper sounds if enabled g A countdown on screen appears while test is in progress A flashing result is available on screen in 10 seconds h The result is automatically stored into memory i Press the Left Right B7 a buttons to move between marked or unmarked results I Press the Mode z button to save the Marking Status Marked or Unmarked Note if test result is above 8 0 mmol L for B ketone the screen displays HI with Ket displaying If test result is below 0 1 mmol L for B ketone the screen displays LO with Ket displaying Note if the sensor is removed before you start the test the screen goes blank Note if a test is not performed within 2 minutes from the insertion of the sensor the screen goes blank To perform a test take out th
13. ketone test result is shown on the display If test result is higher than 8 0 mmol L Ket the monitor displays HI You may have high blood amp ketone level Retest your blood 8 ketone immediately using a new sensor If your reading is still high you should treat yourself as prescribed by your healthcare professional and or contact your healthcare professional immediately If test result is lower than 0 1 mmol L Ket the screen displays LO No action is required Warning the normal adult blood B ketone range for person without diabetes is less than 0 6 mmol L Consult with your healthcare professional for the blood B ketone range that is appropriate for you If the blood B ketone result is between 0 6 1 5 mmol L and blood glucose is more than 16 7 mmol L this may indicate development of a medical concern You need to contact your healthcare professional for assistance If the blood B Ketone result is more than 1 5 mmol L and blood glucose is more than 16 7 mmol L contact with your healthcare professional immediately This indicates a risk of developing DKA GlucoMen LX PLUS 42338 09 10 Ket e mmol L 225 i24a Ket 925 ieg Ket Im Lo 025 te4a 8 DATA REVIEW IN MEMORY E 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
14. results and you have followed all instructions described in the User Manual call your doctor or healthcare professional GlucoMen LX PLUS 42338 09 10 UK 3 INTRODUCTION 3 11 GlucoMen LX sensor The GlucoMen LX PLUS sensor is designed for use with your GlucoMen LX and GlucoMen LX PLUS meter only Use each sensor only once then discard DO NOT reapply blood to the sensor Requires a very small blood volume 0 3 uL Automatically draws blood into the test area of the sensor e Can be handled with clean dry hands without affecting glucose readings Insertthisend ___ ____ Apply blood drop into meter to front edge 3 12 Important GlucoMen LX sensor Information Only use GlucoMen LX sensor when testing for glucose Remove the sensor from the vial only when ready to test Store the sensor package in a cool dry place below 30 C 86 F Do not refrigerate or freeze Do not store near heat or moisture Store the sensors in their original vial only After removing a sensor from the vial immediately put the vial cap back on and close tightly Do not use sensors beyond the expiration date printed on the package as this may cause inaccurate results Sensors should only be stored for 9 months after opening the vial When first opening a new vial of sensors count forward 9 months and write that date on the vial Discard any remaining sensor after the date you have written on the vial Do not tamper with the sensor Warni
15. to contact us please call A Menarini Diagnostics for assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 GlucoMen LX PLUS 42338 09 10 UK IMPORTANT INFORMATION Before you begin using your new GlucoMen LX PLUS please read all of the instructions provided in this User Manual Your meter uses a CR2450 3 volt coin cell battery In case you need to install a new battery see Paragraph 10 2 at page 47 Perform all quality control checks recommended in this User Manual Consult with your diabetes healthcare professional and follow his her guidance for your blood glucose or 8 ketone monitoring routine The GlucoMen LX PLUS system meter sensors and control solutions does not contain latex by design Notes Cautions and Warnings Notes provide helpful operating information Cautions provide information that is important for meter protection Warnings provide information that is important for user protection or about risk of inaccurate results GlucoMen LX PLUS 42338 09 10 es TeINTENDED USE ssssesssssavsvsssusscavsavovonsnastssesanescusdescvestavvyionsososssaxassasasnassacuedcotassancstabveysbavasonvoasweasessitectouvayebeuiseysotdbvonsbavaisesaoiscesbaebcenaies 7 2 SYMBOLS 3 INTRODUCTION 3 1 The GlucoMen LX PLUS 3 2 Meter Description 3 3 Navigation Buttons 3 4 Overview of GlucoMen LX PLUS 3 5 Kit CONTENTS eesecseseceeneeeeeee 3 6 Env
16. B ketone 10 seconds Sample Volumes Glucose 0 3 uL B Ketone 0 8 uL Battery Life nominal 1000 Tests Low Battery Life About 20 Tests Data Output Port Audio Jack Operating Ranges for both glucose and B ketone e Temperature 5 to 45 C 41 to 113 F Humidity 10 to 90 relative humidity non condensing Weight 75 g 2 65 oz Size 58 x98 x 17mm Meter Data Storage 400 Results GlucoMen LX PLUS 42338 09 10 12 APPENDIX KT 12 2 Chemistry Measurement Glucose test imprecision Refer to GlucoMen LX sensor instruction for use B ketone test imprecision Refer to GlucoMen LX B Ketone sensor instruction for use GlucoMen LX PLUS 42338 09 10 Ss 13 WARRANTY Your GlucoMen LX PLUS meter is warranted to be free of material and workmanship defects for 2 years from the date of purchase except as noted below If at any time during the first 2 years after purchase your GlucoMen LX PLUS meter does not work for any reason other than as described below it will be replaced with a new meter or a substantial equivalent free of charge Should you wish to extend the warranty period for your meter please refer to the warranty card This warranty is subject to the following exceptions and limitations e This warranty is applicable only to the original purchaser e This warranty does not apply to units which malfunction or are damaged due to obvious abuse misuse alteration neglect unauthor
17. COSE TESTING 6 6 B ketone Test Alert Blood Glucose Value 13 9 mmol L or Higher If your own blood glucose value is 13 9 mmol L or higher you will be alerted that a blood B ketone test should also be performed A special trill alarm beep will sound the symbol Ket will be displayed and a segment moving from the left to the right of the screen with 0 5 seconds steps will cycle You are being alerted to check your 8 ketone The alert will automatically stop after one minute or after the sensor is removed ar J g Ket Ket Ket pa 26 ie 0 026 2 50 0 26 250 26 2 50 Note when in this display cycle pressing ANY key will freeze the display showing the glucose value The user can then use the Left Right buttons to toggle between marking and unmarking a test result Note the ketone test alert cycle is NOT applicable to quality control samples GlucoMen LX PLUS 42338 09 10 5 7 B KETONE TESTING uK 7 1 Running a B Ketone Control Solution Test a Insert a GlucoMen LX B Ketone sensor into the GlucoMen LX PLUS meter If the meter was off the screen displays all segments for 2 seconds then the blinking blood drop symbol and Ket appear b Press the Left Right amp 7 d buttons to indicate this sample is a control CTL is shown on the display c Shake the GlucoMen LX Glu Ket control vial Discard a drop before use Squeeze a drop of control solution onto a clean hard dry sur
18. EVIEW IN MEMORY 9 GLUCOLOG DATA MANAGEMENT SOFTWARE 10 BASIC UPKEEP 10 1 Battery Check 10 2 Battery Replacement 10 3 Cleaning and Care 11 DISPLAYS MEANINGS ACTIONS 12 APPENDIX 12 1 Specifications 12 2 Chemistry Measurement 13 WARRANTY GlucoMen LX PLUS 42338 09 10 1 INTENDED USE ux The GlucoMen LX PLUS is intended to be used for the quantitative measurement of glucose and B ketone in capillary whole blood It is intended for use by people with diabetes mellitus at home as an aid to evaluate the effectiveness of diabetes and DKA control It can also be used in clinical settings by healthcare professionals It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on newborns e The GlucoMen LX PLUS is specifically indicated for the quantitative measurement of glucose in whole blood capillary samples obtained from the fingertip palm and forearm or B ketone in whole blood capillary samples obtained from the fingertip only e The GlucoMen LX PLUS is intended for use outside the body in vitro diagnostic use It should only be used with GlucoMen LX sensor and GlucoMen LX B Ketone sensor and GlucoMen LX Glu Ket control solutions It should be used for testing glucose sugar and B ketone only with fresh capillary whole blood samples It should NOT be used to diagnose diabetes and DKA or to test newborns It should NOT be
19. N or OFF On beep sound Sample Marking ON or OFF On End end of SETUP Mode End b Repeatedly press the Mode button to find the Mode you want to change c Press the Left Right B7 8 buttons to choose a new setting for that Mode d Press the Mode button to select the new settings or to skip to the next Mode Note remember to verify and eventually adjust time and date settings as needed to match the local time or daylight savings time and after you replace the battery Once you have completed a blood glucose blood B ketone or control solution test 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 or control solution test result not the current date and time Note ifin SETUP Mode when the sensor is inserted the meter saves all the values entered up to that point and immediately switches to TEST Mode Upon exiting TEST Mode the meter screen goes blank and does not return to SETUP Mode i GlucoMen LX PLUS 42338 09 10 4 SETTING THE TIME DATE MARKERS AND BEEP 4 1 Glucose Result Marking After a blood not control glucose analysis is performed with a valid result and the setup marking is enabled you can mark the glucose result as pre meal post meal exercise or check by scrolling the Left Right B7 8 buttons a The icon displays and flashes one at a time Ra aw mM ZJ Alarm Pre meal Post meal Exercise Check
20. Note if a test is not performed within 2 minutes from the insertion of the sensor the screen goes blank To perform the test take out then replace the sensor starting from Step a Note the GlucoMen LX Glu Ket control solution should be applied to a clean hard and dry surface i e control cap Note the on screen control symbol flashes on and off repeatedly until sufficient control solution has been added to the sensor Beeper sounds if enabled Note if test result is above 33 3 mmol L for glucose the screen displays HI with Glu displayed If test result is below 1 1 mmol L for glucose the screen displays LO Note if the glucose control solution test result is outside the range is either higher or lower your meter or sensors may not be working properly If available repeat the process using a sensor from a new vial Do not use the meter if test results repeatedly fall outside the appropriate range If the problem continues call A Menarini Diagnostics for assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 GlucoMen LX PLUS 42338 09 10 6 GLUCOSE TESTING uK 6 2 Running a Blood Glucose Test a Wash hands with soap and warm water then dry thoroughly As an alternative use alcohol pads to clean area dry thoroughly after cleaning b Insert a GlucoMen LX sensor into the GlucoMen LX PLUS meter If the meter was switched off the screen displays all segments for 2 seconds
21. X PLUS meter should only be cleaned with alcohol wipes swabs Keep liquids from entering the sensor port or the Left Right amp 7 a buttons and the Mode button Caution DO NOT attempt to open the meter to make any repairs Your warranty and all claims will be void Call A Menarini Diagnostics if the meter needs to be replaced GlucoMen LX PLUS 42338 09 10 UK 11 DISPLAYS MEANINGS ACTIONS This section addresses the messages that appear on your displays what they mean and what action you need to take Display What it Means What to Do No action required If all segments are Glu Ket ctl om System Check Verifies that all segments not displayed on meter Si are working Appears when A Menarini Diagnostics for assistance A e Meter is turned on for SETUP Mode and Ouen vs RSh DATA REVIEW Mod UK 0800 243667 eaaa ga Sensor is inserted ae the meter Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 Ket Blood Drop Symbol meter is ready to Apply a blood sample to the sensor accept blood Refer to how to run a blood sample ou Countdown screen 4 seconds for No action required y glucose and 10 seconds for B ketone to perform the test and calculate the result ou A blood glucose test result in mmol L No action required 54 Result is automatically stored into memory es 14a GlucoMen LX PLUS 42338 09 10 3
22. cs for F n assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 GlucoMen LX PLUS 42338 09 10 11 DISPLAYS MEANINGS ACTIONS E Display What it Means What to Do System Hardware Error Call A Menarini Diagnostics for F assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 Operating Temperature Error Meter is outside the required testing F g temperature range of 5 to 45 C 41 to 113 F Move meter and sensors to a warmer or cooler area and wait a few minutes Used Sensor Error used or damaged Retest with a new sensor F 4 sensor Blood Sample Error Incorrect application of blood sample or control solution onto the sensor or the F y sensor may be damaged Review your sampling technique The blood sample quantity may be incorrect or hematocrit may be out of the allowed range for glucose measurement GlucoMen LX PLUS 42338 09 10 UK 11 DISPLAYS MEANINGS ACTIONS Display What it Means What to Do Sensor is inserted upside down or not Insert the sensor correctly with LX or completely in ket facing up and out Meter does Battery is dead Replace the battery not turn e Battery is installed incorrectly or there is Check that the battery is correctly on after no battery in the meter installed with the sign facing yo
23. ctions Glucoject branded pricking devices and lancets are products manufactured by Owen Mumford Ltd Brook Hill Woodstock Oxford OX20 ITU UK GlucoMen LX PLUS 42338 09 10 Ss 4 SETTING THE TIME DATE MARKERS AND BEEPER Your GlucoMen LX PLUS meter is preset with time and date Having the correct time and date of each blood test result helps you and your healthcare professional track changes in your therapy It is important to check the correct time and date so you have records of when you tested In case time and date are not set all blood monitoring results will be marked and will not be included in averages Your GlucoMen LX PLUS meter offers a beeper function that is preset ON This tells you when enough blood is applied to the sensor when test is completed and prompts you through other steps in using your meter a Press the Mode button for longer than 3 seconds The meter if in SLEEP Mode wakes up displays all segments for 3 seconds and enters the SETUP Mode Glu Ket Ctl 2 deg mom Avg mold A ea 48 08 88 08 GlucoMen LX PLUS 42338 09 10 4 SETTING THE TIME DATE MARKERS AND BEEPER uk This brings the meter display to the first setup screen Time Modes Screen Display Hour Flashing 12 00 Minutes Flashing 12 00 Year Flashing 28 05 2010 Month Flashing 28 05 2010 Day Flashing 28 05 2010 i200 Beep O
24. d batteries in compliance with local regulations je DOSS Consult instructions for use xa GlucoMen LX PLUS 42338 09 10 3 INTRODUCTION uK 3 1 The GlucoMen LX PLUS The GlucoMen LX PLUS meter is a hand held testing device that measures glucose and 8 ketone in capillary blood The meter activates after a GlucoMen LX sensor green colour or GlucoMen LX R Ketone sensor light purple colour is inserted The screen displays Glu or Ket depending on which type of sensor is inserted The test process starts once the blood comes into contact with the sensor A simple one step process provides a result e Test results are available in 4 glucose or 10 R ketone seconds The memory is for one user only The meter can hold 400 test results The meter is powered by a battery already installed that can perform approximately 1000 tests Time and date are preset on the meter Caution the meter should 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 battery to eliminate the risk of battery leakage Also protect the meter from moisture prolonged direct sunlight and extreme temperatures GlucoMen LX PLUS 42338 09 10 UK 3 INTRODUCTION 3 2 Meter Description a Insert sensor here Use the ejector to remove the LCD Display test strip Left button Right button Mode button
25. dly e g after a meal after taking insulin or during or after exercise If you routinely have widely fluctuating blood glucose values that are often low hypoglycaemic If you are using an insulin pump If you are feeling unwell or ill If you are under extra stress If you suffer from hypoglycaemic unawareness If your forearm test results do not match the way you feel retest using your finger or palm Warning always seek the advice of your doctor or healthcare professional before choosing to use forearm and palm sites Bruising may occur with forearm and palm testing Warning B ketone testing must not use the forearm or palm site Only use the fingertip for B ketone testing 1 Jungheim K Koshinsky T 2002 Glucose Monitoring at the Arm Risky delays of hypoglycemia and hyperglycemia detection Diabetes Care 25 6 956 960 2 Bina D M Anderson R L Johnson M L Bergenstal R M Kendall D M 2003 Clinical Impact of Prandial State Exercise and Site Preparation on the Equivalence of Alternative Site Blood Glucose Testing Diabetes Care 26 4 981 985 3 Peled N Wong D Gwalani S L 2002 Comparison of Glucose levels in capillary blood samples obtained from a variety of body sites Diabetes Technol Ther 4 35 44 GlucoMen LX PLUS 42338 09 10 E 6 GLUCOSE TESTING iu 6 5 Your Blood Glucose Test Results Your blood glucose test result is shown on the display If your test result is highe
26. e You have symptoms such as weakness deep breathing headache or confusion Your doctor or healthcare professional advises you to do so GlucoMen LX PLUS 42338 09 10 a 3 INTRODUCTION uK 3 10 Important Health Related Information Diabetic ketoacidosis DKA is a potentially life threatening complication in patients with diabetes mellitus DKA arises because of an absolute lack or ineffectiveness of insulin in the body and therefore predominantly occurs in Type diabetic patients The association of insulin deficiency and increased counterregulatory hormones leads to altered production and disposal of glucose in response to which the body switches to burning lipids The free fatty acids that are released are subsequently oxidised to acidic ketone bodies mainly B hydroxybutyrate but also acetone and acetoacetate into the liver DKA may be the first symptom of previously undiagnosed diabetes mainly in paediatric patients but it may also occur in known diabetics due to a variety of causes such as intercurrent illness emotional stresses or poor compliance with insulin therapy Repeated high blood glucose levels i e persistently higher than 13 9 mmol L for several hours fruity odour to the breath vomiting nausea stomach pain dehydration frequent urination deep gasping breathing confusion and occasionally coma are typical symptoms If you are experiencing symptoms that are not consistent with your blood glucose or ketone test
27. ely e While the meter is in SLEEP Mode OFF pressing the Mode x button for less than 1 5 seconds turns on the meter and enters DATA REVIEW Mode While the meter is in SLEEP Mode OFF pressing the Mode button for longer than 3 seconds turns on the meter and enters SETUP Mode While the meter is ON pressing the Mode button for longer than 1 5 seconds manually turns off the meter SLEEP Mode 3 4 Overview of GlucoMen LX PLUS To perform a test the operator simply inserts a sensor waits for the blood drop symbol to appear on the screen Glu or Ket also appears which indicates that the meter is ready brings the sensor to the drop of blood obtains a test result in 4 Glu or 10 Ket seconds The test result is automatically stored into the meter s memory The operator can recall and review test data stored in the meter GlucoMen LX PLUS 42338 09 10 3 INTRODUCTION uK 3 5 Kit Contents e GlucoMen LX PLUS meter Carry case Battery CR2450 3V already installed 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 3 6 Environmental Conditions The storage temperature range for the meter 25 to 46 C 13 to 115 F The storage temperature range for the sensors 4 to 30 C 39 2 to 86 F The storage temperature range for the control solution 2 to 30 C 35 6 to 86 F
28. en replace the sensor starting from Step a Note the Blood Drop symbol flashes on and off repeatedly until sufficient blood has been added to the sensor Note the meter will time out after 2 minutes of non use or if the sensor is removed The keys are disabled until a sensor is inserted Results and marking status are saved if the meter times out the sensor is removed or the meter is turned off Note do not press the sensor directly against the skin Touch the sensor gently to the blood drop Warning excessive squeezing should be avoided as hemolysis may lead to inaccurate results Warning your lancing device is for your personal use only DO NOT share with others Sharing the lancing device or lancets can transmit serious even grave infections To avoid accidental needle stick 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 PLUS 42338 09 10 7 B KETONE TESTING uK Warning 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 Warning discard the used lancets in accordance with local regulations for biohazardous waste Warning cleaning of the puncture site is important GlucoMen LX PLUS 42338 09 10 Ss 7 B KETONE TESTING 7 3 Your Blood B Ketone Test Result Your blood
29. er times out in one minute A currently set post meal test reminder alarm is disabled if you perform another test and mark it as the post meal result The currently set post meal test reminder alarm is also disabled if you go into SETUP Mode and turn marking OFF The currently set post meal test reminder alarm is also disabled if you go into SETUP Mode and change the date time The currently set post meal test reminder alarm is also disabled if you view stored results and disable the alarm at the 1 day average screen You can disable or keep enabled the alarm by pressing either the Left Right 7 Xd buttons and then press the Mode x button If the post meal test reminder alarm expires during a glucose or a ketone analysis the meter ignores and disables the alarm Once a post meal test reminder alarm has been disabled you cannot re enable the alarm again e The meter can support only one post meal test reminder alarm at a time e The meter can NOT preserve the currently set post meal test reminder alarm after battery replacement reset GlucoMen LX PLUS 42338 09 10 UK 4 SETTING THE TIME DATE MARKERS AND BEEPER 4 2 B ketone Result Marking After a blood not control ketone analysis is performed with a valid result and setup marking is enabled mark check or unmark blank the ketone result by pressing the Left Right B7 8 buttons The check icon displays and flashes Select the desired marking by pressing the Mode button whi
30. face i e control cap d Pick up the meter with sensor inserted and touch the sensor to the GlucoMen LX Glu Ket control solution drop e The display does a countdown from 10 to 1 A flashing amp ketone quality control test result is available on screen in 10 seconds f Compare the result on the display with the range printed on the sensor foil pouch If the result falls within the range your GlucoMen LX PLUS meter and GlucoMen LX 8 Ketone sensor are working correctly g The result is automatically stored into the memory Out of range results may be caused by the following An error in performing the control test retest and follow the instructions carefully The GlucoMen LX Glu Ket control may have expired or been contaminated Check the expiration date on the GlucoMen LX Glu Ket control vial GlucoMen LX Glu Ket control is good for only 3 months after opening Make sure the GlucoMen LX Glu Ket control vial is closed when not in use Expired GlucoMen LX 8 Ketone sensor check the expiration date on the sensor pouch The GlucoMen LX B Ketone sensor may have been damaged This can be caused by extreme temperature Retest using a new sensor Meter malfunction the meter may not be working properly GlucoMen LX PLUS 42338 09 10 UK 7 B KETONE TESTING Note if the sensor is removed before you start the test the screen goes blank Note it is important to select control solution tes
31. he display does a countdown from 4 to 1 A glucose control test result is available on screen in 4 seconds f Compare the result on the display with the range printed on the sensor vial If the result falls within the range your GlucoMen LX PLUS meter and GlucoMen LX sensor are working correctly g The result is automatically stored into memory Marked CTL glucose control solution results are not included in the average Out of range results may be caused by the following An error in performing the control test Retest and follow the instructions carefully The GlucoMen LX Glu Ket control may have expired or have been contaminated Check the expiration date on the GlucoMen LX Glu Ket control vial GlucoMen LX Glu Ket control is good for only 3 months after opening Make sure the GlucoMen LX Glu Ket control vial is closed when not in use Expired GlucoMen LX sensor Check the expiration date on the sensor vial e The GlucoMen LX sensor may have been damaged This can be caused by extreme temperatures or by leaving the sensor vial cap open Retest using a new sensor gt GlucoMen LX PLUS 42338 09 10 UK 6 GLUCOSE TESTING Meter malfunction The meter may not be working properly Note if the sensor is removed before you start the test the screen goes blank 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
32. ironmental Conditions 3 7 Before Testing 3 8 Reasons to Check for Low Blood Glucose 3 9 Reasons to Check for 8 Ketone 3 10 Important Health Related Information 3 11 GlucoMen LX Sensor sccssssesesessteseeeenees 3 12 Important GlucoMen LX sensor Information 3 13 GlucoMen LX B ketone Sensor ccccsccsssneeseeeee 3 14 Important GlucoMen LX B Ketone sensor Information 3 15 Limitations 3 16 Lancing Device 4 SETTING THE TIME DATE MARKERS AND BEEPER 4 1 Glucose Result Marking 4 2 B ketone Result Marking 5 GlucoMen LX GLU KET CONTROLS 5 1 Important Information for GlucoMen LX Glu Ket control i GlucoMen LX PLUS 42338 09 10 a 6 GLUCOSE TESTIN Gi csssovonsssssssavsavavossnasassasavagnnnsssncstnupeaynsssssnvsavavonduasavensvevaevonvssectanysnsbseus oven ONV NEESTAS NOISES ASNO 6 1 Running a Glucose Control Solution Test a 6 2 Running a Blood Glucose Test 1 12111 6 3 Obtaining and Applying a Blood Sample from Forearm or Palm 6 4 Forearm and Palm Testing Limitations and Considerations 6 5 Your Blood Glucose Test Results sssrinin 6 6 B ketone Test Alert Blood Glucose Value 13 9 mmol L or Higher 7 B gt KETONE TESTING sicsicsscscsessnsssscaceschonsuvtssctonnsassteccecteue 7 1 Running a B ketone Control Solution test 7 2 Running a Blood amp ketone Test 7 3 Your Blood R ketone Test Result 8 DATA R
33. ized maintenance or failure to operate meter in accordance with instructions e There is no other express warranty for this product The option of replacement described above is the warrantor s only obligation under this warranty The original purchaser must contact A Menarini Diagnostics UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 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 PLUS 42338 09 10 GlucoMen LX PLUS 42338 09 10 GlucoMen LX PLUS 42338 09 10 GlucoMen LX PLUS 42338 09 10
34. lancets in the device after testing or arm the lancing device with a new sterile lancet unless ready to use Warning 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 Warning discard the used lancets in accordance with local regulations for biohazardous waste Warning cleaning of the puncture site is important Note if the sensor is removed before you start the test the screen goes blank Note if a test is not performed within 2 minutes from the insertion of the sensor the screen goes blank To perform a test take out then replace the sensor starting from Step a Note the Blood Drop symbol flashes on and off repeatedly until sufficient blood has been added to the sensor Note the meter will time out after 2 minutes of non use or if the sensor is removed The keys are disabled until a sensor is inserted Results and marking status are saved if the meter times out the sensor is removed or the meter is turned off GlucoMen LX PLUS 42338 09 10 6 GLUCOSE TESTING Baa Note you must apply the sample to the sensor while the blood drop symbol is flashing in the display If the meter turns off before sample application remove sensor 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 do not press the se
35. le the icon is displaying and flashing Note the meter cannot save the marking status if the one minute time out occurs or the ketone sensor is removed GlucoMen LX PLUS 42338 09 10 5 GLUCOMEN LX GLU KET CONTROL ux GlucoMen LX Glu Ket control solutions are standard solutions containing known amounts of both glucose and 8 hydroxybutyrate R ketone Glucose or R ketone control solution tests can be performed anytime you need to check if your meter and sensors are working correctly A glucose or 8 ketone control solution test Can be performed when you first get your meter and at least once a week thereafter Can be performed each time you open and begin using a new vial of GlucoMen LX sensor or you begin using a GlucoMen LX B Ketone sensor from a new foil pouch Must be performed if you leave the GlucoMen LX sensor vial cap open for a cumulative time exceeding the normal one consider the vial to be open for about 10 seconds test Must be performed if the meter is dropped damaged or exposed to liquids Must be performed if you think your test results are not accurate or if your test results are not consistent with how you feel A glucose or 8 ketone control solution test is similar to a blood glucose test or a blood ketone test except you use GlucoMen LX Glu Ket control and not a blood sample Use this glucose and 8 ketone control solution to check if your GlucoMen LX PLUS meter and GlucoMen LX senso
36. ll blood glucose test No action required BF results taken in the last 24 hours Glucose only Mom Avg mmol tdAY GlucoMen LX PLUS 42338 09 10 11 DISPLAYS MEANINGS ACTIONS uK Display What it Means What to Do Glu oo Mom Avg mmol dAY No test results in the last 24 hours No action required Glucose only Glu o8 Mom Avg mmol dAY The average of all blood glucose test results taken in the last 7 days No action required Glucose only Glu No test results in the last 7 days No action required ooa Glucose only Man eo AY ou The average of all blood glucose test No action required results taken in the last 14 days Glucose only en mo dA4 Glu 000 Mom Avg mmol NAY No test results in the last 14 days No action required Glucose only J GlucoMen LX PLUS 42338 09 10 UK 11 DISPLAYS MEANINGS ACTIONS Display What it Means What to Do 60 Mom Avg mmol 30dAY The average of all blood glucose test results taken in the last 30 days No action required Glucose only Glu ann Mom Avg mmotl 30 dA4 No test results in the last 30 days No action required Glucose only There are NO results in memory No action required eS 14a Battery is getting low but you can still perform a test Ba
37. ng the sensor vial contains small parts Keep the sensor vial away from children and pets GlucoMen LX PLUS 42338 09 10 3 INTRODUCTION uK 3 13 GlucoMen LX B Ketone sensor The GlucoMen LX B Ketone sensor is designed for use with your GlucoMen LX PLUS meter only Use each sensor only once then discard DO NOT reapply blood to the sensor Requires a very small blood volume 0 8 uL Automatically draws blood into the test area of the sensor e Can be handled with clean dry hands without affecting R ketone readings Insert this end into meter Apply blood drop to front edge 3 14 Important GlucoMen LX B Ketone sensor Information Only use GlucoMen LX 8 Ketone sensor when testing for 8 ketone Remove the sensor from the foil only when ready to test Store the sensor package in a cool dry place below 30 C 86 F Do not refrigerate or freeze Do not store near heat or moisture Store the sensors in their original packaging only Do not use the sensors beyond the expiration date printed on the package as this may cause inaccurate results Do not tamper with the sensor Warning the sensor packaging contains small parts Keep the sensors and packaging away from children and pets GlucoMen LX PLUS 42338 09 10 UK 3 INTRODUCTION 3 15 Limitations The GlucoMen LX sensor and GlucoMen LX B Ketone sensor give accurate results when the following limitations are observed The sensors should
38. not be used to diagnose diabetes DKA or to test newborns Each sensor is for single use only Do NOT reuse Use a new sensor each time you test Your sensors are for personal use only Do NOT share with others Use only fresh capillary whole blood e There is no effect on blood glucose or B ketone values for altitudes up to 3000 meters 10000 feet above sea level The meter gives accurate results within the temperature range 5 to 45 C 41 to 113 F Extremes in humidity higher than 90 and lower than 10 may affect results Both GlucoMen LX sensor and GlucoMen LX R Ketone sensor are calibrated against plasma If you want to compare your meter with a laboratory instrument you have to use fresh capillary whole blood with the meter and venous plasma with the laboratory instrument taking venous blood from the arm of the patient immediately after self testing measurement The result you get from your meter may differ from the tight controlled laboratory result This is due to normal differences existing between the capillary and venous compartment Glucose test results may be falsely low if the patient is severely dehydrated e Critically ill patients should not be tested with home blood glucose and B ketone meters GlucoMen LX PLUS 42338 09 10 3 INTRODUCTION uK 3 16 Lancing Device The diagram below shows the components of the Lancing Device Refer to the Instructions for Use of the Lancing Device for detailed instru
39. nsor directly against the skin Touch the blood drop gently with the sensor j GlucoMen LX PLUS 42338 09 10 UK 6 GLUCOSE TESTING 6 3 Obtaining and Applying a Blood Sample from Forearm or Palm Glucose Testing Only The GlucoMen LX PLUS significantly reduces the pain of blood glucose monitoring by requiring blood samples as small as 0 3 uL only The GlucoMen LX PLUS additionally offers the possibility to test blood glucose at sites other than the finger i e forearm and palm These sites have fewer nerve endings than fingers hence the pain associated to sampling is further reduced a Select the forearm palm heel or palm side test site in the highlighted areas as shown The area should be free from visible veins moles and hair and away from the bone b Wash area with warm soapy water Rinse and dry completely before lancing the site c Attach the clear cap to the lancing device Press and hold the lancing device FIRMLY against the forearm or palm GlucoMen LX PLUS 42338 09 10 E 6 GLUCOSE TESTING d Continue to hold FIRMLY and press the release button to lance the area e Continue to hold the device pressing FIRMLY until a proper blood drop forms The clear cap allows you to see the blood drop f Apply blood drop to the edge of the sensor The blood is drawn into the sensor Hold the sensor to the blood drop until you hear a short beep or see the meter begin to count down
40. r or GlucoMen LX 8 Ketone sensor are working properly Use this solution to practice or to check that you are following the correct testing procedure without using your own blood If the meter reading is within the GlucoMen LX Glu Ket control s acceptable range the GlucoMen LX PLUS system is working properly GlucoMen LX PLUS 42338 09 10 UK 5 GLUCOMEN LX GLU KET CONTROL 5 1 Important Information for GlucoMen LX Glu Ket control Only use the GlucoMen LX Glu Ket control for the test Check the expiration date on the GlucoMen LX Glu Ket control vial Do not use GlucoMen LX Glu Ket control past the expiration date or you may get inaccurate results Only store for 3 months after first opening When you open a new vial of GlucoMen LX Glu Ket control count forward 3 months and write that date on the label of the GlucoMen LX Glu Ket control vial Discard any remaining solution after the date you have written on the vial Store the GlucoMen LX Glu Ket control tightly closed at room temperature below 30 C 86 F Do not freeze Shake the GlucoMen LX Glu Ket control vial vigorously before using If your glucose control solution test results or 8 ketone control solution test results repeatedly falls outside the range printed on the GlucoMen LX sensor vial or GlucoMen LX B Ketone sensor foil pouch The GlucoMen LX PLUS meter may not be working properly do not use the meter to test your blood The GlucoMen
41. r than 33 3 mmol L the meter displays HI You may have a high blood sugar concentration Retest your blood glucose immediately using a new sensor If your reading is still high retest using the control solution If the result of the control solution test falls within the expected range confirming correct functioning of the system you should treat yourself as advised by your healthcare professional and or contact your healthcare professional immediately If your test result is lower than 1 1 mmol L the meter displays LO You may have a low blood sugar concentration Retest your blood glucose immediately using a new sensor If your reading is still low you should treat yourself as advised by your healthcare professional and or contact your healthcare professional immediately If you receive an Error Message see Paragraph 11 at page 54 of this user manual Warning test results greater than 13 3 mmol L may mean high blood sugar concentrations hyperglycaemia Test results lower than 3 3 mmol L may mean low blood sugar concentrations 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 BA mmol L 25 24o Glu 025 ieg M rm LLI 025 t24a GlucoMen LX PLUS 42338 09 10 UK 6 GLU
42. stored in the refrigerator or in the car Warning The GlucoMen LX PLUS contains small parts Keep the system out of reach of small children and pets Since any meter may fail break or be misplaced you should always have a backup meter This product may become infectious in the course of use Discard the product in accordance with local regulations for biohazardous waste Warning blood samples and blood products are potential sources of hepatitis and other infectious agents Handle all blood products with care Items that are used to measure glucose and B ketone e g sensors lancets and alcohol swabs must be disposed of in accordance to local regulations to avoid risk to anyone GlucoMen LX PLUS 42338 09 10 m Manufacturer CONT Contents of Set use i i s diagnostic medical devices Serial number IVD In Vitro Diagnostic Medical Device This product fulfils the requirements Attention read user manual before C of Directive 98 79 EC on in vitro 0123 W Direct current voltage SE LF TESTI NG In vitro device for self testing Blood Glucose and ketone Meter Catalogue number Blood glucose and B ketone meter Biohazard This meter could be potentially contaminated due to the blood samples used LOT Batch code Significant additions or changes from previous user manual revision Temperature limitation Use by Contents sufficient for lt n gt tests Dispose of use
43. t so the test result does not appear to be one of your blood test results Note if a test is not performed within 2 minutes from the insertion of the sensor the screen goes blank To perform a test take out then replace the sensor starting from Step a Note the on screen control symbol flashes on and off repeatedly until sufficient B ketone control solution has been added to the sensor beeper sounds if enabled Note if test result is above 8 0 mmol L for ketone the screen displays HI with Ket displayed Note if the B ketone control solution test result is outside the range is either higher or lower your meter and sensors may not be working as a system Repeat the process using a new sensor Do not use the meter if test results repeatedly fall outside the appropriate range If the problem continues call A Menarini Diagnostics for assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 GlucoMen LX PLUS 42338 09 10 3 7 B KETONE TESTING uK 7 2 Running a Blood B Ketone Test Warning blood samples from forearm or palm are NOT suitable for B ketone testing Only use blood from the fingertip when testing for B ketone a Wash your hands with soap and warm water then dry thoroughly As an alternative use alcohol pads to clean area dry thoroughly after cleaning b Insert a GlucoMen LX 8 Ketone sensor light purple colour into the GlucoMen LX PLUS meter If meter was off the screen
44. ttery will appear on all screens We suggest that you replace the battery immediately There is only enough power to perform 20 tests For free replacement batteries call UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 GlucoMen LX PLUS 42338 09 10 11 DISPLAYS MEANINGS ACTIONS uK Display What it Means What to Do Ou ct A glucose control solution test result No action required eS 24a Ket When a blood glucose value is 13 9 Perform a blood amp ketone test mmol L or higher three screens will cycle with the glucose result 026 i250 eu A pre meal glucose reading with alarm The user has the option to set a post 54 enabled meal test reminder after 2 5 hours to t re do a glucose test awx 1025 124g Olu A pre meal marked glucose sample test No action required 6H result a O25 24a Glu A post meal marked glucose sample test No action required 5 H result aa 25 4g E GlucoMen LX PLUS 42338 09 10 UK 11 DISPLAYS MEANINGS ACTIONS Display What it Means What to Do ou An after exercise marked glucose sample No action required 5 H test result O25 124g Glu A check marked glucose sample test No action required 5 H result T 025 4am Ket A check marked R ketone sample test No action required HE result 025 eve Software Error Call A Menarini Diagnosti
45. u inserting Call A Menarini Diagnostics for a SENSON assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 Not enough blood sample Repeat the test with a new sensor Meter Sample applied after meter Repeat the test with a new sensor does not automatically turned off pegintest Sensor may be damaged Repeat the test with a new sensor countdown after Meter may not be working properly After 3 attempts call A Menarini applying Diagnostics for assistance a blood UK 0800 243667 sample Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 GlucoMen LX PLUS 42338 09 10 3 12 APPENDIX uK 12 1 Specifications Analyte Glucose test Blood 8 amp D glucose B ketone test Blood amp hydroxybutyrate B ketone Test Methodology Glucose Glucose oxidase GOD biosensor B ketone amp hydroxybutyrate dehydrogenase biosensor Sensor Coding Glucose Not required B ketone Not required Test Results Glucose mmol L plasma values e B ketone mmol L plasma values Sample Type e Glucose Fresh Capillary Whole Blood e B ketone Fresh Capillary Whole Blood E GlucoMen LX PLUS 42338 09 10 UK 12 APPENDIX Test Range Glucose 1 1 to 33 3 mmol L e B ketone 0 1 to 8 0 mmol L Acceptable Hematocrit Range 25 60 Assay time e Glucose 4 seconds e

User Manual - Giuseppe Di Grande

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