A. Menarini Diagnostics Glucomen LX PLUS User Manual Download

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GlucoMen LX PLUS - 42338 - 09/10

Contents of Set

This product fulfils the requirements

of Directive 98/79/EC on

in vitro

diagnostic medical devices

In Vitro

Diagnostic Medical Device

In vitro

device for self-testing

Blood glucose and ß-ketone meter

Biohazard - This meter could be

potentially contaminated due to

the blood samples used
Significant additions or changes

from previous user manual

revision

Contents sufficient for <n> tests

Dispose of used batteries in
compliance with local regulations

2. SYMBOLS

Manufacturer

Attention, read user manual before

use

Serial number

Direct current (voltage)

Catalogue number

Batch code

Temperature limitation

Use by

Consult instructions for use

3. INTRODUCTION

Summary of Contents for Glucomen LX PLUS

Page 1: ...User Manual Read this user manual carefully before you start testing ...

Page 2: ...7286 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 ß 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 ...

Page 3: ... 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 ß 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 ...

Page 4: ...trol checks recommended in this User Manual Consult with your diabetes healthcare professional and follow his her guidance for your blood glucose or ß 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 met...

Page 5: ...od Glucose 14 3 9 Reasons to Check for ß Ketone 14 3 10 Important Health Related Information 15 3 11 GlucoMen LX sensor 16 3 12 Important GlucoMen LX sensor Information 16 3 13 GlucoMen LX ß ketone sensor 17 3 14 Important GlucoMen LX ß Ketone sensor Information 17 3 15 Limitations 18 3 16 Lancing Device 19 4 SETTING THE TIME DATE MARKERS AND BEEPER 20 4 1 Glucose Result Marking 22 4 2 ß ketone Re...

Page 6: ...t Results 35 6 6 ß ketone Test Alert Blood Glucose Value 13 9 mmol L or Higher 36 7 β KETONE TESTING 37 7 1 Running a ß ketone Control Solution test 37 7 2 Running a Blood ß ketone Test 39 7 3 Your Blood ß ketone Test Result 42 8 DATA REVIEW IN MEMORY 43 9 GLUCOLOG DATA MANAGEMENT SOFTWARE 45 10 BASIC UPKEEP 46 10 1 Battery Check 46 10 2 Battery Replacement 47 10 3 Cleaning and Care 47 11 DISPLAYS...

Page 7: ...itro diagnostic use It should only be used with GlucoMen LX sensor and GlucoMen LX ß Ketone sensor and GlucoMen LX Glu Ket control solutions It should be used for testing glucose sugar and ß 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 stored in the refrigerator or in the car Warning The GlucoMen LX plu...

Page 8: ...one meter Biohazard This meter could be potentially contaminated due to the blood samples used Significant additions or changes from previous user manual revision Contents sufficient for n tests Dispose of used batteries in compliance with local regulations 2 SYMBOLS Manufacturer Attention read user manual before use Serial number Direct current voltage Catalogue number Batch code Temperature limi...

Page 9: ...he sensor A simple one step process provides a result Test results are available in 4 glucose or 10 ß 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 damag...

Page 10: ...3 2 Meter Description GlucoMen LX PLUS meter C101000171XL L ood Glucose and ß ketone Meter Insert sensor here Right button Left button Mode button LCD Display C101000171XL mmol L Blood Glucose and ß ketone Meter Use the ejector to remove the test strip ...

Page 11: ...reen Note with no activity time out occurs after the following times 1 minute for all screens 2 minutes during test mode 3 minutes when the download cable is inserted 3 INTRODUCTION Glucose Ketone Control Low Battery Indicator mg dL or mmol L Test Results Average Test Results AM or PM Indicator Hour Minute Date Day Markers Alarm Pre Meal Post Meal Exercise and Mark Blood or Control Drop Indicator ...

Page 12: ...tely While the meter is in SLEEP Mode OFF pressing the Mode 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 ...

Page 13: ...ge 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 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 walki...

Page 14: ...lood 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 3 9 Reasons to Check for ß 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 nause...

Page 15: ...nly ß 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...

Page 16: ...ckage 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 ...

Page 17: ...ucoMen LX β Ketone sensor Information Only use GlucoMen LX ß Ketone sensor when testing for ß 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 pa...

Page 18: ...e 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 ß 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...

Page 19: ...e diagram below shows the components of the Lancing Device Refer to the Instructions for Use of the Lancing Device for detailed instructions Glucoject branded pricking devices and lancets are products manufactured by Owen Mumford Ltd Brook Hill Woodstock Oxford OX20 ITU UK ...

Page 20: ...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 longe...

Page 21: ...e a new setting for that Mode d Press the Mode button to select the new settings or to skip to the next Mode Note remembertoverifyandeventuallyadjusttimeanddatesettingsasneededtomatchthelocaltimeordaylight savingstimeandafteryoureplacethebattery Onceyouhavecompletedabloodglucose bloodß ketoneorcontrol solutiontest thelastresultwillappearthenexttimeyourmeteristurnedon Thedateandtimedisplayedistheda...

Page 22: ...g 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 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 ...

Page 23: ...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 disab...

Page 24: ...a valid result and setup marking is enabled mark check or unmark blank the ketone result by pressing the Left Right buttons The check icon displays and flashes Select the desired marking by pressing the Mode button while 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 ...

Page 25: ... 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 ß ketone control solution test is similar to a blood glucose test or a blood ß ketone test except you use GlucoMen LX...

Page 26: ...lts or ß ketone control solution test results repeatedly falls outside the range printed on the GlucoMen LX sensor vial or GlucoMen LX ß 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 LX sensor or GlucoMen LX ß Ketone sensor may not be working properly do not use the sensors to test your blood Call A Menarini Dia...

Page 27: ...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 i...

Page 28: ...ontrol 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...

Page 29: ...Glu displaying 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 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 bee...

Page 30: ...ancets 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 scr...

Page 31: ...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 sensor directly against the skin Touch the blood drop gently with the sensor ...

Page 32: ...es 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 ...

Page 33: ...our 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 changin...

Page 34: ... 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 β ketone testing must not use the forearm or palm site Only use the fingertip for β ketone testing 1 Jungheim K Koshinsky T 2002 Glucose Monitoring at the Arm Risky delays of hypoglycemia and hyperglycemia de...

Page 35: ...y 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 ma...

Page 36: ...egment moving from the left to the right of the screen with 0 5 seconds steps will cycle You are being alerted to check your ß ketone The alert will automatically stop after one minute or after the sensor is removed 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 ...

Page 37: ... 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 ß 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 instr...

Page 38: ... control symbol flashes on and off repeatedly until sufficient ß 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 ß 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 pr...

Page 39: ...ughly after cleaning b Insert a GlucoMen LX ß Ketone sensor light purple colour into the GlucoMen LX plus meter If meter was off the screen displays all segments for 2 seconds After 3 seconds the blinking blood drop symbol appears with Ket displaying 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 th...

Page 40: ... 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...

Page 41: ... 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 ...

Page 42: ...er than 0 1 mmol L Ket the screen displays LO No action is required Warning the normal adult blood ß ketone range for person without diabetes is less than 0 6 mmol L Consult with your healthcare professional for the blood ß ketone range that is appropriate for you If the blood ß 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 me...

Page 43: ...tons to view all the data in memory The Left 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 te...

Page 44: ...st 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 8 DATA REVIEW IN MEMORY ...

Page 45: ...ble 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 9 GLUCOLOG DATA MANAGEMENT SOFTWARE ...

Page 46: ...0 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 ...

Page 47: ... 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 LX plus meter should only be cleaned with alcohol wipes swabs Keep liquids from entering the sensor port or...

Page 48: ...quired If all segments are not displayed on meter call A Menarini Diagnostics for assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 Blood Drop Symbol meter is ready to accept blood Apply a blood sample to the sensor Refer to how to run a blood sample Countdown screen 4 seconds for glucose and 10 seconds for β ketone to perform the test and calculate the result...

Page 49: ...h you should treat yourself as advised by your healthcare professional and or contact your healthcare professional immediately Your blood ß ketone reading is higher than 8 0 mmol L Your blood glucose reading is lower than 1 1 mmol L You may have low blood sugar Retest your blood glucose immediately If your reading is still LO treat yourself as prescribed by your healthcare professional and or cont...

Page 50: ... mmo L stored in the meter s memory with date time No action required A blood ß ketone test result in mmol L stored in the meter s memory with date time No action required End of Setup Mode or DATA REVIEW Mode No action required The average of all blood glucose test results taken in the last 24 hours No action required Glucose only Display What it Means What to Do ...

Page 51: ...en in the last 7 days No action required Glucose only No test results in the last 7 days No action required Glucose only The average of all blood glucose test results taken in the last 14 days No action required Glucose only No test results in the last 14 days No action required Glucose only 11 DISPLAYS MEANINGS ACTIONS Display What it Means What to Do ...

Page 52: ...re are NO results in memory No action required Battery is getting low but you can still perform a test Battery 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 11 DISPLAYS MEANINGS ACTIONS Display What it Means...

Page 53: ... glucose result Perform a blood ß ketone test A pre meal glucose reading with alarm enabled The user has the option to set a post meal test reminder after 2 5 hours to re do a glucose test A pre meal marked glucose sample test result No action required A post meal marked glucose sample test result No action required 11 DISPLAYS MEANINGS ACTIONS Display What it Means What to Do ...

Page 54: ...k marked glucose sample test result No action required A check marked ß ketone sample test result No action required Software Error Call A Menarini Diagnostics for assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 11 DISPLAYS MEANINGS ACTIONS Display What it Means What to Do ...

Page 55: ...1 to 113 F Move meter and sensors to a warmer or cooler area and wait a few minutes Used Sensor Error used or damaged sensor Retest with a new sensor Blood Sample Error Incorrect application of blood sample or control solution onto the sensor or the 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 gluc...

Page 56: ...stics for assistance UK 0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 Meter does not begin test countdown after applying a blood sample Not enough blood sample Repeat the test with a new sensor Sample applied after meter automatically turned off Repeat the test with a new sensor Sensor may be damaged Repeat the test with a new sensor Meter may not be working properly Af...

Page 57: ...etone Test Methodology Glucose Glucose oxidase GOD biosensor ß ketone ß hydroxybutyrate dehydrogenase biosensor Sensor Coding Glucose Not required ß ketone Not required Test Results Glucose mmol L plasma values ß ketone mmol L plasma values Sample Type Glucose Fresh Capillary Whole Blood ß ketone Fresh Capillary Whole Blood 12 APPENDIX ...

Page 58: ...tone 10 seconds Sample Volumes Glucose 0 3 µL ß Ketone 0 8 µL Battery Life nominal 1000 Tests Low Battery Life About 20 Tests Data Output Port Audio Jack Operating Ranges for both glucose and ß ketone 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 x 98 x 17 mm Meter Data Storage 400 Results 12 APPENDIX ...

Page 59: ... PLUS 42338 09 10 UK 12 2 Chemistry Measurement Glucose test imprecision Refer to GlucoMen LX sensor instruction for use ß ketone test imprecision Refer to GlucoMen LX ß Ketone sensor instruction for use 12 APPENDIX ...

Page 60: ...er 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 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 Menarin...

Page 61: ...61 GlucoMen LX PLUS 42338 09 10 UK ...

Page 62: ...62 GlucoMen LX PLUS 42338 09 10 UK ...

Page 63: ...63 GlucoMen LX PLUS 42338 09 10 UK ...

Page 64: ...kshire RG41 5RA Tel 44 1189 444100 Fax 44 1189 444111 Menarini Helpline UK 0800 243 667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 Email glucomen menarinidiag co uk A MENARINI DIAGNOSTICS S r l Via Sette Santi 3 50131 Firenze Italia 0123 UK 42338 09 10 ...

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