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A. Menarini Diagnostics Glucomen LX PLUS User Manual

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Summary of Contents for A. Menarini Diagnostics Glucomen LX PLUS

  • Page 1 User Manual Read this user manual carefully before you start testing...
  • Page 2 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 GlucoMen LX PLUS - 42338 - 09/10...
  • Page 3 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:...
  • Page 4 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...

  • Page 5: Table Of Contents

    4. SETTING THE TIME, DATE, MARKERS AND BEEPER ......................4.1 Glucose Result Marking ..............................4.2 ß-ketone Result Marking ..............................5. GlucoMen® LX GLU/KET CONTROLS ............................5.1 Important Information for GlucoMen® LX Glu/Ket control ................... GlucoMen LX PLUS - 42338 - 09/10...
  • Page 6 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...

  • Page 7: Intended Use

    Handle all blood products with care. Items that are used to measure glucose and ß-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...

  • Page 8: Symbols

    Significant additions or changes Temperature limitation from previous user manual revision Use by Contents sufficient for <n> tests Dispose of used batteries in Consult instructions for use compliance with local regulations GlucoMen LX PLUS - 42338 - 09/10...

  • Page 9: Introduction

    Also, protect the meter from moisture, prolonged direct sunlight and extreme temperatures. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 10: Meter Description

    LCD Display ood Glucose and ß-ketone Meter Blood Glucose and ß-ketone Meter Left button Right button Mode button mmol/L C101000171XL C101000171XL GlucoMen® LX PLUS meter GlucoMen LX PLUS - 42338 - 09/10...
  • Page 11 GlucoMen® LX PLUS meter screen 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 GlucoMen LX PLUS - 42338 - 09/10...

  • Page 12: Navigation Buttons

    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...

  • Page 13: Kit Contents

    GlucoMen LX PLUS - 42338 - 09/10...

  • Page 14: Before Testing

    • You feel increasingly thirsty and urinate more frequently than usual • 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...

  • Page 15: Important Health Related Information

    If you are experiencing symptoms that are not consistent with your blood glucose or ß-ketone test results and you have followed all instructions described in the User Manual, call your doctor or healthcare professional. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 16: Glucomen® Lx Sensor

    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 Warning: the sensor vial contains small parts. Keep the sensor vial away from children and pets. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 17: Glucomen® Lx® Ss-Ketone Sensor

    • 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...

  • Page 18: Limitations

    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 • Critically ill patients should not be tested with home blood glucose and ß-ketone meters GlucoMen LX PLUS - 42338 - 09/10...

  • Page 19: Lancing Device

    The 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. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 20: Setting The Time, Date, Markers And Beeper

    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. GlucoMen LX PLUS - 42338 - 09/10...
  • Page 21 Note: if in 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. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 22: Glucose Result Marking

    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...
  • Page 23 • Once a post-meal test reminder alarm has been disabled, you cannot re-enable the alarm again • The meter can support only one post-meal test reminder alarm at a time • The meter can NOT preserve the currently set post-meal test reminder alarm after battery replacement (reset) GlucoMen LX PLUS - 42338 - 09/10...

  • Page 24: Ss-Ketone Result Marking

    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. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 25: Glucomen® Lx Glu/Ket Controls

    • 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...

  • Page 26: Important Information For Glucomen® Lx Glu/Ket Control

    ß-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 ß-ketone concentration. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 27: Glucose Testing

    • Expired GlucoMen® LX sensor. Check the expiration date on the sensor vial • 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 GlucoMen LX PLUS - 42338 - 09/10...
  • Page 28 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...

  • Page 29: Running A Blood Glucose Test

    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...
  • Page 30 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...
  • Page 31 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. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 32: Obtaining And Applying A Blood Sample From Forearm Or Palm

    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...

  • Page 33: Forearm And Palm Testing: Limitations And Considerations

    Only use finger or palm testing when the glycemic levels are expect to change rapidly. Do not use forearm testing: • For a blood β-ketone test • For at least 2 hours after you have eaten or injected insulin GlucoMen LX PLUS - 42338 - 09/10...
  • Page 34 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...

  • Page 35: Your Blood Glucose Test Results

    (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 PLUS - 42338 - 09/10...

  • Page 36: Ss-Ketone Test Alert: Blood Glucose Value 13.9 Mmol/L Or Higher

    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...

  • Page 37: Β-Ketone Testing

    • The GlucoMen® LX ß-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...
  • Page 38 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...

  • Page 39: Running A Blood Ss-Ketone Test

    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. Squeeze the finger to form a drop of blood. GlucoMen LX PLUS - 42338 - 09/10...
  • Page 40 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...
  • Page 41 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...

  • Page 42: Your Blood Ss-Ketone Test Result

    If the blood ß-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...

  • Page 43: Data Review In Memory

    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. GlucoMen LX PLUS - 42338 - 09/10...
  • Page 44 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. GlucoMen LX PLUS - 42338 - 09/10...

  • Page 45: Glucolog: Data Management Software

    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...

  • Page 46: Basic Upkeep

    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...

  • Page 47: Battery Replacement

    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...

  • Page 48: Displays, Meanings, Actions

    No action required. glucose and 10 seconds for β-ketone to perform the test and calculate the result. A blood glucose test result in mmol/L. No action required. Result is automatically stored into memory. GlucoMen LX PLUS - 42338 - 09/10...
  • Page 49 Retest your blood glucose immediately. 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 healthcare professional immediately. GlucoMen LX PLUS - 42338 - 09/10...
  • Page 50 End of SETUP Mode or DATA REVIEW No action required. Mode. The average of all blood glucose test No action required. Glucose only. results taken in the last 24 hours. GlucoMen LX PLUS - 42338 - 09/10...
  • Page 51 Glucose only. The average of all blood glucose test No action required. Glucose only. results taken in the last 14 days. No test results in the last 14 days. No action required. Glucose only. GlucoMen LX PLUS - 42338 - 09/10...
  • Page 52 Battery will appear on all immediately. There is only enough screens. 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...
  • Page 53 The user has the option to set a post- enabled. meal test reminder after 2.5 hours to re-do a glucose test. A pre-meal marked glucose sample test No action required. result. A post-meal marked glucose sample test No action required. result. GlucoMen LX PLUS - 42338 - 09/10...
  • Page 54 No action required. result. A check marked ß-ketone sample test No action required. result. Software Error. Call A. Menarini Diagnostics for assistance: (UK) 0800 243667 (Republic of Ireland) 1800 709903 (Northern Ireland) 0800 7837286 GlucoMen LX PLUS - 42338 - 09/10...
  • Page 55 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...
  • Page 56 • Meter may not be working properly. After 3 attempts, call A. Menarini after Diagnostics for assistance: applying (UK) 0800 243667 a blood sample. (Republic of Ireland) 1800 709903 (Northern Ireland) 0800 7837286 GlucoMen LX PLUS - 42338 - 09/10...

  • Page 57: Appendix

    • 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 GlucoMen LX PLUS - 42338 - 09/10...
  • Page 58 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 GlucoMen LX PLUS - 42338 - 09/10...

  • Page 59: Chemistry Measurement

    12. APPENDIX 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 GlucoMen LX PLUS - 42338 - 09/10...

  • Page 60: Warranty

    (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.
  • Page 61 GlucoMen LX PLUS - 42338 - 09/10...
  • Page 62 GlucoMen LX PLUS - 42338 - 09/10...
  • Page 63 GlucoMen LX PLUS - 42338 - 09/10...
  • Page 64 A. MENARINI DIAGNOSTICS LTD 405 Wharfedale Road, Winnersh, Wokingham Berkshire, 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...

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