Beurer GL44 lean Instructions For Use Manual
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Beurer GL44 lean Instructions For Use Manual

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Instructions for use
GL44 lean
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Code-free
BLOOD GLUCOSE MONITOR
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Summary of Contents for Beurer GL44 lean

  • Page 1 Instructions for use GL44 lean Code-free BLOOD GLUCOSE MONITOR Step by step...

  • Page 3: Table Of Contents

    8 What if there are problems? ....................31 9 Technical specifications ......................33 10 Comparison of measured values with laboratory values .......... 35 11 Usage limits for specialist personnel from the healthcare sector ......36 12 Warranty and customer service ..................39 Beurer GL44 lean...

  • Page 4: Getting To Know Your Device

    Your Beurer team. Getting to know your device The GL44 lean blood glucose monitoring system is intended for fast and simple blood glucose measurement of fresh capillary blood samples, either for self-testing or in a clinical environment by trained personnel.

  • Page 5: Scope Of Delivery And Accessories

    • The blood glucose monitor, test strips and additionally available control solutions have been spe- cially designed to complement each other. For this reason, use only test strips and control solutions that have been approved for this monitor. Note • Use original manufacturer accessories only. Beurer GL44 lean...

  • Page 6: Replacements

    The symbols on the packaging and type plate of the monitor and accessories represent the following: In vitro diagnostic device Manufacturer Serial number Observe the instructions for use Temperature limit Not for re-use/for single use +2°C to +30°C only Green dot (Der Grüne Punkt): Use by German dual waste collection system Beurer GL44 lean...
  • Page 7 In the instructions for use, the symbols represent the following: Warning Warning instruction indicating a risk of injury or damage to your health/your patient’s health. Important Safety note indicating possible damage to the device/accessory. Note Note on important information. Beurer GL44 lean...

  • Page 8: Warnings And Safety Notes

    Consult your GP regularly regarding your measured values. Never independently alter the procedures prescribed by your GP. • Despite the ease of use of the Beurer GL44 lean monitor for self-monitoring blood glucose levels, you may need to obtain instructions for using the system from your healthcare professional (for...
  • Page 9 • Very high levels of humidity may influence the test results. Relative humidity of more than 90% may lead to inaccurate results. Note • The Beurer GL44 lean monitoring system is intended for measuring capillary and venous whole blood. Storage and maintenance Warning •...
  • Page 10 Dispose of all blood samples and materials with which you or your patients come into contact correctly in order to prevent injury and infection of other persons. • After use, dispose of test strips and lancets in a puncture-proof container. Beurer GL44 lean...

  • Page 11: Description Of Device And Accessories

    ESCRIPTION OF DEVICE AND ACCESSORIES 3.1 Blood glucose monitor Front 1 Slot for test strips 2 Display 3 Labelling button 4 On/Off button 5 PC connection 6 “+ –” rocker switch Rear 1 Battery compartment (bottom side) 2 Reset button Beurer GL44 lean...

  • Page 12: Lancing Device And Lancet Needles

    The monitor is supplied with the following basic settings: • Acoustic signal off Warning Ensure that you are using the device with the correct blood glucose unit (either mg/dL or mmol/L) setting for you. If in doubt, consult your GP. Beurer GL44 lean...

  • Page 13: Test Strips

    ) on the label. The shelf life is limited to the expiry date (see date next to the hourglass symbol  ). This does not apply for individual test strips, which are to be used immediately after opening. Beurer GL44 lean...

  • Page 14: Initial Use And Basic Settings

    • The batteries are almost empty if the battery replacement symbol appears. Replace both batteries as soon as possible. • If “ ” appears on the display, the battery power level is so low that no more measurements are possible. Beurer GL44 lean...

  • Page 15: Making And Changing Basic Settings

    • Use the lancing device only with lancet needles from the same manufacturer. Using other lancet needles may prevent the lancing device from working properly. • If you are using a third-party lancing device, please read the respective Instructions for Use. Beurer GL44 lean...

  • Page 16: Preparing To Take A Blood Sample

    • Please note that insufficient blood circulation at the puncture area, e.g. caused by cold temperatures or illness, may lead to incorrect results. Important Do not apply any blood samples or control solutions to the test strip before inserting it in the monitor. Remove the cap from the lancing device. Beurer GL44 lean...
  • Page 17 Firmly insert a test strip into the device with the contacts first. Please make sure that the front is facing you. You can touch any part of the test strip with clean, dry hands. Use the test strip within three minutes of removal. Beurer GL44 lean...
  • Page 18 Briefly remove the test strip and reinsert it so that the device automatically switches itself back on. • Contact Customer Services if you are unable to fill the test strip with blood correctly. Beurer GL44 lean...

  • Page 19: Reading The Result And Labelling Measurements

    Pressing again labels the value with . c) Pressing yet again labels the value with d) Pressing a final time removes the label. The selected label is stored in the memory of the device when it is switched off. Beurer GL44 lean...

  • Page 20: Post-Processing And Disposal

    Seek medical advice if dubious results persist. • Immediately seek medical attention if your symptoms are not in line with your measured blood glu- cose values and you have observed all instructions for the Beurer GL44 lean blood glucose moni- toring system.
  • Page 21 Evaluating critical measured values Display Blood glucose Action Very low blood glucose Seek medical attention level immediately. under 20 mg/dL (under 1.1 mmol/L) Low blood glucose level Have a suitable snack. Follow your GP’s instructions. under 70 mg/dL (under 3.9 mmol/L) Beurer GL44 lean...

  • Page 22: Functional Check Using Control Solution

    Important • Do not use control solutions by a different manufacturer. Correct functioning of your monitor can only be tested using Beurer control solutions (LEVEL3 + LEVEL4). • Control solution measurements: When using the device, specialist personnel must follow statutory guidelines.
  • Page 23 95% of all tests. Warning The specified value range (see test strip box or information sheet with the test strips in film packaging) only applies for the control solution. This is not a recommended value for your blood glucose level. Beurer GL44 lean...
  • Page 24 Repeat the test and follow the instructions. formed. Warning Do not use the system to measure your blood glucose level if you are repeatedly provided with measurements outside the specified range when using control solution. Contact Customer Services. Beurer GL44 lean...

  • Page 25: Measurement Memory

    The recorded measured value with the measurement unit, time, “Mem” and any measurement label is briefly displayed together with the memory space number (image 1). The memory space number is then replaced in the display by the date (image 2). Image 1 Beurer GL44 lean...

  • Page 26: Displaying Average Blood Glucose Values

    You can cancel the process at any time. To do so, press the On/Off button or wait until the device switches itself off automatically after 2 minutes. Explanation Average value Number of days, e.g. 7 Number of saved val- ues used to calculate the average Beurer GL44 lean...

  • Page 27: Displaying Average Blood Glucose Values For Labelled Values

    • the unit of measurement for blood glucose values and • “ ” are shown on the display. Press “+” [6] repeatedly to display the average value for 14, 30 and 90 days “after meals” . Beurer GL44 lean...
  • Page 28 Note: Speed function You are in the measurements memory. By pressing the label button [3], you can switch to the different 7-day average values. In this way, you can get to the desired average value more quickly. For example: Beurer GL44 lean...

  • Page 29: Reset To Basic Settings

    6.5 Transferring measurements to a PC The GL44 lean monitoring system includes a PC interface [5] that enables you to transfer measured values saved on the device to a PC (for the position of the connection port, see page 11).

  • Page 30: Storing, Maintaining And Disinfecting The Device

    TORING MAINTAINING AND DISINFECTING THE DEVICE Storing Keep the Beurer GL44 lean monitoring system in the case supplied after each measurement and do not expose it to direct sunlight. Note • Do not store the device, test strips and control solution in your vehicle, in the bathroom or in a cool- ing appliance! •...

  • Page 31: What If There Are Problems

    • Insert an unused test strip that has not expired. serted. • Repeat the blood glucose measurement. Err001 System error. Remove batteries, reinsert batteries. Should the problem persist, contact Customer Services. Err002 Insufficient blood on the test strip. Repeat the measurement using a new test strip. Beurer GL44 lean...
  • Page 32 The basic settings of the device were changed Remove the test strip and press the “On/Off” but- and the changes were not completed (see ton until “ ” is displayed. “Making and changing basic settings” on Repeat test. page 15). Device faulty. Contact Customer Services. Beurer GL44 lean...

  • Page 33: Technical Specifications

    The test is based on the measurement of an electric current that is generated by the chemical reaction of the glucose with the enzyme glucose dehydrogenase (Aspergillus oryzae) on the strip. Beurer GL44 lean...
  • Page 34 The control solution is a red solution with the following D-glucose level (in percentage shares). Substances LEVEL 3 control solution LEVEL 4 control solution D-glucose 0.14% 0.37% Non-reactive components 99.86% 99.63% Standards The Beurer GL44 lean monitoring system corresponds to the European Directives IVD (98/79/EC) and MDD (93/42/EC). Beurer GL44 lean...

  • Page 35: Comparison Of Measured Values With Laboratory Values

    OMPARISON OF MEASURED VALUES WITH LABORATORY VALUES Precision Three lots of the GL44 lean blood glucose test strips have been tested to assess the precision of the GL44 lean blood glucose monitoring system. This includes a repeat assessment using venous blood and a laboratory precision assessment using the control material.

  • Page 36: Usage Limits For Specialist Personnel From The Healthcare Sector

    (Within ±0.83 mmol/L or ±15%) 592/600 (98.67%) In comparison to the YSI, the GL44 lean met the EN ISO 15197:2015 standard, whereby 95% of the blood glucose values measured have to fall within the following zones: either ±15 mg/dL (±0.83 mmol/L) of the measured average values when using the reference measuring procedure for blood glucose concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations...
  • Page 37 Beurer GL44 lean blood glucose monitoring system; therefore, using the device with these samples is not recommended. 3. In the case of severely ill patients, blood glucose monitors for home use should not be used. 4. The effect of interfering substances on the measurements depends on the concentration in the blood.
  • Page 38 Salicylic acid 60 mg/dL (4.34 mmol/L) -0.1 mg/dL 7.6% (-0.01 mmol/L) Tolbutamide 100 mg/dL (3.70 mmol/L) 0.5 mg/dL -0.8% (0.03 mmol/L) Tolazamide 2.5 mg/dL (0.08 mmol/L) -2.3 mg/dL 1.8% (-0.13 mmol/L) Triglyceride 800 mg/dL (9.37 mmol/L) -7.50 mg/dL -4.0% (-0.42 mmol/L) Uric acid 16.5 mg/dL (0.98 mmol/L) 6.6 mg/dL 1.8% (0.37 mmol/L) Xylose 9.5 mg/dL (0.63 mmol/L) 5.6 mg/dL 6.6% (0.31 mmol/L) Beurer GL44 lean...

  • Page 39: Warranty And Customer Service

    In case of returning the unit please add a copy of your receipt and a short report of the defect. The following warranty terms shall apply: 1. The warranty period for BEURER products is either 5 years or- if longer- the country specific warranty period from date of purchase.
  • Page 40 Beurer GmbH Söflinger Straße 218 89077 Ulm, Germany • • www.beurer-gesundheitsratgeber.com www.beurer-healthguide.com • www.beurer.com...

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