instructions for use mg/dL GL50 GB Codefree germanl engineering 3 IN 1 BLOOD GLUCOSE MONITOR step by step Beurer GmbH • Söflinger Straße 218 www.beurer.
Contents 1 Getting to know your instrument................................................................................. 4 1.1 Delivery scope, replacements and accessories...................................................................... 5 1.2 Functions of the device........................................................................................................... 6 1.3 Signs and symbols...........................................................................................................
1 Getting to know your instrument Dear customer, Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, blood glucose measurement, body temperature, pulse, gentle therapy, massage and air. Please read these Instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain. With kind regards, Your Beurer team.
1.1 Delivery scope, replacements and accessories Check that the set packaging has not been tampered with and make sure that all contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address.
Follow-up purchases You can also obtain test strips, control solution and lancet needles without a prescription. Item REF 50 test strips REF 464.15 Control solution LEVEL 3 and 4 REF 464.16 100 lancet needles REF 457.01 1.2 Functions of the device This device is intended for measuring the blood glucose content in human blood. It is also suitable for self-testing at home.
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2 Warnings and safety notes Risk of infection All components of the blood glucose monitor and its accessories may come into contact with human blood and are therefore a possible source of infections. Warning • This blood glucose monitor must display the blood glucose content in mg/dL. The unit of measurement mg/dL accompanies each blood glucose value. Please contact Customer Services if the device does not display mg/dL.
• An excessively high or low hematocrit value (proportion of red blood cells) may lead to incorrect measurements. In the event of a very high hematocrit value (above 55%), the displayed blood glucose value may be too low; in the event of a very low hematocrit value (below 30%), it may be too high. Consult your GP if you do not know your hematocrit value. • Do not use the test strips to measure blood glucose values on newborns.
Batteries/Saving measured values Warning • Keep batteries out of reach of children. Children may put batteries in their mouth and swallow them. This may severely damage their health. In such cases, seek medical assistance immediately! • Normal batteries must not be charged, heated or thrown into an open fire (risk of explosion!). Important • Batteries must not be taken apart or short circuited. • Always replace all batteries at the same time and use batteries of the same type.
The codes below are printed on batteries containing harmful substances: • Pb = Battery contains lead, • Cd = Battery contains cadmium, • Hg = Battery contains mercury. For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Please dispose of the unit in accordance with EC Directive 2002/96/EC – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal.
3.2 Lancing device and lancet needles 1 2 3 4 5 6 AST cap (transparent) Cap Protective lancet disc Sterile lancet needles Lancet holder Dial for setting different penetration depths 7 Tensioning slider 8 Trigger 3.3 USB cover If you would like to use the blood glucose monitor without the integrated lancing device, you can use the supplied USB cover in place of the lancing device. 3.
3.5 Test strips Front Rear  1 Gap for blood input 2 Handle 3 Contacts You can identify the rear by the contact tracks. Insert the test strip into the device so that the contacts are pointing inside the slot. Make sure that the front of the test strip is facing you. Note Read carefully the following information on handling and storing your test strips. The test strips will only provide accurate measured results if all notes are followed.
• Test strips expire three months after the box is opened. Make a note of the expiry date (opening date + 3 months ) on the label. The shelf life is limited to the expiry date (see date next to the hourglass symbol ). • Discontinue use of the test strips if one of the two expiry dates has passed ( / ). • You can touch any part of the test strip with clean, dry hands. • Use the test strip for measurement immediately after removing it from the box. • Do not bend, cut or otherwise modify the test strips.
6 Reattach the clip to the rear of the monitor. Fit the lancing device and monitor back together. Note • If the replace battery symbol appears, it means that the batteries are almost empty. Replace both batteries as soon as possible. • If “ ” appears on the display, the battery power level is so low that no more measurements can be taken. 4.2 Making and changing basic settings 1 Remove the batteries and reinsert them.
5 Deleting stored values Proceed as follows to delete stored values: • Press the “+” or “–” button. “Mem” and “ ” are displayed • Confirm by pressing the ON/OFF button. “Mem” and “ ” flash in the display. • To irreversibly delete your values, press the ON/OFF button again to confirm. “Mem”, “ ” and “ ” are displayed. If you do not wish to delete your values, press the “+” or “–” button. “Mem” and “ ” are displayed again. Confirm by pressing the ON/OFF button.
2 Prepare all parts Prepare the following items: GL50 monitor (A), test strip box (D) and sterile lancet needles (E). You will also need the AST cap for measurements on other parts of the body (B). 3 Wash your hands Wash your hands with soap and warm water before taking a blood sample. This not only ensures optimal hygiene but also encourages good blood circulation at the puncture area on the finger. Dry your hands carefully.
3 Remove the protective lancet disc Remove the protective lancet disc by turning clockwise. Retain the protective disc for the safe disposal of the used lancet needle after taking a blood sample. 4 Select cap and attach. You need to use a different cap depending on the area from which you take the sample: - Fingertip: Cap (black) - Other body parts: AST cap (transparent) Warning Do not use the AST cap to take blood samples from the finger. Place the selected cap on the lancing device.
5.3 Taking a blood sample and measuring the glucose level Warning • Change the puncture area each time you take a measurement, e.g. use a different finger or the other hand. Repeatedly using the same area may cause inflammation or scarring. • If the cap is not in place, there is a risk of injury from the exposed lancet. • Do not squeeze your finger to obtain a larger drop of blood. If squeezed, the blood is diluted with tissue fluid and this may lead to an incorrect result.
4 Lancing to take a blood sample The lancing device can now be used to take a blood sample. Make sure that the blood remains as a droplet and is not spread. - Blood sample from the fingertip Firmly position the lancing device slightly to the side of the centre of the fingertip. Press the trigger. Remove the lancing device from the finger. A round drop of blood of at least 0.6 microlitres (corresponds to approx. 1.4 mm, original size: ) must have formed.
6 Apply blood to the test strip Turn the monitor by 180°. Hold the blood input gap (at the tip of the test strip) to the drops of blood until the gap is completely filled and the monitor in the display starts counting backwards. Do not press the penetration area (fingertip or other body parts) to the test strip. The blood must not be spread. The blood is sucked into the gap. OK Note Error message “Err002” appears on the display if the gap was not correctly and sufficiently filled with blood.
Label measured value You have the following options for labelling measured values. Before a meal After a meal General label (e.g. after exercising) Labelling measured values enables you, your GP or diabetes consultant to better monitor your blood glucose values. For example, you can display the average values of all measurements taken before a meal. To label a measurement, proceed as follows: 1 The measured value can be labelled as soon as it is displayed.
3 Stick protective disc on needle Place the retained protective disc flat on a hard surface. Stick the tip of the needle into the protective disc (image 1) so the needle is covered (image 2). 4 Remove and dispose of lancet needle Press the trigger again so that you can grip the shaft. Carefully remove the lancet needle from the lancing device and dispose of the lancet in a puncture-proof container. Carefully dispose of all blood samples and materials that you have come into contact with.
Blood glucose The following table provides a classification of blood glucose values according to the diabetes guidelines of the German Diabetes Association (Deutsche Diabetes Gesellschaft – DDG).
5.7 Functional check using control solution The control solution is used to test the entire blood glucose monitoring system. This helps to determine whether the monitor and the test strips are working optimally together and whether the test is being performed correctly. Perform the control solution test if you suspect that the blood glucose monitor and/or the test strips could be faulty or if you have repeatedly measured unusual blood glucose values.
4 Drip control solution on surface Choose a clean surface to carry out the functional test correctly. Shake the control solution well before use. Undo the cap and press two drops next to each other on the clean surface without touching them. Use the second drop for the measurement. Note Never apply the control solution straight from the bottle to a test strip. Reason: The remaining solution in the bottle will be contaminated if the top of the bottle comes into contact with the test strip.
If measured values are outside the specified range, check the following possible causes: Cause Action • The first drop of control solution was not dis- Rectify the cause and repeat the test. posed of. • The tip of the bottle was not cleaned correctly. • The bottle was not shaken well enough. Control solution or test strip is contaminated. Repeat the test using a new bottle of control solution and/or new test strip.
6 Measurement memory For each measurement, your blood glucose value is automatically saved with the date and time unless “ ” was activated for a blood glucose measurement using control solution. The memory can store a maximum of 480 measured values. If the memory is full, the oldest value is replaced by the most recent value. You can call up every individual measured blood glucose value. You can also calculate and display the average value for the last 7, 14, 30 and 90 days.
6.2 Displaying average blood glucose values You can display the average measured blood glucose value from the last 7, 14, 30 and 90 days. 1 Switch the monitor on using the on/off button [1]. The initial display is shown briefly. Press the “+” rocker switch twice [3]. The measurement unit of the blood glucose value, “ ” and the average value are displayed (this means: 07 = 7, d = days). 2 Press “+” repeatedly to display the average value for 7, 14, 30 and 90 days.
2 Press “+” repeatedly to display the average value of all measured values for 14, 30 and 90 days. After the average of all measured values for 90 days is displayed, • the seven-day average for values measured “before a meal” • the symbol • the unit of measurement for blood glucose values and •“ ” are shown on the display. Press “+” repeatedly to display the average blood glucose level from the last 14, 30 and 90 days taken "before a meal" .
6.4 Deleting individual measured values from the memory 1 Press the buttons as described in “6.1 Displaying individual values” on page 28 until the value that you would like to delete is displayed. 2 Press and hold the ON/OFF button. Also press the “–” button for two seconds. “ ”, “Mem” and the number of the value to be deleted flash. Press the ON/OFF button again. “ ”, the number of the value to be deleted, “Mem” and “ ” are displayed.
Evaluating measured values on the PC 1 The blood glucose monitor must be switched off. Insert the monitor’s USB connector into a free USB port on your PC. In the event that the measuring device is not recognised, please try using another active USB point. 2 “ ” is shown on the display of the blood glucose monitor. Saved data can now be viewed on your PC. 3 See the information on evaluating values in the software manual.
Note The blood glucose monitor is made of precision components. The accuracy of the measurements and service life of the device depend on its careful handling: • Protect the device from impacts and do not drop it. • Protect the device from damaging factors such as moisture, dirt, dust, blood, control solution or water, marked temperature fluctuations, direct sunlight and extreme cold. • Do not use the device in the vicinity of strong electromagnetic fields, radio systems or mobile telephones.
Problem: device does not switch on Cause Solution Batteries empty. Replace batteries. Incorrectly inserted or missing batteries. Check whether the batteries have been inserted correctly (see “4.1. Removing the battery insulation strips, replacing the batteries” on page 14). Test strip inserted incorrectly or not completely. Firmly insert the test strip into the slot on the device with the contacts first. Make sure that the front of the test strip is facing you (see “Test strip” on page 13).
9 Technical specifications Dimensions (L x W x H) Weight Power supply Battery life Measured value memory Average values Automatic switch-off Storage/ transport temperature Operating ranges Measuring range, glucose Blood sample Required volume of blood Blood glucose measuring duration Calibration Test procedure Usage System function test 123 x 28 x 16 mm 36 g (incl.
Only a small amount of blood is required (0.6 microlitres) and measurement takes approx. five seconds. The test strip detects blood glucose values from 20 to 630 mg/dL. Chemical components of the test strip sensor • FAD glucose dehydrogenase 6% • Potassium ferricyanide 56% • Non-reactive components 38% Control solution functionality The control solution contains a fixed amount of glucose that reacts with the test strip. A test with control solution is similar to a blood test.
Usage limits for specialist personnel from the healthcare sector: 1. If the patient exhibits the following symptoms, it may be the case that no correct values can be obtained: • Acute dehydration • Acute hypotension (low blood pressure) • Shock • Hyperosmolar hyperglycaemic condition (with or without ketosis) 2. Lipaemic samples: cholesterol levels up to 500 mg/dL and triglycerid levels up to 1,000 mg/dL do not influence the results.
10 Guarantee and customer service Warranty We offer a 3-year product warranty against material and production faults. The warranty does not cover: • Damage due to improper operation • Wearing parts • Deficiencies already known to the customer upon purchase • Cases of personal negligence on the part of the customer • Outside interference The warranty does not affect the customer’s statutory rights. To assert a warranty claim within the warranty period, the customer must provide proof of purchase.
GL50_mg/dL_0813_GB Subject to errors and changes