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Summary of Contents for Beurer medical GL 44 lean
- Page 1 GL 44 lean BLOOD GLUCOSE MONITOR Step by step GL 44 lean Lancet needles / Lanzetten / lancettes / lancetas / lancette LD 04...
- Page 3 Contents 1. Getting to know your device ....................4 1.1 Scope of delivery and accessories ..................5 1.2 Replacements ......................... 6 1.3 Functions of the device ......................6 1.4 Signs and symbols .........................6 2. Warnings and safety notes ....................8 3. Description of device and accessories ................
- Page 4 1. G ettinG to know your device Dear customer, Thank you for choosing a product from our range. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, blood glucose, body temper- ature, pulse, gentle therapy, massage and air.
- Page 5 1.1 Scope of delivery 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.
- Page 6 1.2 Replacements You can also obtain test strips, control solution and lancets without a prescription. Item 50 test strips REF 463.04 Control solution LEVEL 3 and 4 REF 464.16 100 soft touch lancets 33G REF 457.24 100 lancet needles 28G REF 457.01 100 safety lancets REF 457.41...
- Page 7 Green dot (Der Grüne Punkt): Use by German dual waste collection system Maximum shelf life after initial Contents su cient for <n> tests opening in months Batch designation Order number Art.-Nr. Unit of measurement for blood Sterilised by radiation (lancets) glucose value Warning, see accompanying Biohazard, risk of infection...
- Page 8 2. w arninGs and safety notes Risk of infection All components of the monitor and its accessories may come into contact with human blood and are therefore a possible source of infection. Warning • Blood glucose values are displayed in mg/dL or mmol/L.
- Page 9 • This device may be used by people with reduced mental capabilities provided that they are super- vised or have been instructed on how to use the device safely and are fully aware of the consequent risks of use. • A lack of water, high fluid loss, for example perspiration, frequent passing of water, severe hypo- tension (low blood pressure), shock or hyperosmolar hyperglycaemic non-ketotic coma may lead to incorrect measurements.
- Page 10 • Choking hazard! Small children may swallow and choke on batteries. Store batteries out of the reach of small children. • Observe the plus (+) and minus (-) polarity signs. • If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth. •...
- Page 11 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 service life. Dispose of the device at a suitable local collection or recycling point in your country.
- Page 12 3.2 Display symbols 1 Date 2 Symbols for labelling measurements 3 Measured value display, HI, LO display, average blood glucose value, Err 4 Blood droplet symbol 5 Speaker symbol 6 Hand symbol 7 Test strip symbol 8 Blood glucose unit mmol/L 9 Blood glucose unit mg/dL 10 Battery replacement symbol 11 Memory symbol...
- Page 13 Insert the test strip into the de- vice 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 measurements if all information is followed.
- Page 14 4. i nitial use and basic settinGs 4.1 Removing the battery insulation strip, replacing the batteries Note • Two batteries are included in delivery of the blood glucose monitor. These have already been inserted into the battery compartment. • Remove the insulation strip before initial use.
- Page 15 Set the year (calendar to 2099) by pressing the “+” or “–” button. Confirm by pressing the On/ O button [4]. The day display flashes. Proceed as described above for the day, month, hour and minute. Switching the acoustic signal on/o To switch the acoustic signal on/o , press the “+”...
- Page 16 5.2 Taking a blood sample Warning • Change the puncture area for each measurement, e.g. a di erent finger or the other hand. Repeat- edly using the same area may cause inflammation, numbness or scarring. • Without the cap, there is a danger of injury from the exposed lancet. •...
- Page 17 Pull the tensioning device back until it audibly engages. Release the tensioning device. This automatically snaps back into the default po- sition. The lancing device is now ready for use. Put the already prepared lancing device to one side and prepare the device for measurement. Take a test strip from the box and immediately close it again.
- Page 18 Hold the blood input gap (at the tip of the test strip) to the drop of blood until the gap is completely filled and the monitor in the display starts counting backwards. Do not press the penetration area to the test strip. The blood must not be spread.
- Page 19 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 o . 5.4. Post-processing and disposal Remove the test strip from the device with the test strip ejection slider. Carefully dispose of the test strip according to the currently applicable regulations to avoid infecting others.
- Page 20 • Do not ignore symptoms of too high/low blood glucose levels. Consult your doctor. Blood glucose values The following tables list blood glucose values based on the STANDARDS OF MEDICAL CARE IN DIABETES 2016 from the ADA (American Diabetes Association). Time of the blood glucose Normal blood Increased risk of...
- Page 21 Display Blood glucose Action High blood glucose level If this high value persists 2 hours on an empty stomach, after your last meal, this may in- above 100 mg/dL dicate hyperglycaemia (high blood (5.6 mmol/L) glucose). Seek medical attention to coordinate any measures, if ap- 2 hours after a meal plicable.
- Page 22 The check performed at room temperature is used as a general functional check. The operating range specified in the technical specifications is valid without restriction. Hold the monitor so that the display is facing you. Insert a test strip into the slot on the monitor with the contacts first. Ensure the front of the test strip is facing you (see “Test strip”, page 12).
- Page 23 If measurements are outside the specified range, check the following possible causes: Cause Action • The first drop of control solution was Rectify the cause and repeat the test. not disposed of. • The tip of the bottle was not cleaned correctly.
- Page 24 6. m easurement 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.
- Page 25 Image 2 Pressing the rocker switch “–” [6] will display the previous measured value each time. You can display a maximum of 480 previous measurements. You can cancel the process at any time. To do so, press the On/O button or wait until the device switches itself o automatically after 2 minutes.
- Page 26 6.3 Displaying average blood glucose values for labelled values You can display the average measured blood glucose value for labelled values from the last 7, 14, 30 and 90 days. Switch the monitor on using the On/O button [4]. The initial display is shown briefly. Press the “+”...
- Page 27 After displaying the average value for 90 days “after meals” • the average for the last 7 days of values labelled as “general” • the symbol • the unit of measurement for blood glucose values and • “ ” are shown on the display. Press “+”...
- Page 28 6.4 Reset to basic settings The monitor must be switched o . Remove the battery compartment lid. Press the ’RESET’ button for 1 second. All settings are then deleted. Close the battery compartment lid again. The monitor is now in the settings mode. 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 29 Transferring measurements The monitor must be switched o . Insert the larger, flat USB connector of the connection cable into a USB port on your PC. Insert the mini USB connector into the integrated interface socket on the GL44 lean monitoring system.
- Page 30 Note The 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.
- Page 31 Cause Solution Err003 The haematocrit value is outside the Repeat the measurement using a new test strip. range 20–60%. Should the problem persist, contact Customer Services. Err005 System error. Remove batteries, reinsert batteries. Should the problem persist, contact Customer Services. Unknown error messages.
- Page 32 9. t echnical specifications Type GL 44 Dimensions (W x H x D) 52 x 95 x 16 mm Weight 44 g incl. batteries Power supply 2 x 3 V CR 2032 button cell batteries Battery life 1000 measurements Measured value memory 480 measured values with date/time Data retained when batteries are changed Average values...
- Page 33 During the reaction, a mediator transports electrons through the electrode surface and so generates a current. The monitor analyses this current. The current flow is proportional to the glucose content in the blood sample. The results are shown on the blood glucose monitor display. Only a small amount of blood is required (0.6 microlitres) and the duration of measurement is approx.
- Page 34 10. c 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 35 Results of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L) Within ±5 mg/dL Within ±10 mg/dL Within ±15 mg/dL (Within ±0.28 mmol/L) (Within ±0.56 mmol/L) (Within ±0.83 mmol/L) 101/168 (60.12%) 161/168 (95.83%) 166/168 (98.81%) Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L) Within ±5% Within ±10% Within ±15%...
- Page 36 tested with the 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 e ect of interfering substances on the measurements depends on the concentration in the blood.
- Page 37 Blood glucose Influence value 50-100 mg/dL 250-350 mg/dL (2.8-5.6 mmol/L) (13.9-19.4 mmol/L) Concentration of tested substances Ibuprofen 50 mg/dL (2.43 mmol/L) -2.6 mg/dL -1.9% (-0.15 mmol/L) Icodextrin 1094 mg/dL (0.64~0.78 mmol/L) -4.17 mg/dL -2.9% (-0.23 mmol/L) L-Dopa 2 mg/dL (0.10 mmol/L) 9.3 mg/dL 7.9% (0.52 mmol/L)
- Page 38 12. i ld 04 nstructions for use of the lancinG device and lancets 12.1 Purpose The lancing device is intended to be used in conjunction with a separate lancet to take a blood sample for measuring the sugar content of human capillary blood. Use the lancing device with lancets only on the skin areas intended for taking the glucose measurement (fingertips).
- Page 39 12.3 Device description Lancing device and lancets 28. Cap 29. Protective lancet disc 30. Sterile lancet 31. Lancet holder 32. Lancet ejection 33. Trigger button 34. Tensioning device 12.4 Initial use Unpack the lancing device and check that all the contents are present and intact. Before using the device for the first time, check that the lancing process works correctly.
- Page 40 Setting the penetration depth You can set seven di erent penetration depths on the lancing device. The penetration depth is displayed as a number. • 1-3 = for soft or thin skin • 4-6 = for normal skin • 7-9 = for thick or callused skin Turn the movable upper part of the cap until the desired penetration depth is displayed.
- Page 41 Place the retained protective disc flat on a hard surface. Stick the needle tip into the protective disc so the needle is no longer exposed. Take care not to touch the used lancet. Use the sliding switch on the side. This causes the lancet to drop out of the holder.
- Page 42 Beurer GL44 lean...
- Page 43 Beurer GL44 lean...
- Page 44 GL 44 lean Beurer GmbH Söflinger Straße 218 89077 Ulm, Germany • • www.beurer.com www.beurer-healthguide.com • Lancet needles / Lanzetten / lancettes / lancetas / lancette: SteriLance Medical (Suzhou) Inc. Emergo Europe B.V. No.168 PuTuoShan Road Westervoortsedijk 60, New District, 215153 Suzhou, Jiangsu 6827 AT Arnhem, The Netherlands PEOPLE’S REPUBLIC OF CHINA...
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