Beurer medical GL 44, Instructions For Use Manual

Page 1: ...GL 44 EN Lancet needles Lanzetten lancettes lancetas lancette GL 44 LD 03 Instructions for use Blood glucose monitor Step by step...

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Page 3: ...red blood glucose values 18 5 6 Functional check using control solution 19 6 Measurement memory 22 6 1 Displaying individual values 22 6 2 Displaying average blood glucose values 23 6 3 Displaying ave...

Page 4: ...samples either for self testing or in a clinical environment by trained personnel It enables you to measure your blood glucose quickly and easily store the measured values and dis play the average of...

Page 5: ...g device C 10 test strips D 10 sterile lancet needles 5 x 28G blue 5 x 33G purple E 2 button cell batteries 3 V CR2032 already inserted F 1 practical case G 1 USB cable These instructions for use addi...

Page 6: ...easured values Display the average measured blood glucose value from the last 7 14 30 and 90 days Display the average of the labelled measured blood glucose values from the last 7 14 30 and 90 days Se...

Page 7: ...urement for blood glucose value Warning see accompanying documents Biohazard risk of infection Medical device MDR Symbol CE labelling This product satisfies the requirements of the applicable European...

Page 8: ...and others who use this system on several patients must be aware that all prod ucts or objects that come into contact with human blood must be handled even after cleaning as though they could transfer...

Page 9: ...g this device Use fresh whole blood only Do not use serum or plasma Use capillary blood without squeezing the penetration area Squeezing the area causes the blood to be diluted with tissue fluid and t...

Page 10: ...ose values are retained when the batteries are replaced If applicable the date and time must be reset after replacing the batteries Use lithium ion batteries only Repairs Note Do not open the device F...

Page 11: ...ollection or recycling point in your country Dispose of the device in accordance with EC Directive WEEE Waste Electrical and Electronic Equipment If you have any questions please contact the local aut...

Page 12: ...10 Battery replacement symbol 11 Memory symbol 12 Temperature symbol 13 Time Note The monitor is supplied with the following basic settings Acoustic signal off Backlighting off Warning Ensure that yo...

Page 13: ...r the box is opened Make a note of the expiry date opening date 18 months 18 M on the label The shelf life is limited to the expiry date see date next to the hour glass symbol This does not apply for...

Page 14: ...are inserted the correct way round in accordance with the markings Observe the graphic in the battery compartment 4 Close the battery compartment lid again carefully Note The batteries are almost emp...

Page 15: ...f the protective disc on a lancet needle has already been removed do not use the lancet needle If you drop the lancing device with an inserted lancet needle carefully pick it up and dispose of the lan...

Page 16: ...lso note the following If the blood glucose test results do not match how you feel carry out another test using blood from your fingertip DO NOT change your treatment purely on the basis of a measurem...

Page 17: ...ive seconds The measurement is then shown on the display Read the measured value For explanations and actions for the measured values see chapter 5 5 Evaluating measured blood glucose values If an err...

Page 18: ...ucose Below 100 mg dL Below 5 6 mmol L 100 125 mg dL 5 6 6 9 mmol L 126 mg dL 7 0 mmol L Two hours after an oral glucose tolerance test con sumption of 75 g Below 140 mg dL Below 7 8 mmol L 140 199 mg...

Page 19: ...0 mmol L Take another measurement using a new test strip If the display is the same as before seek medical as sistance immediately 5 6 Functional check using control solution The control solution is u...

Page 20: ...ferent ways It is therefore of vital importance that control solution measurement is always performed in control solution mode If this mode is not used results may be obtained that are outside the tar...

Page 21: ...test Control solution and or test strips have passed their expiry date or are contaminated Repeat the test using a new bottle of control solution and or new test strip from a new box or new film packa...

Page 22: ...lue for the last 7 14 30 and 90 days Note If you have already saved measured values and you reset the date the average values are calculated as from the new period indicates an empty memory for measur...

Page 23: ...glucose value from the last 7 14 30 and 90 days 1 Switch the monitor on using the On Off button 4 The initial display is shown briefly Press the rocker switch 6 twice The measurement unit of the bloo...

Page 24: ...all measured values for 14 30 and 90 days After the average of all measured val ues for 90 days is displayed the 7 day average for values meas ured before meals the symbol the unit of measurement for...

Page 25: ...any time To do so press the On Off button or wait until the device switches itself off automatically after 2 minutes Note Speed function You are in the measurements memory By pressing the label button...

Page 26: ...ive evaluation is only possible if you have correctly set the date and time see page 14 During data transfer no measurements can be taken The measurements remain saved on the monitor after they have b...

Page 27: ...alcohol The lancing device must not be immersed in water or other liquids or be cleaned in the dishwasher Dry the lancing device using a lint free cloth 7 2 Disinfection Device Please comply with the...

Page 28: ...itor and test strip have reached room temperature 20 C to 26 C The check performed at room temperature is used as a general functional check The operating range specified in the technical specificatio...

Page 29: ...est strip and a larger drop of blood Please note the correct filling of the test strip see page 16 Faulty test strip Repeat the test using a new test strip Blood was applied while the device was switc...

Page 30: ...functionality Test strips enable a quantitative measurement of the glucose level in fresh whole blood When the gap for taking blood comes into contact with a drop of blood it is automatically filled...

Page 31: ...tive IVD 98 79 EC The lancet needles comply with the Europe an directive MDD 93 42 EC The lancing device complies with the regulation EU MDR 2017 745 on medical devices 10 Comparison of measured value...

Page 32: ...mol L Within 5 Within 10 Within 15 182 432 42 13 358 432 82 87 426 432 98 61 Results of the system accuracy for combined glucose concentrations between 36 0 mg dL 2 0 mmol L and 442 5 mg dL 24 6 mmol...

Page 33: ...r 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...

Page 34: ...dL 0 0018 mmol L 3 0 mg dL 0 17 mmol L 1 3 Ibuprofen 50 mg dL 2 43 mmol L 2 6 mg dL 0 15 mmol L 1 9 Icodextrin 1094 mg dL 0 64 0 78 mmol L 4 17 mg dL 0 23 mmol L 2 9 L Dopa 2 mg dL 0 10 mmol L 9 3 mg...

Page 35: ...these instructions for use Never use the lancing device on injured inflamed or scarred skin Never use the lancing device on areas already affected by a sensory disorder If you drop the lancing device...

Page 36: ...cet needles from the same manufacturer Using other lancet needles may permanently prevent the lancing device from working properly 12 3 Device description Lancing device and lancet needles 1 Cap 2 Pro...

Page 37: ...netration depth is displayed by the markings in the cap soft or thin skin normal skin thick or callous skin Turn the moving upper part of the cap until the desired penetration depth is displayed 6 Pul...

Page 38: ...fingertip Do NOT change your treatment purely on the basis of a measurement that was carried out using blood taken from an alternative area Carry out another test with blood from your fin gertip in or...

Page 39: ...GmbH S flinger Stra e 218 89077 Ulm Germany hereinafter referred to as Beurer provides a warranty for this product subject to the requirements below and to the extent described as follows The warranty...

Page 40: ...urchased as seconds or as used goods consequential damage arising from a fault in this product however in this case claims may exist arising from product liability or other compulsory statutory liabil...

Page 41: ...Beurer GL44 41...

Page 42: ...42 Beurer GL44...

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Page 44: ...o 168 PuTuoShan Road New District Suzhou 215153 China GL 44 Beurer GmbH S flinger Stra e 218 89077 Ulm Germany www beurer com www beurer healthguide com LD 03 Beurer GmbH S flinger Stra e 218 89077 Ul...