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Beurer GL44

Automatic switch-off

2 minutes after last actuation

Storage/transport temperature

Temperature: +2 °C – +30 °C

Relative humidity: < 90%

Operating ranges

Temperature: +10 °C – +40 °C

Relative humidity: < 90% non-condensing

Measurement range, glucose

Glucose: 20 – 630 mg/dL (1.1 - 35.0 mmol/L)

Blood sample

Capillary whole blood

Amount of blood

0.6 microlitres

Blood glucose measurement duration

Approx. 5 seconds

Calibration

Plasma

Testing method

Amperometric bio sensor

Use

Suitable for self-testing

System function test

Each time device is switched on

The serial number is located on the device or in the battery compartment.

EMC

This device complies with the European standard EN 61326 and is subject to specific precautions

with regard to electromagnetic compatibility. Please note that portable and mobile HF communica-

tion systems may interfere with this device. For more details, please contact our Customer Services

at the address indicated.

Test strip 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 by simple cap-

illary action. The blood is sucked into the absorbing gap on the test strip and the monitor measures

the blood glucose level in the blood.

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.

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. five seconds. The test strips

detect blood glucose values from 20 to 630 mg/dL (1.1 to 35.0 mmol/L).

Chemical components of the test strip sensor

• FAD glucose dehydrogenase 6%

• Potassium ferricyanide

56%

• Non-reactive components

38%

Содержание GL 44

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

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 41: ...Beurer GL44 41...

Страница 42: ...42 Beurer GL44...

Страница 43: ......

Страница 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...

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