Beurer GL 50 Pure White mgl/dL Blood Glucose Monitor Instructions for Use PDF

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Summary of Content for Beurer GL 50 Pure White mgl/dL Blood Glucose Monitor Instructions for Use PDF

3-IN-1 BLOOD GLUCOSE MONITOR Step by step

GL 50 EN

2 Beurer GL50

1 Getting to know your device ................................................................................................3 1.1 Delivery scope, replacements and accessories .....................................................................4 1.2 Replacements .........................................................................................................................5 1.3 Functions of the device ..........................................................................................................5 1.4 Signs and symbols .................................................................................................................6

2 Warnings and safety notes ...................................................................................................7

3 Description of device and accessories...........................................................................10 3.1 Blood glucose monitor .........................................................................................................10 3.2 Lancing device and lancet needles ......................................................................................10 3.3 USB cover ............................................................................................................................11 3.4 Display symbols ...................................................................................................................11 3.5 test strips ..............................................................................................................................12

4 Initial use and basic settings .............................................................................................13 4.1 Removing the battery insulation strips, replacing the batteries ...........................................13 4.2 Adjusting basic settings .......................................................................................................14

5 Taking measurements..........................................................................................................15 5.1 Preparing to take a blood sample .........................................................................................15 5.2 Preparing the lancing device for taking a sample .................................................................16 5.3 Taking a blood sample and measuring the glucose level .....................................................17 5.4 Reading the result and labelling measurements ...................................................................19 5.5. Post-processing and disposal .............................................................................................20 5.6 Evaluating measured blood glucose values .........................................................................21 5.7 Functional check using control solution ...............................................................................23

6 Measurement memory ........................................................................................................26 6.1 Displaying individual values ..................................................................................................26 6.2 Displaying average blood glucose values ............................................................................27 6.3 Displaying average blood glucose values for labelled values ..............................................27 6.4 Evaluating measured values on a PC ...................................................................................29

7 Storing, maintaining and disinfecting the device ........................................................30 7.1 Maintenance ........................................................................................................................30 7.2 Disinfection ...........................................................................................................................30

8 Troubleshooting .....................................................................................................................31

9 Technical specifications .....................................................................................................33

10 Comparison of measured values with laboratory values ..........................................34

11 Usage limits for specialist personnel from the healthcare sector ..........................36

12 Warranty and customer service ........................................................................................38

Contents

Beurer GL50 3

1 GettinG 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 temperature, pulse, gentle therapy, massage and indoor air quality. Please read these instructions 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.

Getting to know your device The GL50 blood glucose measuring system is intended for fast and simple blood glucose measurement of fresh whole-blood 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 display the average of all measured values, thereby providing optimum assistance for monitoring your diabetes. Testing is exclusively performed externally (IVD). The backlit display shows measured values clearly. The user-friendly design with handy test strips, and simple controls with just a small number of buttons guarantee clear yet reliable measurements. The device can be directly connected to a PC using the integrated USB connection. You can evaluate the measured values on your PC using special software (in English and German language) and use the results to monitor your blood glucose values.

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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. In case of any doubt, do not use the device and contact your retailer or the specified Customer Service address.

A 3-in-1 monitor: lancing device, plug-in USB and monitor

B USB cover

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

These instructions for use, additional information

The blood glucose monitor (A), test strips (C) and additionally available control solutions have been specially designed to complement each other. For this reason, use only test strips (C) and control solutions that have been approved for this blood glucose monitor (A).

Note

Use original manufacturer accessories only.

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1.2 Replacements You can also obtain test strips, control solution and lancets without a prescription.

Item REF

50 test strips REF 464.15

50 test strips, individually film packed REF 464.17

100 test strips REF 464.13

Control solution LEVEL 3 and 4 REF 464.16

100 33G soft-touch lancets REF 457.24

100 28G lancet needles REF 457.01

100 safety lancets REF 457.41

200 safety lancets REF 457.42

1.3 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. The monitor enables you to quickly and simply: Measure your blood glucose level Display, labelled and save measured values Display the average measured blood glucose value for the last 7, 14, 30 and 90 days Display the average of the labelled measured blood glucose values for the last 7, 14, 30 and 90 days Set the time and date. Evaluate the saved measured values on a PC using special software. The monitor also includes the following monitoring functions: Warning in the event of unsuitable temperatures Battery replacement display when batteries are low Warning that test strip is insufficiently filled

Warning

Do not use the device to diagnose diabetes; it is only intended for regular monitoring. Consult your GP about insulin dosage.

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1.4 Signs and symbols 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 restrictions +2C to +30C

Green dot (Der Grne Punkt): German dual waste collection system

Not for reuse/for single use only Contents sufficient for tests

Use by / Art.-Nr.

Order number

18 M

Maximum shelf life after initial opening in months

Unit of measurement for blood glucose value

LOT Batch designation Biohazard, risk of infection

Warning, see accompanying documents Sterilised by radiation (lancets)

Medical device (MDR Symbol)

CE labelling This product satisfies the requirements of the applicable European and national directives.

In the instructions for use, the symbols represent the following:

Warning

Warning instruction indicating a risk of injury or damage to your health/your patients health.

Important

Safety note indicating possible damage to the device/accessory.

Note

Note on important information.

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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 infection.

Warning

Blood glucose values are displayed in mg/dL or mmol/L. You risk damaging your health if you measure your blood glucose value using a unit of measurement with which you are not familiar, misinterpret the values and consequently take incorrect measures. Therefore, please ensure that this monitor displays a unit of measurement with which you are familiar. The unit of measurement accompanies each blood glucose value. Please contact Customer Services if the device displays the incorrect unit of measurement.

When using the monitor for multiple persons, observe the generally applicable regulations regarding disinfection, safety and contamination.

Medical carers and others who use this system on multiple patients must be aware that all products or objects that come into contact with human blood must be handled as though they could transfer pathogens, even after cleaning.

The lancing device is suitable for self-testing. Do not share the lancing device or lancet needles with others or among multiple patients (risk of infection!).

Use a new, sterile lancet needle for each blood sample (for single use only).

General notes

Warning

Do not use the device in the vicinity of strong electromagnetic fields and keep it away from radio systems or mobile telephones.

Measuring the blood glucose content

Warning

The measurements taken by you are for your information only they are not a substitute for a medical examination! Consult your GP regularly regarding your measured values. Never alter the procedures prescribed by your GP of your own accord.

The Beurer GL50 monitor provides a simple way of monitoring your own blood glucose levels, however you may need to obtain information on how to use the system from your healthcare professional (for example, your GP, chemist or diabetes consultant). Only proper use guarantees exact measurements.

This device may be used by people with reduced mental capabilities provided that they are supervised 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 from perspiration, frequent passing of water severe hypotension (low blood pressure), shock or hyperosmolar hyperglycaemic non-ketotic coma (HHNKC) may lead to incorrect measurements.

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A haematocrit value (proportion of red blood cells) between 30% and 55% has no significant influence on the measurement results.

A very high or low haematocrit value (proportion of red blood cells) may lead to incorrect measurements. In the event of a very high haematocrit value (above 55%), the displayed blood glucose value may be too low; in the event of a very low haematocrit value (below 30%), it may be too high. Consult your GP if you do not know your haematocrit value.

Do not use the test strips to measure blood glucose values of newborns. Do not use NaF or potassium oxalate anticoagulants to prepare for venous blood samples. Do not test any severely ill patients using this device. Use fresh capillary 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 this may lead to an incorrect measurement. Do not use the test strips at altitudes above 7,010 metres. Very high levels of humidity may influence the test results. Relative humidity of more than 90% may

lead to inaccurate results.

Note

The Beurer GL50 measuring system is intended for measuring capillary and venous whole blood.

Storage and maintenance

Warning

Store the monitor and its accessories out of the reach of small children and pets. Small parts such as lancet needles, batteries or test strips may be life-threatening if swallowed. If swallowed, seek medical attention immediately.

The test strip box contains desiccant, which may irritate the skin or eyes when inhaled or swallowed. Keep the box out of the reach of children.

The monitor is made from precision and electronic components. The accuracy of the measured values and service life of the device depend on its careful handling: Protect the device and its accessories from impact, humidity, dirt, significant temperature fluctuations

and direct sunlight. Do not store the device, test strips or control solution in your vehicle, in the bathroom or in a cooling appliance.

Do not drop the device.

Batteries / Saving measured values

Notes on handling batteries

If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.

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. Protect the batteries from excessive heat.

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Risk of explosion! Do not throw batteries into a fire. Do not charge or short-circuit batteries. If the device is not to be used for a relatively long period, take the batteries out of the battery

compartment. Use identical or equivalent battery types together only. Always replace all batteries at the same time. Do not use rechargeable batteries! Do not disassemble, open or crush the batteries.

Note

The stored blood glucose 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. Failure to comply with this instruction will void the warranty. Do not repair the device yourself. Proper operation can no longer be guaranteed in this case. Please contact Customer Services for repairs.

Disposal

Warning

It is essential to comply with the generally applicable safety precautions for handling blood when disposing of materials from the monitor. 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.

Note

Batteries must not be disposed of with household waste. As a consumer, you are required by law to recycle used batteries. You can recycle your old batteries at public collection points in your community or wherever batteries of the relevant type are sold. 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. Dispose of the device at a suitable local collection 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 authorities responsible for waste disposal.

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3 description of device and accessories

3.1 Blood glucose monitor Monitor overview

1 Lancing device 2 Plug-in USB 3 Monitor

Front Rear

1 On/Off button 2 Display 3 Rocker switch 4 Test strip slot

1 Battery cover

3.2 Lancing device and lancet needles 1 Cap 2 Protective lancet disc 3 Sterile lancet needle 4 Lancet holder 5 Dial for setting different piercing depths 6 Tensioning slider 7 Trigger 1

2 3 4 5 6 7

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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.

3.4 Display symbols

1 Speaker symbol 2 Temperature symbol 3 Replace battery symbol 4 Time 5 Date 6 Measured value display, HI, LO display,

average blood glucose value, ERR, USB 7 Symbols for labelling measurements 8 Memory symbol 9 Test strip and blood droplet symbol 10 Blood glucose unit mg/dL 11 Blood glucose unit mmol/L

Note

To read the measured values correctly, the underline must be below the measured values.

Note

The monitor is supplied with the following basic settings: Acoustic signal on Backlighting on

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.

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3.5 test strips Front Rear

1

2

3

1 Gap for blood input 2 Grip area 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

Carefully read the following information on handling and storing your test strips. The test strips will only provide accurate measurements if all information is followed.

Warning

Use each test strip only once and only for one patient!

Handling test strips

Note

Securely close the test strip box immediately after taking out a test strip. Do not use the test strips if they have expired. The use of expired test strips may lead to incorrect

measurements. The expiry date is located next to the hourglass symbol on the box or on the respective film packaging of the individual test strips.

The test strips expire 18 months after the box is opened; note down the expiry date (date of opening plus 18 months 18 M ) on the label. In the event of overlap, 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 the film packaging.

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Discontinue use of the test strips if one of the two expiry dates ( / 18 M ) 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/film packaging. Do not bend, cut or otherwise modify the test strips. Do not use test strips that have come into contact with fluids.

Storing test strips

Note

Keep the test strips in a cool, dry place above +2C and below +30C. Do not expose the test strips to direct sunlight or heat. Do not store in your vehicle, in the bathroom or in a cooling appliance.

Permitted relative air humidity below 90%. The test strips must be stored in the original box/unopened film packaging never use other

containers.

4 initial use and basic settinGs

4.1 Removing the battery insulation strips, 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.

1 Carefully pull the lancing device and monitor apart.

2 Remove the battery compartment lid on the underside of the device. To do so, slide the cover in the direction of the imprinted arrow.

3 When replacing the batteries, remove all batteries. The device retains the date and time as long as one battery is still inserted. If applicable, reset the date and time (see 4.2 Adjusting basic settings on page 14).

CR2032

CR2032

4 Insert two new CR 2032 3 V batteries. Make sure that the batteries are inserted the correct way round in accordance with the markings. Observe the graphic in the battery compartment.

5 Close the battery compartment lid again carefully.

6 Fit the lancing device and monitor back together.

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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 are possible.

4.2 Adjusting basic settings

1 Remove the batteries and reinsert them. Alternatively, press and hold the + button and the On/Off button for a minimum of 5 seconds. An acoustic signal sounds. The year display flashes.

2 Setting the date and time

Note

You must set the date and time, otherwise, you will not be able to save your measured values correctly with a date and time and access them again later.

The time is displayed in the 24-hour format. Set the year (calendar to 2099) by pressing the + or button. Confirm by pressing the On/Off button. The day display flashes. Proceed as described above for the day, month, hour and minute. and are displayed. The background of the display is simultaneously illuminated for a few seconds.

3 Switching backlighting on/off To switch the blue backlighting off, press the + or button. and are displayed. Confirm by pressing the On/Off button. , and the speaker symbol are displayed.

4 Switching the acoustic signal on/off To switch the acoustic signal off, press the + or . and are displayed. The speaker symbol is no longer shown in the display. Confirm by pressing the On/Off button.

5 The monitor is now ready for use.

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5 takinG measurements

Warning

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

lancet.

Important

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 accompanying instructions for use.

5.1 Preparing to take a blood sample

1 Choose a part of the body from which to take a blood sample The lancing device is intended for taking blood samples from the fingertip or other body parts such as the palm of the hand, forearm or upper arm. We recommend taking blood samples from the fingertip. To make the procedure as painless as possible, do not take samples directly from the centre of the fingertip, but slightly to either side.

Warning

In the event of suspected hypoglycaemia: take blood from the fingertip only. Reason: changes to blood glucose levels can be quickly detected in blood samples taken from the fingertip.

2 Prepare all parts Prepare the following items: GL50 measuring device (A), test strip box or test strips in film packaging (C) and sterile lancet needles (D).

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.

Warning

If you have used alcohol for cleaning, ensure that the area has fully dried prior to measuring.

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5.2 Preparing the lancing device for taking a sample

1 Remove the cap Hold the monitor with the lancing device cover in one hand. With your other hand, remove the cap from the monitors lancing device.

2 Insert the lancet needle Insert a sterile lancet needle into the lancing device.

Note

Your starter set contains lancet needles in 2 different sizes. If you are unable to take an adequate blood sample using the smaller needles (purple, 33G), please use the slightly larger needles (blue, 28G).

Push it firmly onto the lancet until it audibly engages and cannot be pushed further into the holder.

3 Remove the protective lancet disc Remove the protective lancet disc by turning it to a horizontal position. Retain the protective disc for the safe disposal of the used lancet nee- dle after taking a blood sample.

4 Replace cap Place the cap onto the lancing device. Make sure that the curved part of the cap fits on the curved part of the lancing device. Press firmly on the cap until it audibly engages.

5 Select the piercing depth You can set seven different piercing depths on the lancing device using the dial with raised bars. The length of the bar represents the required penetration depth. 1 to 2: soft or thin skin 3 to 5: normal skin 6 to 7: thick or calloused skin Turn the dial until the required bar is in the centre of the black marking.

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6 Tension the lancing device Pull the slider back in the direction of the arrow (on the image: to the right) until it stops and then release. The slider automatically springs back into position. The lancing device is now tensioned.

5.3 Taking a blood sample and measuring the glucose level

Warning

Change the puncture area each time you take a measurement, e.g. using 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 droplet of blood. If squeezed, the blood is diluted with

tissue fluid and this may lead to an incorrect measurement. Please note that insufficient blood circulation at the puncture area, e.g. caused by cold temperatures

or illness, can lead to incorrect results.

Important

Do not apply any blood samples or control solutions to the test strip before inserting it in the monitor.

1 Prepare the test strip Take a test strip from the box/film packaging and immediately close it again. Use the test strip within three minutes of removal.

2 Insert test strip Take the monitor in your left hand. Hold the blood glucose monitor so that the display is facing you and the Beurer logo is on the right-hand side.

Insert the test strip contacts-first into the slot on the rear end of the blood glucose monitor. Make sure that the front of the test strip is facing you. You can touch any part of the test strip with clean, dry hands.

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3 The device switches on automatically The device switches on automatically and briefly shows all information indicators on the display. The device is ready for use as soon as the test strip symbol and the flashing blood droplet symbol are displayed.

Important

If parts of the display are missing, stop using the device and immediately contact customer services. To test whether all information indicators are displayed, pull the test strip out of the device and hold the On/Off button when subsequently switching on the device.

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 does 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 in diameter, original size: ) is required.

Please also 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 measurement that was carried out

using blood taken from an alternative area. Carry out another test with blood from your fingertip in order to confirm the test result.

If you frequently fail to notice that you have a low blood glucose level, carry out a test using blood from your fingertip.

5 If necessary, repeat the process If you do not obtain sufficient blood, repeat the lancing process in a different area, with increased piercing depth.

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6 Applying blood to the test strip Turn the monitor 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 part of the body) to the test strip. The blood must not be spread. The blood is sucked into the gap.

Note

Error message Err 002 appears on the display if the gap was not correctly and sufficiently filled with blood. Repeat the measurement using a new test strip and an increased piercing depth.

OK

OK

Note

Do not apply blood to the sides of the test strips. Do not add blood later if the device does not start the measurement. Remove the test strip and

end this test. Use a new test strip. If the test strip has already been inserted into the device but no blood is added to the test strip

within 2 minutes, the device switches itself off. 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.

5.4 Reading the result and labelling measurements Reading the result Hold the blood glucose monitor so that the display is facing you (Beurer logo on the right-hand side). As soon as the blood input gap is filled with sufficient blood, the device performs the blood glucose measurement. The monitor counts down for approx. 5 seconds. The measurement is then shown on the display.

Read your measured value. Check again that you have read the result correctly. The underline must be below the measured value, otherwise you need to turn the monitor by 180. For explanations of and actions relating to the measured values, see 5.6 Evaluating measured blood glucose values on page 21. If an error message is displayed, read chapter 8. Troubleshooting on page 31.

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Labelling the measurement You have the following options for labelling measured values:

Before meal

After meal

General labelling (e.g. after exercising).

Labelling measured values enables you, your GP or your 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 do this, proceed as follows:

1 The measured value can be labelled as soon as it is displayed. Once the value disappears from the display, it can no longer be labelled.

2 Press the "" rocker switch repeatedly. Pressing once adds the label Before meals. Pressing again adds the label After meals. Pressing a third time adds the label General label. Pressing a fourth time removes the label.

3 The selected label is stored in the memory of the device when it is switched off.

5.5. Post-processing and disposal

1 Remove test strip Remove the test strip from the device and carefully dispose of it in accordance with the applicable regulations to avoid infecting others.

2 Remove the cap Carefully remove the cap from the lancing device.

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3 Affix protective disc to 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).

Image 1 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. This prevents injuries and the infection of others.

5 Replace cap Place the cap back on the device.

5.6 Evaluating measured blood glucose values Your blood glucose monitor can process measured values between 20 and 630 mg/dL (1.1 and 35.0 mmol/L). The warning is displayed for measured values below 20 mg/dL (1.1 mmol/L). The warning is displayed for measured values above 630 mg/dL (35.0 mmol/L).

Warning

If you suspect that the blood glucose results are incorrect, first repeat the test and, if applicable, perform a functional test using control solution. Seek medical advice if dubious results persist.

Seek medical attention immediately if your symptoms do not correspond to your measured blood glucose values and you have followed all instructions for the Beurer GL50 blood glucose measuring system.

Do not ignore symptoms of too high/low blood glucose levels. Always seek medical attention!

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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 measurement

Normal blood glucose values

Increased risk of diabetes (prediabetes)*

If you have diabetes

On an empty stomach (fasting plasma glucose)

Below 100 mg/dL Below 5.6 mmol/L

100125 mg/dL 5.6 6.9 mmol/L

126 mg/dL 7.0 mmol/L

Two hours after an oral glucose tolerance test (consumption of 75 g)

Below 140 mg/dL Below 7.8 mmol/L

140199 mg/dL 7.8 11.0 mmol/L

200 mg/dL 11.1 mmol/L

*  The risk increases continually, beginning with values below the lower limit of the range and increasing disproportionately towards the upper limit of the range.

Overview of glycaemic recommendations for non-pregnant adults with diabetes

A1C < 7.0%* < 53 mmol/L*

Preprandial capillary plasma glucose 80130 mg/dL* 4.47.2 mmol/L*

Peak value of postprandial capillary plasma glucose**

< 180 mg/dL* 10.0 mmol/L*

*  For individual patients, more or less strict glycaemic targets may be appropriate. The target values should be adjusted depending on the length of time the person has had diabetes, age/life expectancy, accompanying diseases, known cardiovascular diseases or advanced microvascular complications, hypoglycaemia unawareness, as well as individual patient considerations.

**  The postprandial glucose value can serve as a target value if the A1C values are not met despite the preprandial glucose targets having been reached. Postprandial blood glucose measurements should be taken one to two hours after the start of a meal, as this is when diabetics values are generally highest.

Critical blood glucose values

Display Blood glucose Action

Very low blood glucose level

under 20 mg/dL (under 1.1 mmol/L)

Immediately seek medical attention.

Low blood glucose level

under 70 mg/dL (under 3.9 mmol/L)

Have a suitable snack. Follow your GPs instructions.

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Display Blood glucose Action

High blood glucose level on an empty stomach, above 100 mg/dL (5.6 mmol/L)

2 hours after a meal over 140 mg/dL (7.8 mmol/L)

If this high value persists 2 hours after your last meal, this may indicate hyperglycaemia (high blood glucose). Seek medical attention to coordinate any measures, if applicable.

High blood glucose level, possibly ketones

over 240 mg/dL (13.3 mmol/L)

Conduct ketone test For this purpose, seek medical attention.

Very high blood glucose level

over 630 mg/dL (35.0 mmol/L)

Take another measurement using a new test strip. If the display is the same as before: seek medical assistance immediately.

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. Also test the monitor if it has been dropped or is damaged. Control solution is available separately. For the control solution test, please observe the additional notes in the instructions for use for the control solution.

Important

Do not use third-party control solution. Correct functioning of your monitor can only be tested using Beurer LEVEL 3 + LEVEL 4 control solutions.

Control solution measurements: when using the device, specialist personnel must follow statutory guidelines.

Do not apply any blood samples or control solutions to the test strip before inserting it in the monitor.

Performing a functional test using control solution

Warning

To obtain correct results, the measuring device, the test strip and the control solution must be the same temperature. For the Functional test using the control solution, the temperature must be between 20 C and 26 C.

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1 Insert test strip Hold the monitor so that the display is facing you. Insert a test strip, contacts-first into the slot on the monitor. Make sure that the front of the test strip is facing you (see 3.4 Test strips on page 12).

2 Wait until the device is ready for use The device automatically switches on and briefly shows the initial display. The device is ready for use as soon as the test strip symbol and the flashing blood droplet symbol are displayed.

IMPORTANT: Control solutions and blood react to temperature influences in different 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 target range.

3 Activate control mode Press the rocker switch (+ or ) to change to control mode. is shown on the display. In control mode, the measured value is not saved, meaning your statistics will not be affected. However, if you do want to save the control measurement in the memory, press the rocker switch (+ or ) again. disappears from the display.

4 Drip control solution onto surface Choose a clean surface to carry out the functional test correctly. Shake the control solution well before use. Undo the cap and squeeze 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.

5 Apply drop to the test strip Hold the input gap (at the tip of the test strip) to the drop of control solution until the gap is completely filled. When the gap is sufficiently filled with solution, the device performs a measurement. The device counts down for approx. 5 seconds. The measurement is then shown on the display.

6 Evaluate result of functional test Check whether the result is within the specified range of results for the control solution. This range of results is printed on the test strip box or the test strip packaging or on the information sheet included.

Beurer GL50 25

Expected results At room temperature, the measurements from the test using the control solution should be within the range printed on the test strip box or on the information sheet included with the test strips in film packaging in approx. 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. If measurements are outside the specified range, check the following possible causes:

Cause Action

The first drop of control solution was not disposed of.

The tip of the bottle was not cleaned correctly. The bottle was not shaken well enough.

Rectify the cause and repeat the test.

Control solution or test strip is contaminated. Repeat the test using a new bottle of control solution and/or new test strip.

The control solution, test strip or blood glucose monitor is too warm or too cold.

Bring the control solution, test strip and monitor to room temperature (+20 C to +26 C) and repeat the test. 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.

The test strips and control solution were kept at a temperature and humidity outside the specified range.

Repeat the test using new, correctly stored accessories (test strips and control solution).

Damaged test strips. Possible causes include Test strips were exposed to fresh air for too

long. Test strip box was not closed completely. Film packaging was already opened or

damaged.

Repeat the test using a new test strip and/or correctly stored test strips from a new box or new film packaging.

Test strip or control solution has expired. Repeat the test using a new bottle of control solution and/or new test strip from a new box or new film packaging.

Functional test using control solution was performed incorrectly.

Repeat the test and follow the instructions.

Problem with the blood glucose monitor Contact Customer Services.

26 Beurer GL50

Warning

If you repeatedly obtain measured values outside the specified range when using control solution, discontinue using the system to measure your blood glucose level. Contact Customer Services.

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 blood glucose value for the last 7, 14, 30 and 90days.

Note

If you have already saved measured values and you reset the date, the average values are calculated from the new period.

--- indicates an empty memory for measured values. Press the On/Off button to switch off the device.

6.1 Displaying individual values The individual values from the last 480 measurements are displayed. The most recent measured value is displayed first, and the oldest last. The date and time are also displayed on the monitor at the same time.

1 Switch the monitor on using the On/Off button [1]. The initial display is shown briefly. Press the + or rocker switch [3].

2 Mem and the number of saved blood glucose tests are displayed briefly (Image 1). The display then changes to the most recent saved value including the measurement unit, date, time, Mem and any label (Image 2).

Image 1

Image 2

Beurer GL50 27

3 Each time you press the rocker switch again, first the memory space number will be displayed and then the relevant measured value. You can display a maximum of 480 previous measurements.

4 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.

6.2 Displaying average blood glucose values You can display the average measured blood glucose value for 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 [3] twice. 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.

3 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.

1 Number of days, e.g. 7, for which the average value is calculated 2 Number of saved values used to calculate the average, e.g. 8 3 Average value

6.3 Displaying average blood glucose values for labelled values You can display the average measured blood glucose value for labelled values for 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 [3] twice. The measurement unit of the blood glucose value, and the average of all measured values are displayed (this means: 07 = 7, d = days).

28 Beurer GL50

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 7-day average for values measured before meals the symbol, the unit of measurement for blood glucose values and are shown on the display.

Press + repeatedly to display the average blood glucose value for the last 14, 30 and 90 days for values measured before meals .

After displaying the average value for 90 days before meals the 7-day average for values measured After meals the symbol, the unit of measurement for blood glucose values and are shown on the display.

Press + repeatedly to display the average value for 14, 30 and 90 days after meals .

Beurer GL50 29

2 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 + repeatedly to display the average blood glucose value from the last 14, 30 and 90 days for values labelled as general .

3 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.

6.4 Evaluating measured values on a PC The GL50 monitor features an integrated plug-in USB stick. GlucoMemory blood glucose evaluation software is installed on the USB stick (for position of the USB connection, see page 10). The GL50 is compatible with Diabass and SiDiary. GlucoMemory blood glucose evaluation software is pre-installed on the monitors USB stick. You do not need to install the software locally on a PC. This software enables you to evaluate your saved measured values, add insulin doses with manual entries and print or export your results as a PDF or CSV file. The software helps you and your GP to better monitor your blood glucose level. For more information, please read the software manual for the GlucoMemory software, including all the necessary information and a detailed description of how to use the software (in English and German language).

Note

An effective evaluation is only possible if you have set the date and time correctly (see Setting the date and time on page 14).

Measurements cannot be taken while the USB stick is connected to a PC. The measurements remain saved on the blood glucose monitor when the USB stick is removed from

the PC. It is not possible to save software entries on the USB stick. Values are read-only.

30 Beurer GL50

Evaluating measured values on the PC

1 The monitor must be switched off. Insert the monitors 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 port.

2 is shown on the display of the monitor. Saved data can now be viewed on your PC.

3 See the information on evaluating values in the software manual.

7 storinG, maintaininG and disinfectinG the device

Storing Keep the Beurer GL50 blood glucose monitor in the case supplied after each measurement and do not expose it to direct sunlight.

Note

Do not store the device, test strips or control solution in your vehicle, in the bathroom or in a cooling appliance, if this would not comply with the storage conditions specified.

Retain these instructions for use. Remove the batteries if you do not intend to use the device for a prolonged period of time. Only clean the device when it is switched off.

7.1 Maintenance Clean the surface of the device using a soft, slightly damp cloth (water or a mild cleaning solution). Dry the device using a lint-free cloth. Make sure that moisture does not enter the test strip insertion slot. Do not spray cleaning products directly onto the device. Do not submerge the device in water or any other fluids and make sure that no fluids can get into the device.

7.2 Disinfection Please comply with the generally applicable guidelines on disinfection when using the device on different persons. Do not submerge the device in disinfection solutions or any other fluids and make sure that no fluids can enter the device.

The cap on the integrated lancing device can be disinfected with 7075% alcohol. Disinfect the cap at least 1 x a week and submerge the cap in alcohol for approx. 10 minutes. Allow the cap to air dry.

Beurer GL50 31

Note

The monitor is made from precision components. The accuracy of the measurements and service life of the device depend on its careful handling: Protect the device from impact 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. If the device is used in a dry environment, in particular near synthetic materials (clothes containing

synthetic fibres and carpets, for example), the damaging static discharges which occur may cause erroneous results.

Do not use the device near sources of strong electromagnetic radiation, as this may affect normal operation.

It is a advisable to conduct an assessment of the electromagnetic environment before using the device commercially.

8 troubleshootinG

Display messages on batteries and blood glucose measurement

No. Cause Solution

LP Batteries empty. Replace all batteries.

Ht Temperature of the measuring environment, blood glucose monitor or test strip above the permitted range.

Repeat the test using a new test strip as soon as the measuring environment, monitor 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 specifications is valid without restriction.

Lt Temperature of the measuring environment, blood glucose monitor or test strip below the permitted range.

Repeat the test using a new test strip as soon as the measuring environment, monitor 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 specifications is valid without restriction.

Err Used or contaminated test strip inserted.

Insert an unused test strip that has not expired. Repeat the blood glucose measurement.

Err 001 System error. Remove batteries, reinsert batteries. Should the problem persist, contact Customer Services.

32 Beurer GL50

No. Cause Solution

Err 002 Insufficient amount of blood on the test strip.

Repeat the measurement using a new test strip.

Err 005 System error. Remove batteries, reinsert batteries. Should the problem persist, contact Customer Services.

Unknown error messages. Remove batteries, reinsert batteries. Should the problem persist, contact Customer Services.

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 13).

Test strip inserted incorrectly or not completely. Firmly insert the test strip, contacts-first into the slot on the device. Make sure that the front of the test strip is facing you (see Test strips on page 12).

Device faulty. Contact Customer Services.

Problem: The test does not start after inserting the test strip into the device and applying blood

Cause Solution

Insufficient blood or test strip not filled correctly. Repeat test using a new test strip and a larger drop of blood.

Faulty test strip. Repeat the test using a new test strip.

Blood was applied while the device was switched off.

Repeat the test using a new test strip and only apply blood when flashes.

The basic settings of the device have been changed and these changes were not completed (see 4.2 Adjusting basic settings on page 14).

Remove the test strip and press the On/Off button repeatedly until is displayed. Repeat test.

Device faulty. Contact Customer Services.

Beurer GL50 33

9 technical specifications

Dimensions (L x W x H) 123 x 28 x 16 mm Weight 36 g (including batteries) Power supply 2 x 3 V CR 2032 button cell batteries Battery life Over 1,000 measurements Measured value memory 480 measured values with date/time

Data retained when batteries are changed Average values for 7, 14, 30, 90 days Automatic switch-off 2 minutes after last actuation Storage/ transport temperature

Temperature: +2 C to +30 C Relative humidity: < 90%

Operating ranges Temperature: +10C to +40C Relative humidity: < 90% non-condensing

Measurement range, glucose Glucose: 20630 mg/dL (1.135.0 mmol/L) Blood sample Capillary whole blood, venous whole blood Required volume of blood 0.6 microlitres Blood glucose measurement duration Approx. 5 seconds Calibration Plasma Testing method Amperometric bio sensor Usage 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 communication 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 (capillary or venous). When the gap for taking blood comes into contact with a drop of blood, it is automatically filled by a simple capillary action. The blood is sucked into the absorbing gap on the test strip and the monitor measures the glucose level in the blood.

34 Beurer GL50

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 measurement takes approx. 5 seconds. The test strip detects 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%

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. However, control solution is used instead of blood. The measurement using control solution must be within the result range. This value range is printed on every test strip box and/or on the information sheet included with the test strips in film packaging.

Chemical composition of the control solution The control solution is a red solution with the following D-glucose level (in percentage shares).

Ingredients Control solution LEVEL 3 Control solution LEVEL 4 D-glucose 0.14% 0.37% Non-reactive components 99.86% 99.63% Standards

The Beurer GL50 blood glucose monitor complies with the European standards: IVD (98/79/EC) and MDD (93/42/EC).

10 comparison of measured values with laboratory values

Precision Three lots of the GL50 blood glucose test strips have been tested to assess the precision of the GL50 blood glucose measuring system. This includes a repeat assessment using venous blood and a laboratory precision assessment using the control material. The blood glucose content of the venous blood samples ranges from 46.1 to 433.5 mg/dL (2.6 to 24.1 mmol/L) and control material from three concentrations is used.

Beurer GL50 35

Results of the repeat precision measurements

Sample Venous blood Grand mean value Pooled standard deviation

Pooled coefficient of variation (%)

mg/dL mmol/L mg/dL mmol/L mg/dL mmol/L

1 46.1 2.6 51.2 2.8 3.1 0.2 6.1

2 79.5 4.4 85.1 4.7 3.9 0.2 4.6

3 126.8 7.0 130.1 7.2 4.9 0.3 3.8

4 220.5 12.3 221.2 12.3 8.6 0.5 3.9

5 295.0 16.4 293.4 16.3 9.9 0.5 3.4

6 433.5 24.1 448.2 24.9 12.5 0.7 2.8

Results of the intermediate precision measurement

Sample Grand mean value of the control material

Pooled standard deviation Pooled coefficient of variation (%)mg/dL mmol/L mg/dL mmol/L

1 76.6 4.3 2.1 0.1 2.7

2 134.0 7.4 2.5 0.1 1.9

3 338.1 18.8 8.1 0.4 2.4

System accuracy The GL50 blood glucose monitor in comparison to the YSI. Three lots of GL50 blood glucose test strips have been tested to assess the system accuracy of the GL50 blood glucose measuring system and to compare it with the reference method in which capillary whole blood concentrations of 32.4 to 511.8 mg/dL (1.8 to 28.4 mmol/L) have been used.

Results of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L)

Within 5 mg/dL (Within 0.28 mmol/L)

Within 10 mg/dL (Within 0.56 mmol/L)

Within 15 mg/dL (Within 0.83 mmol/L)

121/204 (59.3%) 183/204 (89.7%) 201/204 (98.5%)

Results of the system accuracy for glucose concentrations 100 mg/dL (5.55 mmol/L)

Within 5% Within 10% Within 15%

242/474 (51.5%) 404/474 (85.2%) 462/474 (97.5%)

36 Beurer GL50

Results of the system accuracy for combined glucose concentrations between 32.4 mg/dL (1.8 mmol/L) and 511.8 mg/dL (28.4 mmol/L).

Within 15 mg/dL or 15% (within 0.83 mmol/L or 15%)

663/678 (97.8%)

In comparison to the YSI, the GL50 met the EN ISO 15197:2015 standard, wherein 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 value when using the reference measuring procedure for blood glucose concentrations <100 mg/dL (<5.55 mmol/L) or 15% for blood glucose concentrations of 100 mg/dL (5.55 mmol/L). 99% of the individual measured blood glucose values must fall within zones A and B of the Consensus Error Grid (CEG) for diabetes type 1.

Performance evaluation by the user A study to assess the glucose values of blood samples of capillary blood from the fingertips, which were obtained from 113 individuals that had no special training, produced the following results: 97.1% within 15 mg/dL (0.83 mmol/L) and 95.6% within 15% of the values obtained in the medical laboratory with glucose concentrations of at least 100 mg/dL (5.55 mmol/L).

You will find further details and information regarding blood glucose results and various technologies in generally relevant specialist medical literature.

11 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 (13 mmol/L) and triglyceride levels up to

1000 mg/dL (11.4 mmol/L) do not influence the results. Severely lipaemic blood samples were not tested with the Beurer GL50 blood glucose monitor; 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. The maximum concentrations of certain substances listed below do not significantly influence the measurements.

Beurer GL50 37

Concentration of tested substances

50100 mg/dL (2.85.6 mmol/L)

250-350 mg/dL (13.9-19.4 mmol/L)

Acetaminophen 7 mg/dL (0.46 mmol/L) 6.6 mg/dL (0.37 mmol/L)

4.5%

Ascorbic acid 4 mg/dL (0.23 mmol/L) 3.3 mg/dL (0.18 mmol/L)

5.1%

Bilirubin 3.3 mg/dL (0.06 mmol/L) 0.1 mg/dL (0.01 mmol/L)

-1.4%

Cholesterol 400 mg/dL (10.34 mmol/L) -6.8 mg/dL (-0.38 mmol/L)

-6.2%

Creatinine 30 mg/dL (2.65 mmol/L) 0.0 mg/dL (0.00 mmol/L)

-0.1%

Dopamine 2.2 mg/dL (0.14 mmol/L) 5.0 mg/dL (0.28 mmol/L)

1.0%

EDTA 5.0 mg/dL (0.17 mmol/L) -2.0 mg/dL (-0.11 mmol/L)

-2.4%

Ephedrine 40 mg/dL (2.42 mmol/L) -3.9 mg/dL (-0.22 mmol/L)

2.4%

Galactose 20 mg/dL (1.11 mmol/L) -3.1 mg/dL (-0.17 mmol/L)

0.5%

Gentisic acid 7 mg/dL (0.45 mmol/L) 7.2 mg/dL (0.40 mmol/L)

2.9%

Glutathione 1 mg/dL (0.03 mmol/L) -2.6 mg/dL (-0.14 mmol/L)

-3.7%

Haemoglobin 300 mg/dL (0.05 mmol/L) -3.1 mg/dL (-0.17 mmol/L)

-2.6%

Heparin 2.1 mg/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%

Blood glucose valueInfluence

38 Beurer GL50

Concentration of tested substances

50100 mg/dL (2.85.6 mmol/L)

250-350 mg/dL (13.9-19.4 mmol/L)

L-Dopa 2 mg/dL (0.10 mmol/L) 9.3 mg/dL (0.52 mmol/L)

7.9%

Maltose 278 mg/dL (7.72 mmol/L) -1.53 mg/dL (-0.09 mmol/L)

-2.6%

Methyldopa 4 mg/dL (0.19 mmol/L) 7.3 mg/dL (0.41 mmol/L)

0.9%

Pralidoxime iodide 5 mg/dL (0.14 mmol/L) 1.7 mg/dL (0.09 mmol/L)

-0.1%

Sodium salicylate 40 mg/dL (2.50 mmol/L) -3.1 mg/dL (-0.17 mmol/L)

-0.6%

Salicylic acid 60 mg/dL (4.34 mmol/L) -0.1 mg/dL (-0.01 mmol/L)

7.6%

Tolbutamide 100 mg/dL (3.70 mmol/L) 0.5 mg/dL (0.03 mmol/L)

-0.8%

Tolazamide 2.5 mg/dL (0.08 mmol/L) -2.3 mg/dL (-0.13 mmol/L)

1.8%

Triglyceride 800 mg/dL (9.37 mmol/L) -7.50 mg/dL (-0.42 mmol/L)

-4.0%

Uric acid 16.5 mg/dL (0.98 mmol/L) 6.6 mg/dL (0.37 mmol/L)

1.8%

Xylose 9.5 mg/dL (0.63 mmol/L) 5.6 mg/dL (0.31 mmol/L)

6.6%

12 warranty and customer service

Beurer GmbH, Sflinger Strae 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 conditions below shall not affect the sellers statutory warranty obligations which ensue from the sales agreement with the buyer. The warranty shall apply without prejudice to any mandatory statutory provisions on liability.

Blood glucose valueInfluence

Beurer GL50 39

Beurer guarantees the perfect functionality and completeness of this product.

The worldwide warranty period is 5 years, commencing from the purchase of the new, unused product from the seller.

The warranty only applies to products purchased by the buyer as a consumer and used exclusively for personal purposes in the context of domestic use. German law shall apply.

During the warranty period, should this product prove to be incomplete or defective in functionality in accordance with the following provisions, Beurer shall carry out a repair or a replacement delivery free of charge, in accordance with these warranty conditions.

If the buyer wishes to make a warranty claim, they should approach their local retailer in the first instance: see the attached International Service list of service addresses.

The buyer will then receive further information about the processing of the warranty claim, e.g. where they can send the product and what documentation is required.

A warranty claim shall only be considered if the buyer can provide Beurer, or an authorised Beurer partner, with - a copy of the invoice/purchase receipt, and - the original product.

The following are explicitly excluded from this warranty: - deterioration due to normal use or consumption of the product; - accessories supplied with this product which are worn out or used up through proper use

(e.g. batteries, rechargeable batteries, cuffs, seals, electrodes, light sources, attachments and nebuliser accessories);

- products that are used, cleaned, stored or maintained improperly and/or contrary to the provisions of the instructions for use, as well as products that have been opened, repaired or modified by the buyer or by a service centre not authorised by Beurer;

- damage that arises during transport between manufacturer and customer, or between service centre and customer;

- products purchased 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 liability provisions).

Repairs or an exchange in full do not extend the warranty period under any circumstances.

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GL 50 Beurer GmbH Sflinger Strae 218 89077 Ulm, German

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