Beurer medical GL 50 User manual

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.

4 Beurer GL50
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.
A3-in-1 monitor: lancing device, plug-in USB and monitor
BUSB cover
C10 test strips
D10 sterile lancet needles (5 x 28G blue, 5 x 33G purple)
E2 button cell batteries, 3 V CR2032 (already inserted)
F1 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.

Beurer GL50 5
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 insuciently filled
Warning
•
Do not use the device to diagnose diabetes; it is only intended for regular monitoring.
•
Consult your GP about insulin dosage.

6 Beurer GL50
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
+2°C to +30°C
Green dot (Der Grüne Punkt):
German dual waste collection
system
Not for reuse/for single use only Contents sucient for <n> 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 patient’s health.
Important
Safety note indicating possible damage to the device/accessory.
Note
Note on important information.

Beurer GL50 7
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.

8 Beurer GL50
•
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
T
he 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 aected 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.

Beurer GL50 9
•
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.

10 Beurer GL50
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/O 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 dierent piercing depths
6 Tensioning slider
7 Trigger
123 4567

Beurer GL50 11
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.

12 Beurer GL50
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.

Beurer GL50 13
•
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 +2°C and below +30°C. 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.

14 Beurer GL50
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/O 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/O 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/o
To switch the blue backlighting o, press the “+” or “–” button. “ ” and “ ” are displayed.
Confirm by pressing the On/O button.
“”, “ ” and the speaker symbol are displayed.
4
Switching the acoustic signal on/o
To switch the acoustic signal o, press the
“+” or “–”
.
“” and “ ” are displayed.
The speaker symbol is no longer shown in the display.
Confirm by pressing the On/O button.
5
The monitor is now ready for use.

Beurer GL50 15
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.

16 Beurer GL50
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 monitor’s 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 dierent 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 dierent 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.

Beurer GL50 17
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 dierent 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 insucient 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.

18 Beurer GL50
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/O 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.
P
lease 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 sucient blood, repeat the lancing process in a dierent area, with
increased piercing depth.

Beurer GL50 19
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 suciently 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 o. 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 sucient 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.

20 Beurer GL50
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 o.
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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