Beurer GL44 lean User manual

Instructions for use
EN
Code-free
BLOOD GLUCOSE MONITOR
Step by step
GL44 lean

Beurer GL44 lean 3
Contents
1 Getting to know your device..................................................................................................4
1.1 Scope of delivery and accessories.........................................................................................5
1.2 Replacements.........................................................................................................................6
1.3 Functions of the device ..........................................................................................................6
1.4 Signs and symbols .................................................................................................................6
2 Warnings and safety notes .....................................................................................................8
3 Description of device and accessories ............................................................................11
3.1 Blood glucose monitor .........................................................................................................11
3.2 Lancing device and lancet needles ......................................................................................12
3.3 Display symbols ...................................................................................................................12
3.4 Test strips .............................................................................................................................13
4 Initial use and basic settings ...............................................................................................14
4.1 Removing the battery insulation strip, replacing the batteries .............................................14
4.2 Making and changing basic settings....................................................................................15
5 Taking the blood glucose measurement ..........................................................................15
5.1 Preparing to take a blood sample ........................................................................................16
5.2 Taking a blood sample .........................................................................................................16
5.3 Reading the result and labelling measurements ..................................................................19
5.4. Post-processing and disposal .............................................................................................20
5.5 Evaluating measured blood glucose values .........................................................................20
5.6 Functional check using control solution ...............................................................................22
6 Measurement memory ..........................................................................................................25
6.1 Displaying individual values..................................................................................................25
6.2 Displaying average blood glucose values ............................................................................26
6.3 Displaying average blood glucose values for labelled values ..............................................27
6.4 Reset to basic settings .........................................................................................................29
6.5 Transferring measurements to a PC .....................................................................................29
7 Storing, maintaining and disinfecting the device ..........................................................30
7.1 Cleaning ...............................................................................................................................30
7.2 Disinfection...........................................................................................................................30
8 What if there are problems? ................................................................................................31
9 Technical specifications........................................................................................................33
10 Comparison of measured values with laboratory values..........................................35
11 Usage limits for specialist personnel from the healthcare sector .........................36
12 Warranty and customer service .......................................................................................39

4 Beurer GL44 lean
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 temper-
ature, pulse, gentle therapy, massage and air.
Please read these instructions for use 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 GL44 lean blood glucose monitoring system is intended for fast and simple blood glucose
measurement of fresh capillary 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 dis-
play the average of all measured values, thereby providing optimum assistance for monitoring your
diabetes. The test is performed exclusively externally (IVD).
The large display shows the measured values clearly. The user-friendly design with handy test strips
and the simple controls with just a small number of buttons guarantee simple, yet reliable measure-
ments.
The device can be connected to a PC using the USB cable, which is available as an accessory. You
can evaluate the measured values on your PC using blood glucose diary software and use the results
to monitor your blood glucose values.
Blood glucose diary software is available to download for free at www.beurer.com.

Beurer GL44 lean 5
1.1 Scope of delivery and accessories
Check that the set packaging has not been tampered with and make sure that all contents are present.
Before use, ensure that there is no visible damage to the device or accessories and that all packaging
material has been removed. If you have any doubts, do not use the device and contact your retailer
or the specified Customer Service address.
5
A 1 blood glucose monitor
B1 lancing device
C 10 test strips
D 10 sterile lancet needles (5 x 28G blue, 5 x 33G purple)
E 2 button cell batteries, 3 V CR2032 (already inserted)
F 1 practical case
These instructions for use, additional information
• If the packaging has sustained considerable damage or the contents are incomplete, please return
the system to your retailer.
• The blood glucose monitor, test strips and additionally available control solutions have been spe-
cially designed to complement each other. For this reason, use only test strips and control solutions
that have been approved for this monitor.
Note
• Use original manufacturer accessories only.

6 Beurer GL44 lean
1.2 Replacements
You can also obtain test strips, control solution and lancets without a prescription.
Item REF
50 test strips REF 463.04
Control solution LEVEL 3 and 4 REF 464.16
100 soft touch lancets 33G REF 457.24
100 lancet needles 28G REF 457.01
USB cable REF 164.069
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, label and save measured values
• Display the average measured blood glucose value from the last 7, 14, 30 and 90 days
• Display the average of the labelled measured blood glucose values from the last 7, 14, 30 and 90days
• Set the time and date
• Transfer stored measured values to a PC for evaluation (additional accessories required)
The monitor also includes the following monitoring functions:
• Warning in the event of unsuitable temperatures
• Battery replacement display for low batteries
• Warning that test strip is insuciently filled
Warning
• Do not use the device to diagnose diabetes; it is intended for regular monitoring only.
• Consult your GP with regard to insulin doses.
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 limit
+2°C to +30°C Not for re-use/for single use only
Use by Green dot (Der Grüne Punkt): German dual waste collection
system

Beurer GL44 lean 7
Maximum shelf life after initial
opening in months Contents sucient for <n> tests
Batch designation
/
Art.-Nr. Order number
Sterilised by radiation (lancets) Unit of measurement for blood
glucose value
Warning, see accompanying
documents Biohazard, risk of infection
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.

8 Beurer GL44 lean
2 WARNINGS AND SAFETY NOTES
Risk of infection
All components of the monitor and its accessories may come into contact with human
blood and are therefore a possible source of infection.
Warning
• Blood glucose values are displayed in mg/dL
or mmol/L.
You risk damaging your health if you meas-
ure your blood glucose value using a unit of
measurement with which you are not famil-
iar, misinterpret the values and subsequently
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 measure-
ment.
• When using the monitor for various persons, observe the generally applicable regulations regarding
disinfection, safety and contamination.
• Medical carers and others who use this system on several patients must be aware that all prod-
ucts or objects that come into contact with human blood must be handled, even after cleaning, as
though they could transfer pathogens.
• The lancing device is suitable for self-testing. Never share the lancing device or lancet needles with
others or amongst various 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 no substitute for a medi-
cal examination! Consult your GP regularly regarding your measured values. Never independently
alter the procedures prescribed by your GP.
• Despite the ease of use of the Beurer GL44 lean monitor for self-monitoring blood glucose levels,
you may need to obtain instructions for using the system from your healthcare professional (for
Example

Beurer GL44 lean 9
example, your GP, chemist or diabetes consultant). Only proper use will guarantee exact measure -
ments.
• This device may be used by people with reduced mental capabilities provided that they are super-
vised or have been instructed on how to use the device safely and are fully aware of the consequent
risks of use.
• A lack of water, high fluid loss, for example perspiration, frequent passing of water, severe hypo-
tension (low blood pressure), shock or hyperosmolar hyperglycaemic non-ketotic coma may lead
to incorrect measurements.
• A haematocrit value between 20% and 60% has no significant influence on the measurements.
• A very high or low haematocrit value (proportion of red blood cells) may lead to incorrect meas-
urements. In the event of a very high haematocrit value (above 60%), the displayed blood glucose
value may be too low; in the event of a very low haematocrit value (below 20%), 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 on 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 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 above an altitude of 7010 m.
• Very high levels of humidity may influence the test results. Relative humidity of more than 90% may
lead to inaccurate results.
Note
• The Beurer GL44 lean monitoring 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, parts of the lancing device, batteries or test strips may be life-threatening when
swallowed. If swallowed, seek medical attention immediately.
• The test strip box contains desiccant, which may irritate the skin or eyes when inhaled or swal-
lowed. Keep the box out of the reach of children.
The monitor is made from precision and electronic components. The accuracy of the measured val-
ues and service life of the device depend on its careful handling:
• Protect the device and its accessories from impacts, humidity, dirt, marked temperature fluctua-
tions and direct sunlight. Do not store the device, test strips and control solution in your vehicle,
in the bathroom or in a cooling appliance!
• Do not drop the device.

10 Beurer GL44 lean
Batteries/Saving measured values
Notes on handling batteries
• If your skin or eyes come into contact with battery fluid, rinse the aected area 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 batteries from excessive heat.
• 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 com-
partment.
• Use identical or equivalent battery types 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.
• Do not dismantle the lancing device into individual parts, except in the steps described in these
instructions.
• 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.

Beurer GL44 lean 11
Note
Empty, completely flat batteries must be disposed of through specially designated collection boxes,
recycling points or electronics retailers. You are legally required to dispose of the batteries.
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 service 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.
3 DESCRIPTION OF DEVICE AND ACCESSORIES
3.1 Blood glucose monitor
Front
1
Slot for test strips
2 Display
3 Labelling button
4 On/Obutton
5 PC connection
6 “+ –” rocker switch
Rear
1 Battery compartment
(bottom side)
2 Reset button
1
4
2
3
5
6
reset
CR2032 CR2032
1
2

12 Beurer GL44 lean
3.2 Lancing device and lancet needles
1 Cap
2 Protective lancet disc
3 Sterile lancet needle
4 Lancet holder
5 Lancet ejection
6 Trigger
7 Tensioning device
3.3 Display symbols
1 Date
2 Symbols for labelling measurements
3 Measured value display, HI, LO display,
averageblood glucose value, Err
4 Blood droplet symbol
5 Speaker symbol
6 Hand symbol
7 Test strip symbol
8 Blood glucose unit mmol/L
9 Blood glucose unit mg/dL
10 Battery replacement symbol
11 Memory symbol
12 Temperature symbol
13 Time
Note
The monitor is supplied with the following basic settings:
• Acoustic signal o
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.
6
5
1
2
34
7
5
1
2
3
4
5
68
9
10
11
12
13
7

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3.4 Test strips
Front Rear
3
2
1
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 de-
vice so that the contacts are
pointing inside the slot.
Make sure that the front of the
test strip is facing you.
Note
Read carefully the following information on handling and storing your test strips. The test strips will
only provide accurate measurements if all information is followed.
Warning
Use each test strip only once and for one patient only!
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 re-
spective film packaging of the individual test strips.
• Test strips expire six months after the box is opened. Make a note of the expiry date (opening date
+ 6 months ) on the label. 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.

14 Beurer GL44 lean
• Discontinue use of the test strips if one of the two expiry dates ( / ) 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 humidity: below 90%.
• The test strips must be stored in the original box/unopened film packaging – never use other con-
tainers.
4 INITIAL USE AND BASIC SETTINGS
4.1 Removing the battery insulation strip, replacing the batteries
Note
• Two batteries are included in delivery of the
blood glucose monitor. These have already
been inserted into the battery compartment.
• Remove the insulation strip before initial
use.
1
Remove the battery compartment lid on the underside of the device.
2
When replacing the batteries, remove all batteries. The device retains the date and time as
long as one battery is still inserted. If necessary, reset the date and time (see “Making and
changing basic settings”, page 15).
3
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.
4
Close the battery compartment lid again carefully.
Note
• The batteries are almost empty if the battery replacement symbol appears. 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.
reset
CR2032 CR2032

Beurer GL44 lean 15
4.2 Making and changing basic settings
1
Remove the batteries and reinsert them. Alternatively, press 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 [4].
The day display flashes.
Proceed as described above for the day, month, hour and minute.
3
Switching the acoustic signal on/o
To switch the acoustic signal on/o, press the “+” or “–” button. “ ”, “ ” and the speaker
symbol are displayed for switched on, and “ ” and “ ” are displayed for switched o.
Confirm by pressing the On/Obutton [4].
4
The monitor is now ready for use.
5 TAKING THE BLOOD GLUCOSE MEASUREMENT
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 an inserted lancet needle, 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 respective Instructions for Use.

16 Beurer GL44 lean
5.1 Preparing to take a blood sample
1
Using the lancing device, you can take a blood sample from the fingertip. To make the pro-
cedure 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 detected quickly in blood samples taken
from the fingertip.
2
Prepare the following items: monitor, test strip box or test strips in film packaging, lancing
device, sterile lancet needles.
3
Wash your hands with soap and warm water before taking a blood sample. This not only en-
sures 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.
5.2 Taking a blood sample
Warning
• Change the puncture area for each measurement, e.g. a dierent finger or the other hand. Repeat-
edly using the same area may cause inflammation, numbness or scarring.
• Without the cap, there is a danger of injury from the exposed lancet.
• Do not squeeze your finger to obtain a larger drop of blood. If squeezed, the blood is diluted with
tissue fluid and this may lead to an incorrect measurement.
• Please note that insucient blood circulation at the puncture area, e.g. caused by cold temperatures
or illness, may lead to incorrect results.
Important
Do not apply any blood samples or control solutions to the test strip before inserting it in the monitor.
1Remove the cap from the lancing device.
5

Beurer GL44 lean 17
2Place a sterile lancet needle into the lancing device and secure the
lancet.
Note
Your starter set contains lancet needles in 2 dierent sizes. If you
are unable to take an adequate blood sample using the smaller nee-
dles (purple, 33G), please use the slightly larger needles (blue, 28G).
3Remove the protective disc of the lancet by rotating it while holding
the shaft of the lancet. Retain the protective disc for the safe disposal
of the used lancet needle after taking a blood sample.
4Place the cap onto the lancing device.
5
5Setting the penetration depth
You can set nine dierent penetration depths on the lancing device.
The penetration depth is displayed by a number in the cap.
• 1-3 = for soft or thin skin
• 4-6 = for normal skin
• 7-9 = for thick or callused skin
Turn the moving upper part of the cap until the desired penetration
depth is displayed.
5
6Pull the tensioning device back until it audibly engages. Release the
tensioning device. This automatically snaps back into the default po-
sition. The lancing device is now ready for use.
7Put the already prepared lancing device to one side and prepare the device for measurement.
8
Take a test strip from the box and immediately close it again.
9Hold the monitor so that the display is facing you.
10
Firmly insert a test strip into the device with the contacts first. Please
make sure that the front is facing you. You can touch any part of the
test strip with clean, dry hands.
Use the test strip within three minutes of removal.

18 Beurer GL44 lean
11
The device automatically switches on and shows the start display.
The device is ready to take measurements as soon as the hand and the droplet symbol
flash.
12 You may now use the lancing device to take a blood sample. Make
sure that the blood remains as a droplet and is not spread. Immedi-
ately use the blood droplet to take a measurement.
Blood sample from the fingertip
The best penetration areas are the middle finger and the ring finger.
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, original size:) must have formed.
5
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 fin-
gertip in order to confirm the test result.
• If you often fail to notice that you have a low blood glucose level, carry out a test using blood
from your fingertip.
13
If there is an insucient amount of blood, repeat steps 1 to 12 with a greater penetration depth.
14 Hold the blood input gap (at the tip of the test strip) to
the drop of blood until the gap is completely filled and
the monitor in the display starts counting backwards. Do
not press the penetration area to the test strip. The blood
must not be spread. The blood is sucked into the gap.
Note
Error message “002” appears on the display if the gap was not correctly and suciently filled
with blood. Repeat the measurement using a new test strip and a greater penetration depth.
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.
• The device switches itself oif the test strip has already been inserted into the device but no blood
is added to the test strip within two minutes. 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.
OK

Beurer GL44 lean 19
5.3 Reading the result and labelling measurements
Reading the result
As soon as the gap is suciently filled with blood, the device performs the blood glucose measure-
ment. The monitor counts down for approx. five seconds.
The measurement is then shown on the display.
Read the measured value. For explanations and actions for the measured values, see chapter “5.5
Evaluating measured blood glucose values”. If an error message is displayed, read chapter “8. What
if there are problems?”
Labelling measured values
You have the following options to label measured values.
Before meals.
After meals.
General labelling (e.g. after exercising).
Labelling measured values enables you, your GP or diabetes consultant to better monitor your blood
glucose values. For example, you can display the average values of all measurements taken before
meals.
The measured value can be labelled as soon as it is displayed. You cannot label it later.
For this purpose, briefly press the labelling button [3].
a) Pressing once labels the value with .
b) Pressing again labels the value with .
c) Pressing yet again labels the value with .
d) Pressing a final time removes the label.
The selected label is stored in the memory of the device when it is switched o.

20 Beurer GL44 lean
5.4. Post-processing and disposal
1
Remove the test strip from the device with the test strip ejection slider. Carefully dispose of the
test strip according to the currently applicable regulations to avoid infecting others.
2Carefully remove the cap from the lancing device.
5
3Place the retained protective disc flat on a hard surface. Stick the tip
of the needle into the protective disc so the needle is covered. Take
care not to touch the used lancet.
4
Use the sliding switch on the side. This causes the lancet to drop
out of the holder.
Carefully dispose of all blood samples and materials that came into
contact with you or your patient. Dispose of the lancet in a punc-
ture-proof container. This prevents injuries and the infection of others.
5Place the cap back onto the lancing device.
5
5.5 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.
• Immediately seek medical attention if your symptoms are not in line with your measured blood glu-
cose values and you have observed all instructions for the Beurer GL44 lean blood glucose moni-
toring system.
• Do not ignore symptoms of too high/low blood glucose levels. Consult your doctor.