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.