Beurer GL50 User manual

|
instructions for use
GL50
GB
3 IN 1 BLOOD GLUCOSE MONITOR
step by step
Codefree
E
A
S
Y
T
O
U
S
E

2 Beurer GL50
1 Getting to know your instrument........................................................................................3
1.1 Delivery scope, replacements and accessories.....................................................................4
1.2 Follow-up purchases.............................................................................................................. 5
1.3 Functions of the device..........................................................................................................5
1.4 Signs and symbols................................................................................................................. 5
2 Warnings and safety notes ................................................................................................... 6
3 Description of units and accessories................................................................................9
3.1 Blood glucose monitor...........................................................................................................9
3.2 Lancing device and lancet needles...................................................................................... 10
3.3 USB cover............................................................................................................................ 10
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 Making and changing 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............................................................................... 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 Evaluating measured values on a PC...................................................................................28
7 Storing, maintaining and disinfecting the device ........................................................ 29
7.1 Maintenance ........................................................................................................................29
7.2 Disinfection .......................................................................................................................... 29
8 What if there are problems?...............................................................................................30
9 Technical specifications...................................................................................................... 32
10 Comparison of measured values with laboratory value ............................................33
11 Usage limits for specialist personnel from the healthcare sector.......................... 35
12 Guarantee and customer service .....................................................................................37
Contents

Beurer GL50 3
1 GettinG to know your instrument
Dear customer,
Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested
products for applications in the areas of heat, weight, blood pressure, blood glucose measurement,
body temperature, 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 instrument
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 dis-
play the average of all measured values, thereby providing optimum assistance for monitoring your
diabetes. The test is performed exclusively externally (IVD).
The backlit display shows 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 measurements.
The device can be connected directly to a PC using the integrated USB connection. You can evaluate
the measured values on your PC using special software (in English and German) 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 pre-
sent. 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 Services address.
A“3 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).

Beurer GL50 5
Note
•Use original manufacturer accessories only.1.2 Follow-up purchases
You can also obtain test strips, control solution and lancet needles without a prescription.
Item REF
50 test strips REF 464.15
Control solution LEVEL 3 and 4 REF 464.16
100 Soft touch lancet needles 33G REF 457.24
100 lancet needles 28G REF 457.01
200 safety lancets REF 457.40
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 blood glucose 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
•Evaluate the saved measured values on a PC using special software.
The blood glucose monitor also includes the following monitoring functions:
•Warning in the event of unsuitable temperatures
•Low battery display
•Low test strips warning
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, type plate of the blood glucose monitor and accessories represent
the following:
In vitro diagnostics Manufacturer
Serial number Please observe the Instructions
for use

6 Beurer GL50
Temperature limit
+2°C to +30°C
Green dot (Der Grüne Punkt):
German dual waste collection
system
Not for re-use/For single use
only Contents sucient for <n> tests
Use by /
Art.-Nr.
Order number
Maximum shelf life after
initial opening in months
Unit of measurement for blood
glucose value
Batch designation Biohazard, risk of infection
Warning, see accompanying
documents Sterilised by radiation (lancets)
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 unit/accessory.
Note
Note on important information
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 infections.
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 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 measurement.

Beurer GL50 7
•When using the blood glucose monitor for various persons, observe the generally applicable regu-
lations 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. Do not 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 medical
examination! Consult your GP regularly regarding your measured values. Do not alter the procedures
prescribed by your GP.
•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 pro-
fessional (for example, your GP, chemist or diabetes consultant). Only proper use will guarantee
precise measurements.
•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 (HHNKC)
may lead to incorrect measured results.
• Ahematocrit value (proportion of red blood cells) between 30 % and 55 % has no significant influ-
ence on the measurement results.
•An excessively high or low hematocrit value (proportion of red blood cells) may lead to incorrect
measurements. In the event of a very high hematocrit value (above 55%), the displayed blood glu-
cose value may be too low; in the event of a very low hematocrit value (below 30%), it may be too
high. Consult your GP if you do not know your hematocrit 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. If the area is squeezed, the blood is
diluted with tissue fluid and this may lead to an incorrect result.
•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 inexact results.

8 Beurer GL50
Note
The Beurer GL50 measuring system is intended for measuring capillary whole blood.
Storage and maintenance
Warning
•Store the blood glucose monitor and its accessories out of reach of small children and pets. Small
parts, such as lancet needles, 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 swallowed.
Keep the box out of the reach of children.
The blood glucose monitor is made from precision and electronic components. The accuracy of the
measurements 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.
Batteries/Saving measured values
Notes on handling batteries
•If your skin or eyes come into contact with battery fluid, flush out the aected areas with water and
seek medical assistance.
• Choking hazard! Small children may swallow and choke on batteries. Store the 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.
• Risk of explosion! Never throw batteries into a fire.
•Do not charge or short-circuit batteries.
•If the device is not to be used for a long period, take the batteries out of the battery compartment.
•Use identical or equivalent battery types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, split 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.

Beurer GL50 9
Repairs
Note
•Do not open the device. Failure to comply will result in voiding of the warranty.
•Do not repair the device. 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 blood glucose 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
The 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 useful life. Dispose of the unit at a suitable local collection or recycling point. 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 units and accessories
3.1 Blood glucose monitor
An overview of the monitor
1 Lancing device
2 Plug-in USB
3 Monitor

10 Beurer GL50
Front Rear
1 ON/OFF button
2 Display
3 Rocker switch
4 Slot for test strips
1 Battery cover
3.2 Lancing device and lancet needles
1 Cap
2 Protective lancet disc
3 Sterile lancet needles
4 Lancet holder
5 Dial for setting
dierent penetration depths
6 Tensioning slider
7 Trigger
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.
1
23 4567