Beurer medical GL 48 User manual

GL 48
EN
Instructions for use
Blood glucose monitor
Step by step
Lancet needles / Lanzetten / lancettes / lancetas / lancette
GL 48
LD 04
Codefree

Beurer GL48 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 ...................................................................................................................7
2. Warnings and safety notes.....................................................................................................8
3. Description of device and accessories..............................................................................11
3.1 Blood glucose monitor ............................................................................................................11
3.2 Display symbols......................................................................................................................12
3.3 Test strips...............................................................................................................................13
4. Initial use and basic settings ...............................................................................................14
4.1 Removing the battery insulation strips, replacing the batteries ..................................................14
4.2 Making and changing basic settings ........................................................................................14
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........................................................................18
5.4 Evaluating measured blood glucose values ..............................................................................19
5.5 Functional check using control solution ................................................................................... 20
6. Measurement memory ..........................................................................................................23
6.1 Displaying individual values .....................................................................................................23
6.2 Displaying average blood glucose values .................................................................................24
6.3 Displaying average blood glucose values for labelled values.....................................................25
6.4 Transferring measurements to a PC .........................................................................................27
7. Storing, maintaining and disinfecting the device ............................................................ 28
7.1 Cleaning .................................................................................................................................28
7.2 Disinfection ............................................................................................................................29
8. What if there are problems?................................................................................................. 29
9. Technical specifications .......................................................................................................31
10. Comparison of measured values with laboratory values ...............................................32
11. Usage limits for specialist personnel from the healthcare sector ............................... 34
12. Instructions for use for the lancing device LD 04 ............................................................37
12.1 Proper use ............................................................................................................................37
12.2 Warnings and safety notes ....................................................................................................37
12.3 Device description ................................................................................................................38
12.4 Initial use .............................................................................................................................. 38
12.5 Usage ..................................................................................................................................38
12.6 Post-processing and disposal ...............................................................................................40
12.7 Cleaning and maintenance ....................................................................................................40
12.8 Disposal ............................................................................................................................... 40
13. Warranty/service .................................................................................................................... 41

4 Beurer GL48
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 tempe-
rature, 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 GL48 blood glucose measuring 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 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 USB cable provided. 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 GL48 5
1.1 Scope of delivery and accessories
Check that the set packaging has not been tampered with and make sure that all components 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
A1 blood glucose monitor
B1 lancing device LD 04
C10 test strips
D10 lancets (5x lancet needles (blue, 28G) and 5x soft touch lancets (purple, 33G))
E2 button cell batteries, 3 V CR2032 (already inserted)
F1 practical case
G1 USB cable
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 specially
designed to complement each other. For this reason, use only test strips and control solutions that
have been approved for this measuring device.
Note
• Use original manufacturer accessories only.

6 Beurer GL48
1.2 Replacements
You can also obtain test strips, control solution and lancets without a prescription.
Item REF
100 test strips REF 463.72
50 test strips REF 463.70
Control solution LEVEL 7 and 8 REF 463.64
100 soft touch lancets 33G REF 457.24
100 lancet needles 28G 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 measuring device 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 the stored measured values to a PC for evaluation
The measuring device 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.

Beurer GL48 7
1.4 Signs and symbols
The following symbols are used on the device, in these instructions for use, on the packaging and on
the type plate for the device:
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
In vitro diagnostic device Not for re-use/
for single use only
Serial number Manufacturer
Temperature limit
+2 °C to +30 °C Contents sucient for <n> tests
Use by /
Art.-Nr.
Item number
Batch designation
Unit of measurement for blood
glucose value
Sterilised by radiation (lancets) Biohazard, risk of infection
Important: check the instructions
for use for important safety-relat-
ed information such as warnings
and precautions
Consult instructions for use
Medical device (MDR Symbol)
CE labelling
This product satisfies the re-
quirements of the applicable Eu-
ropean and national directives.
21
PAP
Dispose of packaging in an en-
vironmentally friendly manner

8 Beurer GL48
2. warninGs and safety notes
Risk of infection
All components of the measuring device 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 familiar,
misinterpret the values and subsequent-
ly take incorrect measures. Ensure that this
measuring device displays a unit of meas-
urement 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 measuring device 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 products
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 procedu-
res prescribed by your GP.
• Despite the simple usage of the Beurer GL48 system for self-monitoring of blood glucose levels,
you may possibly need to obtain instructions for using the system from your healthcare professi-
onal (for example, your GP, chemist or diabetes consultant). Only proper use will guarantee exact
measurements.
09.03. 12:38
mg/dL
95
09.03. 12:38
35
mmol/L
Example

Beurer GL48 9
• 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.
• This device is not suitable for use by people (including children) with restricted physical, sensory
or mental abilities, or lack of experience and/or lack of knowledge, unless they are supervised by
someone who is responsible for their safety, or have received instructions from this person on how
to use the device. Do not allow children to play with the device.
• 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 measured results.
• A haematocrit value between 20% and 60% has no significant influence on the measurement re-
sults.
• An excessively 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 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 GL48 measuring system is intended for measuring capillary and venous whole blood.
Storage and maintenance
Warning
• Store the measuring device 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-thre-
atening when swallowed. If swallowed, seek medical attention immediately.
• The test strip box contains desiccant, which may irritate the skin or eyes when inhaled or swallo-
wed. Keep the box out of the reach of children.
The measuring device is made from precision and electronic components. The accuracy of the mea -
sured values and service life of the device depend on its careful handling:
• Protect the device and its accessories from impacts, humidity, dirt, marked temperature fluctuations
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 GL48
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.
• 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 of the measuring device. 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.