11. Comparison of measured values with laboratory values ............................ 28
12. Warranty and customer service ............................................................................... 30
Beurer GL42 mg/dL 3
1.
GettinGtoknowyourinstrument
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, 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 notes they contain.
With kind regards,
Your Beurer team.
Getting to know your instrument
The GL42 blood glucose monitor 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 display 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 measurements.
4 Beurer GL42 mg/dL
1.1 Delivery scope, replacements 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 Services address.
A
B
D
C
G
E
F
A1 Blood glucose monitor
B1 lancing device
C10 test strips
DAST cap with groove for taking blood samples from alternative parts of the body
E1 button cell battery, 3 V CR2032 (already inserted)
F10 sterile lancet needles
G1 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 specially
designed to complement each other. For this reason, use only test strips and control solutions that
have been approved for this blood glucose monitor.
Note
•
Use original manufacturer accessories only.
Beurer GL42 mg/dL 5
Follow-up purchases
You can also obtain test strips, control solution and lancet needles without a prescription.
ItemREFPIP Germany
50 test stripsREF 461.15PIP 10146271
Control solution LEVEL 5 and 6REF 457.11PIP 10146288
100 lancet needlesREF 457.01PIP 03774707
1.2 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 90days
•
Set the time and date
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.
1.3 Signs and symbols
The symbols on the packaging, type plate of the blood glucose monitor and accessories represent
the following:
In vitro diagnosticsManufacturer
Serial numberObserve the instructions for use
Temperature limit
+2 °C to +30 °C
Not for re-use/For single use only
Use by
6 Beurer GL42 mg/dL
PCT: certification symbol for
products that are exported to the
Russian Federation and members
of the CIS
Green dot (Der Grüne Punkt):
German dual waste collection
system
Maximum shelf life after initial
warninGsandsafetynotes
opening in months
Contents sucient for <n> tests
Batch designation
Sterilised by radiation (lancets)
Warning, see accompanying
documents
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.
Itemno.
/
Order number
Unit of measurement for blood
glucose value
Biohazard, risk of infection
2.
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
•
This blood glucose monitor must display the blood glucose content in mg/dL. The unit of measure-
ment mg/dL accompanies each blood glucose value. Please contact Customer Services if the device
does not display mg/dL. 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 therefore
take incorrect measures.
•
When using the blood glucose monitor for various persons, observe the generally applicable regula-
tions 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).
Beurer GL42 mg/dL 7
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.
•
Despite the simple usage of the Beurer GL42 monitor for self-monitoring of blood glucose levels, you
may possibly need to obtain instructions for using the system from your healthcare professional (for
example, your GP, chemist or diabetes consultant). Only proper use will guarantee exact measurements.
•
A lack of water, high fluid loss, for example perspiration, frequent passing of water, severe hypoten-
sion (low blood pressure), shock or hyperosmolar hyperglycaemic non-ketotic coma may lead to
incorrect measured 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 60%), the displayed blood glucose value may be too low; in the event of a very low hematocrit value (below 20%), 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.
• The level of Acetaminophen (up to 10 mg/dL), Ascorbic acid (up to 4 mg/dL), Bilirubin (up to
20 mg/dL), Cholesterol (up to 500 mg/dL), Creatinine (up to 10 mg/dL), Dopamine (up to 5 mg/dL),
EDTA (up to 400 mg/dL), Fructose (up to 200 mg/dL), Galactose (up to 200 mg/dL), Gentistic acid
(up to 2 mg/dL), Glutathione (up to 3 mg/dL), Haemoglobin (up to 200 mg/dL), Heparin (up to
60 mg/dL), Ibuprofen (up to 40 mg/dL), Icodextrin (up to 200 mg/dL), Lactose (up to 200 mg/dL), L‐
DOPA (up to 3.0 mg/dL), Maltose (up to 200 mg/dL), Methyl‐DOPA (up to 1.25 mg/dL), Pralidoxime
Iodide (up to 1.25 mg/dL), salicylate (up to 20 mg/dL), Tetracycline (up to 4 mg/dL), Tolazamide
(up to 55ug/dL), Tolbutamide (up to 100 mg/dL), Triglyceride (up to 3000 mg/dL), Uric acid (up to
7mg/dL), and Xylose (up to 5 mg/dL) in blood has no significant interference reaction (the average
dierence between the test sample and the control sample ≤ 0.55 mmol/L (10 mg/dL) at glucose
concentration of 50~100 mg/dL and ≤ 10% at glucose concentration of 250‐300 mg/dL) on GL42.
• The xylose level (up to 10 mg/dL) in the blood causes a significant deviation with the GL42 device
(average deviation between test and control test >0.55 mmol/L (10 mg/dL) with a blood glucose
concentration of 50-100 mg/dL and >10% with a blood glucose concentration of 250-300 mg/dL).
•
Use fresh capillary 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 6,000 m.
8 Beurer GL42 mg/dL
•
Very high levels of humidity may influence the test results. Relative humidity of more than 90% may
lead to inexact results.
Note
•
The Beurer GL42 mg/dL measuring system is intended for measuring capillary and venous 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, 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 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 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.
Batteries / Saving measured values
Warning
•
Keep batteries out of the reach of children. Children could put batteries in their mouth and swallow
them. This may severely damage their health. In such cases, seek medical assistance immediately!
•
Normal batteries must not be charged, heated or thrown into an open fire (risk of explosion!).
Important
•
Batteries must not be taken apart or short circuited.
•
Leaking batteries may damage the device. If you do not intend to use the device for longer periods,
remove the batteries from the battery compartment.
Attention!
•
Leaking or damaged batteries may burn the skin, therefore use suitable protective gloves if this is
the case.
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 GL42 mg/dL 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.
•
Do not dismantle the lancing device into individual parts, except in the steps described in these in-
structions.
•
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 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
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. Please dispose of the unit 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 GL42 mg/dL
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