Beurer GL 42 User Manual

mg/dL
instructions for use
Codefree
BLOOD GLUCOSE MONITOR
Step by Step
GL42
Beurer GmbH • Söflinger Straße 218 • 89077 Ulm, Germany www.beurer.com
germanlengineering
Contents
1. Getting to know your instrument...............................................................................4
1.1 Delivery scope, replacements and accessories ....................................................... 5
1.2 Functions of the device ................................................................................................. 6
1.3 Signs and symbols ........................................................................................................ 6
2. Warnings and safety notes ...........................................................................................7
3. Description of units and accessories ....................................................................11
3.1 Blood glucose monitor ................................................................................................ 11
3.2 Display symbols ........................................................................................................... 12
3.3 Test strips ...................................................................................................................... 12
4. Initial use and basic settings ..................................................................................... 14
4.1 Removing the battery insulation strips, replacing the battery ............................. 14
4.2 Making and changing basic settings........................................................................ 14
5. Blood glucose measurement ....................................................................................15
5.1 Evaluating the result .................................................................................................... 15
5.2 Evaluating measured blood glucose values .......................................................... 16
6. Functional check using control solution ............................................................17
7. Measured value memory spaces ............................................................................ 20
7.1 Displaying individual values ....................................................................................... 20
7.2 Displaying average blood glucose values ............................................................... 21
7.3 Displaying average blood glucose values for highlighted values ....................... 21
7.4 Deleting individual measured values from the memory ........................................ 23
7.5 Deleting all stored values ........................................................................................... 24
8. Storing, maintaining and disinfecting the device ............................................ 24
8.1 Cleaning ........................................................................................................................ 24
8.2 Disinfection ................................................................................................................... 24
9. What if there are problems? ......................................................................................25
10. Technical specifications .............................................................................................27
11. Comparison of measured values with laboratory values ............................ 28
12. Warranty and customer service ............................................................................... 30
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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, 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.
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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
A 1 Blood glucose monitor
B 1 lancing device
C 10 test strips
D AST cap with groove for taking blood samples from alternative parts of the body
E 1 button cell battery, 3 V CR2032 (already inserted)
F 10 sterile lancet needles
G 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 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.
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Follow-up purchases
You can also obtain test strips, control solution and lancet needles without a prescription.
Item REF PIP Germany
50 test strips REF 461.15 PIP 10146271
Control solution LEVEL 5 and 6 REF 457.11 PIP 10146288
100 lancet needles REF 457.01 PIP 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 90days
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 diagnostics 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
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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
warninGs and safety notes
opening in months
Contents sucient 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.
Itemno.
/
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).
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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 55ug/dL), Tolbutamide (up to 100 mg/dL), Triglyceride (up to 3000 mg/dL), Uric acid (up to 7mg/dL), and Xylose (up to 5 mg/dL) in blood has no significant interference reaction (the average dierence 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.
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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.
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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.
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