Beurer GL 40 User Manual

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BLOOD GLUCOSE
MONITORING SYSTEM
instructions for use
Step by ste
GL40
mmol/L
GB
IVD
Beurer GmbH • Söflinger Str. 218 • D-89077 Ulm, Germany www.beurer-medical.com
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Contents
1 About Your Beurer Blood Sugar Measuring Device.................................4
1.1 Delivery scope, replacement parts and accessories .....................................5
1.2 Functions of the unit ......................................................................................6
1.3 Signs and symbols ........................................................................................7
2 Safety information and warnings............................................................... 8
3 Description of the unit and accessories..................................................12
3.1 Blood sugar measuring device ....................................................................12
3.2 Lancing device and needle lancets .............................................................12
3.3 Display symbols .......................................................................................... 13
3.4 Test strips.................................................................................................... 14
4 Using the unit for the first time and basic settings ................................ 16
4.1 Removing the battery insulation strip, replacing the batteries .....................16
4.2 Basic settings ..............................................................................................17
5 Measuring your blood sugar ....................................................................18
5.1 Acquiring blood samples .............................................................................18
5.2 Measuring the blood sugar value ................................................................22
5.3 Evaluating a blood sugar measured value...................................................23
5.4 Function check with control solution............................................................25
6 The Measured Value Memory ................................................................... 27
6.1 Displaying individual values.........................................................................27
6.2 Displaying average blood sugar levels ........................................................ 28
6.3 Deleting the measured value memory.........................................................28
6.4 Transferring measured values to a computer ..............................................29
7 Storage and maintenance of the unit.......................................................31
8 Troubleshooting ........................................................................................32
9 Technical specifications ...........................................................................34
10 Guarantee and Customer Service............................................................37
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1 About Your Beurer Blood Glucose Measuring Device
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, 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
About Your Beurer Blood Glucose Measuring Device
The Blood Glucose Measuring device is designed for fast, uncomplicated measurement of blood sugar. You can use it to determine your blood sugar content, save the measured values and display the average of the measured values. The large display with background lighting makes the measured values easy to read. The user-friendly design with the handy measurement strips and reduction of the operating controls to 2 buttons guarantees simple, yet accurate measurements. The unit can be connected to a computer via a USB cable (not included in the scope of delivery). Using special software, you can evaluate your measured values on the PC and use the evaluations for monitoring your blood sugar levels.
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1.1 Delivery scope, replacement parts and accessories
Inspect your set for external damage to the carton packaging and for completeness of the content.
Item Designation
A 1 Blood Glucose Measuring device B 1 lancing device with AST cap for taking blood samples from alternative sites C 10 test strips D 10 sterile needle lancets E 2 button cell batteries 3 V CR2032 (pre-installed) F 1 practical carry case
These instructions for use, additional information material
If the box has sustained extensive damage or if any contents are missing, please re­turn the system to the retailer.
The Blood Glucose Measuring device, test strips and control solutions (LEVEL1 + LEVEL2 - available to purchase separately) are all designed to be used together. Therefore use only the test strips and control solution intended for this measuring de­vice.
Note
Only use the manufacturer's original accessories.
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Purchasing supplies
Test strips, control solution and lancets are also available for purchase without a prescrip­tion.
Item REF
50 test strips REF 464.01
Control solution LEVEL1 + LEVEL2 REF 463.07
100 needle lancets REF 457.01
Beurer GL40 PC Kit (connection
REF 463.10
cable, driver and test software)
1.2 Functions of the unit
This device is intended for measuring the blood sugar content of human blood. It is also suitable for individual, private use.
Using this measuring device, you can quickly and easily:
Measure your blood sugar.
Display and save your measured values.
Display your average blood sugar measurements from the last 7, 14, 30 and 90 days.
Set the time and date.
upload your stored measured values to a PC for evaluation (additional accessories
required).
The measuring device also features the following control functions:
A warning in the event of unsuitable temperatures.
Battery change reminder when battery power is low.
Warning
This unit is only to be used for regular monitoring and not for the diagnosis of
diabetes.
Discuss your insulin dose with your doctor.
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1.3 Signs and symbols
The symbols on the packaging and the nameplate of the measuring device and accesso­ries have the following meaning:
In-vitro diagnostics
SN: Serial number
Temperature range +2°C to +30°C
Not for reuse/For single use only
Expiry date
Maximum shelf life after opening in months
Lot number
Sterilised by radiation (lan­cets)
Caution, refer to accompa­nying documents
The following symbols in these instructions mean
Warning Warning instruction indicating a risk of injury or damage to health.
Important Safety note indicating possible damage to the unit/accessories.
Note Important information to be noted.
Unit of measure for blood
mmol/L
Manufacturer
Refer to instructions for use
PCT: Certification for prod­ucts exported to the Russian Federation and CIS coun­tries
Grüner Punkt: German re­cycling system
Contents sufficient for <n> tests
Order number
Biohazard, risk of infection
sugar value
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2 Safety information and warnings
Risk of infection
All components of the measuring device and accessories may come into contact with human blood, and are therefore a possible source of infection.
Warning
This measuring device must display the blood sugar content in mmol/L. The unit of
measure mmol/L appears next to each blood sugar level reading. Be sure to contact customer service if your measuring device does not display mmol/L. You risk dam­aging your health if you perform a blood sugar measurement using an unfamiliar unit of measure, since values may be interpreted incorrectly and cause the wrong correc­tive measures to be taken.
If the measuring device is used by more than one person, follow the generally applica­ble rules concerning disinfection, safety and contamination.
Medical professionals and others who use this system on more than one patient should be aware that all products or items that come into contact with human blood should be handled as though they could transfer pathogens, even after cleaning them.
The lancing device is suitable for household use. Never share the lancing device or needle lancet with others. Never use it on more than one patient (Risk of infection!).
Use a new sterile needle lancet for each blood test (for one-time use only).
General notes
Warning
Do not use the unit near strong electromagnetic fields, wireless systems or mobile telephones.
Measuring blood sugar
Warning
The measured values you determine are useful for information purposes only – they are not intended to replace consultation with your doctor. Discuss your measured values with your doctor regularly. Do not change any aspects of your treatment unless instructed by your doctor.
Water deficiency or a large loss of fluid, for example by sweating, can lead to false meas­urement results.
A very high or very low haematocrit value (proportion of red blood cells) can lead to incor­rect measurements. With a very high haematocrit value (over 60%), the displayed blood sugar value may be too low. If you have a very low haematocrit value (below 20%), the blood sugar value may be too high. If you do not know your haematocrit value, ask your doctor.
Do not use the test strips to take blood sugar measurements of newborn infants.
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Metabolites such as ibuprofen, sodium salicylate, tetracycline, tolbutamide, unconjugated bilirubin, cholesterol, creatinine, triglycerides, galactose, maltose, xylose, paracetamol, gen­tisic acid, levodopa, dopamine, methyldopa, uric acid and ascorbic acid do not affect the re­sult so long as they lie within the physiological value range.
Do not use this unit to test any seriously ill patient.
Warning
Lipemia effects: Increased blood triglycerides up to 33.9 mmol/L hardly affect the results. Above this level, however, the blood sugar test may be affected.
Only use fresh capillary whole blood. Do not use serum or plasma.
Use capillary blood obtained without squeezing the puncture site. Squeezing causes
interstitial fluid to dilute the blood and leads to a false measurement result.
Do not use the test strips at elevations over 3048 m.
Note
The Beurer GL40 mmol/L measuring system is suitable for measuring capillary whole blood.
Storage and maintenance
Warning
Store the measuring device and accessories out of the reach of young children. Small parts, such as needle lancets, batteries or test strips, can be life-threatening if swal­lowed. If parts are swallowed, seek medical advice immediately.
The test strip container contains a desiccant that may cause skin or eye irritations if inhaled or swallowed. Keep the container out of reach of young children.
The measuring device is made from precision and electronic components. The accuracy of the measured values and service life of the unit depend on careful use:
Protect the unit and accessories from impacts, moisture, dirt, large temperature fluc­tuations and direct sunlight. Do not store the unit, the test strips and the control solu­tion in a refrigerator, bathroom or car!
Do not let the unit fall.
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Batteries/Saving measured values
Warning
Make sure batteries are not accessible to children. Children can put batteries in their mouth and swallow them. This can cause severe harm to their health. In this case, consult a physician immediately!
Normal batteries must not be recharged, heated or thrown into an open flame (danger of explosion!).
Important
Do not disassemble or short-circuit the batteries.
Always replace all batteries at the same time and use batteries of the same type. Do
not use any rechargeable batteries.
Leaking batteries may damage the unit. If you do not intend to use the unit for a pro­longed period, remove the batteries from the battery compartment.
Caution!
Leaking or damaged batteries can cause burns if they come into contact with your skin. In this case, wear suitable safety gloves.
Note
The stored blood sugar measured values are retained when you replace the batteries. The date and time are also retained when you replace the batteries and when the bat­teries are empty.
Only use lithium-ion batteries.
Repairs
Note
Never open the unit. Opening the unit invalidates the guarantee.
Do not perform any repairs on the unit yourself, otherwise correct functioning of the
unit can no longer be guaranteed.
If repairs are required, please contact customer service.
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Disposal
Warning
When disposing of the materials of the measuring device, be sure to observe the gen­erally applicable safety precautions for handling blood. Carefully dispose of all blood samples and materials with which you or your patients have come into contact, in or­der to prevent injury and infection of others.
After use, dispose of the test strips and lancets in a sharp-proof container.
Note
In the interest of protecting the environment, the unit must not be thrown out with the household waste at the end of its service life. Please dispose of the unit in accordance with EU directive 2002/96/EC – WEEE (Waste Electrical and Electronic Equipment). For any queries, please contact the municipal authority responsible for disposal.
Standard and rechargeable batteries should not be disposed of along with household waste. As a consumer, you are legally obliged to return used batteries for proper disposal. You can hand in your used batteries at public collection points in your district or sales outlets where batteries of this type are sold.
The following symbols are found on batteries that contain harmful substances: Pb = battery contains lead Cd = battery contains cadmium Hg = battery contains mercury
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3 Description of the unit and accessories
3.1 Blood Glucose Measuring device
Item Designation
1
2
3
6
1 Receptacle for test strips, with
2 Display 3 ON/OFF button 4 Computer port 5 Battery compartment (underside) 6
5
4
3.2 Lancing device and needle lancets
Item Designation
1 Cap with scale for adjusting the
2 Protective disk for the lancet 3 Sterile needle lancet 4 Lancet holder 5 Release button 6 Tensioning device 7 Lancet ejector
lighting
ST rocker button
puncture depth
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