instructions for use GL40 mg/dL GB BLOOD GLUCOSE MONITORING SYSTEM Step by step IVD Beurer GmbH • Söflinger Str. 218 • D-89077 Ulm, Germany www.beurer-medical.
Beurer GL40 mg/dL
Contents 1 About Your Beurer Blood Glucose Monitoring 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...............................................................
1 About Your Beurer Blood Glucose Monitoring 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.
1.1 Delivery scope, replacement parts and accessories Inspect your set for external damage to the carton packaging and for completeness of the content.
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 cable, driver and test software) REF 463.10 1.2 Functions of the unit This device is intended for measuring the blood glucose content of human blood. It is also suitable for individual, self-testing.
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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 glucose content in mg/dL. The unit of measure mg/dL appears next to each blood glucose level reading. Be sure to contact customer service if your measuring device does not display mg/dL.
• 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 3000 mg/dL hardly affect the results.
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.
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.
3 Description of the unit and accessories 3.1 Blood Glucose Monitoring device 1 2 3 Item Designation 1 Receptacle for test strips, with lighting 2 Display 3 ON/OFF button 4 Computer port 5 Battery compartment (underside) 6 ST rocker button 6 5 4 3.
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3.4 Test strips Front view Rear view 1 Slit for blood collection 2 Hold here You will know which side is the rear from the contact panels. 3 Contacts Insert the test strip into the unit so that the contacts are visible in the slit. Ensure that the front side of the test strip is facing you.
Note Read the following information about handling and storing your test strips carefully. The test strips are guaranteed to yield accurate measurement results only if you observe all instructions. Warning • Each test strip is to be used only once and only for one patient! Handling test strips Note • Once you have removed the test strip, tightly close the container again immediately. • Do not use test strips if the expiry date has passed. The use of expired test strips can lead to inaccurate measurements.
4 Using the unit for the first time and basic settings 4.1 Removing the battery insulation strip, replacing the batteries Note • Two batteries are included in the delivery scope of your blood-glucose monitoring device. They are already inserted in the battery compartment. • Before using the unit the first time, you must remove the insulation strip. 1 Remove the cover of the battery compartment on the underside of the unit. 2 When you perform a battery change, remove all batteries.
4.2 Basic settings 1 Remove the batteries and then reinsert them. A beep sounds. The year display flashes. 2 Setting the date and time. Note • You must set the date and time. Only if you do that can you save your measured values correctly with the date and time and later retrieve them. • The time is displayed in 24-hour format. Set the year (calendar extends to 2099) by pressing the S or T button. Confirm via the ON/OFF button [3]. The day display flashes.
5 Measuring your blood glucose Warning If you drop the lancing device while a needle lancet is inserted, pick it up carefully and dispose of the lancet. Important • Use the lancing device only with needle lancets from the manufacturer. Use of other needle lancets can impair the function of the lancing device. • If the lancing device is manufactured by a third party, consult their instructions for use. 5.
Taking the blood sample Warning • Change the prick point for each test, e.g. another finger or the other hand. Repeated pricks at the same point can lead to inflammation, numbness or scars. • Do not use the AST cap to take a blood sample from the finger. • Never squeeze the finger to obtain a larger droplet of blood. Squeezing causes interstitial fluid to dilute the blood; this can lead to a false measurement result.
5 Setting the puncture depth: You can preset six different puncture depths on the lancing device by turning the cap. A small bar means a shallow puncture depth, and a large bar means a deep puncture depth. The difference in puncture depth between the smallest and largest click position is approx.
8 If insufficient blood was collected, increase the puncture depth and repeat steps 5 to 7. 9 Untwist the cap and carefully remove it from the lancing device. 10 Place the protective disk you kept earlier flat on a hard surface. Pierce the protective disk with the tip of the needle so that the needle is covered. 11 Slide the lancet ejector towards the needle lancet until the needle lancet is released from the lancing device. Dispose of the lancet in a sharp-proof container.
5.2 Measuring the blood glucose value 1 Hold the measuring device so that the display is facing you. 2 Insert a test strip, contacts first, into the unit. Ensure that the front side is facing you. You can handle any part of the test strip with clean, dry hands. 3 The unit switches on automatically and shows the start display. As soon as the hand and symbols are flashing, the unit is ready to perform measurements. 4 Hold the blood collection slit (at the point of the test strip) against the blood droplet.
5.3 Evaluating a blood glucose measured value Your Blood Glucose Monitoring device can process measured values between 20 and 630 mg/dL. The warning message "Lo" is displayed for measured values below 20 mg/dL. The warning message "Hi" is displayed for a measured value above 630 mg/dL. Note • If you suspect that the blood glucose values are incorrect, first repeat the test and, if necessary, perform a function test using the control solution.
Evaluating critical measured values Display Blood glucose Remedy Hypoglycaemia Below 20 mg/dL Immediate medical attention required. Low blood glucose Below 70 mg/dL Eat a suitable snack or small meal. High blood glucose With an empty stomach Above 100 mg/dL If the value remains high 2 hours after your last meal, this may indicate hyperglycaemia (high blood glucose). Discuss with your doctor any possible action to take in this case.
5.4 Function check with control solution The control solution is used for checking the whole Blood Glucose Monitoring system. This enables you to determine whether the measuring device and the test strips are functioning correctly together and whether the test is performed correctly. You should perform a control solution test if you suspect that the measuring device or test strips may be faulty, or if you repeatedly receive unexpected blood glucose results.
Results to be expected At room temperature, the measurement results for 95% of all control solution tests should lie within the results range printed on the test strip container. Warning The results range printed on the test strip container applies only for the control solution. This is not a recommended value for your blood glucose content. If measurement results are outside the specified range, check the following possible causes: Cause • The first drop of control solution was not disposed of.
6 The Measured Value Memory Your blood glucose level is automatically stored with every measurement, unless "CtL" was activated during a blood glucose measurement with control solution. The measured value memory can store up to a maximum of 480 values. Once this number is reached, the measured value always replaces the oldest value in the memory. You can retrieve each individual blood glucose measured value.
6.2 Displaying average blood glucose levels You can display the average blood glucose value from the last 7, 14, 30 and 90 days. 1 The measuring device must be switched off. Press the rocker button S [5]. The start display appears briefly. Press the rocker button S [5] again. The blood glucose level unit, "7 days" and the average value are displayed. 2 PressS [5] repeatedly to display the average value for 14, 30 and 90 days. 3 You can cancel the process at any time.
6.4 Transferring measured values to a computer The GL40 measuring system has a built-in computer interface [4] which you can use to transfer the measured values stored in your unit to a computer. (For the position of the connection socket, see p. 12). You can acquire the connection cable as the accessory set 'Beurer GL40 PC Kit' in a specialist store (see "Delivery scope, replacement parts and accessories").
Transferring your measurement data 1 The measuring device must be switched off. Insert the larger, flat USB connector of the connection cable into a USB port on your computer. Insert the mini USB connector into the computer interface port on your measuring device. 2 "-> PC" appears in the display of the measuring device. The measuring device is now ready for data transfer. 3 Follow the transferring and evaluating information in the software and in the instructions for the Beurer PC Kit.
7 Storage and maintenance of the unit Storing your unit Store the measuring device after each use in the case provided. Note • Keep these instructions for use. • If you will not use the unit for a prolonged period, remove the batteries. Maintenance The surface of the unit can be cleaned with a damp cloth (moistened with water or a mild cleaning solution). Dry the unit using a lint-free cloth. If used by more than one person, please follow the generally applicable regulations concerning disinfection.
8 Troubleshooting Messages on the display for batteries and blood glucose measurement No. LP Ht Lt Err Cause Flat batteries Temperature of the measurement room, measuring device or test strip above the allowable limit. Temperature of the measurement room, measuring device or test strip below the allowable limit. Used or contaminated test strip was inserted. 001 System error 005 Memory error 32 Action Replace all batteries.
Problem: Unit does not turn on. Cause Flat batteries Incorrectly inserted or missing battery. Test strip is inserted with the wrong side or not completely. Action Replace the batteries. Verify that the batteries are inserted correctly (see "Inserting and replacing the batteries", page 16). Insert the test strip, contacts first, into the slot on the unit. Ensure that the front side of the test strip is facing you (see "Test strips", page 14). Unit is defective Contact customer service.
9 Technical specifications Dimensions (WHD) Weight Electrical power Battery life Measured value memory Average values Automatic switch-off Storage/ transport temperature Operating ranges Glucose measurement range Blood sample Blood quantity Measuring time for blood glucose Calibration Test method Application System function test 34 47 x 85 x 14 mm 43 g (including batteries) 2 x 3V CR2032 button cell batteries More than 1000 measurements 480 measured values with date/time Data retention when replacing th
EMC This unit complies with European standard EN 61326 and is subject to specific safety precautions in terms of electromagnetic compatibility. Note that portable and mobile RF communication equipment can affect this unit. Further details can be requested by contacting the customer service address provided below. Note regarding function of test strips The test strips enable a quantitative measurement of the glucose content of capillary whole blood.
Note regarding function of the control solution The control solution contains a fixed concentration of glucose that reacts with the test strip. A test with the control solution is performed in the same way as a blood test, but the control solution is used instead of blood. The measurement result from the control solution must lie within the results range. This results range is printed on every test strip container.
10 Guarantee and Customer Service Guarantee This product comes with a 3-year guarantee for material and manufacturing faults. The guarantee does not apply: • in the case of damage caused by improper use • to wearing parts • to deficiencies of which the customer was aware at the time of purchase • to personal negligence on the part of the customer • in the case of third-party intervention This guarantee does not affect your statutory rights.
Beurer GL40 mg/dL
Beurer GL40 mg/dL 39
GL40_mg-dL_0511_GB Subject to errors and changes without notification.
