instructions for use GL32 mg/dL GB BLOOD SUGAR MEASURING DEVICE Step by step Beurer GmbH ● Söflinger Straße 218 ● 89077 Ulm ● Germany Phone: +49 800 6645222 ● E-mail: kd@beurer.de ● www.beurer-medical.
Contents: Blood Sugar Measuring Device GL32 mg/dL 1 About Your Beurer Blood Sugar Measuring Device ............2 1.1 Delivery scope, replacement parts and accessories .................................2 1.2 Functions of the device .............................................................................3 1.3 Signs and symbols ....................................................................................4 2 Safety information and warnings...........................................
1 ABOUT YOUR BEURER BLOOD SUGAR MEASURING DEVICE Read these instructions for use and all accompanying information material carefully and thoroughly before performing your first blood sugar measurement. Store the operating instructions in a safe place where they can be accessed by other users. 1.
Replacement parts and additional accessories Test strips, control solution and lancets are also available for purchase without a prescription. Item 50 test strips MEDIUM control solution 100 needle lancets Beurer GL32, GL34, BGL60 PC kit (connecting cable, drivers and test software) REF REF 464.00 REF 457.02 REF 457.01 REF 462.10 1.2 Functions of the device This device is intended for measuring the blood sugar content of human blood. It is suitable for self-testing and does not have to be encoded.
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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 mg/dL.The unit of measure mg/dL follows the blood sugar value. If your device does not display mg/dL, contact customer services immediately.
• Only use fresh capillary whole blood. Do not use serum or plasma. • Use capillary blood obtained without squeezing the puncture site. When squeezed, the blood is diluted with lymph from the tissues and therefore leads to an incorrect measurement result. • Do not use the test strips at an altitude above 3275 m. Note The Beurer GL32 mg/dL measuring system is designed for measuring capillary whole blood.
Note • The stored blood sugar values remain saved during a battery change. The date and time are retained during battery replacement and if the batteries are run down. • Each time you change the batteries, use two batteries of the same type, the same brand and the same capacity. Alkaline batteries should be used wherever possible. Repairs Note • Never open the device. Opening the device invalidates the guarantee.
3 DESCRIPTION OF DEVICE AND ACCESSORIES 3.1 Lancing device and needle lancets 1 1: Cap 2 3 2: Protective disk for the lancet 4 3: Sterile needle lancet 5 6 4: Lancet holder 5: Release button 6: Tensioning device 3.2 Blood sugar measuring device Front view Rear view 1: Test strip slot 1: Two alkaline batteries of type 1.
Display symbols for the blood sugar measurement: 1: Code symbol (not functional) 8: Blood droplet symbol 6 2: Arrow symbol for test strips 9: Blood sugar unit mg/dL 3: Value display 10: Blood sugar unit mmol/L (not functional) 4: Low blood sugar value (not functional) 5: High blood sugar value (not functional) 6: Test strip symbol 7: Speaker (not functional) Beurer GL32 mg/dL 11: Ketone measurement recommended (not functional) 12: Memory deleted symbol 13: Memory symbol 9
Other display symbols: 14: Temperature symbol 17: Battery change symbol 15: Date: Day-Month 18: CTL for control solution 16: Time: Hours-minutes 19: DAY AVG for average value over 7, 14, 21, 28, 60 or 90 days Note This blood sugar measuring device is supplied with the blood sugar unit mg/dL.
3.3 Test strips Front view Rear view 1: Slit for blood collection The rear side of the test strip is marked with an 'X'. 2: Hold here 3: Contacts Insert the test strip into the device so that the contacts are visible in the slit. Ensure that the front side of the test strip is facing you. Read the following information about handling and storing your test strips carefully. The test strips can only be guaranteed to return accurate results if you follow all instructions carefully.
Handling test strips Note • Before using the first test strip, ensure that the seal on the container is unbroken. If the seal is damaged, do not use the test strips. • 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. The expiry date is located on the container next to the egg timer symbol .
4 USING THE DEVICE FOR THE FIRST TIME AND BASIC SETTINGS 4.1 Inserting and replacing the batteries Note Two batteries are included in the delivery scope of your blood-sugar measuring device. The batteries are stored inside the case. 1 2 3 4 Remove the lid of the battery compartment on the rear of the device (see "3.2 Blood sugar measuring device", page 8). If you are replacing the batteries, first remove both the old batteries. The device retains the date and time when the batteries are replaced.
3 Setting the date and time Note • The date and time must always be set. Otherwise, you cannot accurately save measured values with a date and time or call them up later. • The time is displayed in 24-hour format, for example: 20:32. Set the year (the calendar runs until 2049) by pressing the ON/OFF/Forwards button . Press "SET" to confirm the year. The month display flashes. Repeat the above procedure for the month, day, hours, and minutes. 4 "dEL" is displayed and the memory symbol flashes.
5.1 Obtaining a blood sample Preparing to take the blood sample a site on the body from where you wish to take the blood sample. You 1 Choose can use the lancing device to take a blood sample from the fingertip or alternative sites such as the palm of the hand, forearm, upper arm, thigh, or calf. We recommend that you take the blood sample from the fingertip.
1 Twist to remove the cap from the lancing device. 2 Place a sterile needle lancet in the lancing device and push the lancet firmly into place. 3 Remove the protective disc from the lancet by twisting while holding the shaft of the lancet firmly. Keep the protective disc for safe disposal of the used needle lancet after you have obtained the blood sample.
7 The lancing device can now be used to take the blood sample. Ensure that the blood remains in a droplet form and is not smeared. Blood sample from the fingertip Place the lancing device firmly against the finger, slightly to the side of the centre of the fingertip. Press the release button. Lift the lancing device from the finger. A round blood droplet of at least 0.5 microlitres (approx. 1.2 mm, original size: z) is required.
11 Carefully remove the needle lancet from the lancing device and discard the lancet in a suitable sharp-proof container. Carefully dispose of all blood samples and materials with which you have come into contact. This prevents injury and prevents infection spreading to other people. 12 Twist the (grey) cap back in place. 5.2 Measuring the blood sugar value 1 2 3 4 Hold the measuring device so that the display is facing you. Insert a test strip, contacts first, into the device.
Remove the test strip from the device and dispose of it carefully in accordance with the applicable guidelines in order to prevent infection of other people. 6 Note • If the device does not begin the measurement, do not subsequently apply more blood. Instead, remove the test strip and end the test procedure. Start again using a new test strip. • If the test strip is already inserted in the device and you do not apply any blood to the test strip within three minutes, the device switches itself off.
Critical blood sugar values Display Blood sugar Lo = Severe hypoglycaemia (low blood sugar) Action Immediate medical attention required. Below 20 mg/dL Low Eat a suitable snack or small meal. Follow your doctor's advice. Below 70 mg/dL High Fasting: Above 100 mg/dL 2 hours after eating: Above 140 mg/dL High, possible ketones If this high value is still present 2 hours after the last meal, this may indicate hyperglycaemia (high blood sugar).
5.4 Function test using control solution The control solution is used for checking the whole blood sugar measuring 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. It is very important that you perform these tests using the control solution to ensure accurate measuring results. CAUTION Never use control solutions made by other manufacturers.
• Do not use the control solution if either of these dates has expired ( / ). • Allow the measuring device, test strips and control solution to reach room temperature (+20°C to +25°C). Performing a function test using the control solution Hold the measuring device so that the display is facing you. 1 2 3 4 5 6 7 8 9 Insert a test strip into the slit on the measuring device, contacts first. Ensure that the front side of the test strip is facing towards you (see "3.3 Test strip", page 11).
Expected results 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 sugar level. If measurement results are outside the specified range, check the following possible causes: Cause • The drop of control solution was not discarded.
6 THE MEASURED VALUE MEMORY Your blood sugar value is stored automatically each time you take a measurement. Exception: if "CTL" is activated during a measurement with control solution, the value is not stored. The measured value memory can store up to a maximum of 448 values. Once this number is reached, the measured value always replaces the oldest value in the memory. You can display the average value for the last 7, 14, 21, 28, 60 and 90 days, as well as displaying each value individually.
3 The number of the measurement flashes briefly (fig. 1) and the most recent value is displayed (fig. 2). Each time you press the ON/OFF/Forwards button , the previous measured value is displayed. You can display a maximum of 448 previous measured values. After the last available individual value, the device displays "End" followed by "OFF". Note • You can use the back button to return to measured values that have already been displayed. • You can cancel the process at any time.
3 The average value for 7 days is displayed, together with the number of measured values recorded within this period (in the diagram: 14 measured values within the last 7 days). Press the button repeatedly to display the average value for 14, 21, 28, 60 and 90 days and the corresponding number of measurements. After the last available average value, the device displays "End" followed by "OFF". Note You can cancel the process at any time.
6.4 Transferring measured values to a PC The Beurer GL32 mg/dL measuring system features a PC interface that you can use to upload your stored blood sugar measurement values to a PC. Using special software, you can evaluate your measured values on the PC and use the evaluations for monitoring your blood sugar levels. The connection cable is available from your retailer as the accessory set "Beurer GL32, GL34, BGL60 PC kit" (see "1.1 Delivery scope, replacement parts and accessories", page 2).
Note • You cannot perform blood sugar measurements while the blood sugar measuring device is connected to a PC. • Effective evaluation of the measured values is only possible if you have set the date and time correctly (see "4.2 Basic settings", page 13). • The measured values remain stored on the measuring device after transfer to the PC. Disconnecting the device from the PC 1 Pull the jack plug from the blood sugar measuring device. 2 The measuring device switches off automatically.
7 STORAGE AND MAINTENANCE Storing your device After use, store the measuring device in the supplied case. Note • Keep these instructions for use in a safe place. • If you do not use the device for a prolonged period of time, remove the batteries. Maintenance Clean the surface of the device using a damp cloth (water or mild detergent). Dry the device using a lint-free cloth. Note The measuring device is made from precision components.
Problem: Device does not turn on. Cause Flat batteries Battery missing or incorrectly inserted Test strip was not fully inserted or inserted on the wrong side Device is defective Action Replace the batteries. Check whether the batteries are inserted correctly (see "4.1 Inserting and replacing the batteries", page 13). Insert the test strip, contacts first, into the slit on the device. Ensure that the front side of the test strip is facing towards you (see "3.3 Test strip", page 11).
9 TECHNICAL DETAILS GL32 mg/dL Dimensions 96 x 46 x 20 mm Weight 69 g (including batteries) Electrical power 2 x 1.
EMC This device complies with European standard EN 61326 and is subject to specific preventive measures in terms of electromagnetic compatibility. Note that portable and mobile high-frequency communications equipment may interfere with this device. 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.
Comparison between measured values and laboratory values Performance characteristics: Accuracy and precision The blood sugar results were compared with the YSI 2300 laboratory device. At a concentration of < 75 mg/dL, ≥ 95% of values were within +/- 15 mg/dL, while at a sugar concentration ≥ 75 mg/dL, > 98% were within 20% of the reference values. The CV (coefficient of variation) (%) is < 5 %. The blood sugar measuring device is therefore comparable with a laboratory system.
GL32_mg-dL_0109_GB Subject to error and change