Related Manuals for Beurer medical GL60
Summary of Contents for Beurer medical GL60
- Page 1 GL60 BLOOD GLUCOSE MONITOR Step by step Blood glucose measuring system, GL60 (including GL60, test strips for GL60) Soft LD 04...
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Page 3: Table Of Contents
12.6 Blood sample from the fingertip ....................35 12.7 Please also note the following: ......................36 12.8 Final steps and disposal ....................... 36 12.9 Cleaning and maintenance ..........................36 12.10 Disposal 13. Guarantee and Customer Services ..................37 Beurer GL60... -
Page 4: Dear Customer
Your Beurer team. Getting to know your device The GL60 blood glucose monitor is intended for fast and simple blood glucose measurement in 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, save the measured values and display the average of all measured values, thereby providing optimum assistance for monitoring your diabetes. -
Page 5: Follow-Up Purchases
– 50 pcs GL60 test strips 463.58 PZN 16382647 100 pcs GL60 test strips 463.63 PZN 16382653 GL60 control solution (LEVEL 9 & LEVEL 10) 463.75 PZN 16382682 100 pcs Lancet needles 457.01 PZN 3774707 100 pcs Soft-touch lancets 457.24... -
Page 6: Signs And Symbols
(in this example, 6 months) Manufacturer Not for reuse / for single use only Authorised representative in the Sterilised by radiation (lancets) European Community Indicates that the device should Importer symbol not be re-sterilised after it has been sterilised once. Beurer GL60... -
Page 7: Warnings And Safety Notes
• Medical carers and others who use this system on multiple patients must be aware that all products or objects that come into contact with human blood must be handled as though they could transfer pathogens, even after cleaning. Beurer GL60... -
Page 8: General Notes
Consult your physician regularly to discuss your measured values. Never independently deviate from your physician’s instructions. • Though the Beurer GL60 monitor for self-monitoring of blood glucose levels is simple to use, you may need to seek instruction in using the system from a healthcare professional (for example, your physician, chemist or diabetes consultant). -
Page 9: Storage And Maintenance
• Do not disassemble, open or crush the batteries. Note • The saved 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 of the correct type only. Beurer GL60... -
Page 10: Description Of Equipment, Accessories And/Or Replacement Parts
3. d escription of equipment accessories and or replacement parts 3.1 Blood glucose monitor Front 1. Slot for test strips 2. Display 3. “ON/OFF” button 4. “+” button 5. “-” button 6. Plug-in USB 7. Cap Beurer GL60... -
Page 11: Display Symbols
Ensure that you are using a device with the correct blood glucose unit (either mg/dL or mmol/L) option for you. The blood glucose unit on the device cannot be set or changed. If you are unsure, consult your physician. Beurer GL60... -
Page 12: Handling Test Strips
• You can touch any part of the test strip with clean, dry hands. • Do not bend, cut or otherwise modify the test strips. • Do not use test strips that have come into contact with fluids. Beurer GL60... -
Page 13: Initial Use And Basic Settings
14). Insert two new CR2032 batteries. Make sure that the batteries are inserted the correct way round in accordance with the markings. Observe the graphic in the battery compartment. Carefully close the battery compartment cover. Beurer GL60... -
Page 14: Making And Changing Basic Settings
Confirm by pressing the “ON/OFF” button. Setting the language Set the language by using the “+” and “-” buttons to switch between languages. The languages available are: DE, IT, EN, FR, ES and TR. Confirm your selection using the “ON/OFF” button. Beurer GL60... -
Page 15: Setting The Date And Time
• Use the lancing device only with lancet needles from the same manufacturer. Using other lancet needles may prevent the lancing device from working properly. • If using a lancing device from another manufacturer, please read the accompanying instructions for use. Beurer GL60... -
Page 16: Reading The Result And Labelling The Measurement Values
5.1 Reading the result and labelling the measurement values Reading the result As soon as the recess is su ciently filled with blood, the device performs the blood glucose measurement. The monitor counts down for approx. five seconds. The measurement is then shown on the display. Beurer GL60... -
Page 17: Final Steps And Disposal
• Please contact your physician if your symptoms are not in line with your measured blood glucose values and you have observed all instructions for the Beurer GL60 Blood Glucose Monitoring System. • Do not ignore symptoms of too high/low blood glucose levels. Consult your physician. - Page 18 Measurement result is outside Immediate medical treatment is the detectable range required. below 10 mg/dL (below 0.56 mmol/L) Low blood glucose level Have a suitable snack. Follow the instructions from your below 70 mg/dL physician. (below 3.9 mmol/L) mg/dL mmol/L Beurer GL60...
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Page 19: Functionality Check Using Control Solution
The operating range specified in the technical specifications is valid without restriction. Testing at room temperature serves as a general functionality check. The operating range specified in the technical specifications is valid without restriction. Beurer GL60... -
Page 20: Expected Results
Warning The specified range of values only applies for the control solution. This is not a recommended value for your blood glucose level. If measurements are outside the specified range, check the following possible causes: Beurer GL60... -
Page 21: Measured-Value Memory
• If you have already saved measured values and you reset the date, the average values are calculated as from the new period. • “---” indicates an empty measured-value memory. Press the “ON/OFF” button to switch o the device. Beurer GL60... -
Page 22: Displaying Individual Values
You can cancel the process at any time. To do so, press the “ON/OFF” button or wait until the device switches itself o automatically after 2 minutes. Pos. Meaning Average value Number of days, e.g. 7 Number of saved values used to calculate the average Beurer GL60... -
Page 23: Displaying Average Blood Glucose Values For Labelled Values
” repeatedly to display the average of “general” labelled values from the last 14, 30 and 90 days. You can cancel the process at any time. To do so, press the “ON/OFF” button or wait until the device switches itself o automatically after 2 minutes. Beurer GL60... -
Page 24: Transferring Of Measured Values
Storage Keep the Beurer GL60 measuring system in the case supplied after each measurement and do not expose it to direct sunlight. Note • Do not store the device, test strips or control solution in a vehicle, in the bathroom or in a cooling appliance! •... -
Page 25: Cleaning
Temperature of the measuring Repeat the test using a new test strip as soon as the environment, blood glucose monitor or measuring environment, monitor and test strip have test strip above the permitted range. reached the permissible operating temperature. Beurer GL60... - Page 26 The basic settings of the device were changed and Remove the test strip and press the “ON/OFF” button the changes were not completed (see “Making and until is displayed. changing basic settings” on page 14). Repeat test. Defective device. Contact Customer Services. Beurer GL60...
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Page 27: Technical Specifications
Test strip functionality Test strips enable a quantitative measurement of the glucose level in fresh whole blood. When the recess for collecting blood comes into contact with a droplet of blood, it is automatically filled by simple capillary action. Beurer GL60... - Page 28 99.65% Standards The Beurer GL60 measuring system complies with European guidelines IVD (98/79/EC) and MDR (EU) 2017/745). We hereby confirm that this product complies with the European RED Directive 2014/53/EU. The CE Declaration of Conformity for this product can be found under: https://www.beurer.com/web/we-landingpages/de/cedeclarationofconformity.php...
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Page 29: Comparison Of Measured Values With Laboratory Values
Precision Three batches of the GL60 blood glucose test strips were tested to assess the precision of the GL60 blood glucose measuring system. This included a repeatability assessment using venous blood and a laboratory precision assessment using the control material. -
Page 30: Usage Limitations For Specialist Personnel In The Healthcare Sector
(Within ±0.83 mmol/L or ±15%) 595/600 (99.2%) In comparison to the YSI, the GL60 met the EN ISO 15197:2015 standard, whereby 95% of the blood glucose values measured have to fall within the following ranges: either ±15 mg/dL (± 0.83 mmol/L) of the measured average value when using the reference measuring procedure for blood glucose concentrations of <100 mg/dL... - Page 31 75.226 mmol/L -7.7 mg/dL -4.1% (-0.43 mmol/L) Methyldopa 3 mg/dL 0.142 mmol/L 8.3 mg/dL -1.20% (0.46 mmol/L) Pralidoxime iodide 5 mg/dL 0.189 mmol/L 6.6 mg/dL -3.93% (0.37 mmol/L) Salicylate 500 µg/ml 3.62 mmol/L 3.7 mg/dL -2.2% (0.2 mmol/L) Beurer GL60...
- Page 32 -2.8 mg/dL -2.1 % (-0.15 mmol/L) Tetracycline 5 mg/dL 0.112 mmol/L -7.8 mg/dL -5.07 % (-0.43 mmol/L) Tolazamide 6 mg/dL 0.193 mmol/L 4.6 mg/dL 2.03 % (0.26 mmol/L) Xylitol 0.09 mg/dL 0.006 mmol/L -0.2 mg/dL -6.0 % (-0.01 mmol/L) Beurer GL60...
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Page 33: Instructions For Use Of The Ld 04 Lancing Device And The Soft Lancets
Repeatedly using the same area may cause inflammation, numbness or scarring. • Make sure the puncture area is hygienically clean. Risks to the device • Use the lancing device only with lancets from the same manufacturer. Using other lancets may permanently prevent the lancing device from working properly. Beurer GL60... -
Page 34: Device Description
Remove the protective lancet disc by turning it while holding the shaft of the lancet. Retain the protective disc for the safe disposal of the used lancet after taking a blood sample. Place the cap onto the lancing device. Beurer GL60... -
Page 35: Blood Sample From The Fingertip
If there is an insu cient amount of blood, repeat steps 1 to 7 with a greater penetration depth. Remove the test strip from the device using the test strip ejection slider. Carefully dispose of the test strip in accordance with the currently applicable regulations, to avoid infecting other people. Beurer GL60... -
Page 36: Final Steps And Disposal
It is essential to comply with the generally applicable safety precautions for handling blood when disposing of the lancing device and lancets. Carefully dispose of all blood samples and materials with which you have come into contact in order to prevent injury and infection of others. Beurer GL60... -
Page 37: Guarantee And Customer Services
Repairs or a full exchange do not extend the guarantee period under any circumstances. OUR COMMITMENT TO YOU: We aim to satisfy customers by providing high-quality medical devices and the best customer service. Please contact Customer Services if you are not entirely satisfied with the product. Beurer GL60... - Page 38 Available without need for a prescription from your pharmacist or outlets selling Beurer blood glucose monitors. Please contact our Customer Services team if you have any further questions concerning the lancing device. Current status of service addresses www.beurer.com/service Beurer GL60...
- Page 39 Beurer GL60...
- Page 40 ® The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Beurer GmbH is under license. Other trademarks and trade names are those of their respective owners. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S.
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