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1. ja auuunanwannnawanaaananuawanuunaan 19 5 4 Reading the result and labelling measurements ccccessessstesssteesseessseessseesesesessseeesaes 21 5 5 POSE DIOCESSING ANG GISDOSAl naa AABANGAN 22 5 6 Evaluating measured blood glucose Values 0a AA AA 23 o f Functional check using centre SOMMMOM aaa AA UA AA 25 6 Measurement MEMO aaa NAGKAANAK AGA 28 6eT Displaying IMG idaan aaa ANA AA 28 6 2 Displaying average blood glucose Yale 8 aman ama 29 6 3 Displaying average blood glucose values for labelled VaIUCS ccsccccesssecsssseeeesseeeesseaes 29 6 4 Deleting individual measured values from the memory ccccccececeseeseeeesseeeeseeesseessseeeseaes 31 bo Deleting all Stored VAISS aa AA AA 31 6 6 Evaluating measured values ona PO aaa AG ANA AA AA 31 7 Storing maintaining and disinfecting the device 32 Bl WAS MAING A EAE AA ETEA VEE T A AE O N N N 32 Te DANE aaa AA 32 8 What if there are problems 1 1 171117mmmnnmmrasmm 33 9 Technical specifications oo cc cecccceceescesesscseeseseesssssseesessessessseesssesstessnenseaneseeess 35 10 Guarantee and customer service XXXa aaa 38 Beurer GL50 mmol L 3 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 measurement body temperature pul
2. Repeat the test using a new bottle of control solution and or new test strip Bring the control solution test strips and blood glucose monitor to room temperature 20 C to 26 C and repeat the test Repeat the test using new correctly stored ac cessories test strips and control solution Repeat the test using a new test strip and or a new box of correctly stored test strips Repeat the test using a new bottle of control so lution and or new test strip from a new box Repeat the test and follow the instructions Contact Customer Services If you repeatedly obtain measured values outside the specified range when using control solution dis continue using the system to measure your blood glucose level Contact Customer Services Beurer GL50 mmol L 2f For each measurement your blood glucose value is automatically saved with the date and time un less LEL was activated for a blood glucose measurement using control solution The memory can store a maximum of 480 measured values If the memory is full the oldest value is replaced by the most recent value You can call up every individual measured blood glucose value You can also calculate and display the average value for the last 7 14 30 and 90 days i Note e f you have already saved measured values and you reset the date the average values are calculated as from the new period e indicates an empty memory for measured values Press the ON OFF
3. 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 NN Warning e 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 e The Beurer GL50 monitor provides a simple way of monitoring your own blood glucose levels how ever you may need to obtain information on how to use the system from your healthcare profes sional for example your GP chemist or diabetes consultant Only proper use will guarantee precise measurements e Alack 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 HHNKC may lead to incorrect measured results 8 Beurer GL50 mmol L e 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 55 the displayed blood glu cose value may be too low in the event of a very low hematocrit value below 30 it may be too high Consult your GP if you do not know your hematocrit value e Do not use the test strips to measure blood glucose values on newborns e Do not use NaF or potassium oxalate anticoagulants to prepare for v
4. Proceed as follows to delete stored values e Press the or button Mem and dt are displayed e Confirm by pressing the ON OFF button Mem and dt flash in the display e To irreversibly delete your values press the ON OFF button again to confirm Mem dti and Ux are displayed If you do not wish to delete your values press the or button Mem and ux are dis played again Confirm by pressing the ON OFF button The blood glucose monitor is now ready for use AN Warning e f the protective disc on a lancet needle has already been removed do not use the lancet needle e f you drop the lancing device with an inserted lancet needle carefully pick it up and dispose of the lancet AN Important e Use the lancing device only with lancet needles from the same manufacturer Using other lancet needles may prevent the lancing device from working properly e f you are using a third party lancing device please read the accompanying Instructions for use 5 1 Preparing to take a blood sample Choose a part of the body from which to take a blood sample The lancing device is intended for taking blood samples from the fingertip or other body parts such as the palm of the hand forearm or upper arm We recommend taking blood samples from the fingertip To make the procedure as painless as possible do not take samples directly from the centre of the fingertip b
5. The measured result is then shown on the display Evaluate result of functional test Check whether the result is within the specified range of results for the control solution This range of results is printed on the test strip box Expected results At room temperature the measured values from the test using the control solution should be within the range printed on the test strip box in approx 95 of all tests AN Warning The result range printed on the test strip box applies only to the control solution This is not a rec ommended value for your blood glucose level 26 Beurer GL50 mmol L If measured values are outside the specified range check the following possible causes e The first drop of control solution was not dis posed of e The tip of the bottle was not cleaned correct ly e The bottle was not shaken well enough Control solution or test strip is contaminated The control solution test strip or blood glucose monitor is too warm or too cold The test strips and control solution were kept at a temperature and humidity outside the speci fied range Damaged test strips Possible causes include e Test strips were exposed to fresh air for too long e Test strip box was not closed completely Test strip or control solution has expired Functional test using control solution was per formed incorrectly Problem with the blood glucose monitor AN Warning Rectify the cause and repeat the test
6. rectly Faulty test strip Blood was applied while the device was switched off The basic settings of the device have been changed and these changes were not com pleted see 4 2 Making and changing basic settings on page 15 Device faulty 34 Repeat test using a new test strip and a larger drop of blood Repeat the test using a new test strip Repeat the test using a new test strip and only apply blood when gt s flashes Remove the test strip and press the ON OFF button until OFF is displayed Repeat test Contact Customer Services Beurer GL50 mmol L Dimensions L x W x H 123 x 28 x 16 mm Weight 36 g incl batteries Power supply 2 x 3 V CR 2032 button cell batteries Battery life Over 1000 measurements Measured value memory 480 measured values with date time Data retained when batteries are changed Average values for 7 14 30 90 days Automatic switch off Two minutes after last actuation Storage Temperature 2 C 30 C transport temperature Relative humidity lt 90 Operating ranges Temperature 10 C 40 C Relative humidity lt 90 non condensing Measuring range glucose Glucose 1 1 35 0 mmol L Blood sample capillary whole blood Required volume of blood 0 6 microlitres Blood glucose measuring duration Approx 5 seconds Calibration Plasma Test procedure Amperometric bio sensor Usage Suitable for self testing System function test Each time device is switched on EMC This de
7. Repeat the test using a new test strip as soon as the measuring environment blood glucose monitor and test strips have reached room tem perature 20 C to 2670 Repeat the test using a new test strip as soon as the measuring environment blood glucose monitor and test strips have reached room tem perature 20 C to 2670 e Insert an unused test strip that has not ex pired e Repeat the blood glucose measurement Remove batteries reinsert batteries Contact Customer Services if the problem persists Repeat the measurement using a new test strip Remove batteries reinsert batteries Contact Customer Services if the problem persists Remove batteries reinsert batteries Contact Customer Services if the problem persists 33 Problem device does not switch on Batteries empty Incorrectly inserted or missing batteries Test strip inserted incorrectly or not completely Device faulty Replace batteries Check whether the batteries have been in serted correctly see 4 1 Removing the bat tery insulation strips replacing the batteries on page 14 Firmly insert the test strip into the slot on the device with the contacts first Make sure that the front of the test strip is facing you see Test strip on page 13 Contact Customer Services Problem the test does not start after inserting the test strip into the device and applying blood Insufficient blood or test strip not filled cor
8. button to switch off the device 6 1 Displaying individual values The individual values from the last 480 measurements are displayed The most recent measured value is displayed first and the oldest last The date and time are also displayed on the monitor at the same time Switch the monitor on using the on off button 1 The initial display is shown briefly Press the or rocker switch 3 Mem and the number of saved blood glucose tests are displayed briefly Image 1 The display then changes to the most recent saved value including the measurement unit date time Mem and any label Image 2 Cy CG o aj ka DI mmol L c 36 Gui nga Image 1 Image 2 Each time you press the rocker switch again first the memory space number will be displayed and then the relevant measured value You can display a maximum of 480 pre vious measurements You can cancel the process at any time To do so press the ON OFF button or wait until the device switches itself off automatically after two minutes 28 Beurer GL50 mmol L 6 2 Displaying average blood glucose values You can display the average measured blood glucose value from the last 7 14 30 and 90 days Switch the monitor on using the on off button 1 The initial display is shown briefly Press the rocker switch twice 3 The measurement unit of the blood glucose value Wi d and the average value are displayed this mea
9. removed If you have any doubts do not use the device and contact your retailer or the specified Customer Services address 3 in 1 monitor Lancing device plug in USB and monitor AST cap for taking blood samples from alternative parts of the body USB cover 10 test strips 10 sterile lancet needles 2 button cell batteries 3 V CR2032 already inserted 1 practical case DITIMIO O WI T These Instructions for use additional information e The blood glucose monitor A test strips D and additionally available control solutions have been specially designed to complement each other For this reason use only test strips D and control solutions that have been approved for this blood glucose monitor A O Note e Use original manufacturer accessories only Beurer GL50 mmol L 5 Follow up purchases You can also obtain test strips control solution and lancet needles without a prescription 50 test strips REF 464 15 Control solution LEVEL 3 and 4 REF 464 16 100 lancet needles REF 457 01 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 e Measure your blood glucose level e Display label and save measured values e Display the average measured blood glucose value from the last 7 14 30 and 90 days e Display the average of the labelled measured bloo
10. segments are missing stop using the device and immediately contact customer services To test whether the full display is completely displayed pull the test strip out of the device and hold the On Off button when subsequently switching on the device mmol L Beurer GL50 mmol L 19 20 Lancing to take a blood sample The lancing device can now be used to take a blood sample Make sure that the blood remains as a droplet and is not spread Blood sample from the fingertip Firmly position the lancing device slightly to the side of the centre of the fingertip Press the trigger Remove the lancing device from the finger A round drop of blood of at least 0 6 microlitres corresponds e to approx 1 4 mm original size e must have formed Blood sample from other body parts AST Find a soft area away from any bones without any visible blood ves sels and with as little hair as possible Warm the penetration area to a enhance circulation by gently massaging the area Press and hold the i lancing device against the penetration area for a few seconds and then press the trigger Continue to hold the lancing device against the I skin until a round drop of blood has formed under the cap Maintain the pressure until the drop of blood reaches a size of at least 0 6 mi crolitres corresponds to approx 1 4 mm original size Carefully remove the lancing device from the skin O Note Only take blood from other areas of the bo
11. General label e g after exercising Labelling measured values enables you your GP or diabetes consultant to better monitor your blood glucose values For example you can display the average values of all measurements taken before a meal To label a measurement proceed as follows The measured value can be labelled as soon as it is displayed Once the value disappears from the display it can no longer be labelled Press the rocker switch repeatedly e Pressing once adds the label Before a meal e Pressing again adds the label After a meal e Pressing a third time adds the label General label e Pressing a fourth time removes the label The selected label is stored in the memory of the device when it is switched off 5 5 Post processing and disposal Remove test strip Remove the test strip from the device and carefully dispose of it in ac cordance with the applicable regulations to avoid infecting others Remove cap Carefully remove the cap from the lancing device Ey 22 Beurer GL50 mmol L es Stick protective disc on needle Place the retained protective disc flat on a hard surface Stick the tip of the needle into the protective disc image 1 so the needle is cov ered image 2 akoy Image 1 Image 2 na Remove and dispose of lancet needle Press the trigger again so that you can grip the shaft Carefully remove the lancet needle from the lancing device and disp
12. a meal Below 7 8 mmol L 7 8 11 1 mmol L gt 11 1 mmol L Source German Diabetes Association Deutsche Diabetes Gesellschaft DDG 2009 Critical blood glucose values cam ga mmol L Ul l mmol L GT Gui AL BI faron m 24 Very low blood glucose level Below 1 1 mmol L Low blood glucose level Below 3 9 mmol L High blood glucose level e On empty stomach over 5 6 mmol L e Two hours after a meal over 7 8 mmol L High blood glucose level possibly ketones Above 13 3 mmol L Very high blood glucose level Above 35 0 mmol L Seek medical attention immedi ately Have a suitable snack Follow your GP s instructions If this high value persists two hours after your last meal this may indi cate hyperglycaemia Seek medi cal attention to coordinate any measures if applicable Perform a ketone test For this pur pose seek medical attention Take another measurement using a new test strip If the display is the same as before seek medical at tention immediately Beurer GL50 mmol L 5 7 Functional check using control solution The control solution is used to test the entire blood glucose monitoring system This helps to deter mine whether the monitor and the test strips are working optimally together and whether the test is being performed correctly Perform the control solution test if you suspect that the blood glucose monitor and or the test strips could be faulty or if you hav
13. d glucose values from the last 7 14 30 and 90 days e Set the time and date e Evaluate the saved measured values on a PC using special software The blood glucose monitor also includes the following monitoring functions e Warning in the event of unsuitable temperatures e Low battery display e Low test strips warning AN Warning e Do not use the device to diagnose diabetes it is intended for regular monitoring only e Consult your GP with regard to insulin doses 6 Beurer GL50 mmol L 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 taal Serial number ME yer Temperature limit 2 C 2 C to 30 C CG EX Not for re use For single use only 3 Use by VA Maximum shelf life after Gn initial opening in months YA Batch designation REF STERILE R Sterilised by radiation lancets N Warning see accompanying Ah documents YU In the Instructions for use the symbols represent the following NN Warning Manufacturer Please observe the Instructions for use PCT certification symbol for products that are exported to the Russian Federation and members of the CIS Green dot Der Gr ne Punkt German dual waste collection system Contents sufficient for lt n gt tests Order number Unit of measurement for blood glucose value Biohazard risk of infection Warning instruction indicating a risk
14. dy at the following times e On an empty stomach more than two hours after most recent meal e At least two hours after administration of insulin e At least two hours after physical activity Please also note the following e f the blood glucose test results do not match how you feel carry out another test using blood from your fingertip e DO NOT change your treatment purely on the basis of a measurement that was carried out us ing blood taken from an alternative area Carry out another test with blood from your fingertip in order to confirm the test result e f you often fail to notice that you have a low blood glucose level carry out a test using blood from your fingertip If necessary repeat the process If you do not obtain sufficient blood repeat the lancing process with a greater penetration depth in a different area Beurer GL50 mmol L Apply blood to the test strip Turn the monitor by 180 Hold the blood input gap at the tip of the test strip to the drops of blood until the gap is completely filled and the monitor in the display starts counting backwards OK Do not press the penetration area fingertip or other body parts to 6 the test strip The blood must not be spread The blood is sucked NY into the gap Ss O Note Error message Err 002 appears on the display if the gap was not correctly and sufficiently filled with blood Repeat the measurement using a new test strip and a greater
15. e repeatedly measured unusual blood glucose values Also test the blood glucose monitor if it has been dropped or is damaged The control solution is available separately Please observe the additional notes in the instructions for using the control solution for the test NN Important e Do not use third party control solution Correct functioning of your monitor can only be tested using Beurer LEVEL3 LEVEL4 control solutions e Control solution measurements When using the device specialist personnel must follow statutory guidelines e Do not apply any blood samples or control solutions to the test strip before inserting it in the moni tor Performing a functional test using control solution NN Warning To obtain correct results the monitor test strip and control solution must be the same temperature For the Functional test using control solution the temperature is to be between 20 C and 26 C Insert test strip Hold the blood glucose monitor so that the display is facing you Insert a test strip into the slot on the blood glucose monitor with the contacts first Make sure that the front of the test strip is facing you see 3 4 Test strips on page 13 Wait until the device is ready for use The device automatically switches on and briefly shows the initial display The device is ready for use as soon as the test strip symbol and the flashing blood droplet symbol 6 are displayed IMPORTANT Control solutions and blo
16. enous blood samples e Do not test any severely ill patients using this device e Lipemia effects High blood triglyceride values of up to 11 4 mmol L have minimum influence on the results However triglyceride values above this level may affect the blood glucose test e High blood cholesterol values of up to 13 mmol L have minimum influence on the results However cholesterol values above this level may affect the blood glucose test e Use fresh capillary whole blood only Do not use serum or plasma e Use capillary blood without squeezing the penetration area If the area is squeezed the blood is di luted with tissue fluid and this may lead to an incorrect result e Do not use the test strips above an altitude of 7010 m e Very high levels of humidity may influence the test results Relative humidity of more than 90 may lead to inexact results i Note The Beurer GL50 mmol L measuring system is intended for measuring capillary whole blood Storage and maintenance NN Warning e Store the blood glucose monitor and its accessories out of reach of small children and pets Small parts suchas lancet needles batteries or test strips may be life threatening when swallowed If swallowed seek medical attention immediately e 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 compon
17. ents The accuracy of the measurements and service life of the device depend on its careful handling e 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 e Do not drop the device Beurer GL50 mmol L 9 Batteries Saving measured values Warning e Keep batteries out of reach of children Children may put batteries in their mouth and swallow them This may severely damage their health In such cases seek medical assistance immediately e Normal batteries must not be charged heated or thrown into an open fire risk of explosion AN Important e Batteries must not be taken apart or short circuited e Always replace all batteries at the same time and use batteries of the same type e 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 e Leaking or damaged batteries may burn the skin therefore use suitable protective gloves if this is the case O Note e 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 e Use lithium ion batteries only Repairs O Note e Do not open the device Failure to comply will result in voiding of the warra
18. er upon purchase e Cases of personal negligence on the part of the customer e Outside interference The warranty does not affect the customer s statutory rights To assert a warranty claim within the warranty period the customer must provide proof of purchase The warranty claim must be submit ted within a period of 3 years from the date of purchase to BEURER GmbH Soflinger Stra e 218 D 89077 Ulm Germany In the event of a warranty claim the customer reserves the right to have the goods repaired at our own workshop or at a workshop authorised by us No further rights are granted to the customer on the basis of the warranty Customer service address Please contact our customer service if you have any questions Please refer to the address list enc losed for our customer service address OUR COMMITMENT TO YOU We aim to satisfy you by providing high quality medical products and the best customer service Please contact our customer service if you are not entirely satisfied with the product 38 Beurer GL50 mmol L j med beure saburya pue soua 01 108 qng gd F190 1 0WW 9919
19. he PC e t is not possible to save software entries on the USB stick Values are read only Beurer GL50 mmol L 31 Evaluating measured values on the PC The blood glucose monitor must be switched off Insert the monitor s USB connector into a free USB port on your PC In the event that the measuring device is not recognised please try using another active USB point 5b is shown on the display of the blood glucose monitor Saved data can now be viewed on your PC See the information on evaluating values in the software manual Storing Keep the Beurer GL50 blood glucose monitor in the case supplied after each measurement and do not expose it to direct sunlight O Note e Do not store the device test strips and control solution in your vehicle in the bathroom or in a cool ing appliance e Retain these Instructions for use e Remove the batteries if you do not intend to use the device for a prolonged period of time e Only clean the device when it is switched off 7A Maintenance Clean the surface of the device using a soft slightly damp cloth water or a mild cleaning solution Dry the device using a lint free cloth Make sure that moisture does not enter the test strip insertion slot Do not spray cleaning agent di rectly on the device Do not submerge the device in water or any other fluids and make sure that no fluids can enter the device 7 2 Disinfection Please comply with the generally applicable guide
20. ide 56 e Non reactive components 38 Control solution functionality The control solution contains a fixed amount of glucose that reacts with the test strip A test with control solution is similar to a blood test However control solution is used instead of blood The measured result using control solution must be within the result range This range is printed on each test strip box Chemical composition of the control solution The control solution is a red solution with the following D glucose level in percentage shares Ingredients Control solution LEVEL 3 Control solution LEVEL 4 D glucose 0 14 0 37 Non reactive components 99 86 99 63 Standards The Beurer GL50 blood glucose monitor complies with the European standards IVD 98 79 EC and MDD 93 42 EC Comparison of measured values with laboratory values Performance characteristics accuracy and precision Whole blood glucose test results were compared with the YSI 2300 laboratory device At a concentra tion of lt 4 2 mmol L 98 were at 0 8 mmol L while at a glucose concentration of 24 2 mmol L gt 98 were within 20 of the reference values The CV coefficient of variation is lt 5 The blood glucose monitor is therefore comparable to a laboratory system You will find further details and information regarding blood glucose results and various technologies in general medical literature on the subject 36 Beurer GL50 mmol L Usage limits for specialist personne
21. in USB 1 3 Monitor Front Rear 1 1 ON OFF button 1 Clip 2 2 Display 2 Battery cover 3 Rocker switch 3 Clip removable 4 Slot for test strips Beurer GL50 mmol L 11 3 2 Lancing device and lancet needles 1 AST cap transparent 2 Cap 3 Protective lancet disc 4 Sterile lancet needles il 5 Lancet holder 6 Dial for setting different penetration depths 1 7 Tensioning slider 8 Trigger 3 0 USB cover If you would like to use the blood glucose monitor without the integrated lancing device you can use the supplied USB cover in place of the lancing device 3 4 Display symbols 1 2 7 3 8 taai 9 noon 19 5 CC 44 6 1 Speaker symbol 7 Symbols for labelling measurements 2 Temperature symbol 8 Memory symbol 3 Replace battery symbol 9 Test strip and blood droplet symbol 4 Time 10 Blood glucose unit mg dL 5 Date not functional 6 Measured value display HI LO display 11 Blood glucose unit mmol L average blood glucose value ERR USB O Note To read the measured values correctly the underline must be below the measured values O Note The blood glucose monitor is supplied with the following basic settings e Blood glucose unit mmol L e Acoustic signal on e Backlighting on 12 Beurer GL50 mmol L 3 5 Test strips Front Rear 1 Gap for blood input 2 Handle 3 Contacts Insert the test strip into the device so that the contacts are pointing i
22. l from the healthcare sector 1 If the patient exhibits the following symptoms it may be the case that no correct values can be ob tained e Acute dehydration e Acute hypotension low blood pressure e Shock e Hyperosmolar hyperglycaemic condition with or without ketosis 2 Lipaemic samples cholesterol levels up to 13 mmol L and triglycerid levels up to 11 4 mmol L do not influence the results Severely lipaemic blood samples were not tested with the Beurer GL50 monitor therefore using the device with these samples is not recommended 3 Blood glucose monitors designed for home use should not be used for severely ill patients 4 The effect of interfering substances on the measurements depends on the concentration in the blood The maximum concentrations of certain substances listed below do not significantly influence the measurements Ascorbic acid 0 23 mmol L 10 9 1 8 4 6 Ibuprofen 2 42 mmol L 3 1 2 9 4 6 L dopa 0 09 mmol L 10 6 7 9 4 9 Sodium salicylate 3 12 mmol L 2 6 9 4 0 8 Tetracyclin 0 03 mmol L 5 3 3 8 3 2 Tolbutamide 3 70 mmol L 2 6 12 3 0 9 Unconjugated bilirubin 0 04 mmol L 2 5 4 1 0 2 Uric acid 0 48 mmol L 2 7 9 6 1 8 Xylose 0 27 mmol L 7 6 0 8 7 5 Beurer GL50 mmol L 37 Warranty We offer a 3 year product warranty against material and production faults The warranty does not cover e Damage due to improper operation e Wearing parts e Deficiencies already known to the custom
23. liance e Permitted relative air humidity below 90 e Keep the test strips in the original box only never use other containers 4 1 Removing the battery insulation strips replacing the batteries O HO e Two batteries are included with the blood glucose monitor These have already been inserted into the battery compartment ii Vey TIN e Remove the insulation strip before initial lt Il HI CYC Ji use IW LAX J Carefully pull the lancing device and monitor apart Then detach the removable clip Remove the battery compartment lid on the underside of the device To do so slide the cover in the direction of the imprinted arrow When replacing the batteries remove all batteries The de vice retains the date and time as long as one battery is still inserted If applicable reset the date and time see 4 2 Making and changing basic settings on page 15 Insert two new CR 2032 3 V batteries Make sure that the batteries are inserted the correct way round See the graphic in the battery compartment Close the battery compartment lid again carefully 14 Beurer GL50 mmol L KI Reattach the clip to the rear of the monitor Fit the lancing device and monitor back together O Note e f the replace battery symbol _ appears it means that the batteries are almost empty Replace both batteries as soon as possible e f LP appears on the display the battery power level is so low that
24. lines on disinfection when using the device on dif ferent persons Do not submerge the device in disinfection solutions or any other fluids and make sure that no fluids can enter the device The cap on the integrated lancing device can be disinfected with 70 7596 alcohol Disinfect the cap at least once a week and submerge the cap in alcohol for approx 10 minutes Allow the cap to air dry 32 Beurer GL50 mmol L O Note The blood glucose monitor is made of precision components The accuracy of the measurements and service life of the device depend on its careful handling e Protect the device from impacts and do not drop it e Protect the device from damaging factors such as moisture dirt dust blood control solution or water marked temperature fluctuations direct sunlight and extreme cold e Do not use the device in the vicinity of strong electromagnetic fields radio systems or mobile telephones Display messages on batteries and blood glucose measurement LP Batteries empty Ht Temperature of the measuring envi ronment blood glucose monitor or test strip above the permitted range Lt Temperature of the measuring envi ronment blood glucose monitor or test strip below the permitted range Err Used or contaminated test strip in TB serted Err 001 System error Er 002 Insufficient blood on the test strip Err 005 System error Unknown error messages Beurer GL50 mmol L Replace all batteries
25. mmol L beurer instructions for use GL50 GB i eff 3 IN 1 BLOOD GLUCOSE MONITOR step by step germanlengineering Beurer GmbH Soflinger StraBe 218 89077 Ulm Germany C www beurer com 0483 Contents 1 Getting to know your instrument cece ccceessestesseessesseaseestestesseeseensenseenes 4 1 1 Delivery scope replacements and ACCESSOLICS ccessssecsssseccesseecessseeessssseesssseseessseeeesas 5 1 2 FUCUOMS OT NG DEVICE aaa AGA AA AA 6 1 3 SIGNSANISYMOO15 4na APA ANA GRANADA 7 2 Warnings and safety notes XrrrsBsrsrrsrsrsr amma 8 3 Description of units and accessories 11 1 mn eeseseeseseeseesenenstanesenees 11 SEO Cr OS MONO aan AA 11 3 2 Lancing device and lancet negdIk5 aa Ana AA 12 TS WOOD ONE e E acre ccs KA AA AA AA AA 12 aaa Bilal E AA AG CA 12 3 3 IE SDS ama E E E 13 4 Initial use and basic settings nn 14 4 1 Removing the battery insulation strips replacing the batteries mmausuannuwanuuuanan 14 4 2 Making and changing Dasic Settings aaa Aa Kapa 15 5 Taking measurements 00 0 cccccscssesssssessessestestesseseessssesseseeseessassstsseessansarsaeseeseeseeees 16 5 1 Preparing to take a blood sample Lana AA AG 16 5 2 Preparing the lancing device for taking a sample munannnwawnnaaananananaanananananunansunnaaa 17 5 3 Taking a blood sample and measuring the glucose level
26. ncet until it audibly engages and it cannot be pushed further into the holder Beurer GL50 mmol L 17 Remove the protective lancet disc Remove the protective lancet disc by turning clockwise Retain the protective disc for the safe disposal of the used lancet needle after taking a blood sample Select cap and attach You need to use a different cap depending on the area from which you take the sample Fingertip Cap black Other body parts AST cap transparent AN Warning Do not use the AST cap to take blood samples from the finger Place the selected cap on the lancing device Make sure that the curved part of the cap fits on the curved part of the lancing device Press firmly on the cap until it audibly engages Select the penetration depth You can set seven different penetration depths on the lancing device using the dial with raised bars The length of the bar represents the re quired penetration depth e 1 to 2 soft or thin skin e 3 to 5 normal skin e 6 to 7 thick or callous skin Turn the dial until the required bar is in the centre of the black mark ing Tension the lancing device Pull the slider in the direction of the arrow to the right in the image un til it stops and then release The slider automatically springs back into position The lancing device is now tensioned Beurer GL50 mmol L 5 3 Taking a blood sample and measuring the glucose level NN Important e Change the punctu
27. no more measurements can be taken 4 2 Making and changing basic settings Remove the batteries and reinsert them Alternatively hold down the but a l ton and the ON OFF button for a minimum of five seconds I if l An acoustic signal sounds l Ll IL The year display flashes oi Setting the date and time O Note e You must set the date and time Otherwise you will not be able to save your measured values correctly with a date and time and access them again later e The time is displayed in the 24 hour format Set the year calendar to 2099 by pressing the or button Confirm by pressing the ON OFF button The day display flashes Proceed as described above for the month day hour and minute 215P Lik and on are displayed The background of the display is simultaneously illuminated for a few seconds Switch backlighting on off To switch the blue backlighting off press the or button 215P Lit and DFF are displayed Confirm by pressing the ON OFF button bEEP on and the speaker symbol are displayed Switching the acoustic signal on off To switch the acoustic signal off press the or button bEEP and OFF are displayed The speaker symbol is no longer shown in the display Confirm by pressing the ON OFF button OK and Mem are displayed Beurer GL50 mmol L 15 Deleting stored values
28. ns 07 7 d days Press repeatedly to display the average value for 7 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 off automatically after two minutes 1 Number of days e g 7 for which the average value is calculated 2 Number of saved values used to calculate the average e g 8 3 Average value 6 3 Displaying average blood glucose values for labelled values You can display the average measured blood glucose value for labelled values from the last 7 14 30 and 90 days Switch the monitor on using the on off button 1 The initial display is shown briefly Press the rocker switch twice 3 The measurement unit of the blood glucose value id and the average of all measured values are displayed this means 07 7 d days Beurer GL50 mmol L 29 Press repeatedly to display the average value of all measured values for 14 30 and 90 days After the average of all measured values for 90 days is displayed e the seven day average for values measured before a meal e the symbol e the unit of measurement for blood glucose values and e 7 g are shown on the display Press repeatedly to display the average blood glucose level from the last 14 30 and 90 days taken before a meal After the average value for 90 days taken before a meal is displayed e the seven day ave
29. nside the slot Make sure that the front of the test strip is facing you i Note Read carefully the following information on handling and storing your test strips The test strips will only provide accurate measured results if all notes are followed NN Warning Use each test strip only once and for one patient only Handling test strips O Note e Securely close the test strip box immediately after taking out a test strip e Do not use the test strips if they have expired The use of expired test strips may lead to incorrect measurements The expiry date is printed on the box next to the hourglass symbol amp Beurer GL50 mmol L 13 e Test strips expire three months after the box is opened Make a note of the expiry date opening date 3 months on the label The shelf life is limited to the expiry date see date next to the hourglass symbol 5 e Discontinue use of the test strips if one of the two expiry dates has passed 2 e You can touch any part of the test strip with clean dry hands e Use the test strip for measurement immediately after removing it from the box e Do not bend cut or otherwise modify the test strips e Do not use test strips that have come into contact with fluids Storing test strips O Note e Keep the test strips in a cool dry place above 2 C and below 30 C Do not expose the test strips to direct sunlight or heat Do not store in your vehicle in the bathroom or in a cooling app
30. nty e Do not repair the device Proper operation can no longer be guaranteed in this case e Please contact Customer Services for repairs Disposal AN Warning e tis essential to comply with the generally applicable safety precautions for handling blood when dis posing of materials from 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 e After use dispose of test strips and lancets in a puncture proof container O 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 10 Beurer GL50 mmol L The codes below are printed on batteries containing harmful substances e Pb Battery contains lead e Cd Battery contains cadmium e Hg Battery contains mercury Ph Cd Hg of its useful life Please dispose of the unit in accordance with EC Directive 2002 96 EC WEEE Waste Electrical and Electronic Equipment If you have any questions please con For environmental reasons do not dispose of the device in the household waste at the end X tact the local authorities responsible for waste disposal E 3 1 Blood glucose monitor An overview of the monitor 1 Lancing device 2 Plug
31. od react to temperature influences in different ways It is therefore of vital importance that control solution measurement is always performed in control solution mode If this mode is not used results may be obtained that are outside the target range Activate control mode Press the rocker switch or to change to control mode tt is shown on the display In control mode the measured value is not saved meaning your statistics will not be affected However if you do want to save the control measurement in the memory press the rocker switch or again CEL disappears from the display Beurer GL50 mmol L 25 Drip control solution on surface Choose a clean surface to carry out the functional test correctly Shake the con trol solution well before use Undo the cap and press two drops next to each Q other on the clean surface without touch ing them Use the second drop for the measurement O Note Never apply the control solution straight from the bottle to a test strip Reason The remain ing solution in the bottle will be contaminated if the top of the bottle comes into contact with the test strip Apply drop to the test strip Hold the input gap at the tip of the test strip to the drop of control solution until the gap is completely filled When the gap is sufficiently filled with solution the device performs a measurement The device counts down for approx five seconds
32. of injury or damage to your health your patient s health AN Important Safety note indicating possible damage to the unit accessory i Note Note on important information Beurer GL50 mmol L Risk of infection All components of the blood glucose monitor and its accessories may come into contact D with human blood and are therefore a possible source of infections J NN Warning e This blood glucose monitor must display the blood glucose content in mmol L The unit of measurement mmol L accompanies each blood glucose value Please contact Customer Serv ices if the device does not display mmol L 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 e When using the blood glucose monitor for various persons observe the generally applicable regula tions regarding disinfection safety and contamination e 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 e 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 e Use a new sterile lancet needle for each blood sample for single use only General notes AN Warning
33. ose of the lancet in a puncture proof container Carefully dispose of all blood samples and materials that you have come into contact with This prevents injuries and the infection of others sT Replace cap Place the cap back on the device Turn the clip back over the cap 5 6 Evaluating measured blood glucose values Your blood glucose monitor can process values between 1 1 and 35 0 mmol L The La warning is displayed for measured results below 1 1 mmol L The Hi warning is displayed for measured re sults above 35 0 mmol L NN Warning e f you suspect that the blood glucose results are incorrect first repeat the test and if applicable perform a functional test using control solution Seek medical advice if dubious results persist e Seek medical attention immediately if your symptoms do not correspond to your measured blood glucose values and you have followed all instructions for the Beurer GL50 blood glucose monitor e Do not ignore symptoms of too high low blood glucose levels Always seek medical attention Beurer GL50 mmol L 23 Blood glucose The following table provides a classification of blood glucose values according to the diabetes guide lines of the German Diabetes Association Deutsche Diabetes Gesellschaft DDG On an empty stomach e Whole blood capillary Below 5 0 mmol L 5 0 6 1 mmol L gt 6 1 mmol L haemolysed e Plasma venous Below 5 6 mmol L 5 6 6 9 mmol L 5 6 9 mmol L Two hours after
34. penetration depth O Note e Do not add blood later if the device does not start measurement Remove the test strip and end this test Use a new test strip e f the test strip has already been inserted into the device but no blood is added to the test strip within two minutes the device switches itself off Briefly remove the test strip and reinsert it so that the device automatically switches itself back on e Contact Customer Services if you are unable to cover the test strip in blood correctly 5 4 Reading the result and labelling measurements Read the result Hold the blood glucose monitor so that the display is facing you Beurer logo on the right hand side As soon as the blood input gap is filled with sufficient blood the device performs the blood glucose measurement The blood glucose monitor counts down for approx five seconds The measured result is then shown on the display Read your measured value Check again that you have read the result correctly The underline must be below the measured value otherwise you need to turn the monitor by 180 For explanations of and measures regarding the measured values see 5 6 Evaluating measured blood glucose val ues on page 23 If an error message is displayed read chapter 8 What if there are problems on page 33 Beurer GL50 mmol L 21 Label measured value You have the following options for labelling measured values Before a meal After a meal e
35. rage for values measured after a meal e the symbol e the unit of measurement for blood glucose values and e a d are shown on the display Press repeatedly to display the average blood glucose level from the last 14 30 and 90 days taken after a meal Y After the average value for 90 days taken after a meal is displayed e the average for the last seven days of values labelled as general e the symbol e the unit of measurement for blood glucose values and e ng d are shown on the display Press repeatedly to display the average blood glucose level from the last 14 30 and 90 days for values labelled as general 3 You can cancel the process at any time To do so press the ON OFF button or wait until the device switches itself off automatically after two minutes Beurer GL50 mmol L 6 4 Deleting individual measured values from the memory Press the buttons as described in 6 1 Displaying individual values on page 28 until the value that you would like to delete is displayed Press and hold the ON OFF button Also press the button for two seconds JEL Mem and the number of the value to be deleted flash Press the ON OFF button again dEL the number of the value to be deleted Mem and OK are displayed If you do not wish to delete the value briefly press the or button You are taken back to the memo
36. re area each time you take a measurement e g use a different finger or the other hand Repeatedly using the same area may cause inflammation or scarring e f the cap is not in place there is a risk of injury from the exposed lancet e Do not squeeze your finger to obtain a larger drop of blood If squeezed the blood is diluted with tissue fluid and this may lead to an incorrect result e Please note that insufficient blood circulation at the puncture area e g caused by cold temperatures or illness can lead to incorrect results AN Warning Do not apply any blood samples or control solutions to the test strip before inserting it in the monitor Prepare the test strip Take a test strip from the box and immediately close it again Use the test strip within three minutes of removing it from the box Insert test strip Take the monitor in your left hand Hold the blood glu cose monitor so that the display is facing you and the Beurer logo is on the right hand side Insert the test strip into the slot on the rear end of the blood glucose monitor with the contacts first Make sure that the front of the test strip is facing you You can touch any part of the test strip with clean dry hands The device switches on automatically The device switches on automatically and briefly shows the full display The device is ready for use as soon as the test strip symbol and the flashing blood droplet symbol are displayed NN Warning If
37. ry area The device then indicates that the subsequent measured value has moved to the memory space of the deleted measured value 6 5 Deleting all stored values Proceed as described in 4 2 Making and changing basic settings under the section entitled Delet ing stored values on page 16 6 6 Evaluating measured values on a PC The GL50 monitor features an integrated plug in USB stick The blood glucose evaluation software GlucoMemory is installed on the USB stick for position of the USB connection see page 11 The GL50 is compatible with Diabass and SiDiary The blood glucose evaluation software GlucoMemory is pre installed on the monitor s USB stick You do not need to install the software locally on a PC This software enables you to evaluate your measured values add insulin doses and print or export your results as a PDF or CSV file The soft ware helps you and your GP to better monitor your blood glucose level For more information please read software manual for the GlucoMemory software Including all the ne cessary information and a detailed description of how to use the software in English and German O Note e An effective evaluation is only possible if you have set the date and time correctly see Setting the date and time on page 15 e Measurements cannot be taken while the USB stick is connected to a PC e The measurements remain saved on the blood glucose monitor when the USB stick is removed from t
38. se 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 Getting to know your instrument The GL50 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 dis play the average of all measured values thereby providing optimum assistance for monitoring your diabetes The test is performed exclusively externally IVD The backlit display shows 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 measure ments The device can be connected directly to a PC using the integrated USB connection You can evaluate the measured values on your PC using special software in English and German and use the results to monitor your blood glucose values 4 Beurer GL50 mmol L 1 1 Delivery scope replacements and accessories Check that the set packaging has not been tampered with and make sure that all contents are pre sent Before use ensure that there is no visible damage to the device or accessories and that all packaging material has been
39. ut slightly to either side NN Warning e In the event of suspected hypoglycaemia take blood from the fingertip only Reason changes to blood glucose levels can be detected quickly in blood samples taken from the fingertip e Blood samples from the fingertip and samples taken from another body part AST may pro duce completely different results It is essential to seek medical advice before taking meas urements from other body parts 16 Beurer GL50 mmol L Prepare all parts Prepare the following items GL50 monitor A test strip box D and sterile lancet needles E You will also need the AST cap for measurements on other parts of the body B Wash your hands Wash your hands with soap and warm water before taking a blood sample This not only en sures optimal hygiene but also encourages good blood circulation at the puncture area on the finger Dry your hands carefully Also ensure that the puncture area is hygienically clean when taking blood samples from other body parts AST NN Warning If you have used alcohol for cleaning ensure that the area has fully dried prior to measuring 5 2 Preparing the lancing device for taking a sample Remove cap First bend the clip backwards Hold the monitor by the lancing device cover in one hand With your other hand remove the cap from the lancing device 7 ngg Insert lancet needle Insert a sterile lancet needle into the lancing device Push firmly on the la
40. vice complies with the European standard EN 61326 and is subject to specific precautions with regard to electromagnetic compatibility Please note that portable and mobile HF communica tion systems may interfere with this unit For more details please contact Customer Services at the address indicated Test strip functionality Test strips enable a quantitative measurement of the glucose level in fresh whole blood When the gap for taking blood comes into contact with a drop of blood it is automatically filled by simple capillary action The blood is sucked into the absorbing gap on the test strip and the blood glucose monitor measures the blood glucose level in the blood The test is based on the measurement of an electric current that is generated by the chemical reaction of the glucose with the enzyme glucose dehydrogenase Aspergillus sp on the strip During the reaction a mediator transports electrons through the electrode surface and so gener ates a current The blood glucose monitor analyses this current The current flow is proportional to the glucose con tent in the blood sample The results are shown on the blood glucose monitor display Beurer GL50 mmol L 35 Only a small amount of blood is required 0 6 microlitres and measurement takes approx five sec onds The test strip detects blood glucose values from 1 1 to 35 0 mmol L Chemical components of the test strip sensor e FAD glucose dehydrogenase 6 e Potassium ferricyan

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