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User Manual

0539-08-0

1-02_R2_24/02/20

HMM Diagnostics GmbH
D-69221 Dossenheim, Germany
www.hmm.info

Self-Monitoring Blood Glucose System

Please read this manual thoroughly before first
using this device

Содержание smartLAB Sprint

Страница 1: ...er Manual D10539 08 01 02_R2_24 02 2011 HMM Diagnostics GmbH D 69221 Dossenheim Germany www hmm info Self Monitoring Blood Glucose System Please read this manual thoroughly before first using this device ...

Страница 2: ......

Страница 3: ...10 The smartLAB pro test strips 12 Explanation of symbols 13 III Setup functions Insert batteries 15 Turning the meter on off 16 Function check 19 Control solution testing 20 Running a blood glucose test 24 Alternate Site Testing AST with the transparent cap 27 Understanding your test results 28 Displaying stored results 32 Displaying average values 33 Additional device settings 34 ...

Страница 4: ...IV Miscellaneous Maintenance 38 Frequently Asked Questions 38 Troubleshooting 42 Limitations of the measurement procedure 45 Warranty 47 ...

Страница 5: ... assist you in monitoring your blood glucose on a regular basis Please read this manual thoroughly before you begin testing It provides you and your diabetes care team with important information and step by step direction to use meter correctly Although your smartLAB sprint system is easy to use you should consult your healthcare profes sional this may be your doctor diabetes nurse educator or pha...

Страница 6: ... catalyzes the oxidation of glucose to produce glyconic acid During the reaction a mediator transfers electrons to the electrode surface and generates a cur rent The amount of the current is proportional to the amount of glucose present in the blood sample The glucose concentration is measured by your smartLAB sprint meter and displayed on the screen after 5 seconds Intended use This blood glucose...

Страница 7: ...the meter clean and store it in a safe place Protect from direct sunlight to ensure a longer lifespan The strip slot should be kept free from dirt dust blood stains and water stains Do not store the meter and test strips in a car a bathroom or a refrigerator And the meter strips and lancing device should be kept away from children or pets Please refer to the limitations of the procedure before tes...

Страница 8: ...ls using this system on multiple patients should be aware that all prod ucts or objects that come in contact with human blood even after cleaning should be handled as if capable of transmitting viral disease You can download the test results from the meter memory to a computer for more in depth analysis Requires according soft ware and a Bluetooth interface Do not touch the test strip with wet han...

Страница 9: ...d Code 888 That is because all test strip charges only use this code This will make it easier for you to use your smartLAB product free from errors Avoidance of coding errors If Code 888 DOES NOT appear while inserting a test strip your meter either needs to be recoded or your glucose meter is not com patible with these smartLAB pro blood glucose test strips In either case please contact your dist...

Страница 10: ... 20 630 mg dL 1 1 35 0 mmol L 3 Measuring duration 5 seconds 4 Time mode AM PM 24 hours 5 Memory 450 values 6 Operating temperature 10 C 40 C 50 F 104 F 7 Relative humidity RH 90 8 Blood sample 0 6 µL capillary whole blood 9 Calibration Plasma equivalent 10 Hematocrit Hct 30 55 11 Battery type 2 1 5 V AAA Lithium batteries 12 Battery life over 1000 measure ments 11 Display size 40 x 32 mm 12 Meter...

Страница 11: ... can download values to your PC with this port S Button right side Turn on the meter or enter setting mode In setting mode memory but ton M Button left side Displays stored values In setting mode selection key TEST STRIP INSERTION SLOT Insert the test or check strip here ...

Страница 12: ...test strips Note You can find the test strip expira tion date on the vial label next to the symbol Expiration date Vial opening date please note Electrode Insert direction Grip zone Reaction zone Aperture Application zone ...

Страница 13: ...ve 98 79 CE for in vitro diagnostic medical devices Lot number Expiration date For in vitro diagnostic use only Use Lithium battery CR 2032 3V Single use only Storage temperature Manufacturer Before use read manual first Catalogue number Serial number Control solution Opening date of test strip vial ...

Страница 14: ... 1 User manual 1 carrying bag 2 AAA 1 5V Alkali batteries 1 smartLAB lancing device 1 smartLAB Check Strip 1 smartLAB Quick Start instruction 10 smartLAB lancets 10 smartLAB problood glucose test strips 1 smartLAB control solution 1 smartLAB warranty card ...

Страница 15: ... Open the battery lid on the back side of the smartLAB sprint meter and insert the batteries pay ing attention to the polarity Close the battery lid Note 1 Remove the batteries when you will not be using the meter for one month or longer 2 Values won t be deleted when the batteries are replaced Meter batteries lancets test strips etc must be disposed of according to local regulations at the end of...

Страница 16: ... S button longer than 3 seconds Du ring the shut down process the current year flashes on the display until it turns off Setting date time and measuring unit When inserting or replacing the batteries date time and the measuring unit have to be set again if the displayed values are not correct Carry out the following steps 1 Enter setting mode With the meter switched on press the S button to enter ...

Страница 17: ...irst two digits for the month start flashing To change the value press M to save and continue with day setting press the S button To change the day value push the M button and fi nally save your settings with the S button 3 Setting the time After having set the date the colon between hours and minutes starts flashing Press the M button to choose between AM PM and 24 hours system Note AM means the ...

Страница 18: ...button After that proceed in the same way for the minute setting 4 Choosing a measurement unit After the time setting the meter automatically continues with the measurement unit setting The LCD reads SCL and mg dL Press the M button for approx 10 seconds to change the unit to mmol L Save your settings by pushing the S button Your smartLAB sprint setting is now completed ...

Страница 19: ... you to control if your smartLAB meter works properly from time to time though 1 Insert check strip into the meter Make sure your check strip is inserted with writing to top The meter will turn on automatically and the display will show CHK 2 Check message in LCD display The function check will take approx 3 seconds The check can pro duce the following messages on the display OK your meter works p...

Страница 20: ...u have repeated a test and the test results are still lower or higher than expected You are practicing the test procedure Note Professional users are instructed to follow federal state and local guidelines concerning QC practices About the smartLAB control solution smartLAB control solution is for in vitro diagnostic use only smartLAB control solution is not intended for human consumption or injec...

Страница 21: ... 30 C 86 F Do not freeze nor refrigerate Running a smartLAB control solution test Please make sure you have all necessary items at hand when run ning a control solution test You need the smartLAB sprint meter a smartLAB pro test strip and smartLAB control solution 1 Switch on the meter Take a strip out of the vial and immediately close it Insert the strip into the meter in the direction of the arr...

Страница 22: ... note OK indicates a cor rect measurement The measurement is finished with another signal beep and the measured value is shown on the display Leave the test strip in its slot 3 Comparing the results acceptable range Compare the result with the acceptable range indicated on the test strip vial The acceptable range is indicated in both units mg dL and mmol L Please pay attention on comparing the res...

Страница 23: ...er work properly You can use the check strip to verify the meter s functions Is the control solution expired or conta minated Replace with new control solution to check the performance of your glu cose meter Were test strips and control solution stored in a cool and dry place Repeat the control test with properly stored strips or control solutions Did you follow the testing steps prop erly Read Ch...

Страница 24: ...ut of the vial and immediately close it Insert the strip into the meter in the direction of the arrow on the strip The meter turns on automatically Code 888 appears on the display and af terwards the symbol for applying blood In case Code 888 DOES NOT appear on the display please contact your supplier see chapter Note on smartLAB NO CODE test strips 3 Collecting a blood sample When the blood drop ...

Страница 25: ...tered the reaction zone The meter will now start with the measurement which will last 5 seconds The LCD display shows the remaining time of measurement in seconds Afterwards the note OK indicates a cor rect measurement The measurement is finished with another signal beep and the measured value is shown on the display Note To avoid infections never let anyone else use your lancing device and lancet...

Страница 26: ...trips and lancets Write down the measured result in your personal diabetic log book and take the test strip off the strip slot The meter turns off If you don t take off the test strip the meter will turn off automatically after 5 minutes In order to discard lancets from the smartLAB lancing device remove the end cap and carefully pull the used lancet out of the holder Dispose the lancet according ...

Страница 27: ...ng steps Gently massage the desired punctuation site on your arm or hand for a few seconds This will improve the blood circulation Push the lancing device with the transparent cap against the de sired blood collection site and push the trigger button to gain a sample Exercise a constant pressure until you see through the transpar ent cap that enough blood is gained After that you can carry out the...

Страница 28: ...imal point mg dL results do not include a decimal point If LO appears on the display the monitor has determined that your blood glucose level is lower than 1 1 mmol L or 20 mg dL If HI appears on the display the monitor has determined that your blood glucose level is higher than 35 mmol L or 630 mg dL Please refer to the User Manual for instructions on warning messages Expected results for non dia...

Страница 29: ...sult your healthcare professional before making any changes to your diabetes medication program Note 1 Extremely high humidity may affect the test results A relative humidity greater than 90 may cause inaccurate results 2 A red blood cell count Hematocrit that is either very high above 55 or very low below 30 may not provide accurate results 3 Some studies have shown that electromagnetic fields ma...

Страница 30: ...result to a lab result In order to compare the results of your smartLAB sprint me ter with a laboratory meter it must be guaranteed that both use the same measuring method whole blood measurement Your smartLAB sprint is a plasma calibrated meter This makes it easier to compare its results to lab devices Your blood glucose can change quickly especially after eating tak ing medication or exercising ...

Страница 31: ...of having blood drawn from your arm by a healthcare professional Keep in mind that the lab uses different technology than the meter and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result ...

Страница 32: ...nd the glucose value in its measuring unit By pressing the S but ton again you can go to the next before measured value This way you can scroll through all test results starting with the most recent one 3 Deleting test results Select the test result you want to delete as explained above Keep the M button pushed until dEL and then OK appears on the dis play You will hear a signal tone as well After...

Страница 33: ...lue of the last 7 days By pressing the S button you can switch to the average values of the last 14 or 28 days Pushing the M button will exit the memory mode and bring you back to measurement mode In memo ry mode your meter will power off automatically after 2 minutes when no button is pushed If a test or check strip is in the insertion slot your smartLAB sprint meter will automatically power off ...

Страница 34: ...urrent out side temperature With the meter switched on keep the M button pushed and then press the S button in addition Keep both buttons pushed for at least 3 seconds The LCD will read MEM while both buttons are pushed You can release the buttons when you see C in the upper right display corner and the thermometer symbol in the lower right corner Now the current temperature will be shown To switc...

Страница 35: ...utton Saving with mode OFF Meter will go to the signal tone setting Saving with mode ON You will now have to enter the alarm clock time First both digits for hours are flashing If the meter is set on 24 hours you can adjust the hours by pushing the M button If the current time is after 12 00 o clock you will have to push the M button twelve consecutive times until AM is replaced by PM on the displ...

Страница 36: ...shing the S button 3 Signal tone setting After the alarm settings the meter automatically switches to the signal tone setting mode You can either switch on or off the signal tones of your smartLAB sprint meter Press the M button to choose between ON or OFF and save your settings by pressing the S button Switch signal tones on or off ...

Страница 37: ...d in the left display corner month 2 digits and day 2 digits If you remain in that mode the alarm clock will be activated whenever the clock shows the same time which has been set in the alarm clock mode To stop the alarm press the M button Otherwise the alarm will automatically turn off after 10 seconds Press the M button to leave the additional device settings ...

Страница 38: ...moisture in the test strip slot To clean the lancing device use a mild dishwashing liquid and a soft cloth DO NOT place the entire device under water Please make sure that no liquids enter the meter s apertures Frequently Asked Questions 1 The device won t turn on Please check Are the batteries inserted correctly Are the batteries empty and need to be replaced 2 No symbol after inserting the test ...

Страница 39: ... used Please use a new test strip 5 Blood glucose result too high low Please check Was the test strip exposed to air for a long time Take out the strips from the vial directly before the measurement since humidity and other environmental influences may affect the test result Was the test strip vial tightly closed Humidity and other environmental influences may affect the test results Alternatively...

Страница 40: ...Acid 8 mg dL or 0 5 mmol L Levodopa 10 mg dL or 0 5 mmol L Dopamine 10 mg dL or 0 5 mmol L Methyldopa 2 5 mg dL or 0 12 mmoll L Uric Acid 14 mg dL or 0 4 mmol L 8 Patients undergoing oxygen therapy may have inaccurate results 9 Altitude up to 3050 meters above sea level has no effect on read ings 10 Test results may be false if the patient is severely dehydrated or severely hypertensive in shock o...

Страница 41: ... 13 Grossly lipemic fatty samples may interfere with some meth odologies To be aware of such interferences patients under the supervision of their physician should have baseline glucose val ues established by a clinical laboratory method prior to start ing home glucose monitoring These baseline values should be checked periodically thereafter ...

Страница 42: ...supplier Battery empty Display LP Battery symbol Solution Replace with new batteries Test strip already used or wet Display Err Test strip symbol Solution Use a new test strip System error Display 001 Error Solution Replace batteries first If the error still occurs please contact your local supplier ...

Страница 43: ...oo low please contact your doctor immediately Temperature too high Display Ht Thermometer symbol The operating temperature is too high above the required temperature range from 10 C 40 C 50 F 104 F The error is a warning that a continuation under these conditions might lead to wrong blood glucose readings Solution Take the meter to a location with appropriate working temperature and wait for the n...

Страница 44: ...ning that a continuation under these conditions might lead to wrong blood glucose readings Solution Take the meter to a location with ap propriate working temperature and wait for the next measurement until the error does not oc cur again System error Display FAL Solution Re insert the check strip with writing to top If FAL still occurs please contact your local supplier ...

Страница 45: ... sodium fluoride oxalate as a preservative for blood specimens 7 Hematocrit Test strip results are not significantly affected by hematocrits in range of 30 to 55 Hematocrit levels less than 30 may cause incorrect high readings and hematocrit levels greater than 55 may cause incorrect low readings If you do not know your hema tocrit level consult your healthcare professional 8 Interfering substance...

Страница 46: ...holesterol and triglyceride levels may interfere with the way light is reflected producing erroneous meter results 13 Recent studies have shown that EMI can cause electronic medi cal device performance degradation and could lead to inappro priate therapy 14 Grossly lipemic fatty samples may interfere with some meth odologies To be aware of such interferences patients under the supervision of their...

Страница 47: ...s reason HMM Diagnostics GmbH gives a 2 year war ranty by purchasing this smartLAB product You can even extend the warranty from 2 to 5 years without extra pay when you register your product Please use the warranty card included in your product set Wear parts batteries etc are excluded from warranty ...

Страница 48: ...gnostics GmbH Friedrichstr 89 D 69221 Dossenheim Germany mail info hmm info www hmm info Manufacturer Weitere Informationen zu den smartLAB Produkten More information on our smartLAB products www smartlab org ...

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