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User Manual

042

1-08-0

1-02_R1_24/02/20

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

Self-Monitoring Blood Glucose Meter

Please read this manual thoroughly before
first using this device

Содержание smart LAB mini

Страница 1: ...ser Manual D10421 08 01 02_R1_24 02 2011 HMM Diagnostics GmbH D 69221 Dossenheim Germany www hmm info Self Monitoring Blood Glucose Meter Please read this manual thoroughly before first using this device ...

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Страница 3: ...nstalling batteries 13 Function check 14 Notes on using smartLAB pro blood glucose test strips 15 Note on smartLAB NO CODE test strips 16 Running a blood glucose test 17 Alternate Site Testing AST with the transparent cap 19 Reading stored test results from memory 20 Understanding your test results 20 Control solution testing 23 IV Miscellaneous Maintenance 27 Troubleshooting 28 Limitations of the...

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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 mini system is easy to use you should consult your healthcare profes sional this may be your doctor diabetes nurse educator or phar m...

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 mini meter and displayed on the screen after 5 seconds Intended use This blood glucose m...

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 te...

Страница 8: ... for single use only Warning for potential biohazard Healthcare professionals using this system on multiple patients should be aware that all products or objects that come in contact with human blood even after clean ing should be handled as if capable of transmitting viral disease Do not touch the test strip with wet hands Do not use expired test strips see expiration date on the strip vial Do no...

Страница 9: ...20 630 mg dL 1 1 35 0 mmol L 3 Measuring duration 5 seconds 4 Memory 20 values 5 Operating temperature 10 C 40 C 50 F 104 F 6 Relative humidity RH 90 7 Blood sample 0 6 µL capillary whole blood 8 Calibration Plasma equivalent 9 Hematocrit Hct 30 55 10 Battery type 2 CR 3V Lithium bat teries 11 Battery life over 3000 measurements 12 Display size 30 x 30 mm 13 Meter dimensions 80 x 50 x 5 mm 14 Weig...

Страница 10: ...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 11: ...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 12: ...meter 1 User manual 1 smartLAB plastic box 2 CR 2032 3V batteries 1 smartLAB lancing device 1 smartLAB Check Strip 1 smartLAB Quick Start instruction 10 smartLAB lancets 10 smartLAB problood glucose test strips Optional 1 smartLAB control solution ...

Страница 13: ...and the low battery symbol appear on the LCD display Open the battery lid on the back side of the smartLAB mini meter and insert batteries with plus sign to top First insert the battery on the right side and then press the left side down until it clicks 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 ...

Страница 14: ...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 properly FAL change batteries and check again If the message still ap pears please refer to your local supplier 3 Remove check strip The ...

Страница 15: ...se only Do not reuse it Record the date you first open the test strip vial Be sure to check the Expiration Date on the test strip vial The test strip is good for three months from the date the vial is opened or until the Expiration Date on the vial whichever comes first Store the test strip vial and your meter in a cool dry place Store the test strips below 30 C 86 F Do not freeze Do not apply blo...

Страница 16: ...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 17: ...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 18: ...correct measurement The measurement is finished with another signal beep and the meas ured value is shown on the display 5 Storing memories The displayed result is automatically stored in the memory of the meter If more than 20 results are reached the oldest one is de leted 6 Discarding used test strips and lancets Write down the measured result in your personal diabetic log book and take the test...

Страница 19: ...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 desired 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 20: ...ways in clude a decimal 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 ...

Страница 21: ...ed 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 may affect results Do not test near an operating microwave oven Symptoms of high or low blood glucose Being aware of the symptoms of high or low blood glucose can help you understand your test results and decide what to do if t...

Страница 22: ...pare its results to lab devices Your blood glucose can change quickly especially after eating tak ing medication or exercising If you test yourself in the morning then go to the doctor s office for a blood glucose test the results will probably not match even if you are fasting This is typically not a problem with your meter it just means that time has elapsed and your blood glucose has changed If...

Страница 23: ...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 consump tion or injection use only with smartLAB pro test strips Shake the smartLAB control solution well before each use Write the ...

Страница 24: ...rip 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 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 smartLA...

Страница 25: ...he 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 re sults with corresponding units 4 Understanding control test results The label on your test strip vial shows the acceptable ranges for the smartLAB co...

Страница 26: ...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 27: ...ins Following these guidelines carefully will help you get ting the best performance possible Gently wipe the meter s surface with a soft cloth Do not get any 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 ...

Страница 28: ...Display LP Battery symbol Solution Replace with new batteries System error Display 001 Error Solution Replace batteries first If the error still occurs please contact your local supplier System error Display FAL Solution Re insert the ceheck strip with writ ing to top If FAL still occurs please contact your local supplier ...

Страница 29: ...trip 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 next measurement until the error does not ...

Страница 30: ...se 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 Test result is higher than 630 mg dL 35 0 mmol L Display HI Solution Test again If the result is still too high please contact your doctor immediately Test result is under 20 mg dL 1 1 mmol L Display LO Solution Test again If the result is ...

Страница 31: ... 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 hematocrit level consult your healthcare professional 8 Interfering substances...

Страница 32: ...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 33: ...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 34: ...iagnostics 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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