HMM SmartLAB, User Manual

Page 1: ...l HMM Diagnostics GmbH Friedrichstraße 89 D 69221 Dossenheim Germany www hmm info Self Monitoring Blood Glucose System with wireless data transfer Please read this manual thoroughly before first using this device ...

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Page 3: ...cifications 48 The smartLAB nG test strips 49 Explanation of symbols 50 Set content 50 III Setup Operating procedures 51 Installing batteries 51 Function check 52 Wireless Data transfer 53 Notes on using smartLAB nG blood glucose test strips 55 Running a blood glucose test 56 Alternate Site Testing AST with the transparent cap 59 Understanding your test results 60 Optional Control Solution Testing...

Page 4: ...42 IV Miscellaneous 67 Maintenance 67 Troubleshooting 68 Limitations of the measurement procedure 72 Regularity and Safety Notice 74 Warranty 75 ...

Page 5: ...ep by step direction to use meter correctly Although your smartLAB global W nG System is easy to use you should consult your healthcare professional this may be your doctor diabetes nurse educator or pharmacist for instructions on how to use the system The only way to obtain accurate results from any system is to make sure you correctly use it If you have any concerns please call your authorized d...

Page 6: ...g glucose dehydrogenase catalyzes the glucose dehydrogenation It will produce gluconolactone During the reaction a mediator transfers electrons to the electrode surface and generates a current The amount of the current is pro portional to the amount of glucose present in the blood sample After 5 seconds the smartLAB global W nG will show glucose con centration on the screen Intended use This blood...

Page 7: ...malfunction Do not disas semble the meter as it may damage components inside and cause an incorrect reading The warranty will be void if the meter has been disassembled Testing is not valid for neonatal blood specimens Incorrect results may occur when performing the test If you believe you are not feeling well please contact your healthcare professional immediately Always keep the meter clean and ...

Page 8: ...s with home use blood glucose meters Warning for potential biohazard Healthcare professionals using this system on multiple patients should be aware that all products or ob jects that come in contact with human blood even after cleaning should be handled as if capable of transmitting a viral disease Please dispose device according to the local rule of the disposition of electronic device accessory...

Page 9: ...ower than what your blood glucose really is If you think you are dehydrated call your healthcare professional right away If you have followed the steps in the user s manual but still have symptoms that do not seem to match your test results or if you have questions please contact your healthcare professional Please read your test strip instructions carefully for additional health related informati...

Page 10: ...6 Operating temperature 10 C 40 C 50 F 104 F 7 Storage Temperature 20 C 50 C 4 F 122 F 8 Relative humidity RH 90 9 Blood sample 0 6 µL capillary whole blood 10 Calibration Plasma equivalent 11 Hematocrit Hct 30 55 12 Battery type 2 CR 3V Lithium batteries 13 Battery life approx 500 measure ments 14 Display size 30 x 30 mm 15 Meter dimensions 80 x 50 x 5 mm 16 Weight 30g without batteries 17 Data t...

Page 11: ... nG 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 ...

Page 12: ... Storage temperature Manufacturer Before use read manual first Catalogue number Serial number Control solution Opening date of test strip vial Set contents 1 smartLAB global W nG blood glucose meter 1 User manual 1 hard box 2 CR 2032 3V batteries 1 smartLAB lancing device 1 smartLAB Check Strip 1 smartLAB Quick Start instruction 10 smartLAB lancets 10 smartLAB nGblood glucose test strips 1 smartLA...

Page 13: ...st insert the battery on the right side and then press the left side down until it clicks Close the battery lid The display will light up and all symbold will blink for around 10 seconds Afterwards you can use the device Note 1 Remove the batteries when not using the meter for one month or longer 2 Values won t be deleted when the batteries are replaced 3 The device needs to be set again after bat...

Page 14: ...ing 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 After showing OK the device will start to send measu...

Page 15: ...ry protection the display will blink for 5 seconds which indicates that the device is trying to communicate with the gateway to set the device After each measurement the device will send the data to the gate way Saved Data will be transfered automatically every 30 minutes or together with a new Mesaurment You can also manually transfer measured data Please go to Chaper Manually transfer not sent d...

Page 16: ...On the display the wireless symbol will flash afterwards the device is now trying to communicate with gateway and send all data which have not been send yet The last 20 measured values will show display The results will be shown chronologically on the display the first for 3 se conds the values afterwards for 1 second The device will turn off when removing the Check Strip ...

Page 17: ... the bottle The strip is for single use only Do not reuse it Record the date you open the test strip bottle Be sure to check the expiration date on the test strip bottle The test strip is good for 6 months from the date the bottle is opened or until the expiration date on the bottle whichever comes first Store the test strip bottle and your meter in a cool dry place Store the test strips between 2...

Page 18: ...t the strip into the meter in the direction of the arrow on the strip The meter turns on automatically The symbol for applying blood will appear on the display Note If the device could not be set by the gateway after changing the batteries you can still run a blood glucose test When inserting a test strip the display will show nod After that the symbol for applying blood will appear on the display...

Page 19: ...ith 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 480 results are reached the oldest one is de leted After every measurement the meter tries to connect to another pre installed ANT or BLE partner please refer to the chapter Wireless data transfer in this manual to learn how...

Page 20: ...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 re move the end cap and carefully pull the used lancet out of the hol der Dispose the lancet according to local regulations in order to avoid hurting other people Reading stored test results from memory You can re...

Page 21: ...lowing 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 ...

Page 22: ...hours after meals normal glucose values should be less than 120 mg dL 6 7 mmol L Expected results for diabetic adults The normal fasting blood glucose range for an adult with diabetes is 70 130 mg dL 3 9 7 2 mmol L Two hours after meals the blood glucose range for an adult with diabetes is less than 180 mg dL 10 0 mmol L For further queries about diabetes please consult your healthcare professiona...

Page 23: ...y high humidity may affect the test results A relative humidity greater than 90 may cause inaccurate results 2 A red blood cell count Hematocrit below 30 may cause higher results Hematocrit above 55 may cause lower 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 sy...

Page 24: ...ucose can change quickly especially after eating taking 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 you want to compare your meter result to the ...

Page 25: ...cing the test procedure Note Professional users are instructed to follow federal state and local guidelines concerning QC practices About the smartLAB nG control solution smartLAB nG control solution is not intended for human consumption or injection Use only with smartLAB nG test strips Write the date you first opened the bottle on the bottle label The smartLAB nG control solution is durable for ...

Page 26: ...e 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 and the symbol for applying blood 2 Running the control solution test When the symbol for applying blood appears shortly shake the bottle with the smartLAB nG control solution Open the bottle and wipe the tip of the bottle with a tissue Squeeze a little drop o...

Page 27: ...nt is finished with another beep signal 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 results with corresponding units ...

Page 28: ... to open air for a long period of time Repeat the control test with properly stored strips Was the test strip vial capped tightly Or was test strip cap left open If the cap was not tight or the bottle was left uncapped open a new bottle of test strips Do not reuse the strips from the affected bottle Does the meter work properly You can use the check strip to verify the meter s functions Is the con...

Page 29: ...he best performance possible Gently wipe the meter s sur face with a soft cloth Do not get any moisture in the test strip slot Please do not spray any cleaning solution directly onto the system Do not pour liquid into the system or put the system under water or liquid To clean the lancing device use a mild dishwashing liquid and a soft cloth DO NOT place the entire device under water Please make s...

Page 30: ...fter measurement the meter tries to transfer the value to the gateway but a connection can not be established Solution Make sure meter and partner device are in close communication proximity If nec essary set up the Wireless connection again Not enough blood in test strip Display Err and test strip with hand If not enough blood is in the test strip this error will show Solution Use a new test stri...

Page 31: ... Display 005 Error Solution Replace batteries first If Err still oc curs please contact your local supplier Test strip already used or wet Display Err Test strip symbol Solution Use a new test strip 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 ...

Page 32: ...ng 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 occur again Test result is under 20 mg dL 1 1 mmol L Display LO Solution Test again If the result is still too low please contact your doctor immediately ...

Page 33: ...olution 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 Error 002 Display ERR 002 Solution Device was not set by gateway When inserting batteries again please be close to a g...

Page 34: ...strips The test strips are intended for single use only 7 DO NOT use iodoacetic acid fluoride or sodium fluoride oxalate as a preservative for blood specimens 8 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...

Page 35: ...me use blood glucose meter 14 Elevated cholesterol and triglyceride levels may interfere with the way light is reflected producing erroneous meter results 15 Recent studies have shown that EMI can cause electronic medi cal device performance degradation and could lead to inappro priate therapy 16 Lipemic samples Cholesterol level up to 500 mg dL 12 92 mmol L and triglycerides up to 3 000 mg dL 33 ...

Page 36: ...50 1 2006 A11 2009 A1 2010 A12 2011 80 mg dL 4 4 mmol L 250 mg dL 13 9 mmol L 500 mg dL 27 8 mmol L Ascorbic Acid 4 mg dL 0 26 mmol L 10 89 1 76 4 55 Ibuprofen 50 mg dL 2 43 mmol L 3 10 2 88 4 62 L Dopa 1 8 mg dL 0 09 mmol L 10 59 7 91 4 90 Sodium Salicylate 50 mg dL 3 12 mmol L 2 59 9 42 0 84 Tetracycline 1 5 mg dL 0 03 mmol L 5 32 3 81 3 20 Tolbutamide 100 mg dL 3 70 mmol L 2 60 12 30 0 89 Bilir...

Page 37: ...egister online under following website www hmm info en registration Wear parts batteries etc are excluded from warranty L The WEEE logo on the product and the packaging indicates that it is not allowed to dispose of the product in the ordinary household waste It is your responsibility to deliver all the disused electrical and electronic equipment to the respective collection points A separate coll...

Page 38: ...ics GmbH Friedrichstr 89 D 69221 Dossenheim Germany mail info hmm info www hmm info Hersteller Manufacturer Weitere Informationen zu den smartLAB Produkten More information on our smartLAB products www smartlab org ...