User Manual
Contents
1. smartLAB _ mini n Self Monitoring Blood Glucose Meter User Manual Please read this manual thoroughly befo re first using this device HMM Diagnostics GmbH Friedrichstra e 89 D 69221 Dossenheim Germany www hmm info 31 32 Contents I Introduction Measuring principle Intended use Important information Note on smartLAB nG NO CODE test strips II Your smartLAB mini nG Display amp functions Specifications The smartLAB nG test strips Explanation of symbols Set Contents III Setup amp Operating procedures Installing batteries Function check Notes on using smartLAB nG blood glucose test strips Running a blood glucose test Alternate Site Testing AST with the transparent cap Reading stored test results from memory Understanding your test results IV Miscellaneous Maintenance Troubleshooting Limitations of the measurement procedure Regularity and Safety Notice Warranty 35 36 36 37 39 40 40 40 41 42 42 43 43 44 45 46 48 49 49 52 52 53 56 59 59 33 Mm O WH I 34 I Introduction Thank you for using the smartLAB mini nG Self Monitoring Blood Glucose System SMBG This system was designed to be depend amp able easy to use compact lightweight and portable to help you monitor your blood glucose on a regular basis Please read this manual thoroughly before you begin testing It pro vides you and your diabetes care team w2. F Do not freeze e Do not apply blood or control solution to the test strip before you insert it into the meter e Do not touch the test strip with wet hands Do not bend cut or twist the test strips 45 Running a blood glucose test 1 Preparations Before running a blood glucose test make yourself acquaint with the test strips and the lancing device Keep all required ma terials ready for use your smartLAB mini nG meter the smartLAB nG test strips and the smartLAB lancing device includ ing lancets Wash your hands thoroughly with warm water before colleting the blood sample Rinse your hands thoroughly 2 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 3 Collecting a blood sample When the blood drop flashes on the display gently massage the part of your finger tip which you obtain a drop of blood from us ing the lancing device Place the lancing device against the pad of your finger Press the trigger button to activate the lancing device 46 4 Blood glucose measurement Hold the application zone of the test strip vertically onto the blood sample The blood is automatically sucked in the reaction zone of the test strip Be sure to get enough blood on the strip s amp reaction zone otherwise an inaccurate reading may result The signal tone indicates that enough
3. Test results may be false if the patient is severely dehydrated or severely hypertensive in shock or in hypoglycemic hyperosmo lar state with or without ketosis Critically ill patients should not be tested with home 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 6mmol L do not affect the results Grossly lipemic patient samples have not been tested and are not recommended for testing with smartLAB mini nG Blood Glucose System 57 _HSTTING 17 Interfering Substances depend on the concentration The below substances up to the test concentration will not affect the test results bf the interferance tested a 4 mmol L 13 9 mmol L 27 8 mmol L Tetracycline 1 5 mg dL 0 03 mmol L 5 32 3 20 Tolbutamide 100 mg dL 3 70 mmol L 2 60 12 30 0 80 89 Bilirubin 5 o used 2 4 mg dL 0 04 mmol L 2 52 4 05 0 23 58 Regularity and Safety Notice WEEE note The WEEE Waste Electrical and Electronic Equipment Directive that came into effect as European law on 13th February 2003 led to a major change in the disposal of electrical equipment The pri
4. F 8 Blood sample gt 0 6 uL capillary or Battery power Error code Code number smartLAB _ venous whole blood 9 Calibration Plasma equivalent 10 Hematocnt Hct 30 55 11 Battery type 2 CR 3V Lithium bat teries 12 Battery life over 3000 measurements 13 Display size 30 x 30 mm 14 Meter dimensions 80 x 50 x 5 mm 15 Weight 20g without batteries 16 Transportation temperature 20 C 50 C 4 F 122 F 17 Transportation humidity RH lt 90 40 The smartLAB nG test strips Electrode Insert direction 3 T Grip zone Reaction zone oo A Aperture A Application zone Vial opening date ple ase note Expiration date Note You can find the test strip expi ration date on the vial label next to the amp symbol 41 Explanation of symbols eE SO frog AD Caution This product meets the requirements of Directive 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 Opening date of test strip vial Set contents 1 smartLAB mini nG blood glucose meter 1 User manual 1 Wallet for safe transportation 2 CR 2032 3V batteries 1 smartLAB lancing device 1 smartLAB Check Strip 1 smartLAB Quick Start instruction 10 smartLAB lance
5. Germany mail info hmm info www hmm info Weitere Informationen zu den smartLAB Produkten More information on our smartLAB products www smartlab org 60
6. Solution Test again If the result is still too low please contact your doctor immediately 55 Limitations of the measurement procedure 1 DO NOT use serum or plasma sample 2 DO NOT use neonate blood sample 3 DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation 4 Extreme humidity may affect the results A relative humidity gre ater than 90 may cause incorrect results 5 The system is designed to be used at temperatures between 10 C and 40 C 50 F and 104 F Outside this range the system may yield erroneous results 6 DO NOT reuse the test 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 do not know your hema tocrit level consult your healthcare professional 9 Critically ill patients should not be tested with smartLAB nG Blood Glucose Systems 10 DO NOT use during xylose absorption testing Xylose in the blood will interfere Self Monitoring Blood Glucose System 56 11 Patients undergoing oxygen therapy may have inaccurate re sults 12 Altitude up to 3050 meters above sea level has no effect on readings 13
7. blood entered 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 correct measurement The measurement is finished with another signal beep and the measured value is shown on the display 5 Storing memories The displayed result 1s automatically stored in the memory of the meter If more than 20 results are reached the oldest one is deleted 6 Discarding used test strips 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 of the lancet of according to local regulations 47 Alternate Site Testing AST with the transparent cap You can also gain the blood sample from other parts of the body than the finger tip If you want to use Alternate Site Testing please use the trans parent cap for your lancing device Carry out the following steps e Gently massage the desired punctuation site on your arm or hand for a few seconds This will improve the blood circula tion Alternate Blood Collection Sites e Push the lancing device with the transpa
8. ght to ensure a longer lifespan e The strip slot should be kept free from dirt dust blood stains and water stains e Do not store the meter and test strips in a car a bathroom or 37 a refrigerator And the meter strips and lancing device should be kept away from children or pets Remove batteries if the meter will not be used for one month or more Store the kits in a dry place with temperature range is 2 to 30 C 35 6 to 86 F Keep away from direct sunlight and heat Store your test strips in their original vial only Do not transfer them to a new vial or any other container Indicate the date you open the vial D Discard all unused strips immediately after 90 days from open date The strips are for single use only You should not test critically ill patients 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 objects that come in contact with human blood even after cleaning should be handled as if capable of trans mitting a viral disease Please dispose device according to the local rule of the dispo sition of electronic device accessory waste If the equipment is used in a manner not specified by the ma nufacturer the protection provided by the equipment may be 38 impaired Do not touch the test strip with wet hands Do not use expired test strips see expiration date on the st
9. ith important information and step by step direction to use meter correctly Although your smartLAB mini 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 distributor in your country during business hours 35 Measuring principle The smartLAB mini nG Self Monitoring Blood Glucose System is de signed to allow rapid measurement of blood glucose by using an electrochemical biosensor technology This system employs a dis posable dry reagent strip technology based on the FAD binding glucose dehydrogenase Each test strip features an electrode containing FAD binding glu cose dehydrogenase A capillary blood sample is applied to the col lecting area of the strip and is automatically drawn into the reac tion zone where the FAD binding 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 mini nG will show glucose concen tration on the screen Intended use The smartLAB mini nG is intended for the quanti
10. marily purpose of this directive is to prevent electronic was te WEEE while encouraging for reuse recycling and other forms of reprocessing to reduce waste 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 collection and proper recycling of electronic waste helps dealing economically with natural resources Furthermore the recycling of electrical waste gums 15 a contribution to the conservation of our environment and thus the health of all people More information concerning the disposal of elec trical and electronic devices reprocessing and the collection points you can get from the local authorities waste disposal companies from retailers and manufacturers of the device Warranty HMM Diagnostics GmbH products need to fulfill high quality requi rements Because of this 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 regis ter your product Please register online under following website www hmm info en registration Wear parts batteries etc are excluded from warranty 59 m z O WH I Hersteller Manufacturer HMM Diagnostics GmbH Friedrichstr 89 D 69221 Dossenheim
11. ood glucose range appropriate for you Unusual test results If your blood glucose result doesn t match the way you feel follow 49 these steps and then repeat the test 1 Check if the strips are within the expiration date 2 Be sure that the drop of blood completely filled the reaction zone of the test strip 3 Do a function control test with the smartLAB check strip 4 Repeat the Measurement If the values of the repeated measurements are however questiona ble and do not match the way you feel please contact your health care professional before you change your medication Note 1 Extremely high humidity may affect the test results A relative humidity greater than 90 may cause inaccurate results 2 Ared 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 symptoms of high or low blood glucose can help you understand your test results and decide what to do if they seem unusual A high blood glucose would be greater than 240 mg dL 13 33 mmol L A low blood glucose would be below 60 mg dL 3 33 mmol L Here are the most common symptoms High blood glucose hyperglycemia fatigue increased appetite or thirst frequent urination blurred vision headache general ach ing or
12. rent cap against the desired blood collection site and push the trigger button to gain a sample e Exercise a constant pressure until you see through the trans parent cap that enough blood is gained After that you can carry out the blood glucose test as usual 48 Reading stored test results from memory You can read the last 20 test results on the internal memory of your smartLAB mini nG meter by inserting the check strip The results will be shown chronologically on the display HSTTON Understanding your test results The smartLAB nG blood glucose test strips are plasma referenced and calibrated for easier comparison to lab results The unit of blood glucose test results displayed on the screen is either mg dL or mmol L depending on which unit of measurement you have selected The mmol L results will always include a decimal point mg dL results do not include a decimal point Expected results for non diabetic adults The normal fasting glucose range is 70 to 100 mg dL 3 9 to 6 1 mmol L Two 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 professional for the bl
13. rip vial Do not bend cut or twist the strip Consult with your healthcare professional before testing on your palm or forearm Altitude up to 3 048 meters above sea level has no effect on readings _HSTTING gt be BE Health Related Information e If you are experiencing dehydration frequent urination low blood pressure shock or hyperosmolar hyperglycemic nonke totic coma HHNKC you may get a test result that is lower than what your blood glucose really is If you think you are dehydrated call your healthcare professional right away e 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 profes sional e Please read your test strip instructions carefully for additional health related information Note on smartLAB nG NO CODE test strips The smartLAB nG blood glucose test strips compatible with smartLAB 1G glucose systems need not to be coded any more 39 II Your smartLAB mini nG Display amp functions Test result Measuring unit Apply Thermometer blood to the test strip Specifications 1 Type smartLAB mini nG 2 Measuring range 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 lt 90 7 Storage Temperature 20 C 50 C 4 F 122
14. rs please contact your local supplier 53 Memory error Display 005 Error Solution Replace batteries first If Err still occurs please contact your local supplier Test strip already used or wet Display Err amp Test strip symbol Solution Use a new test strip Temperature too high Display Ht amp 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 occur again 54 Temperature too low Display Lt amp Thermometer symbol The operating temperature is too low below 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 occur again HSTTING 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 immedia tely Test result is under 20 mg dL 1 1 mmol L Display LO
15. tative measure ment of glucose in venous whole blood or fresh capillary whole blood from fingertips palm and forearm Testing is done outside the body In Vitro diagnostic use It is indicated for self testing over the counter OTC by persons with diabetes or in clinical settings by healthcare professionals as an aid to monitor the ef fectiveness of diabetes control The meter should be used only with smartLAB 1G blood glucose test strips 36 Important information e The smartLAB mini nG blood glucose meter is designed and approved for testing venous whole blood or fresh capillary whole blood samples from your fingertips palm and forearm The meter is for in vitro diagnostic use ONLY for testing out side the body It should not be used to diagnose diabetes N3 HSI e The smartLAB mini nG blood glucose meter can only be used with smartLAB nG Blood Glucose Test Strips Other test strips will give inaccurate results e Severe impact may cause the meter to malfunction Do not di sassemble the meter as it may damage components inside and cause an incorrect reading The warranty will be void if the meter has been disassembled e Testing is not valid for neonatal blood specimens e Incorrect results may occur when performing the test If you believe you are not feeling well please contact your healthcare professional immediately e Always keep the meter clean and store it in a safe place Pro tect from direct sunli
16. to 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 produce the following messages on the display e OK your meter works properly e FAL change batteries and check again If the message still appears please refer to your local supplier 3 Remove check strip The meter will turn off automatically after removing the test strip Please keep the check strip in the soft case of the meter 44 Notes on using smartLAB nG blood glucose test strips e Use only with smartLAB nG Blood Glucose Meters e Runa control solution test every time you open a new box o test strips e Keep the test strips in their original bottle e After you take a test strip out of the bottle tightly close the bottle immediately This keeps the test strips dry e Use the test strip within three minutes after taking it out of the bottle e The strip is for single use only Do not reuse it e 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 e Store the test strip bottle and your meter in a cool dry place e Store the test strips between 2 C 30 C 36 F 86
17. ts 10 smartLAB nG blood glucose test strips 42 III Setup amp Operating procedures Installing batteries _HSTTING batteries Batteries will normally last for aprox 3000 tests Other types of CR 3V lithium batteries are also accept able yet the capacity of test times may differ Install the batteries when you first use the meter by remv ing the battery protection or replace with new batteries when the LP message and the low battery symbol appear on the LCD dis play Open the battery lid on the back side of the smartLAB mini nG 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 The display will light up for one second Afterwards the device will turn off automatically The meter uses two CR 2032 3V Lithium LP Low battery symbol 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 their usage 43 Function check You can carry out a function check with the Check Strip which is included in your meter set You do not have to do the function check before every measurement It helps you to control if your smartLAB nG meter works properly from time to time though 1 Insert check strip in
18. vomiting 50 Low blood glucose hypoglycemia sweating trembling blurred vision rapid heartbeat tingling or numbness around mouth or fingertips If you are experiencing any of these symptoms test your blood glu cose If your blood glucose result is displayed greater than 240 mg dL 13 33 mmol L or below 60 mg dL 3 33 mmol L and you have symptoms of low or high blood glucose contact your doctor immediately If your blood glucose result does not match how you feel follow the steps under Unusual Test Results Comparing your meter s result to a lab result A common question is how the blood glucose results on your meter compare to the lab results Your blood glucose 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 lab result you must be fasting Bring your meter to the doctor s office and test yourself by fingertips within five minutes of having blood drawn from your arm by a healthcare professional Keep in mind that the lab could use different technology than smartLAB mini nG Blood Glucose System and that blood glucose meters for self testing generally read somewhat lo
19. wer or higher than the lab result For accuracy and precision data and for important information on limitations see the instructions that come with your test strips 51 m Q m l nH IV Miscellaneous Maintenance Your smartLAB mini nG blood glucose meter does not require any special cleaning Just keep the meter free of dirt dust blood and water stains 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 A Please do not spray any cleaning solution directly onto the meter A Do not pour liquid into the system or put the meter 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 A Please make sure that no liquids enter the meter s apertures 52 Troubleshooting Note If you are not sure how to react on error codes please contact your local supplier HSTTING Battery empty Display LP amp Battery symbol N Solution Replace with new batteries 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 strip and restart the measurement procedure System error Display 001 Error Solution Replace batteries first If the error still occu
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