HMM SmartLAB User Manual

Self-monitoring blood glucose system with wireless data transfer

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Self-Monitoring Blood Glucose System with wireless data transfer
Please read this manual thoroughly before first
using this device
User Manual
HMM Diagnostics GmbH
Friedrichstraße 89
D-69221 Dossenheim, Germany
www.hmm.info

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Summary of Contents for HMM SmartLAB

  • Page 1 Self-Monitoring Blood Glucose System with wireless data transfer User Manual Please read this manual thoroughly before first using this device HMM Diagnostics GmbH Friedrichstraße 89 D-69221 Dossenheim, Germany www.hmm.info...
  • Page 3: Table Of Contents

    Set content III. Setup & Operating procedures Installing batteries Function check Wireless Data transfer Notes on using smartLAB nG blood glucose test strips ® Running a blood glucose test Alternate Site Testing (AST) with the transparent cap Understanding your test results...
  • Page 4 IV. Miscellaneous Maintenance Troubleshooting Limitations of the measurement procedure Regularity and Safety Notice Warranty...
  • Page 5: Introduction

    I. Introduction Thank you for using the smartLAB global W nG Self-Monitoring ® Blood Glucose System. This system was produced in close associa- tion with diabetes health care professionals, hospitals and, most importantly, people with diabetes. The measuring results can help you determine the effects of food, exercise and diabetes medica- tions.
  • Page 6: Measuring Principle

    It is used outside the body only (In-vitro diagnostic use). The meter should be used only with smartLAB nG blood glu- ®...
  • Page 7: Important Information

    Important information The smartLAB • ® global W nG blood glucose meter is designed and ap- proved 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 outside the body). It should not be used to diagnose diabetes.
  • Page 8 • 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. •...
  • Page 9: Note On Smartlab ® Ng „No Code" Test Strips

    • 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 ®...
  • Page 10: Your Smartlab ® Global W Ng

    II. Your smartLAB global W nG ® Display & functions M e a s u r i n g result M e a s u r i n g unit Thermometer Apply Wireless blood or con- trol solution to Battery power...
  • Page 11: The Smartlab ® Ng Test Strips

    The smartLAB nG test strips ® Electrode Insert direction Grip zone Reaction zone Aperture Application zone Vial opening date (please note) Expiration date Note: You can find the test strip expira- tion date on the vial label next to the ...
  • Page 12: Explanation Of Symbols

    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 ®...
  • Page 13: Iii. Setup & Operating Procedures

    “LP” mes- sage and the low battery symbol appear on the LCD display. Open the battery lid on the back side of the smartLAB ® global W nG meter and insert batteries with plus sign to top.
  • Page 14: 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. ®...
  • Page 15: Wireless Data Transfer

    Note: The BLE or ANT+ installation on the according partner device varies and can not be explained in every detail, here. Please read the partner device’s user manual thoroughly on how to activate BLE or ANT and how to connect the device to your smartLAB ® global W...
  • Page 16 Manually transfer not sent data You can initialize a manual data tranfer by following these steps: • Insert the Check Strip into the test strip slot. “Chk” and “OK” should show. • 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.
  • Page 17: Notes On Using Smartlab ® Ng Blood Glucose Test Strips

    Notes on using smartLAB nG blood glucose test strips ® • Use only with smartLAB®nG Blood Glucose Meters. • Run a control solution test every time you open a new box of test strips • Keep the test strips in their original bottle.
  • Page 18: Running A Blood Glucose Test

    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 materials ready for use: your smartLAB ® global W nG meter, the smartLAB ®...
  • Page 19 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 reaction zone, otherwise, an inaccurate reading may result.
  • Page 20: Reading Stored Test Results From Memory

    Note: If the glucose value could not be transmitted via ANT or BLE, it will still be saved on the internal memory of your smartLAB ® global W nG. Once the connection can be established the next time, all values that have been measured in the meantime will be transferred to the partner device.
  • Page 21: Alternate Site Testing (Ast) With The Transparent Cap

    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 Test- ing, please use the transparent cap for your lancing device. Car- ry out the following steps: • Gently massage the desired punctuation site on your arm or...
  • Page 22: Understanding Your Test Results

    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.
  • Page 23 3. Do a function control test with the smartLAB ® check strip 4. Optional: Check meter and test strip performance with the smartLAB ® nG control solution. When test results are still questi- onable or inconsistent, consult your healthcare professional be- fore making any changes to your diabetes medication program.
  • Page 24 Keep in mind that the lab could use different technology than smartLAB®global W nG blood glucose meter, and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result.
  • Page 25: Optional: Control Solution Testing

    ® • 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 ®...
  • Page 26 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 ® global W nG meter, a smartLAB nG test strip, and smartLAB nG control solu- ®...
  • Page 27 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 beep signal and the measured value is shown on the display. Leave the test strip in its slot.
  • Page 28: Understanding Control Test Results

    4. Understanding control test results The label on your test strip vial shows the acceptable ranges for the smartLAB nG control solutions. The result you get should be inside ® this range. Make sure you compare the result to the correct level of control.
  • Page 29: Iv. Miscellaneous

    IV. Miscellaneous Maintenance Your smartLAB global W nG Blood Glucose System 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 getting the best performance possible: Gently wipe the meter‘s sur- face with a soft cloth Do not get any moisture in the test strip slot.
  • Page 30: Troubleshooting

    Troubleshooting Note: If you are not sure how to react on error codes, please con- tact your local supplier. Battery empty Display: „LP“ & „Battery symbol “ 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.
  • Page 31 System error Display: „001 Error “ Solution: Replace batteries first. If the error still occurs, please contact your local supplier. Memory error 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“...
  • Page 32 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. 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)).
  • Page 33 Temperature too low Display: „Lt“ & „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 ap- propriate working temperature and wait for the next measurement until the error does not oc-...
  • Page 34: Limitations Of The Measurement Procedure

    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 meters. 10. DO NOT use during xylose absorption testing. Xylose in the blood...
  • Page 35 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 global W nG Blood Glucose Meter. ®...
  • Page 36: Regularity And Safety Notice

    17. Interfering Substances depend on the concentration. The below substances up to the test concentration will not affect the test results: Glucose Bias Concentrations 80 mg/dL 250 mg/dL 500 mg/dL Level of the interferance tested (4.4 mmol/L) (13.9 mmol/L) (27.8 mmol/L) Ascorbic Acid 4 mg/dL (0.26 mmol/L)
  • Page 37: Warranty

    Warranty HMM Diagnostics GmbH products need to fulfill high quality requi- rements. Because of this reason, HMM Diagnostics GmbH gives a 2-year warranty by purchasing this smartLAB product.
  • Page 38 Hersteller/ Manufacturer: HMM Diagnostics GmbH Friedrichstr. 89 D-69221 Dossenheim, Germany mail: info@hmm.info www.hmm.info Weitere Informationen zu den smartLAB Produkten / ® More information on our smartLAB products: ® www.smartlab.org...

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