HNM Diagnostics smartLAB Sprint User Manual

Self-monitoring blood glucose system

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Self-Monitoring Blood Glucose System

User Manual

Please read this manual thoroughly before first

using this device

HMM Diagnostics GmbH

D-69221 Dossenheim, Germany

www.hmm.info

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Page 1 Self-Monitoring Blood Glucose System User Manual Please read this manual thoroughly before first using this device HMM Diagnostics GmbH D-69221 Dossenheim, Germany www.hmm.info...
Page 3: Table Of Contents
Content I. Introduction Measuring principle Intended use Important information Note on smartLAB „NO CODE“-test strips ® II. Your smartLAB sprint ® Display & functions Specifications pro test strips The smartLAB ® Explanation of symbols III. Setup & functions Insert batteries Turning the meter on/off Function check Control solution testing...
Page 4 IV. Miscellaneous Maintenance Frequently Asked Questions Troubleshooting Limitations of the measurement procedure Warranty...
Page 5: Introduction
I. Introduction Thank you for using the smartLAB sprint Self-Monitoring Blood ® Glucose System. This system was produced in close association with diabetes health care professionals, hospitals and, most im- portantly, people with diabetes. The measuring results can help you determine the effects of food, exercise and diabetes medications.
Page 6: Measuring Principle
Measuring principle The smartLAB sprint 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 glucose oxidase method for glucose determination.
Page 7: Important Information
Important information • Severe impact may cause the meter to 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. • Incorrect results may occur when performing the test. If you believe you are not feeling well, please contact your healthcare professional immediately.
Page 8 • 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. Discard all unused strips immediately after 90 days from open date. The strips are for sin- gle use only.
Page 9: Note On Smartlab ® „No Code"-Test Strips
Note on smartLAB „NO CODE“-test strips ® The smartLAB pro blood glucose test strips compatible with ® smartLAB ® glucose meters need not to be coded, any more. Thus, when inserting a test strip, the display will read „Code 888“. That is because all test strip charges only use this code.
Page 10: Your Smartlab ® Sprint
II. Your smartLAB sprint ® Display & functions Error Code test results Test result transfer to Code number computer Measuring unit Thermometer Apply blood or control Battery power solution to the test strip Specifications 9. Calibration: Plasma equivalent 10. Hematocrit (Hct): 30-55% 1.
Page 11 RS-232 DOWNLOAD PORT In combination with the required USB cable, you 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- M-Button (left side) Displays stored values. In setting mode: selection key TEST STRIP INSERTION SLOT Insert the test- or check strip here...
Page 12: The Smartlab ® Pro Test Strips
The smartLAB pro test strips ® Electrode Insert direction Grip zone Reaction zone Application zone Aperture Vial opening date (please note) Expiration date Note: You can find the test strip expira- tion date on the vial label next to the  symbol.
Page 13: Explanation Of Symbols
Explanation of symbols Please refer to the manual 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...
Page 14 Set contents 1 smartLAB ® sprint blood glucose meter 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 pro blood glucose test strips ®...
Page 15: Iii. Setup & Functions
III. Setup & functions Insert batteries The meter uses 2 1,5V AAA Alkali batteries. Batteries will normally last for aprox. 1000 tests. Install the batteries when you first use the meter or replace with new batteries when the “LP” message and the low battery symbol appear on the LCD Low battery display symbols display.
Page 16: Turning The Meter On/Off
Turning the meter on/off Push the S-button longer than 3 seconds to power on your smartLAB ® sprint meter without the use of a test- or check strip. The meter carries out a quick self-test: all digits and symbols are visible on the display and a double signal tone appears.
Page 17 2. Setting the date By shortly pressing the M-button, you can increase the flashing year digits. If you keep the button pushed, the value increases fas- ter. You can save the settings by pushing the S-button. The current year setting will now constantly shown and in the upper left display corner, the first two digits for the month start flashing.
Page 18 Push the S-button to save your settings. After that, the first two digits of the hour start flashing. Use the M-button to adjust the correct hours and save it with the S-button. After that, proceed in the same way for the minute setting. 4.
Page 19: Function Check
In the setting mode, the meter powers off automatically after 2 minutes, when no button is pressed. Note: After changing the measurement unit, all stored data will be converted automatically into the new measuring unit. Function check You can carry out a function check with the Check Strip which is included in your meter set.
Page 20: Control Solution Testing
Please keep the check strip in the soft case of the meter. Control solution testing Running a control test lets you know that your meter and test strips are working properly to give reliable results. You should run a con- trol test when: •...
Page 21 the date the vial is opened or until the „Expiration Date“ on the bottle, whichever comes first. • Do not use smartLAB ® control solution that is past the „Expiration Date“ • The smartLAB control solution can stain clothing. If you spill ®...
Page 22 2. Running the control solution test When the symbol for applying blood appears, shortly shake the bot- tle with the smartLAB ® control solution. Open the bottle and wipe the tip of the bottle with a tissue. Squeeze a little drop of control solution on a clean, not adsorbing surface (plastic, glass, etc.) and close the bottle immediately.
Page 23 Problem Solution Was the test strip exposed to open air for Repeat the control test with properly a long period of time? stored strips. Was the test strip vial capped tightly? This will humidify strips inside. Replace the test strips. Does the meter work properly? You can use the check strip to verify the meter’s functions.
Page 24: 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 sprint meter, the smartLAB ® ® pro test strips and the smartLAB ®...
Page 25 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, other- wise, an inaccurate reading may result.
Page 26 5. Storing memories The displayed result is automatically stored in the memory of the smartLAB ® sprint meter. Your meter stores up to 450 results with date and time. If more than 450 results are reached, the oldest one will be deleted. 6.
Page 27: 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: •...
Page 28: Understanding Your Test Results
Understanding your test results The smartLAB pro blood glucose test strips are whole-blood ref- ® erenced. Your meter is plasma-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 29 Unusual test results: If your blood glucose result doesn‘t match the way you feel, follow 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.
Page 30 High blood glucose (hyperglycemia): fatigue, increased appetite or thirst, frequent urination, blurred vision, headache, general ach- ing, or vomiting. 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.
Page 31 by fingertip within five minutes 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.
Page 32: Displaying Stored Results
Displaying stored results 1. Enter memory mode With the meter switched on, press the M-button to enter memory mode. If no values are saved the display will read „MEM“. Otherwise, the latest test result will be shown. 2. Displaying single test results Up to 450 test results can be stored on the meter.
Page 33: Displaying Average Values
Memory mode Result deleted Displaying average values You can display your average blood glucose values for the last 7, 14 or 28 days with your smartLAB ® sprint meter. To do so, please carry out the following steps: Press the M-button to display the average glucose value of the last 7 days.
Page 34: Additional Device Settings
Note: Please make sure that date and time are set correctly. Other- wise the displayed average values for the last 7, 14 or 28 days might lead to wrong conclusions. Additional device settings Besides the useful average value function, your smartLAB ®...
Page 35 2. Alarm You can use the alarm setting to remind you running a glucose test, for example. The meter shows two setting alternatives: „OFF“ (alarm mode switched off) or „ON“ (alarm mode switched on). By pushing the M-button you can choose the desired mode and save it with the S-button.
Page 36 After that, the next two digits for the minutes start flashing. Use the M-button to adjust the minutes and save your settings by pushing the S-button. 3. Signal tone setting After the alarm settings, the meter automatically switches to the signal tone setting mode.
Page 37 4. Clock Mode After setting the signal tone the meter automatically enters the clock mode settings. In the middle of the display you see the se- conds (2 digits) and 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.
Page 38: Maintenance
IV. Miscellaneous Maintenance Your smartLAB sprint 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.
Page 39 3. No symbol after inserting the check strip. Please check: • Did you insert the dark-blue check strip correctly? The writing must be to the top. 4. No measurement after blood sample has been sucked in. Please check: • Is the reaction zone filled completely (red)? Repeat the glucose test with a new strip.
Page 40 6. 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 profes- sional.
Page 41 12. Recent studies have shown that EMI can cause electronic medi- cal device performance degradation and could lead to inappro- priate therapy. 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.
Page 42: 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. Test strip already used or wet Display: „Err“ & „Test strip symbol“ Solution: Use a new test strip.
Page 43 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 still too low, please contact your doctor immediately.
Page 44 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 45: Limitations Of The Measurement Procedure
Limitations of the measurement procedure 1. DO NOT use serum or plasma sample. 2. DO NOT use neonate blood sample. 3. Extreme humidity may affect the results. A relative humidity greater than 90% may cause incorrect results. 4. The System is designed to be used at temperatures between 10°C and 35°C (50°F and 95°F).
Page 46 9. Patients undergoing oxygen therapy may have inaccurate results. 10. Altitude up to 3050 meters above sea level has no effect on readings. 11. 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).
Page 47: Warranty
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 register your product.
Page 48 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...