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Smart Lab Sprint nG 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
Friedrichstraße 89
D-69221 Dossenheim, Germany
www.hmm.info
43

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Summary of Contents for Smart Lab Sprint nG

  • Page 1 Self-Monitoring Blood Glucose System 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

    Content I. Introduction Measuring principle Intended use Important information Note on smartLAB nG „NO CODE“-test strips ® II. Your smartLAB sprint nG ® Display & functions Specifications The smartLAB ® nG test strips Explanation of symbols Set Content III. Setup & functions...
  • Page 4 IV. Miscellaneous Maintenance Frequently Asked Questions Troubleshooting Limitations of the measurement procedure Regularity and Safety Notice Warranty...

  • Page 5: Introduction

    Although your smartLAB ® sprint nG system is easy to use, you should con- sult your healthcare professional (this may be your doctor, diabetes nurse educator or pharmacist) for instructions on how to use the system.

  • Page 6: Measuring Principle

    Intended use The smartLAB ® sprint nG is intended for the quantitative 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 citro diagnostic use). It is indicated for self-testing...

  • Page 7: Important Information

    The meter is for in vitro diagnostic use ONLY (for testing out- side the body). It should not be used to diagnose diabetes. • The smartLAB ® sprint nG blood glucose system can only be used with smartLAB ® nG Blood Glucose Test Strips. Other test strips will give inaccurate results.
  • Page 8 a refrigerator. And the system, 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).

  • Page 9: Note On Smartlab ® Ng „No Code"-Test Strips

    impaired. Do not touch the test strip with wet hands Do not use expired test strips (see expiration date on the strip 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.

  • Page 10: Your Smartlab ® Sprint Ng

    II. Your smartLAB sprint nG ® Display & functions Folder Symbol Meaning Date Show the moment of month and day. Time Show the moment of time. Test result Show the test result. Record/Aver age Tracking all the test results or average of display /14/30/90 days.

  • Page 11: Specifications

    Specifications 9. Blood sample: ≥ 0,6 µL capillary fresh blood or venous whole blood from 1. Type: smartLAB ® sprint nG fingertips, palm, or forearm 2. Measuring range: 20 ~ 630 mg/dL 10. Calibration: Plasma equivalent (1.1 ~ 35.0 mmol/L) 11.

  • Page 12: 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  symbol.

  • Page 13: Explanation Of Symbols

    Explanation of symbols Caution! 5-seconds result Lot number Keep away form sunlight Expiration date 0.6 μ L blood volume For in vitro diagnostic use only Human-factor flow 1.5V(AAA) x 2 batteries only Single use only Large LCD screen Storage temperature Discard 6 months (180 days) after opening Manufacturer Before use, read manual first...

  • Page 14: Set Content

    Set contents 1 smartLAB sprint nG 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 ® nG Quick Start instruction 10 smartLAB ®...

  • Page 15: Iii. Setup & Functions

    III. Setup & functions Insert and changing batteries 1. Open the battery 2. Insert two bat- 3. Put the battery door on the back of teries and the me- door back in place the meter by pushing ter beeps. and snap it closed. the tab in the direc- The meter turns on tion of the arrow and...
  • Page 16 Low Battery The meter uses two alkaline 1.5V (AAA) batteries. Batteries will normally last for more than 2000 tests. Other types of 1.5V (AAA) batteries are also acceptable, but the capacity of test times may differ. Insert the batteries when you first use the meter or replace with new batteries when the “LP”...

  • Page 17: Setting Time And Date

    Setting Time and Date Setting the current time and date in your meter is important if you use the meter memory. 1. Press the right button to turn the meter 2. The display shows the last 2-digit of the year that flashes at the top of display as well.

  • Page 18: Using Smartlab®Ng Blood Glucose Test Strips

    Using smartLAB®nG Blood Glucose Test Strips • Use only with smartLAB®nG Blood Glucose Systems. • Run a control solution test every time you open a new box of test strips (See Chapter „Control Solution Testing.“) • Keep the test strips in their original bottle. • After you take a test strip out of the bottle, tightly close the bottle immediately.

  • Page 19: Funktion Check

    Function check You can carry out a function check with the Check Strip which is included in your system set. You do not have to do the function check before every measurement. It helps you to control if your smartLAB nG system works properly, from time to time, though.

  • Page 20: 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: • You use the smartLAB ® sprint nG Blood Glucose System for the first time. • You open a new vial of test strips. • You think the meter or test strips might be working incorrectly. • You drop the meter.
  • Page 21 ® Please make sure you have all necessary items at hand when run- ning a control solution test. You need the smartLAB ® sprint nG me- ter, a smartLAB nG test strip, and smartLAB ® ®...
  • Page 22 3. The icons (insert strip) and (apply blood) show themselves. 4. Place the meter on a flat surface, like a table. 5. Remove the control solution bottle cap and wipe the tip of the bottle with a tissue. 6. Squeeze the bottle until a tiny drop forms at the tip of the bottle.

  • Page 23: 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 24: 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 nG meter, the smartLAB ® ® test strips and the smartLAB ®...
  • Page 25 2. Press the left button to set (AC) or (PC) Mode, then press the right button to confirm the setting. 3. The icons (insert strip) and (apply blood) show them- selves. When the blood drop flashes on the display, obtain a drop of blood from your finger.
  • Page 26 The system starts to count down from 5 seconds and then shows the test result. 2. Push the Strip Ejector to remove the test strip. 3. Throw it away after you have compared the reading to the range printed on the test strip bottle. Note: To avoid infections, never let anyone else use your lancing device and lancets.

  • 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: • Gently massage the desired punctuation site on your arm...

  • Page 28: 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 29 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 ques- tionable or inconsistent, consult your healthcare professional before making any changes to your diabetes medication program.
  • Page 30 Keep in mind that the lab could use different technology than smartLAB®sprint nG blood glucose meter, and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result.

  • Page 31: Memory, Storing And Displaying Stored Results

    Memory, Storing and displaying stored results Your meter stores a maximum of 480 test results with the time and date of the test. You can review them at any time. When the memory is full, the oldest result is dropped as the latest is added, so it is very important to have the correct time and date set in the meter.

  • Page 32: Frequently Asked Questions

    IV. Miscellaneous Maintenance Your smartLAB sprint 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.
  • Page 33 2. No symbol after inserting the test strip. Please check: • Did you insert the test strip correctly? The strip needs to be inserted arrow up in the direction of the arrow. 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 34 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 35: 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“ & „Insert“ Solution: Use a new test strip.
  • Page 36 System Error Display: „005“ Solution: Replace the batteries first. If Err appears again, please contact your local dea- ler. Test result is higher than 630 mg/dL (35.0 mmol/L) Display: „HI“ Solution: Test again. If the result is still the same, try a control solution test and if the control solution test falls within the correct range, please call your healthcare professional immediately.
  • Page 37 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)). This alerts users that an incorrect result may occur if the test continues. Solution: Relocate the meter to a location with temperature between 10°C - 40°C (50°F - 104°F).

  • Page 38: 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. DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation. 4. Extreme humidity may affect the results. A relative humidity greater than 90% may cause incorrect results.
  • Page 39 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 sprint nG Blood Glucose Meter. ®...
  • Page 40 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 41: Regularity And Safety Notice

    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 primarily purpose of this directive is to prevent electronic was- te (WEEE), while encouraging for reuse, recycling and other forms of reprocessing to reduce waste.
  • Page 42 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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