Nipro 4Sure Smart Duo Owner's Manual
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Nipro 4Sure Smart Duo Owner's Manual

Blood glucose & b-ketone monitoring system
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IDEAL FOR
OWNER'S MANUAL
Blood Glucose & β-Ketone Monitoring System

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Summary of Contents for Nipro 4Sure Smart Duo

  • Page 1 Sure and Simple IDEAL FOR OWNER’S MANUAL Blood Glucose & β-Ketone Monitoring System...

  • Page 3: Table Of Contents

    Index 1. Safety Information ......................1 2. Important Information ....................2 3. Introduction ........................2 4. Getting Started .......................4 5. Blood Glucose Testing ....................5 6. β-Ketone Testing ......................9 7. Control Solution Testing ....................13 8. Reviewing Test Results ....................16 9. Transferring Data ......................17 10. Maintenance .........................18 11.

  • Page 4: Safety Information

    1. Safety Information Read the following Safety Information thoroughly before using the device. • Use this device ONLY for the intended use described in this manual. • Do NOT use accessories which are not specified by the manufacturer. • Do NOT use the device if it is not working properly or damaged. •...

  • Page 5: Important Information

    2. Important Information • Severe dehydration and excessive water loss may cause readings which are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately. • If your blood glucose or β-Ketone results are lower or higher than usual, and you do not have symptoms of illness, first repeat the test.
  • Page 6 Test Principle Your system measures the amount of glucose or β-Ketone in whole blood. The glucose or β-Ketone testing is based on the measurement of electrical current generated by the reaction of glucose or β-Ketone with the reagent of the strip. The meter measures the current, calculates the blood glucose or β-Ketone level, and displays the result.

  • Page 7: Getting Started

    4. Getting Started Initial Setup Please follow the initial setup procedure before using the device for the first time or after you have replaced the battery. When the battery power is extremely low and “ & ” appears on the screen, the meter cannot be turned on.

  • Page 8: Blood Glucose Testing

    Note: • Press to select Beep On or Beep Off. Press MAIN button to confirm. • When Beep is turned off, the alarm function will remain effective. • You may set it up to four reminder alarms. to change On to OFF. Press MAIN button to •...
  • Page 9 Preparing the Lancing Device 1. Remove the cap. 2. Insert a new lancet firmly into the white lancet holder cup. 3. Remove the protective disk on the lancet. Hold the lancet firmly in place and twist off the protective disk. 4.
  • Page 10 Blood from the fingertip ™ ™ 1. Press the lancing device tip firmly against the lower side of your fingertip. 2. Press the release button to prick your finger. A click indicates that the puncture is complete. Blood from sites other than the fingertip (For Blood Glucose Test Only) ™...
  • Page 11 • It is recommended to discard the first drop of blood as it might contain tissue fluid, which may affect the test result. Performing A Blood Glucose Test 1. Insert the blood glucose test strip into its slot. Wait for the device to display the test strip “...

  • Page 12: Β-Ketone Testing

    Ketone warning • When your blood glucose result is higher than 13.3 mmol/L, the meter will display the blood glucose reading as well as a Ketone warning ( flashing KETONE and • The ketone warning is to notify you that you may be at risk of elevated Ketone levels and a Ketone test is recommended.
  • Page 13 2. Checking the Code Number Make sure that the code number displayed on the device matches the number on the individual foil pack before you proceed. If it matches, you can proceed with your test. 2.0 ~ 3.3 Otherwise, please stop testing and repeat the mmol/L calibration procedure.
  • Page 14 Preparing the Lancing Device 1. Remove the cap. 2. Insert a new lancet firmly into the white lancet holder cup. 3. Remove the protective disk on the lancet. Hold the lancet firmly in place and twist off the protective disk. 4.
  • Page 15 2. Press the release button to prick your finger. A click indicates that the puncture is complete. Important! • Choose a different spot each time you test. Repeated punctures at the same spot may cause soreness and calluses. • Avoid lancing the areas with obvious veins to avoid excessive bleeding. •...

  • Page 16: Control Solution Testing

    Disposing Used Test Strip and Lancet To remove the used test strip, simply push the Test Strip Ejector button upward to eject the used test strip. The device will automatically turn off after the test strip is removed. To remove the used lancet, remove the lancet from the lancing device after you have finished testing.
  • Page 17 2. Apply the 4SURE blood glucose control solution. Shake the control solution vial thoroughly before use. Squeeze out a drop and wipe it off, then squeeze another drop and place it on the top of the vial cap. Hold the device to move the absorbent hole of the test strip to touch the drop.
  • Page 18 To perform a β-Ketone control solution test, do the following: 1. Insert the β-Ketone test strip into the test slot of the device. Wait for the device to display the test strip “ “ and blood drop “ “. 2. Apply the 4SURE β-Ketone control solution. Shake the control solution vial thoroughly before use.

  • Page 19: Reviewing Test Results

    Out-of-range results: If you continue to get results that fall outside the range printed on the individual foil pack, it means that the meter and/or strips might not be working properly. 8. Reviewing Test Results Your device stores the 1000 most recent test results along with respective dates and times in its memory.

  • Page 20: Transferring Data

    You can use your device with an iOS (5.0.1 or higher) Android system (4.3 API Level 18 or higher) to download data from your 4SURE Smart Duo via Bluetooth. Follow the steps below to transmit data from your 4SURE Smart Duo. Please contact Nipro Europe customer service for information regarding available Apps.

  • Page 21: Maintenance

    10. Maintenance Changing Battery You must change the battery immediately and reset the date and time when the battery power is extremely low and “ & ” appears on the screen. The meter cannot be turned on. To change the battery, do the following: 1.
  • Page 22 Meter Disposal The used meter should be treated as contaminated and may carry a risk of infection during measurement. The batteries in this used meter should be removed and the meter should be disposed in accordance with local regulations. The meter falls outside the scope of the European Directive 2002/96/ EC-Directive on waste electrical and electronic equipment (WEEE).

  • Page 23: Important Safety Instructions For Healthcare Professionals

    11. Important Safety Instructions for Healthcare Professionals • Always wear gloves when performing tests and follow your facility’s infection control policy and procedures. • Use a new pair of gloves when performing a patient test. Change gloves between patients. • Wear protective glasses and/or other protective clothing if necessary. •...
  • Page 24 When to clean and disinfect the meter: All surface of meter if visibly soiled must be physically cleaned to remove gross soil. Disinfect the meter between each patient to prevent infection. How to clean and disinfect the meter: The meter must be cleaned prior to the disinfection. Use one disinfecting wipe to clean exposed surfaces of the meter thoroughly and remove any visible dirt, blood, or any other body fluid with the wipe.

  • Page 25: Reference Values

    12. Reference Values Please consult your doctor to determine a target range that works best for you. Reference Value (for blood glucose test) The device provides you with plasma equivalent blood glucose results. Time of day Normal plasma glucose range for people without diabetes Fasting and before meals <...

  • Page 26: Symbol Information

    13. Symbol Information Symbol Referent Symbol Referent For in vitro diagnostic Do not reuse Storage/ Consult instructions for Transportation temperature limitation Use by CE Mark Batch code Manufacturer Dispose of the Serial number packaging properly after use Caution, consult Keep away from accompanying sunlight documents...
  • Page 27 Icon Explanations Test strips can be used 5 Second reaction time from first opening the EXP DATE for blood glucose testing. vial until expiration date 5 Sec Shelf life on the vial Automatically detects 1000 Test 1000 Test Memory Control Solution Auto QC Memory Meter calculates...

  • Page 28: Troubleshooting

    14. Troubleshooting If you follow the recommended steps but the problem persists, or error messages other than the ones below appear, please call your local customer service. Do not attempt to repair the device yourself and never try to disassemble the device under any circumstances.
  • Page 29 Error Message Error Message Cause What To Do Replace the battery The batteries cannot immediately and reset provide enough power for date and time on the a test. meter setting. Repeat the test with a new Strip has been used. strip.
  • Page 30 Blood Glucose Measurement Problem Cause What To Do Replace the battery Batteries exhausted. immediately and reset date and time on the meter setting. The device does not display a message Insert the test strip with Test strip inserted upside after inserting a test contact bars end first and down or incompletely.

  • Page 31: Specifications

    15. Specifications 1000 measurement results with respective date and Memory time Dimensions 89.8 (L) x 54.9 (W) x 18 (H) mm Power Source One 1.5 V AAA alkaline battery Weight 46.1 g (without battery) External output Bluetooth V4.0 or Micro USB Auto electrode insertion detection Auto sample loading detection Features...

  • Page 32: Limited Lifetime Warranty Terms And Conditions

    (ii) any repairs, alterations or other work has been performed by the buyer or others on such item, other than work performed with Nipro Diagnostics (UK) Ltd authorisation and according to its approved procedures; or (iii) the alleged defect is a result of abuse, misuse, improper maintenance, accident or the negligence of any party other than Nipro Diagnostics (UK) Ltd.
  • Page 34 EN-31...
  • Page 36 Distributed by: Nipro Diagnostics (UK) Ltd Unit 12-14 South Point Ensign Way, Hamble Southampton, SO31 4RF United Kingdom Tel: 0800 08 588 08 ForaCare Suisse AG CH-9000 St. Gallen, Switzerland For self-testing and point-of-care-testing of whole blood glucose and β-Ketone...

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