ETF-RD-BKQ-02. Instructions for Use (Rev.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) Introduction Thank you for choosing the Medisign KT26 BT blood β-ketone monitoring system to help monitor your blood βketone levels. The Medisign KT26 BT blood β-ketone monitoring system is designed to be accurate and easy to use. This user manual contains all the information needed to use and maintain the Medisign KT26 BT blood βketone monitoring system. Please read this User Manual carefully before you start the test and do a quality control test.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) Intended Use The Medisign KT26 BT blood β-ketone monitoring system is intended to be used for the quantitative measurement of β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood samples from the fingertips. Venous whole blood testing is limited to healthcare professionals use only.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) Important Information for the Test Strip • NEVER reuse a test strip that is either applied with blood or control solution. The test strips are for single use only. • Before using, please check the test strip expiration date on the box, vial or the foil packet. • Do NOT use test strips that have expired as it may cause inaccurate test results. • Do NOT touch sampling end of the test strip. • Do NOT smear the blood with sampling end of the test strip.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) Storage and Handling of the System • Keep this system dry and keep away from the heat and direct sunlight. • Avoid leaving the meter or test strips in extremely hot or cold places, such as near a heat source or in an extremely hot or cold car. • Do NOT store or use the meter or test strips at high humidity levels, such as in the bathroom or kitchen. • Store the test strips in the original vial between 4 ~ 30℃, at indoor area. Do NOT freeze.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) Table of Contents 1. About the Medisign KT26 BT blood β-ketone monitoring system...................................................................... 8 █ Contents of Kit ............................................................................................................................................ 8 █ Medisign KT26 BT Blood β-Ketone Meter .................................................................................................
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 10. Screen Messages and Troubleshooting ........................................................................................................... 24 █ Screen Messages ....................................................................................................................................... 24 █ Troubleshooting ........................................................................................................................................
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 1.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) █ Medisign KT26 BT Blood β-Ketone Meter Front Side 1. Test Strip port 2. Ejector slider 3. Display 4. Left and right buttons 5. On/off and selection button 1 2 3 4 5 4 Rear Side 6. Battery cover 7.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) █ Meter Display Screen 1 Appears when the test strip is inserted 2 Symbol to mark the control solution test results 3 Appears when the meter pairs with a mobile device 4 Appears when the sound is set to OFF 5 Appears if the meter is out of operating temperature range 6 Segments to display test results or error messages 7 Segments to display the Set-up mode 9 Appears when the meter is ready for application of blood or control solution.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) █ Medisign KT26 Blood β-Ketone Test Strip Medisign KT26 Blood β-Ketone Test Strip Vial Medisign KT26 Blood β-Ketone Test Strip Foil Packet Medisign KT26 Blood β-Ketone Test Strip • The expiration date of the Medisign KT26 blood β-ketone test strip can be found on the vial or the foil packet. IMPORTANT • The Medisign KT26 BT blood β-ketone meter should be used with the Medisign KT26 blood β-ketone test strips.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 2. Settings █ Inserting (or Replacing) the Batteries The batteries need to be inserted before using your Medisign KT26 BT blood β-ketone meter for the first time or when the batteries are low. When the batteries are low the screen will display and blink the on the bottom of the screen. It will be continuously shown until the meter becomes unusable due to low battery. 1. 2. 3. Open the battery compartment cover on the back of the meter.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) █ Acoustic Signal Acoustic signals ( ) are activated by default. If you want to deactivate the acoustic signals, press the < or > button to change the status from ON (activated) to OFF (deactivated). Confirm your choice with the button. NOTE: Turning the beep sound on or off do NOT affect your blood β-ketone measurements. █ Delete Test Results You have the option to delete the entire test results from meter memory. You will see dEL flashing on the screen.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 3. Control Solution Testing The purpose of the control solution testing is to validate that the Medisign KT26 BT blood β-ketone meter is working properly with the test strips. The control solution may NOT be included in the kit. Please contact your pharmacist or healthcare professional or Customer Service to purchase the Medisign KT26 Ketone Control Solution. You should perform a control solution test when: • Using the meter for the first time.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) █ Performing a Control Solution Test NOTE: The code number on the picture above is for the example only. The code number can be different for each test strip batch. 1. Insert the test strip with black lines facing upwards and pointing towards the test strip port. Make sure to firmly and completely insert the test strip into the meter. The meter will turn on automatically and the code number will appear on the screen.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) IMPORTANT • The range printed on the test strip vial or box is for the control solution only. It has nothing to do with your blood β-ketone levels. • The results obtained from control testing do NOT reflect your personal blood β-ketone levels in any way. • If the control solution test result falls outside of the range provided, do the following: Do NOT test your blood β-ketone. Make sure you are using the Medisign KT26 Ketone Control Solution.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 4. Testing Your Blood β-Ketone IMPORTANT SAFETY INFORMATION • Meters that come into contact with blood present a potential risk of transmitting infectious diseases. To prevent infections and/or cross-contamination, maintain good hand hygiene and clean your Medisign KT26 BT blood β-ketone meter as well as the corresponding accessories regularly.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) █ Inserting the Medisign KT26 Blood β-Ketone Test Strip NOTE: The code number on the picture above is for the example only. The code number can be different for each test strip batch. 1. Insert a test strip to turn on the meter automatically. Make sure it is inserted completely without bending the test strip. will appear on screen if the Medisign KT26 blood β-ketone test strip is inserted. 2. The meter identifies the code number automatically.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) █ Applying Blood Place your finger on the tip of the test strip. Ensure that the blood is NOT applied from above. The measurement chamber of the test strip draws the blood of your finger automatically. Your finger should remain still until the measuring chamber is completely filled and you hear the “beep” sound. IMPORTANT • The sample channel at the end of the test strip should show full. When you hear the beep sound, you have enough blood in the test strip.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) IMPORTANT SAFETY INFORMATION Do NOT leave the lancets in the lancing device after use, be sure to dispose of it according to instructions from your healthcare professional. Do NOT reuse the lancet. 5. Understanding Your Blood β-Ketone Test Results █ Blood β-Ketone Results Interpretation If your β-ketone result between 1.5 and 3.0 mmol/L may indicate development of a problem that could require medical assistance.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 6. Displaying Stored Test Results The Medisign KT26 BT blood β-ketone meter automatically stores up to five hundred (500) β-ketone test results together with the date and time. The time and date must be set in order to use the memory function (See Set Date and Time). █ Display of Test Results 1. 2. 3. 4. 5. Begin with the meter turned off. Press the button, you will hear a beep sound and the meter will turn on. The screen will display the date and time.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 7. Downloading Your Test Results to a PC You can transfer test results from the Medisign KT26 BT blood β-ketone meter to a computer. The program can help you to make a report with graphs and tables. To use this feature, you need the Medisign Link Diabetes Management Software and the Medisign Link Cable. For more information, please contact Customer Service.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 9. Cleaning Your Meter Wash and dry your hands before use to prevent damage of the meter and test strips. The meter should be cleaned with a soft cloth or paper towel slightly dampened with one of these cleaning solutions: 70% isopropyl alcohol Mild dishwashing liquid mixed with water 10% household bleach solution made on the day After cleaning, allow the meter to dry completely in a cool place away from direct sunlight.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 10. Screen Messages and Troubleshooting █ Screen Messages This section explains the display screen messages and error messages you may encounter when using your Medisign KT26 BT blood β-ketone meter and test strips. If your meter is still NOT working after you have followed the troubleshooting instructions, contact Customer Service. What you see What it means The meter has detected a problem with the test strip. The test strip is either used or damaged.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) █ Troubleshooting What is happening The meter does NOT work after the blood is applied. The test result is abnormal. The thermometer symbol on the screen. appears The meter does NOT work after the test strip is inserted. What you should do Make sure that the test strip is insert into the test strip slot completely. See if the test strip is covered in debris or lint. Make sure the blood is applied to the test strip correctly.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) 12. Symbols 13. Disposing of the Meter IMPORTANT SAFETY INFORMATION Objects (e. g. the meter) which had been in contact with blood potentially bear the risk for infectious diseases. Please dispose these materials according to local regulations for disposal of contaminated medical devices. Please dispose of the contaminated meter – after removing the battery – according to the regulations applicable to your country.
ETF-RD-BKQ-02. Instructions for Use (Rev.0) THIS WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY TO THE EXCLUSION OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, ALL OF WHICH ARE WAIVED AND DISALAIMED. All warranty claims must be directed to Customer Service. This warranty is extended only to the original purchaser of the meter. References 1. Rewers A. Current controversies in treatment and prevention of diabetic ketoacidosis. Adv Pediatr. 2010;57(1):247-267.
