Medisign MediKeto 82 BT blood β-ketone monitoring system User Manual Page1 / 26
Introduction Thank you for choosing the Medisign MediKeto 82 BT blood β-ketone monitoring system to help monitor your blood β-ketone levels. The Medisign MediKeto 82 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 MediKeto 82 BT blood β-ketone monitoring system. Please read this User Manual carefully before you start the test and do a quality control test.
Intended Use The Medisign MediKeto 82 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. It is intended for self-testing outside of the body (in vitro diagnostic use only) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the diabetes control.
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 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.
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.
Table of Contents 1. About the Medisign MediKeto 82 BT blood β-ketone monitoring system .......................................................... 8 █ Contents of Kit ............................................................................................................................................ 8 █ Medisign MediKeto 82 BT Blood β-Ketone Meter ..................................................................................... 8 █ Meter Display Screen.............................................
9. Cleaning Your Meter ......................................................................................................................................... 22 10. Screen Messages and Troubleshooting ........................................................................................................... 23 █ Screen Messages ....................................................................................................................................... 23 █ Troubleshooting ......................
1.
█ 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. Appears when test strip is inserted.
█ Medisign MediKeto 82 Blood β-Ketone Test Strip . Medisign MediKeto 82 Blood β-Ketone Test Strip Vial • Medisign MediKeto 82 Blood β-Ketone Test Strip Foil Packet Medisign MediKeto 82 Blood β-Ketone Test Strip The expiration date of the Medisign MediKeto 82 blood β-ketone test strip can be found on the vial or the foil packet. IMPORTANT • • • • • • • • • • • The Medisign MediKeto 82 BT blood β-ketone meter should be used with the Medisign MediKeto 82 blood β-ketone test strips.
2. Settings █ Inserting (or Replacing) the Batteries The batteries need to be inserted before using your Medisign MediKeto 82 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. Insert new batteries, with the (+) side facing up.
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. Press the < or > button to choose between YES (delete all test results) or NO (keep all test results). Confirm your choice with the button.
3. Control Solution Testing The purpose of the control solution testing is to validate that the Medisign MediKeto 82 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 Ketone Control Solution. You should perform a control solution test when: • Using the meter for the first time. • You open a new packing box of test strips.
█ Performing a Control Solution Test 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. Verify that the code number displayed matches with the code number on the vial or the foil packet of the Medisign MediKeto 82 blood β-ketone test strips. The code number on the picture above is for the example only.
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 Ketone Control Solution. Make sure the testing environment is between 10 ~ 40℃.
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 MediKeto 82 BT blood β-ketone meter as well as the corresponding accessories regularly.
strip is inserted. 2. The meter identifies the code number automatically. Compare the code number displayed on the LCD with the code number shown on the vial or the foil packet. If they do NOT match, try again with another test strip. If the problem persists, please contact Customer Service. 3. When the blood symbol appears, it indicates that the meter is ready for blood β-ketone testing.
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. Do NOT put urine on the blood β-ketone test strip. Do NOT touch sampling end of the test strip. Do NOT smear the blood with sampling end of the test strip. Do NOT drop the blood directly on the sampling end of the test strip. Do NOT add or apply a second drop of blood. This may cause a false result.
5. Understanding Your Blood β-Ketone Test Results █ Blood β-Ketone Results Interpretation β-Ketone Results Interpretation < 0.6 mmol/L Normal, please consult with a healthcare professional for your appropriate range of blood βketone level. 0.6 ~ 1.5 mmol/L With blood glucose level greater than 300 mg/dL or 16.7 mmol/L, medical consultation with a healthcare professional is recommended. > 1.5 mmol/L With blood glucose level greater than 300 mg/dL or 16.
6. Displaying Stored Test Results The Medisign MediKeto 82 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. 3. 4. 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.
7. Downloading Your Test Results to a PC You can transfer test results from the Medisign MediKeto 82 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. NOTE: While the meter is connected to the PC, you are unable to perform a blood ß-ketone test. 8.
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.
10. Screen Messages and Troubleshooting █ Screen Messages This section explains the display screen messages and error messages you may encounter when using your Medisign MediKeto 82 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.
█ 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.
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. For information about correct disposal, please contact your local council or authority.
ketone test strip and the Medisign Ketone Control Solution. 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. Schade DS, Eaton RP. Metabolic and clinical significance of ketosis. Special Topics in Endocrinology and Metabolism 1982;4:1-27. 2.
FCC Information to User This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
