Medisign MediKeto Plus 82 BT blood glucose and β-ketone monitoring system User Manual Page1 / 35
Introduction Thank you for choosing the Medisign MediKeto Plus 82 BT blood glucose and β-ketone monitoring system to help monitor your blood glucose and blood β-ketone levels. The Medisign MediKeto Plus 82 BT blood glucose and 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 Plus 82 BT blood glucose and β-ketone monitoring system.
Intended Use The Medisign MediKeto Plus 82 BT blood glucose and β-ketone monitoring system is intended to be used for the quantitative measurement of glucose and β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood samples from the fingertips. Alternative site testing (palm and forearm) should be done only for glucose measurement and during a steady-state times. Venous whole blood testing is limited to healthcare professionals use only.
Important Information for the System • • • • • • • • • • • • • • • • Before using the Medisign MediKeto Plus 82 BT blood glucose and β-ketone monitoring system, please read this manual carefully. Use this system only for blood glucose and blood β-ketone test. The Medisign MediKeto Plus 82 BT blood glucose and β-ketone meter should be used with the Medisign GH82 blood glucose test strips and the MediKeto 82 blood β-ketone test strips.
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.
Limitation • • • • • • • • • • • • • • • • • • This system is only for in vitro diagnostics use and for self-testing. This system is NOT designed for use with arterial, serum or plasma samples. Do NOT put urine on the test strip. This system is NOT designed for use with neonatal. This system is NOT for screening or diagnosis of diabetes mellitus. Blood β-ketone testing must NOT use the forearm or palm site. Only use the fingertip for blood βketone testing.
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 Plus 82 BT blood glucose and β-ketone monitoring system ............................ 10 █ Contents of Kit .......................................................................................................................................... 10 █ Medisign MediKeto Plus 82 BT Blood Glucose and β-Ketone Meter ...................................................... 10 █ Meter Display Screen.......................................................................
█ Preparing the Test ..................................................................................................................................... 25 █ Inserting the Medisign MediKeto 82 Blood β-Ketone Test Strip .............................................................. 25 █ Obtaining a Blood Drop ............................................................................................................................ 26 █ Applying Blood .......................................................
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█ Meter Display Screen 2 Appears when the Medisign MediKeto 82 blood β-ketone test strip is inserted Appears when your blood glucose result is equal to or higher than 240 mg/dL 3 Symbol to mark pre-meal or post-meal test results.
█ Medisign GH82 Blood Glucose Test Strip Medisign GH82 Blood Glucose Test Strip Vial Medisign GH82 Blood Glucose Test Strip █ 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 GH82 blood glucose test strip and the Medisign MediKeto 82 blood βketone test strip can be found on the vial or the foil packet.
IMPORTANT • • • • • • • • • • • • The Medisign MediKeto Plus 82 BT blood glucose and β-ketone meter should be used with the Medisign GH82 blood glucose test strips and MediKeto 82 blood β-ketone test strips. Before using, please check the test strip expiration date on the vial or the foil packet. The Medisign GH82 test strips in the vial are good six (6) months after first opening date or until the expiration date, whichever comes first.
2. Settings █ Inserting (or Replacing) the Batteries The batteries need to be inserted before using your Medisign MediKeto Plus 82 BT blood glucose and 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.
█ 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 glucose or 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.
3. Control Solution Testing The purpose of the control solution testing is to validate that the Medisign MediKeto Plus 82 BT blood glucose and 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 GH Glucose Control Solution or the Medisign Ketone Control Solution. You should perform a control solution test when: • Using the meter for the first time.
█ Performing a Control Solution Test For the glucose control For the β-ketone solution test 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 test strips.
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 glucose or blood β-ketone levels. The results obtained from control testing do NOT reflect your personal blood glucose or 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 glucose or blood β-ketone.
4. Testing Your Blood Glucose 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.
2. The meter identifies the code number automatically. Compare the code number displayed on the LCD with the code number shown on the vial. 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 glucose testing. IMPORTANT • Before the test you must make sure that the code number displayed on the meter matches the code number on the test strip vial.
█ 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.
█ Disposing Used Test Strips and Lancets Use a Strip Ejecting Button located on the right side of the meter to remove the used test strip. Used test strips should be safely discarded properly according to instructions from your healthcare professional. Wash your hands thoroughly with soap and water after handling the meter, lancing device or test strips. IMPORTANT SAFETY INFORMATION • • • Used lancets and strips are biohazardous material and can transmit blood-borne diseases.
█ Blood Glucose Result with Smile Symbol The meter will display a sign if the result falls in the range of 80-120 mg/dL. The default value is only for your reference, please consult your health care professional to find out your target blood glucose level. █ Ketone Alert When a blood glucose test result is 240 mg/dL or higher (NOT for a control solution test result), the symbol will appear. It is recommended to check your blood β-ketone. 6.
█ Alternative Site Blood Sampling Forearm sampling: Choose a fleshy area of the forearm away from the bone, visible veins and hair. Sometimes there is less blood flow to the forearm than to the fingertips. To help you get a large enough drop of blood, you may gently massage or apply warmth to the site to increase blood flow. For forearm test sites, apply and release pressure to the lancing device for a few seconds while keeping the lancing device in constant contact with the skin.
7. 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.
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 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. Do NOT hold or shake the meter while it is testing.
8. 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.
9. Displaying Stored Test Results The Medisign MediKeto Plus 82 BT blood glucose and β-ketone meter automatically stores up to five hundred (500) glucose and β-ketone test results together with the date and time. The meter also provides a seven (7), fourteen (14), thirty (30) days’ average to help track a patient’s blood glucose trend. The time and date must be set in order to use the memory and day averaging function (See Set Date and Time).
10. Downloading Your Test Results to a PC You can transfer test results from the Medisign MediKeto Plus 82 BT blood glucose and 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 test. 11.
12. 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.
13. Screen Messages and Troubleshooting █ Screen Messages This section explains the display screen messages and error messages you may encounter when using your Medisign MediKeto Plus 82 BT blood glucose and 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.
15. Symbols 16. 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.
warranty claims is limited to repair or replacement, and in no event shall manufacturer be liable for indirect or consequential damages, or for any loss arising from misuse, improper use, abuse, neglect, unauthorized repair or modification. This warranty is void and of no force and effect in the event of product misuse, improper use, abuse, neglect, unauthorized repair or modification.
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.