INTRODUCTION PRINCIPLE INDICATIONS FOR USE INTRODUCTION We would like to thank you for making a smart decision! The Medi+Sure Blood Glucose Monitoring System is designed for Canadian. The compact and portable Medi+Sure Blood Glucose Meter is easy to use, and displays test results in only 6 seconds. In addition, the meter automatically stores up to 960 test records with respective dates and times, which allows you to monitor your diabetic program efficiently. Thanks again for your support. Before testing, please read this User's Guide thoroughly. It contains all the information you need regarding the Medi+Sure Blood Glucose Monitoring System. If you have questions or need assistance, please call our Customer Assistance line at 1-855-634-7873. For customer assistance outside the operational days and times, please contact your health care provider with questions. TM TM TM PRINCIPLE The Medi+Sure Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample. TM INDICATIONS FOR USE The Medi+Sure Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for use by lay users and should be used by a single patient as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. TM IMPORTANT SAFETY INSTRUCITONS: ● The meter and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients! ● All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. Reference: 1. “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm224025.htm 2. “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html Medi+Sure TM Blood Glucose Monitoring System 2 2 4 6 Setting the Year,Date,Time,and Temperature Unit 7 Alarm setting 9 Testing Control Samples 10 Blood Sampling 11 13 16 How to Clean and Disinfect Your Device 19 2.9 Viewing Date, Time, or Temperature 22 23 23 24 26 Expected Values 28 28 1 Section 1. Contents & Specifications 1.1 Contents Complete Starter Kit: Medi+Sure Blood Glucose Meter , 3-Volt Lithium Coin Battery (CR2032) , User's Guide( Log Book included ), Getting Started Guide , Medi+Sure Blood Glucose Test Strip , Test Strip Instruction, Lancing Device, Lancing Device Instruction ,Carrying Case TM TM Meter only: Medi+Sure Blood Glucose Meter , 3-Volt Lithium Coin Battery (CR2032) , User's Guide , ( Log Book included ) , Getting Started Guide , Carrying Case TM 1.2 Product Specifications & Operating Conditions Meter Specifications： Storage Conditions Temperature：-4°~122°F (-20~+50°C) Humidity RH 80% Memory Capacity 960 test results with respective dates and times Measurement Unit mmol/L Display LCD display Reaction Time 6 seconds Meter Dimensions 54×93×16 mm Meter Weight 53 g (with battery) Measuring Range 1.1~41.7 mmol/L Power Supply One 3V lithium battery (CR2032) Battery Lifetime Over 1,000 tests 2 Test Strip Specifications : Strip Size 35 × 6 × 0.6 mm Storage Conditions Temperature 36~86°F (2~30°C) Humidity：RH 80% Blood Volume 0.6 µL Expiration of Test Strips See print on the top of the box System Operation Conditions : Test Strips Using the Medi+Sure Blood Glucose Test Strips only Operation Conditions Temperature： 50~104°F(10~40°C) Humidity 20%~80%RH. Sample Type Capillary whole blood in finger Hematocrit of Tested Blood 25%~60% Altitude Limit To be used no higher than 10183 feet above sea level. TM √ 3 The meter is calibrated to capillary whole blood equivalent results. 1.3 About the system Medi+Sure Blood Glucose Meter (Front) : TM LCD Display Show blood glucose test results and messages Left Arrow Button / Time display Button Mem Del C Setting Button 1. Setting date, time,and temperature unit. 2. Power off. Main Button 1. Press to recall memory or average 2. Power on M L S Medi+Sure TM Right Arrow Button / Temperature display Button Slot Insert test strip Medi+Sure Blood Glucose Meter (back) : TM Battery Cover A4064I-09C1-0002 Serial Number Medi+Sure Canada Inc. 31A-328 Speedvale Ave. East, Suite 160, Guelph , Ontario, N1E 0J4, Canada. Toll Free : 1-855-634-7873 (or 1-855-MDISURE.) 4 Medi+Sure Blood Glucose Test Strip : TM Sampling Window Application Point Apply blood or control solution to the application point Black-Colored Bars Insert this end with black bars facing up into the test strip slot How to assess that enough blood has been sampled ? Sampling Window Correct Blood Application Not Enough Blood (< 0.6 µL) Look at the sampling window on the test strip. If you have enough blood on the strip, you will not see any white. The sampling window will be completely filled with blood. If it doesn’t have enough blood, it will look like the one on the right above. 5 Section 2. How Your System Works 2.1 Installing / Relacing the Battery Your Medi+Sure Blood Glucose Monitoring System is packed with one 3-volt lithium coin battery that needs to be installed before testing. The battery can last for more than 1,000 tests. However, it varies because of usage, so always keep spare batteries on hand. When the battery symbol appears on the display, it means your battery is low. Although the meter will still provide accurate results, the battery should be replaced as soon as possible. After the battery is replaced, reset the date, time, and units. (See Section 2.2 Setting the Date, Time, and Units.) TM ＊ Steps to Install / Replace the Battery : 1) Flip open the battery cover by pushing the tab. 2) Use the battery cover to pull the battery out of the battery locker. 3) Insert a new battery with the positive (+) side up and make sure the battery is placed under the battery holder. Press the battery down firmly. Slide the battery cover back until it snaps into place. pull F D K 4) The LCD will display “Set” for about 1 second. ＊5) Reset the date,time,and units. 6 2.2 Setting the Year, Date, Time, and Temperature Units ＊ Steps to set the Year, Date, Time, and Temperature Units : 1) Press the “S” button（setting button）≧3 seconds. 2) You will hear a beep, and the meter will power on. The LCD display shows date, time, temperature unit, unit , on thermometer symbol the screen. 3) Press the “S” button（setting button）years flashes on the screen. 4) Press the “＞” button（Right arrow button）or the “＜” button（Left arrow button） until the correct year is displayed. 5) Press the “S” button again, the month flashes on the LCD screen. 6) Press the“＞” button or “＜” button until the correct month is displayed. 7) Press the “S” button. The day flashes. 8) Press the “＞” button or “＜” button until the correct day is displayed. 9) Press the “S” button. The hour flashes. 7 1) Mem Del C M L SS reTM 2) 3) M L SS M 10) Press the“＞” button or “＜” button until the correct hour is displayed. 11) Press the “S” button. The minutes flash. M 12) Press the“＞” button or “＜” S button until the correct minutes Medi+Sure are displayed. 13) Press the “S” button. The unit “mmol/L” is displayed. 14) Press the “S” button. The temperature unit (˚C) is displayed. (Both mmol/L and ˚C are default units.) 15) Press the “S” button. The meter beeps and shut off. All settings will be saved. 4) L TM To quickly adjust a certain number, keep pressing the “＞” or “＜”button until the one you want appears. At any steps if you want to shut the meter off, press the “S” button for about 3 seconds and all setting still can be automatically saved. 8 2.3 Alarm setting ＊ Steps to set the alarms : 1) Press the “＜” button（Left arrow button）≧3 seconds on the front of the meter. 2) You will hear a beep, and the meter M will power on. The LCD display shows S AL 1 (Alarm 1), time on the screen. Medi+Sure 3) Press the “S” button（setting button） to activate the alarm and alarm symbol（ ）flashes on the screen. You can set the alarm On or OFF by pressing the “＞” or “＜” button. 4) Press the “S” button again, the hour flashes on the LCD screen. 5) Press the“＞” button or “＜” button until the correct hour is displayed. 6) Press the “S” button. The minute flashes. 7) Press the “＞” button or “＜” button until the correct minutes is displayed. 8) Press the “S” button, the meter beeps. The LCD display shows “ok”. The AL 1 (Alarm 1) be setting finish. 9) Pressing the “S” button.You can set AL 2~4. 10) Press the “S” button ≧3 seconds, the meter beeps. After “SAVE" display on the screen, the meter shut off. All settings will be saved. L TM 9 2) To quickly adjust a certain number, keep pressing the “＞” or “＜”button until the one you want appears. At any steps if you want to shut the meter off, press the “S” button for about 3 seconds and all setting still can be automatically saved. ＊ Alarm : 1) The alarm duration is 30 seconds. 2) You can press any button and the alarm will stop. 3) Alarm will activate only under sleep mode;alarm will not function while the meter is in use. 2.4 Testing Control Samples ＊ Steps to Test control sample : 1) Prepare the test strip and Glucose Control Solutions. 2) To Start,press the “M” buttton (main button) the meter will power on. 3) Insert an Medi+Sure strip to the 3) strip slot. 4) Press the “＞” button.“L1” refers to Level 1）. You can select L1, L2 or blood by pressing M the “＞” or “＜” button. TM L S Medi+Sure R B e s g e nA P - 1 0 0 0 TM 10 5) When the control bottle symbol flashes on the meter, it means that you can start testing. You have 3 minutes to apply the control solution. If you do not apply the control solution within 3 minutes, the meter will turn off automatically. 6) Use a clean, wet tissue to wipe the cap top of the closed test strip vial. Dry thoroughly. 4) C M L S Medi+Sure TM 7) Gently squeeze a drop onto the strip vial cap top. 8) Let the applied point of the test strip touch the control solution drop. 9) Allow the solution to be automatically drawn into the reaction zone until it is completely filled. 10) After 6 seconds, the result will be shown on the screen. 11) Compare the control test result with the range printed on the label of the test strip vial. In the control mode (L1 or L2), the test result will not store in the meter's memory. For detailed information please refer to the Glucose Control Solution instructions. 2.5 Blood Sampling ＊ Fingertip Blood Sampling : For detailed information of lancing device, please refer to the Lancing device instructions. 11 1) Wash your hands with soap and warm water and dry them thoroughly. Remove the lancing devices cover. 2) Place a new lancet securely into the lancet carrier. 3) Remove the protective cap from the lancet. Do not discard this cap. 4) Place the cover back onto the lancing device. 5) Choose the desired depth of penetration to get a good blood sample with the least amount of discomfort. Adjust the depth setting by turning the cover on the lancing device. Settings: 1 or 2 - for delicate skin. 3 or 4 - for normal skin. 5 or 6 - for thick or callused skin. 6) Hold the lancing device in one hand. Pull the sliding barrel forward with your other hand until an audible click is heard. The lancing device is now loaded and ready to use. The device may be returned to the original position by releasing the sliding barrel. 7) To obtain a better sample of blood, lower the hand from which a sample is to be obtained and shake it a few times. Rub from the palm upward to the fingers with your other hand. 8) Place the end of the lancing device against the finger from which the blood sample is to be obtained. Push the trigger button to puncture the skin. Set the lancing (1) (2) (3) (4) (5) (6) (8) (9) (10) 12 device aside and proceed with your blood glucose test according to blood glucose monitor’s directions. 9) Remove the adjustable comfort tip after the penetration has been made. Put the protective cover back onto the lancet in order not to expose the needle tip. 10) Push forward the ejector, and dispose off the lancet in an approved container. Revert the ejector back; depress the trigger, so the lancing device will turn back to its original state.Put back on the adjustable comfort tip. The blood-borne pathogen (e.g. HBV, HCV, or HIV) may be transmitted if there is shared using of a medical device. The lancing device is intended to be used by a single person and should not be shared. You should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips. Please refer to the section of “ How to Clean and Disinfect Your Device“ for more detailed information on Cleaning and Disinfection. 2.6 Testing Your Blood Glucose ＊ Steps to Test your Blood Glucose : 1) Take one test strip out of the test strip vial. Replace the vial cap immediately and close it tightly. 1) ure i+S ed M TM 2) Insert this test strip (with the black bars facing up) into the test strip slot of the meter. The meter turns on automatically. 13 3) 3) Or you can press the “M” button to turn on the meter, and a test strip symbol will instruct you to insert a test strip. Please insert test strip within 1 minute, then the meter will display the code number. 4) When the blood drop symbol flashes on 4) the meter, it means that you can start testing. You have 3 minutes to apply the blood sample. If you do not apply the sample within 3 minutes, the meter will turn off automatically. 5) Place the lancing device against your fingertip and press the trigger. 6) Pick up the meter and use the most comfortable way to touch the blood drop to the edge of the application point of the test strip. The blood will be drawn into the test strip automatically. You will hear a beep letting you know the test has begun. Medi+Sure TM M L S Medi+Sure TM Sampling Window Correct Blood Application Not Enough Blood (< 0.6 µL) Look at the sampling window on the test strip. If you have enough blood on the strip, you will not see any white. The sampling window will be completely filled with blood. If it doesn’t have enough blood, it will look like the one on the right above. 14 7) When you hear a beep, the meter starts to count down from 6 seconds. After countdown, the test result is displayed with date and time and stored in the meter's memory automatically. If the test result is higher then 13.3 mmol/L include 13.3 mmol/L ,exclamation point ） will be showed on the screen. 8) Record the result in your Log Book. 9) Remove the test strip from the meter. Discard the used test strip and lancet in a puncture-proof container. • When result either falls in a hypoglycemic range (<2.8 mmol/L), or in hyperglycemic range (>13.9 mmol/L) contact your healthcare provider for assistance. CAUTION: If you get a high or low reading and you do not feel ill ; • Repeat your measurement. • Make sure your readings are in mg/dL. • Test your meter with control solution. If you still get a high or low reading, contact your health care professional. The meter should be wiped with suitable disinfectant by following the section of “How to Clean and Disinfect Your Device” in User’s Guide after using or before using in next patient. 15 2.7 How to Clean and Disinfect Your Device STEP1: CLEAN BEFORE DISINFECTING 1.Dispense CaviWipes towelette. 2.Clean surface of your device including meter and lacing device (not shown) with towelette to remove debris and bioburden. 3.Discard used towelette. STEP2: DISINFECT AFTER CLEANING 1.Dispense CaviWipes towelette. 2.Disinfect precleaned surface with towelette for 2 minutes. 3.Discard used towelette. 1.The meter or lancing device should be cleaned whenever it is visibly dirty. It should be disinfected periodically, such as once per week. 2.The number of cleaning and disinfectant for meter and lacing device is up to 18250 cycles that was validated for use with the device over the life of the device. The recommended frequency of disinfection for a single patient use device is once per week equals two wipes per week, one for pre-cleaning and one for disinfection. 3.Our testing was evaluated at least 5 years use life for meter and lancing device. 4. If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be decontaminated prior to use by the seconduser. 5.You should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips. 16 ＊Why is the disinfection of this device required? The FDA in the USA has issued a new regulation regarding public health notifications highlighting the risk of transmission of disease from shared use of fingerstick (lancing) devices and the point of care blood testing device (blood glucose meter). An important step in the new regulations is to prevent a blood-borne pathogen (e.g. HBV) transmitted if there is shared using of medical device (e.g. Blood Glucose Meter and Lancing Device).Hepatitis B virus (HBV) is a small-enveloped DNA virus and a member of the family Hepadnaviridae. The viral envelope surrounding the partially double-stranded DNA genome consists of multiple copies of the viral surface transmembrane proteins inserted into a liquid bilayer derived from the host cell. Due to the envelope of virus, it is very difficult to kill if using 70 % ethanol only. The use of 10 % bleach solutions is effective against the virus, but may lead to physical degradation of our meter.Clinical studies show that with the correct contact time, the glucometer and the lancing device can effectively be disinfected against HBV. What parts of the medical devices will require ＊cleaning and disinfection ? Whole Case Housing Display Cover Button Cap 17 ＊ Information of CaviWipe disinfectant CaviWipes Disinfecting Towelettes were purchased from METREX RESEARCH CORP, and the EPA Reg. is 46781-8. CaviWipes are non-woven disposable towelette pre-saturated with CaviCide, and are intended for use in health care settings such as hospital, dental offices, laboratories, clinics, ophthalmic offices, veterinary facilities and in kitchens and bathrooms. CaviWipes are effective against the Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV-1). The time to kill above viruses is 2 minutes. Diisobutyl-phenoxy-enthoxyethyl dimethyl benzyl ammonium chloride is as the active ingredient for using in CaviWipes Disinfecting Towelettes. It has been shown to be safe for the use the Medi+Sure Blood Glucose Meter. TM Manufacturer: METREX RESEARCH CORPORATION. Address: 28210 Wick Road Romulus, MI 48174 Tel:1-(800) 841-1428 Website: www.metrex.com 1.You can call the service line or go to the website of METREX for purchase information. 2.If you still have question on the section of “ How to Clean and Disinfect Your Device”, please contact our telephone number 1-855-634-7873 for technical assistance. 18 2.8 Reviewing Results in Memory ＊ Steps to Recall Your Test Results in Memary : The Medi+Sure Blood Glucose Meter automatically stores up to 960 test results with respective dates and time. You can review them in order, from the newest to the oldest. Once 960 results are in memory, the meter automatically deletes the oldest result when a new one is added. Results stored in memory will not be lost when you replace the battery. TM 1) Press the “M” button（main button）to turn on the meter. 2) When the test strip symbol flashes, press the “M” button again. 7 days average result will be shown on the screen in 1 minute. 3) Press the “＞” button , 14 days average result will be shown on the screen for 1 minute. 4) Press the “＞” button again, 21 days average result will be shown on the screen for 1 minute. 5) Press the “＞” button again, 28 days average result will be shown on the screen in 1 minute. At any steps if you want to shut the meter off, press the “S” button. 19 6) At 7 days average result, press the “M” button again, you can read test results in memory, the latest test result will be shown for one minute. Press the “＞” or “＜” button to review your test result history. To read sequence of test results in memory, continue to press the ”＞”or “＜” button. To quickly recall a certain test result, keep holding the”＞”or “＜” button until the one you want appears. 7) If you want to delete any memory from 960 memories, you can press the “S” button≧3 seconds. You will see ”Del” flashing on the screen. Then you can press the “S” button again. This memory will be deleted and go to the next one automatically. When you delete the individual memory, the “SEt” flashes on the screen, your memories are rebuilded.The duration is various. 8) When you see the oldest reading, The LCD display shows “Mem Del ALL?” on the screen for 1 minute. 9) If you want to delete all the memories in the meter, press the “S” button≧3 seconds. “----” message will be shown on the screen which means the memories in the meter were all deleted. 10) If you don’t want to clear anything, press the “S” button, the meter turns off. 20 If you do not press the “M” button within 1 minute, the meter will turn off automatically. At any steps of memory mode if you want to shut the meter off, press the “S” button the meter will turn off and all setting still can be automatically saved. 11) Results from tests with control solution are not used in calculation of Average. Mem Mem Mem mmol/L mmol/L mmol/L 21days Mem Mem Mem Del mmol/L 28days Mem Del ALL If you want to turn off the meter while you are in the memory and average, you can press the “S” button. the exception occurred when the meter is counting down. 21 Reset the date is a must after every single replacement of battery; otherwise, the average function is not going to be valid for tracing the memory data. Once resetting is completed,”SEt” will display on the screen, and the meter is going to generate and reload the memories automatically. It is going to take a minute for completing, and the duration is various. 2.9 Viewing Date, Time or Temperature 1) Press the “＜” button（Left arrow button）date, time and clock symbol（ ） will be shown on the screen for 3 seconds and the meter will turn off automatically. If you had set the alarm, alarm symbol（ can be shown on the screen. ） 2) Press the “＞” button（Right arrow button） temperature, temperature unit and thermometer symbol（ ） will be shown on the screen for 3 seconds and the meter will turn off automatically. 22 Section 3. Important Notes 3.1 Caring for Your Meter Taking care of your meter is very simple. Just follow the guidelines shown below： 1) Do not disassemble your meter. If you have any questions, please contact your local authorized distributor of Medi+Sure Blood Glucose Monitoring System. 2) Please use your meter carefully. Avoid throwing, shaking, or dropping it, which may damage its internal parts. 3) Clean the meter’s surface with a soft tissue slightly dampened with water. Do not use alcohol or abrasive solutions. 4) Do not wash or pour liquid on the meter. TM 3.2 Handling & Storage 1) Handle your meter with care and protect it from direct sunlight or extremely high or low temperature. 2) Do not expose your meter and test strips to an environment of high humidity, such as in bathrooms, kitchens, etc. 3) Keep your meter free of dust. 4) It is recommended that you use the carrying case that is designed to store and protect your Medi+Sure Blood Glucose Monitoring System. TM 5) Put your system in an appropriate operating environment at least 30 minutes before testing. 23 3.3 Explanation of Displays • All-symbol Message : When you press the “M” button or insert a test strip into the meter, all symbols will be displayed together for 2 seconds. Then the meter turns on automatically. Mem Del C • New Meter and Test Strip Insertion Message : The meter will instruct you to insert a test strip into the test strip slot by flashing strip symbol on the display. • No Memory In The Meter Message : If there is no memory in the meter, you press ”M” button two times and the meter shows “----” . 24 • Sample Application Message : This requires you to apply the blood sample or control solution to the test strip after inserting a test strip. C C Apply Blood sample Apply Control solution L1 Apply Control solution L2 • Test Result Message : The meter shows results ranging from 1.1 to 41.7 mmol/L with respective dates and times. • HI Message If the test result is higher than 41.7 mmol / L the “HI” message is displayed. • Lo Message If the test result is lower than 1.1 mmol / L the “Lo” message is displayed. 25 • Units of Test Result : You can select mmol/L in setting mode. The units will be displayed along with the test result. Mem Mem 3.4 Error Messages & Troubleshooting When you operate the meter incorrectly, error messages are displayed. Each message is defined below. E-U Cause: (1) Test strip was removed during testing; (2) A damp or used test strip was used; (3) The blood sample was applied before inserting the test strip; (4) The blood sample or control solution was applied without the blood drop or control bottle symbol flashed. Action: (1) Do not remove the test strip before the result is displayed; (2) Repeat the test with a new test strip; (3) Insert the test strip into the meter first and then apply the blood sample. (4) Apply the blood sample or control solution after the blood drop or control bottle symbol flashes. 26 E-O, E-OO, E-tF, E-S Cause: Damaged meter. Action: Contact your local authorized distributor of Medi+Sure Blood Glucose Monitoring System. TM E-t Cause: The system is operated outside the appropriate temperature range (50°~104°F or 10°~40°C). Action: Move your meter and test strips to a place where the temperature is appropriate for running a test. Wait at least 30 minutes and test again. E-b Cause: The battery is low. Action: Replace the battery soon. 27 3.5 Expected Values 1 Expected blood glucose levels for people without diabetes: Time Range (mmol/L) fasting 3.9-6.1 Two hours after meals less than 7.8 1 American Diabetes Association Clinical Practice Recommendations 2004, Diabetes Care, Vol. 27, Supplement 1, p.S9. 3.6 Meter Warranty MediSure Diabetes Care Canada Inc.warrants, to the original purchasers of the Medi+Sure Blood Glucose Meter, that your meter shall be free of defects in materials and workmanships under a life time warranty from the date of purchase. If the meter does not work properly because of defects in materials or workmanships, MediSure Diabetes Care Canada Inc.will replace it with an equivalent product or repair it at no cost to the purchaser. This warranty does not apply to the battery supplied with the meter or to a meter that has been modified, altered, abused, or misused in any way. MediSure Diabetes Care Canada Inc. shall not be responsible for any incidental or consequential damages. NO OTHER WARRANTIES, EXPRESS, OR IMPLIED ARE MADE. Please contact your local authorized distributor for assistance if you have any question about the warranty service. TM 28 Note : If you pick up this book, please contact above.