MediSure Blood Glucose Monitoring System Manual
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MediSure Blood Glucose Monitoring System Manual

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INTRODUCTION ......................................................... 1
TESTING PRINCIPLE .................................................... 2
INDICATIONS FOR USE ............................................... 2
IMPORTANT SAFETY INSTRUCTIONS ........................... 3
CONTENTS AND SPECIFICATIONS ................................ 4
Meter Kit Contents ...................................................... 4
Meter Specifications .................................................... 4
Test Strip Specifications .............................................. 5
System Operating Conditions ...................................... 5
ABOUT THE MediSure SYSTEM ................................... 6
MediSure Blood Glucose Test Strip ............................. 7
HOW YOUR SYSTEM WORKS ...................................... 9
Installing or Replacing the Battery .............................. 9
Powering the Meter On and Off ................................10
Setting the Date & Time ............................................11
Alarm Settings ...........................................................14
Reviewing Results in Memory ...................................15
Viewing Date, Time or Temperature .........................18
Alarm Notes ...............................................................19
BLOOD SAMPLING AND TESTING .............................. 20
Fingertip Blood Sampling ..........................................20
Testing Your Blood Glucose .......................................21
Testing Control Samples ............................................23
STEP 1: Clean Before Disinfecting ..............................25
STEP 2: Disinfect After Cleaning ................................25

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  • Page 1: Table Of Contents

    Test Strip Specifications ..........5 System Operating Conditions ........5 ABOUT THE MediSure SYSTEM ........6 MediSure Blood Glucose Test Strip ......7 HOW YOUR SYSTEM WORKS ........9 Installing or Replacing the Battery ......9 Powering the Meter On and Off ........10 Setting the Date &...
  • Page 2 Why is the disinfection of this device required? ..27 Parts of the medical devices that require cleaning and disinfection ..............28 Information of CaviWipe disinfectant .......29 IMPORTANT NOTES..........30 Caring For Your Meter ..........30 Handling & Storage ............30 Explanation of Displays ..........31 ERROR MESSAGES AND TROUBLESHOOTING ....

  • Page 3: Introduction

    Before testing, please read this User's Guide thoroughly. It contains all the information you need regarding the MediSure Blood Glucose Monitoring System. If you have product related questions please call our Customer Assistance line at 1-855-634-7873 from 8:00 AM to 6:00 PM, Eastern Standard Time Monday through Friday.

  • Page 4: Testing Principle

    TESTING PRINCIPLE The MediSure 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.

  • Page 5: Important Safety Instructions

    • The MediSure® meter should be disinfected after use on each patient. This Blood Glucose Monitoring System may only be used for testing multiple patients when Standard Precautions and the manufacturer’s disinfection procedures are followed.

  • Page 6: Contents And Specifications

    CONTENTS AND SPECIFICATIONS Meter Kit Contents • MediSure Blood Glucose Meter • 3-Volt Lithium Battery (CR2032) • User Guide • Quick Start Guide • Carrying Case • Warranty Card Meter Specifications Temperature: -20°~+50°C Storage Conditions Humidity RH ≦ 80% 960 test results with respective...

  • Page 7: Test Strip Specifications

    Test Strip Specifications Strip Size 35 × 6 × 0.6 Millimeters Temperature: 2°~30°C Humidity: Storage Conditions RH ≦ 80% Blood Volume 0.6 µL Expiration of Test See printed expiry on the side of test Strips strip box or vial System Operating Conditions Use only Medi+Sure Blood Glucose Test Test Strips Strips...

  • Page 8: About The Medisure System

    ABOUT THE MediSure SYSTEM LCD Display Blood Glucose Test Results & Messages Main Button Left Arrow Power on Button Memory Recall Show Time Alarm Set Settings Right Arrow Button Button Set Date & Time Temperature Power Off Strip Port Insert Test...

  • Page 9: Medisure Blood Glucose Test Strip

    Meter Back MediSure Blood Glucose Test Strip...
  • Page 10 How to determine whether blood sample is sufficient NOTE: If the sample is sufficient, the sampling window on the test strip should be full with no white space showing.

  • Page 11: How Your System Works

    HOW YOUR SYSTEM WORKS Installing or Replacing the Battery Your MediSure Blood Glucose Monitoring System is packed with one 3-volt lithium coin battery that needs to be installed before testing. The battery will last for approximately 1,000 tests. Always keep spare batteries on hand.

  • Page 12: Powering The Meter On And Off

    Powering the Meter On and Off Powering the Meter On Press the button to power on the meter. The Meter will power on, and prompt you to insert a test strip. The meter will stay on for 1 minute. Insert a Test Strip into the meter. The Meter will power on, and prompt you to take blood sample.

  • Page 13: Setting The Date & Time

    Setting the Date & Time Press and hold the button for 3+ seconds. The year flashes on the screen. Press the “>” or “<” buttons until the correct year is displayed Press the button again, the month flashes on the LCD screen Press the “>”...
  • Page 14 Press the button. The day flashes. Press the “>” or “<” buttons until the correct day is displayed. Press the button. The hour flashes. Press the “>” or “<” buttons until the correct hour is displayed. Press the button. The minutes flash.
  • Page 15 Press the button. “ ” will display. The meter beeps and shuts off. All date and time settings will be saved. NOTE: • To quickly adjust any function, keep pressing the “>” or “<” buttons until the one you want appears. •...

  • Page 16: Alarm Settings

    Alarm Settings “<” 1. Press and hold the button for 3+ seconds. 2. You will hear a beep and the meter will power on. The LCD display lights up 3. Press the button to activate the alarm and alarm symbol flashes on the screen.

  • Page 17: Reviewing Results In Memory

    Reviewing Results in Memory The MediSure Blood Glucose Meter automatically stores up to 960 test results with date and time. You can review test results from the newest to the oldest. Results stored in memory will not be lost when you replace the battery.
  • Page 18 Viewing 7, 14, 21 and 28 Day Averages 1. While viewing individual test results, Press the button again. 2. The 7 day average result will be shown on the screen for 1 minute. “>” 3. Press the button again, the 14 day average result will be shown on the screen for 1 minute.
  • Page 19 NOTE: • If you do not press the “M” button within 1 minute, the meter will turn off automatically. • At any point in Memory mode if you want to shut the meter off, press the button the meter will turn off and all settings will be automatically saved.

  • Page 20: Viewing Date, Time Or Temperature

    Viewing Date, Time or Temperature “<” 1. Press the button 2. The date, time and clock symbol will be shown on the screen for 3 seconds and the meter will turn off automatically. 3. If the alarm has been set, the alarm symbol will be shown on the screen.

  • Page 21: Alarm Notes

    NOTE: To quickly adjust a certain number, keep pressing the “>” “<” button until the one you want appears. At any steps if you want to shut the meter off, press the button for about 3 seconds and all setting will be automatically saved.

  • Page 22: Blood Sampling And Testing

    BLOOD SAMPLING AND TESTING Fingertip Blood Sampling 1. Wash hands in warm, soapy water. Rinse well and dry thoroughly. 2. Press a single use lancing device firmly onto the chosen site and draw a sufficient blood sample. 3. Dispose of lancet device in a suitable sharps container.

  • Page 23: Testing Your Blood Glucose

    Testing Your Blood Glucose 1. Take one MediSure test strip out of the test strip vial. Replace the vial cap immediately and close it tightly. 2. Insert this test strip with the black bars facing up into the test strip port of the meter.
  • Page 24 it will look like the illustration on the right above. 8. When you hear a beep, the meter starts to count down from 6 seconds. After the countdown, the test result is displayed with date and time, and stored in the meter's memory. 9.

  • Page 25: Testing Control Samples

    Solutions. 1. Press the button. The meter will power on. 2. Insert MediSure strip into the strip port. 3. Press the “>” button to enter control mode. The button “L1” refers to Level 1. You can select L1, L2 or “<”...

  • Page 26: When Control Solution Tests Are Recommended

    Note In the control mode (L1 or L2), the test result will not be stored in the meter's memory. For detailed information please refer to the Glucose Control Solution instructions. When Control Solution Tests are Recommended • A new Vial of test strips is opened. •...

  • Page 27: How To Clean And Disinfect Your Device

    HOW TO CLEAN AND DISINFECT YOUR DEVICE STEP 1: Clean Before Disinfecting 1. Dispense CaviWipes towelette. 2. Clean surface of your device with towelette to remove debris and bio burden. 3. Discard used towelette. STEP 2: Disinfect After Cleaning 1. Dispense CaviWipes towelette. 2.
  • Page 28 Notes 1. Disinfect meter between each patient use. 2. After disinfection, user’s gloves should be removed and hands washed before proceeding to the next patient. 3. The number of times the device can be cleaned and disinfected has been tested for up to 18,250 cycles. The recommended frequency to clean and disinfect in a multi patient setting is after each patient.

  • Page 29: Why Is The Disinfection Of This Device Required

    The use of a 10% bleach solution is effective against viruses such as hepatitis B, but may lead to physical degradation of the meter. Following the disinfection protocol outlined below will prevent blood-borne pathogen transmission and ensure the device is not damaged. For more information, please see http://hclicensed.medisure.ca...

  • Page 30: Parts Of The Medical Devices That Require Cleaning And Disinfection

    Parts of the medical devices that require cleaning and disinfection 1. Whole Case 2. Display Cover 3. Buttons WE RECOMMEND THAT THE ENTIRE DEVICE BE DISINFECTED...

  • Page 31: Information Of Caviwipe Disinfectant

    CaviWipes Disinfecting Towelettes. It has been shown to be safe for the use the MediSure Blood Glucose Meter. Manufacturer: METREX RESEARCH CORPORATION. Address: 28210 Wick Road Romulus, MI 48174 Tel: 1-(800) 841-1428 Website: www.metrex.com...

  • Page 32: Important Notes

    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 MediSure Blood Glucose Monitoring System. 5. Put your system in an appropriate operating...

  • Page 33: Explanation Of Displays

    Explanation of Displays All-symbol Message: When you press the button or insert a test strip into the meter, all symbols will be displayed together for 2 seconds. Then the meter turns on automatically. No Memory in the Meter Message: If there is no memory in the meter, you press button two times and the meter will show “0 Mem”.
  • Page 34 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”...

  • Page 35: Error Messages And Troubleshooting

    ERROR MESSAGES AND TROUBLESHOOTING When you operate the meter incorrectly, error messages are displayed. Each message is defined below. Causes: 1. Test strip was removed during testing. 2. Damaged or used test strip was used. 3. The blood sample was applied before inserting the test strip.
  • Page 36 Wait at least 30 minutes and test again. Cause: The battery is low. Action: Replace the battery soon. For any of the Following Errors: Action: Contact: MediSure for any of these four errors.

  • Page 37: Expected Values

    EXPECTED VALUES Expected blood glucose levels for people without diabetes: Time Range (mmol/L) Fasting < 7.0 Two Hours After < 11.1 Meal American Diabetes Association: Diabetes Care, Volume 35, Supplement 1, January 2012, S4...

  • Page 38: Meter Warranty

    Medi+Sure Canada Inc. warrants, to the original purchasers of the MediSure 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 MediSure meter does not work properly because defects materials workmanships, Medi+Sure Canada Inc.
  • Page 39 NOTES:...

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