MediSure Blood glucose monitoring system User manual

(Multi-User Model)
Medi+Sure Canada Inc. 31A-328 Speedvale Ave. East, Suite 160, Guelph , Ontario, N1E 0J4, Canada.www.medisure.caToll Free: 1-855-MDI-SURE (634-7873)Fax: [phone]E-mail: [email protected]
User Guide
®®
Medi Sure
Blood Glucose Monitoring System
Medi Sure®

Medi+Sure®
Multi-Patient User Guide - Table of Contents
INTRODUCTION .......................................................................................................1
TESTING PRINCIPLE..................................................................................................2
INDICATIONS FOR USE .............................................................................................3
IMPORTANT SAFETY INSTRUCTIONS........................................................................4
CONTENTS AND SPECIFICATIONS.............................................................................5
Kit Contents .......................................................................................................5
Meter Specifications ..........................................................................................5
Test Strip Specifications .....................................................................................5
System Operating Conditions.............................................................................6
ABOUT THE Medi+Sure® SYSTEM............................................................................7
Medi+Sure® LCD Display....................................................................................7
Medi+Sure® Blood Glucose Test Strip ...............................................................8
HOW YOUR SYSTEM WORKS.................................................................................... 9
Installing or Replacing the Battery .....................................................................9
Setting the Date & Time.....................................................................................9
Alarm Setting ...................................................................................................10
Reviewing Results in Memory .......................................................................... 11
Viewing Date, Time or Temperature ................................................................ 12
Alarm Notes ..................................................................................................... 13
BLOOD SAMPLING AND TESTING........................................................................... 14
Finger Tip Blood Sampling................................................................................ 14
Testing Your Blood Glucose.............................................................................. 14
Testing Control Samples................................................................................... 16
HOW TO CLEAN AND DISINFECT YOUR DEVICE...................................................... 17
STEP 1: Clean Before Disinfecting..................................................................... 17
STEP 2: Disinfect After Cleaning .......................................................................17
Why is the disinfection of this device required? .............................................. 18
Parts of the medical devices will require cleaning and disinfection ................. 18
Information of CaviWipe disinfectant .............................................................. 19
IMPORTANT NOTES ............................................................................................... 20
Caring For Your Meter...................................................................................... 20
Handling & Storage .......................................................................................... 20
Explanation of Displays .................................................................................... 20
ERROR MESSAGES AND TROUBLESHOOTING......................................................... 23
EXPECTED VALUES1................................................................................................ 25
METER WARRANTY................................................................................................ 26
Log Book ................................................................................................................ 27

1
INTRODUCTION
We would like to thank you for making a smart decision.
The Medi+Sure® Blood Glucose Monitoring System is designed for
Canadians.
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 results with respective dates and times,
which allows you to monitor your Diabetes program efficiently.
We thank you once 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 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.
For customer assistance outside these times, please leave a message with
your full contact information including a contact phone number. In case of a
medical emergency, please contact your health care provider.

2
TESTING 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.

3
INDICATIONS FOR USE
The Medi+Sure® Blood Glucose Monitoring System is intended for use in the
quantitative measurement of glucose in fresh capillary whole blood from the
finger. It is to be used as an aid in monitoring the effectiveness of a Diabetes
control program. It is not intended for the diagnosis of, or screening for
diabetes mellitus, and is not intended for use on neonates.
Because this is a multi-user device, the disinfection protocol found on pages
17-19 must be followed after each use.

4
IMPORTANT SAFETY INSTRUCTIONS
Users must adhere to Standard Precautions when handling or using this
device. All parts of the glucose monitoring system should be considered
potentially infectious and are capable of transmitting blood-borne pathogens
between patients and healthcare professionals.
The Medi+Sure® 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.
Only auto-disabling, single use lancing devices may be used with
this device.
For more information, refer to “Guideline for Isolation Precautions: Preventing
Transmission of Infectious Agents in Healthcare Settings 2007”,
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html

5
CONTENTS AND SPECIFICATIONS
Kit Contents
Medi+Sure® Multi-Patient Blood Glucose Meter
3-Volt Lithium Coin Battery (CR2032)
User's Guide
Getting Started Guide
Carrying Case
Meter Specifications
Storage Conditions
Temperature: -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 or less
Meter Dimensions
54×93×16 Millimeters
Meter Weight
53 Grams (with battery)
Measuring Range
1.1~41.7 mmol/L
Power Supply
One 3 Volt lithium battery (Model CR2032)
Battery Lifetime
Over 1,000 tests
Test Strip Specifications
Strip Size
35 × 6 × 0.6 Millimeters
Storage Conditions
Temperature: 2°~30°C Humidity: RH ≦80%
Blood Volume
0.6 µL
Expiration of Test
Strips
See printed expiry on the side of test strip box or vial

6
System Operating Conditions
Test Strips
Use only Medi+Sure Blood Glucose Test Strips
Operating Conditions
Temperature: 10°~40° C Humidity: RH ≦80%
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
The meter is calibrated to capillary whole blood equivalent results

7
ABOUT THE Medi+Sure® SYSTEM
Medi+Sure® LCD Display
Show Blood Glucose Test Results and Messages
Medi+Sure®
Meter Back

8
Medi+Sure® Blood Glucose Test Strip
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.

9
HOW YOUR SYSTEM WORKS
Installing or Replacing 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 will
last for approximately 1,000 tests. 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, and time.
1. Open the battery cover by pressing on it and sliding it in
the direction of the arrows on the battery cover.
2. If replacing battery, remove the old battery.
3. Insert a new battery firmly with the positive (+) side up.
4. Replace the battery cover. The LCD will display “Set.”
5. Reset the date, time.
Setting the Date & Time
1. Press and hold the button for 3 seconds.
2. You will hear a beep and the meter will power on.
3. The LCD display shows date, time, temperature and
thermometer symbol on the screen.
4. Press the button and the year flashes on the
screen.
5. Press the button or the button until the correct
year is displayed.
6. Press the button again, the month flashes on
the LCD screen.
7. Press the button or button until the correct month is displayed.
8. Press the button. The day flashes.
9. Press the button or button until the correct day is displayed.

10
10. Press the button. The hour flashes.
11. Press the button or button until the correct hour is displayed.
12. Press the button. The minutes flash.
13. Press the button or button until the correct minutes are displayed.
14. Press the button. The unit “mmol/L” is displayed.
15. Press the button. The temperature unit (˚C) is displayed.
16. Press the button. The meter beeps and shuts off. All settings will
be saved.
NOTE:
To quickly adjust any function, keep pressing the or button until the
one you want appears. At any point, if you want to shut the meter off, press
the button for about 3 seconds and all setting will automatically be
saved.
Alarm Setting
Press and hold the button for 3 seconds.
You will hear a beep and the meter will power on. The LCD display lights up
Press the 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 button again, the hour flashes on the LCD screen.
5) Press the or button until the correct hour is displayed.
6) Press the button. The minute flashes.
7) Press the or button until the correct minutes is displayed.
8) Press the button, the meter beeps. The LCD display shows “ok”.
9) Pressing the button, you can set AL 2 through 4.
10) Press the button at least 3 seconds, the meter beeps. After
“SAVE" displays on the screen, the meter shuts off. All settings will be saved.

11
Reviewing Results in Memory
The Medi+Sure® 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.
1. Press the button to turn on the meter.
2. When the test strip symbol flashes, press the button again. The 7
day average result will be shown on the screen for 1 minute. If there are no
tests recorded in the meter, “----“ is displayed.
3. Press the button again, the 14 day average result will be shown on the
screen for 1 minute.
4. Press the button again, the 21 day average result will be shown on the
screen for 1 minute.
5. Press the button again, the 28 day average result will be shown on the
screen in 1 minute.
6. At any point, if you wish to shut the meter off, press the button.
7. To view the individual test results, go to At the 7 day average result, press
the button again and the last test results in memory will be
displayed, the latest test result will be shown for one minute. The number
in memory (e.g. 001) will flash followed by the result. The date and time
will be displayed at the top of the screen.
8. Press the or button to review your test result history.
9. To view the sequence of test results in the memory, continue to press the
or button.
10. To quickly recall a certain test result, keep holding the or button
until the one you want appears.
11. To delete any test result from the memory, you, press the button
for at least 3 seconds. You will see “Del”flashing on the screen. Then
press the button again. This memory will be deleted and go to the
next one automatically.
12. When you delete the individual memory, the “SEt” flashes on the screen.
13. After scrolling past the oldest reading in memory, the LCD display shows
“Mem Del ALL?” on the screen for 1 minute.

12
14. To delete all the results in the memory, press the button for at
least 3 seconds. “----” message will be shown on the screen. This
indicates that all results in the Memory have been deleted.
If you don’t want to clear delete all test results, scroll to the individual
result and press the button and the meter turns off.
15. 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.
16. Results from tests with control solution are not included in calculating the
7, 14, 21 or 28 day Averages.
Viewing Date, Time or Temperature
1. Press the button date, time and clock symbol will be shown on
the screen for 3 seconds and the meter will turn off automatically.
2. If the alarm has been set, the alarm symbol will be shown on the
screen.

13
3. Press the button and the temperature, and thermometer
symbol will be shown on the screen for 3 seconds and the
meter will turn off automatically.
NOTE:
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 button for about 3 seconds and all setting will be
automatically saved.
Alarm Notes
1. The alarm duration is 30 seconds.
2. You can press any button and the alarm will stop.
3. Alarm will activate only in sleep mode. The alarm will not function while
the meter is in use.

14
BLOOD SAMPLING AND TESTING
Finger Tip 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.
NOTES
•Only an auto-disabling, single use lancing device should be used.
•A new pair of clean gloves should be worn by the user before testing
each patient.
•Please refer to the section of “How to Clean Your Device’ for more
detailed information on Cleaning and Disinfection.
•You should wash hands thoroughly with soap and water after handling
the meter, lancing device, or test strips.
•For more detailed information on cleaning and disinfection refer to
“How to Clean and Disinfect Your Device.“
Testing Your Blood Glucose
1. Take one Medi+Sure® 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. The meter turns on automatically.
3. You can also press the button to turn on the meter, and a test strip
symbol will instruct you to insert a test strip. Insert test strip within 1
minute.
4. 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 the fingertip and press the trigger.
6. Pick up the meter and touch the blood drop to the edge of the application
point of the test strip. The blood will be drawn into the test strip

15
automatically. You will hear a beep letting you know the countdown has
begun.
7. 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 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. If the test result is 13.3 mmol/L or higher, then an exclamation mark !
will be displayed on the screen.
10. Record the result in your Log Book.
11. Remove the test strip from the meter. Discard the used test strip and
lancet in a puncture-proof container.
When a result either falls in a hypoglycemic range, <2.8 mmol/L, or in
the hyperglycemic range >13.9 mmol/L follow the steps below.
CAUTION:
If you get a high or low reading
1. Repeat the test.
2. Test your meter using control solution.
3. 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
directions in the section “How to Clean and Disinfect Your Device” in the
User’s Guide before using with another patient.

16
Testing Control Samples
Prepare the test strip and Glucose Control Solutions.
1. Press the button. The meter will power on.
2. Insert Medi+Sure® 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 blood by pressing the
or button.
4. When the control bottle symbol flashes on the meter, it means that
you can start a control test. 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.
5. Use a clean, wet tissue to wipe the strip vial cap top. Dry thoroughly.
6. Gently squeeze a drop onto the strip vial cap top.
7. Let the tip of the test strip touch the control solution drop.
8. Allow the solution to be automatically drawn into sampling window until it
is completely filled.
9. After 6 seconds, the result will be shown on the screen.
10. Compare the control test result with the range printed on the label of the
test strip vial.
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.

17
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
bioburden.
3. Discard used towelette.
STEP 2: Disinfect After Cleaning
1. Dispense CaviWipes towelette.
2. Disinfect pre-cleaned surface with towelette for 2 minutes.
3. Discard used towelette.
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.

18
4. If the meter is being operated by a second person who is providing testing
assistance to the user, the meter should be disinfected prior to use by the
second user.
5. Wash hands thoroughly with soap and water after handling the meter, or
test strips.
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 finger stick (lancing) devices, and point-of-care blood testing devices
(blood glucose meters).
An important step in these regulations is to prevent a blood-borne pathogens
being transmitted if there is shared use of a medical device.(e.g. Blood
Glucose Meters and test strips).
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.
Parts of the medical devices will require cleaning and disinfection
WHOLE CASE
DISPLAY SCREEN
ALL BUTTONS
TEST STRIP SLOT AREA
WE RECOMMEND THAT THE ENTIRE DEVICE BE DISINFECTED