MediSure BLOOD GLUCOSE MONITORING SYSTEM User guide

Medi
Sure
®
Medi
Sure
Blood Glucose Monitoring System
User Guide
(Multi-User Model)
®
Medi+Sure Canada Inc.
31A-328 Speedvale Ave. East, Suite 160,
Guelph , Ontario,
N1E 0J4, Canada.
www.medisure.ca
Toll Free: 1-855-MDI-SURE (634-7873)
Fax: 855-329-5302
E-mail: info@medisure.ca
®
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
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.
1
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.
2
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.
3
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
4
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
Memory Capacity
Measurement Unit
Display
Reaction Time
Meter Dimensions
Meter Weight
Measuring Range
Power Supply
Battery Lifetime
Temperature: -20°~+50°C Humidity RH ≦ 80%
960 test results with respective dates and times
mmol/L
LCD display
6 Seconds or less
54×93×16 Millimeters
53 Grams (with battery)
1.1~41.7 mmol/L
One 3 Volt lithium battery (Model CR2032)
Over 1,000 tests
Test Strip Specifications
Strip Size
Storage Conditions
Blood Volume
Expiration of Test
Strips
5
35 × 6 × 0.6 Millimeters
Temperature: 2°~30°C Humidity: RH ≦ 80%
0.6 µL
See printed expiry on the side of test strip box or vial
System Operating Conditions
Test Strips
Operating Conditions
Sample Type
Hematocrit of
Tested Blood
Use only Medi+Sure Blood Glucose Test Strips
Temperature: 10°~40° C Humidity: RH ≦ 80%
Capillary whole blood in finger
25%~60%
To be used no higher than 10183 feet above sea
level
The meter is calibrated to capillary whole blood equivalent results
Altitude Limit
6
ABOUT THE Medi+Sure® SYSTEM
Medi+Sure® LCD Display
Show Blood Glucose Test Results and Messages
Medi+Sure®
Meter Back
7
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.
8
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
8. Press the
9. Press the
9
button or
button until the correct month is displayed.
button. The day flashes.
button or
button until the correct day is displayed.
10. Press the
11. Press the
12. Press the
13. Press the
14. Press the
15. Press the
16. Press the
be saved.
button. The hour flashes.
button or
button until the correct hour is displayed.
button. The minutes flash.
button or
button until the correct minutes are displayed.
button. The unit “mmol/L” is displayed.
button. The temperature unit (˚C) is displayed.
button. The meter beeps and shuts off. All settings will
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.
10
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.
11
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.
12
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.
13
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
14
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.
15
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.
16
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.
17
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
18
Information of CaviWipe disinfectant
CaviWipes Disinfecting Towelettes are 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 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.
Manufacturer: METREX RESEARCH CORPORATION.
Address: 28210 Wick Road Romulus, MI 48174
Tel: 1-(800) 841-1428 Website: www.metrex.com
You can call the service line or go to the website of METREX for purchase
information. If you still have questions on the section “How to Clean and
Disinfect Your Device”, please contact the Medi+Sure® Customer Assistance
line 1-855-634-7873 for assistance.
19
IMPORTANT NOTES
Caring For Your Meter
Taking care of your meter is important. Please follow the guidelines shown
below:
1. Do not disassemble your meter. If you have any questions,
please contact Medi+Sure®.
2. Please use your meter carefully. Avoid throwing, shaking, or
dropping it, which may cause damage.
3. Clean the meter’s surface – refer to “How to Clean and Disinfect Your
Device”
4. Do not wash or pour liquid on the meter.
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.
5. Put your system in an appropriate operating environment at least 30
minutes before testing.
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.
20
No Memory in the Meter Message:
If there is no memory in the meter, you press
two times and the meter shows “----”.
button
Sample Application Message:
This requires you to apply the blood sample or control solution to the test
strip after inserting a test strip.
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.
21
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.
22
ERROR MESSAGES AND TROUBLESHOOTING
When you operate the meter incorrectly, error messages are displayed. Each
message is defined below.
Cause:
Test strip was removed during testing.
Damaged or used test strip was used.
The blood sample was applied before inserting the test
strip.
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.
Contact: Medi+Sure® for any of these four errors.
23
Cause:
The system is operating outside the appropriate temperature
range 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.
Cause:
The battery is low.
Action:
Replace the battery soon.
24
EXPECTED VALUES
1
Expected blood glucose levels for people without diabetes:
Time
Range (mmol/L)
Fasting
< 7.0
Two Hours After Meal
< 11.1
1
American Diabetes Association: Diabetes Care, Volume 35, Supplement 1,
January 2012, S4
25
METER WARRANTY
Medi+Sure 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 Medi+Sure® meter does not work properly because of
defects in materials or workmanships, Medi+Sure 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. Medi+Sure
Canada Inc. shall not be responsible for any incidental or consequential
damages.
NO OTHER WARRANTIES, EXPRESS, OR IMPLIED ARE MADE.
Please contact Medi+Sure® at 1-855-634-7873 for assistance if you have any
questions about the warranty service.
26
Medi+Sure®
Log Book
DATE
TIME
TEST
RESULT
AC / PC
AC
PC
AC
PC
AC
PC
AC
PC
AC
PC
AC
PC
AC
PC
AC
PC
AC
PC
AC
PC
27
NOTES/Patient Name
NOTES:
28
Personal Information
Name
Address
Home Phone
Mobile Phone
Hospital
Physician
Email
Diagnosis Date
Additional Information:
29