MediSure DGEMP01M User manual

Blood Glucose Monitoring System
(DGEMP01M)
Owner’s Manual
Owner’s Manual

Dear MediSure Empower (DGEMP01M)
System Owner:
Thank you for purchasing the MediSure Empower Blood Glucose
Monitoring System (DGEMP01M). This manual provides important
information to help you to use the system properly. Before using this
product, please read the following contents thoroughly and carefully.
Regular monitoring of your blood glucose levels can help you and
your doctor gain better control of your diabetes. Due to its compact
size and easy operation, you can use the MediSure Empower
Blood Glucose Monitoring System (DGEMP01M) to easily
monitor your blood glucose levels by yourself anywhere, any time.
If you have other questions regarding this product, please contact
the local customer service or place of purchase.
Intended Use
This MediSure Empower Blood Glucose Monitoring System
(DGEMP01M) is intended for use outside the body (in vitro
diagnostic use) by people with diabetes at home as an aid to
monitoring the effectiveness of diabetes control. It is intended to be
used for the quantitative measurement of glucose (sugar) in fresh
whole blood samples (from the finger, palm, forearm and upper
arm).
It should not be used for the diagnosis or screening of diabetes, or
testing on the newborn.
This system is for single person use and should not be shared.
Version 1.0 20221/08
311-4183100-xxx

IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
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 biohazards and can potentially
transmit infectious diseases, even after you have performed cleaning
and disinfection.
For more information, please visit
⚫“FDA Public Health Notification: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010)
http://wayback.archive-
it.org/7993/20170111013014/http://www.fda.gov/MedicalDevices/
Safety/AlertsandNotices/ucm224025.htm
⚫“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
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories not specified by the manufacturer.
3. Do NOT use the device if it is not working properly or if it is damaged.
4. This device does NOT serve as a cure for any symptoms or diseases. The data
measured is for reference only. Always consult your doctor to have the results
interpreted.
5. The blood glucose test strip cannot be used for the testing of newborns.
6. Before using this device to test blood glucose, read all instructions thoroughly

and practice the test. Carry out all the quality control checks as directed.
7. Keep the device and testing equipment away from young children. Small items
such as the battery cover, batteries, test strips, lancets and vial caps are choking
hazards.
8. Use of this instrument in a dry environment, especially if synthetic materials are
present (synthetic clothing, carpets etc.) may cause damaging static discharges
that may cause erroneous results.
9. Do NOT use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with accurate operation.
10. Proper maintenance and periodic control solution testing are essential to the
longevity of your device. If you are concerned about your accuracy of
measurement, please contact the local customer service or place of purchase for
help.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
SCAN THIS QR CODE FOR ONLINE SUPPORT

TABLE OF CONTENTS
BEFORE YOU BEGIN...............................................................................................1
Important Information.................................................................. 1
Test Principle ..............................................................................2
Contents of System.....................................................................2
Meter Overview...........................................................................3
Display Screen............................................................................4
Test Strip..................................................................................... 4
SETTING THE METER .............................................................................................5
THE FOUR MEASURING MODES ...........................................................................7
CONTROL SOLUTION TESTING.............................................................................7
Do a control solution test when: .................................................. 7
Performing a Control Solution Test.............................................. 7
TESTING WITH BLOOD SAMPLE.........................................................................10
Preparing the Lancing Device for Blood Testing ........................ 10
Preparing the Puncture Site ...................................................... 10
Performing a Blood Glucose Test ..............................................12
Alternative Site Testing.............................................................. 14
METER MEMORY ...................................................................................................15
Reviewing Test Results ............................................................. 15
Reviewing Blood Glucose Day Average Results........................ 15
DOWNLOADING RESULTS ONTO A COMPUTER ..............................................16
MAINTENANCE ......................................................................................................18
Battery ......................................................................................18
Replacing the Battery................................................................ 18
Cleaning and Disinfection.......................................................... 19
Disinfecting Procedures ............................................................ 20
Caring for Your Test Strips......................................................... 23
Important Control Solution Information ......................................24
SYSTEM TROUBLESHOOTING ............................................................................25

Result Readings........................................................................ 25
Troubleshooting ........................................................................ 27
DETAILED INFORMATION .....................................................................................28
Comparing Meter and Laboratory Results................................. 28
SYMBOL INFORMATION .......................................................................................29
SPECIFICATIONS ...................................................................................................30

1
BEFORE YOU BEGIN
Important Information
⚫Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional
immediately.
⚫If your blood glucose results are lower or higher than usual, and
you do not have any symptoms of illness, first repeat the test. If
you have symptoms or continue to get results which are higher or
lower than usual, follow the treatment advice of your healthcare
professional.
⚫Use only fresh whole blood samples to test your blood glucose.
Using other substances will lead to inaccurate results.
⚫If you are experiencing symptoms that are inconsistent you’re your
blood glucose test results and you have followed all the
instructions given in this owner’s manual, contact your healthcare
professional.
⚫The device should not be used on severely hypotensive
individuals or patients in shock. Readings which are lower than
actual values may occur for individuals experiencing a
hyperglycemic- hyperosmolar state, with or without ketosis. Please
consult the healthcare professional before use.
⚫Limitation
The device should not be used on individuals in hyperglycemic-
hyperosmolar state, with or without ketosis; not for neonatal use; not
for use on critically ill patients.

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Test Principle
Your system measures the amount of glucose in whole blood. The
glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip.
The meter measures the current, calculates the glucose level, and
displays the result. The strength of the current produced by the
reaction depends on the amount of glucose in the blood sample.
Contents of System
Your new Blood Glucose Monitoring System kit includes the
following:
1. MediSure Empower Blood Glucose Monitor (DGEMP01M) × 1
2. Owner’s Manual × 1
3. Protective Wallet × 1
4. Lancing Device (DGEMP001L) × 1
5. Sterile Lancets (DGEMP030N) × 10
6. Log Book and Warranty Card x 1
7. Quick Start Guide × 1
Glucose Control Solution (DGEMP01C Low W2 + High B3) × 1
MediSure Empower Blood Glucose Test Strips (c), glucose control
solutions (d), lancing device (e), or sterile lancets (f) may not be
included in the kit. They can be purchased separately. Please make
sure you have those items needed for a test beforehand.
The strip port cable is not provided in the kit but an accessory for the
data transmission feature connecting to your PC (see section
“Downloading Results onto your Computer”). Please contact local
customer services or the place of purchase for obtaining the cable.
NOTE:

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If any items are missing from your kit or it was opened prior to use,
please contact customer service at 1-855-634-7873 or
[e-mail] or contact your place of purchase for
assistance.
Meter Overview
1. Test Strip Ejector
Eject the used strip by pushing up this button.
2. Display Screen
3. Down Button (▼)
4. M Button (M)
Enter the meter memory and silence a reminder alarm.
5. Up Button (▲)
6. Test Strip Slot / Strip Port Communication
Insert test strip here to turn the meter on for testing.
Connect strip port cable for data transmission.
7. Battery Compartment

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Display Screen
Test Result
Low Battery Symbol
Low/High Symbol
Test Strip Symbol
Error Message
Blood Drop Symbol
Memory Mode
QC Mode
QC- control solution test
Measuring Mode
AC –before meal
PC –after meal
Gen –any time of day
Date
Time
Day Average
Alarm Symbol
Measurement Unit
Ketone Warning
Test Strip
Absorbent Hole
Confirmation Window
Test Strip Handle
Contact Bars
ATTENTION:
The front side of test strip should face up when inserting test strip. Test
results might be wrong if the contact bar is not fully inserted into the test slot.
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NOTE:
The MediSure Empower Blood Glucose Monitoring System
(DGEMP01M) should only be used with MediSure Empower Blood Glucose
Test Strips (DGEMP01S or DGEMP01F). Using other test strips with this
meter can produce inaccurate results.
SETTING THE METER
Before using your meter for the first time or if you change the meter
battery, you should check and update these settings.
Entering the Setting Mode (a)
Start with the meter off (no test strip inserted). Press and hold ▲
and ▼ at the same time.
1. Setting the date
The sequence of the date setting is: YEAR → MONTH → DAY.
With the YEAR / MONTH / DAY flashing in sequence, press ▲
or ▼ to select the correct number. Press M.
2. Setting the time format
Press ▲ or ▼ to select the desired time format (12h or 24h).
Press M.
3. Setting the time
With the HOUR / MINUTE flashing in sequence, press ▲ or ▼
to select the correct number. Press M.
4. Setting the low and high target range for measuring mode
The sequence of the low and high target range setting is: Gen
low → Gen high → AC low → AC high → PC low →PC high.
With the settings mentioned above flashing in sequence, press
▲ or ▼ until the desired target appears. Press Mto confirm.

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5. Setting the beep sound On/Off
With the flashing, press ▲ or ▼ to set the beep sound On or
Off. Press Mto confirm.
6. Deleting the memory
With “dEL” and “ ” on the display, press ▲ to select “no” to
keep the results in memory, and then press M. To delete all the
results, press ▲to select “yes”, and then press Mto delete all
the memory records.
7. Setting the reminder alarm
Your meter has four reminder alarms. The meter will display
“On”or “OFF” and “ ”. If you don’t want to set an alarm, press
▲ or ▼ to select “OFF”, and then press Mto skip this step. Or
select “On” and press M to proceed.
With the hour/minute flashing in sequence, press ▲ or ▼ to
select the correct hour/minute. Press M and go to the next alarm
setting.
NOTICE:
When the alarm beeps, press M to switch it off. Otherwise, it will
beep for 2 minutes then switch off.
Congratulations! You have completed all settings!
NOTE:
⚫These parameters can ONLY be changed in the setting mode.
⚫If the meter is idle for 3 minutes during the setting mode, it will switch off
automatically.

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THE FOUR MEASURING MODES
The meter provides you with four modes for measuring, General,
AC, PC and QC. You can switch between each mode by:
1. Start with the meter switched off. Insert a test strip to turn on the
meter. The screen will display a flashing “ ” and “Gen”.
2. Press ▲ to switch between General, AC and PC mode.
3. Press M to switch to QC mode.
CONTROL SOLUTION TESTING
Do a control solution test when:
⚫You first receive the meter
⚫At least once a week to routinely check the meter and test strips
⚫You begin using a new vial of test strips
⚫You suspect the meter or test strips are not working properly
⚫Your blood glucose test results are not consistent with how you
feel, or if you think the results are not accurate
⚫Practicing the testing process, or
⚫You have dropped or think you may have damaged the meter.
Performing a Control Solution Test
To perform a control solution test, you will need: (b), (c) and (d).
1. Insert the test strip to turn on the meter
Insert the test strip into the meter. Wait for the meter to display
the “ ” and “ ”.

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2. Press M to mark this test as a control solution test
With “QC” displayed, the meter will store your test result in
memory under “QC”. If you press M again, the “QC” will
disappear and this test is no longer a control solution test.
Warning:
When doing the control solution test, you have to mark it so that the test
results will NOT mix with the blood glucose TEST RESULTS stored in the
memory. Failure to do so will mix up the blood glucose test results with the
control solution test results in memory.
3. Apply control solution (g)
Shake the control solution vial thoroughly before use. Squeeze
out the first drop and wipe it off, then squeeze out another drop
and place it on the tip of the vial cap. Hold the meter to move the
absorbent hole of the test strip to touch the drop. Once the
confirmation window fills completely, the meter will begin
counting down.
NOTE:
To avoid contaminating the control solution, do not directly apply control
solution onto a strip.
4. Read and compare the result
After counting down to 0, the control solution test result will
appear on the display. Compare this result with the range printed
on the test strip vial and it should fall within this range. If not,
please read the instructions again and repeat the control
solution test.

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Out-of-range results
If you continue to have test results fall outside the range printed on
the test strip vial, the meter and strips may not be working properly.
Do NOT test your blood. Go to www.medisure.ca/support or call
customer service at 1-855-MDI-SURE for help.
NOTE:
⚫The control solution range printed on the test strip vial is for control solution
use only. It is not a recommended range for your blood glucose level.
⚫See the MAINTENANCE section for important information about your
control solutions.