EPS Bio Technology EasyMax EM44 User manual

EM44
Self-Monitoring Blood Glucose System
User’s Manual
Please read this User’s Manual thoroughly
Before using your blood glucose meter
Dear EM44 SMBG System Owner,

Thank you for using the EM44 Self-Monitoring Blood Glucose (SMBG) System. We designed this system to be
dependable, easy-to-use, compact, lightweight and portable to help you monitor your blood glucose on a
regular basis.
Please read this manual thoroughly before you begin testing. This manual provides you and your diabetes
care team with important information and step-by-step direction to use the EM44 Self-Monitoring Blood
Glucose System.
Thanks again for choosing the EM44 SMBG.
Intended Use
The EM44 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of
glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done
outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single
patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The
system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative
site testing can be only used during steady-state blood glucose conditions.

Important Safety Instructions
Lancets and meters are for single use only. A new, sterile lancet should be used one time you perform a test.
The lancing device, lancets and meter are NOT to be shared between users or other family members. Do
NOT use on multiple individuals. Sharing a lancing device and lancets may transmit blood borne pathogens,
such as viral hepatitis.
All parts of the kit are considered biohazardous and may transmit infection, even if you have performed
cleaning and disinfection. Wash hands thoroughly with soap and water after handling the meter or lancing
device.
For further information, please see: "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.
"CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Blood borne Pathogens" (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

Standard Accessories
The EM44 Blood Glucose meter and accessories are working together to measure the amount of glucose in
your blood. The system includes:
Optional Accessories
• Carrying Case
• User’s Manual
• Self-Test Log Book
• EM44 Blood Glucose Meter
• Test Strip Instructions
• EM44 Glucose Test Strips (10 pcs)
• CR2032 Lithium Cell 3V Battery (2 pcs)
• Lancing device
• Lancets (10 pcs)
• AST Lancing Device Cap
• Glucose Control Solution Instructions
• EM44 Level 2 Control Solution
• EM44 Level 3 Control Solution
Note:
1. EM44 Level 2 Control Solution is included with the system.
2. EM44 Level 3 Control Solution is available. For purchase, please call the Customer Care Service
toll-free at 866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM).

Why is it so important to test blood glucose regularly?
Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day.
We have made this SMBG system as simple as possible to help you use it regularly. Your meter is easy to
use, and you can adjust the lancing device for your comfort.
Do you need help?
If you have questions or need assistance, please call the Customer Care Service toll-free at 866-994-3345
(Eastern Time, Mon-Fri 9:00AM~5:00PM). During non-service hours, please contact your healthcare provider.
Please complete your warranty card and mail it, so you receive the best customer service possible and news
about product update.
Note:
Although the EM44 SMBG System is easy to use, you may need to consult with your
healthcare professional (this may be your doctor, pharmacist or diabetes nurse educator)
for instructions on how to use the system. Only the correct use of the system will ensure
accurate results.

Important Information about Your New Meter
 EM44 blood glucose meter is designed and approved for testing fresh capillary whole blood samples
from your fingertip and forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the
body). It should not be used to diagnose diabetes.
 EM44 blood glucose meter can only be used with EM44 Blood Glucose Test Strips. Other test strips will
give inaccurate results.
 Testing is not valid for neonatal blood specimens.
 Do not disassemble the meter as this may cause damage to the components resulting in incorrect
readings. Disassembling the meter will also void the warranty.
 Always keep the meter clean and store it in a safe place. Protect the meter from direct sunlight to ensure
a longer lifespan.
 You should not store the meter and test strips in a car, bathroom, or refrigerator.
 Keep the meter, test strips and lancing device away from children and pets.
 You should not test critically ill patients with home-use blood glucose meters.
 Incorrect results may occur when performing the test. If you believe you are not feeling well, please
contact your healthcare professional.
 Remove batteries if the meter will not be used for one month or more.

Note:
 Consult with your healthcare professional before testing on your forearm.
 Do not touch the strips with wet hands.
 Do not use expired strips (the expiration date is shown on the bottle.)
 Do not bend, cut or twist the strips.
 Altitude up to 10,000 feet above sea level has no effect on readings.

Health-Related Information
 If you are experiencing dehydration, frequent urination, low blood pressure, shock or hyperosmolar
hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than what your blood
glucose really is. If you think you are dehydrated, call your doctor right away.
 If you have followed the steps in the user’s manual, but still have symptoms that don’t seem to match
your test results, contact your Healthcare Professional or physician immediately. If you have questions
regarding the use of the meter, please call the Customer Care Service toll-free at 866-994-3345 (Eastern
Time, Mon-Fri 9:00AM~5:00PM). During non-service hours, please contact your healthcare provider.
 Please read your test strip instructions carefully for additional health-related information.
Table of Contents
Chapter 1: Understanding Your Meter ….......................................................................................................11

The EM44 Blood Glucose Meter …............................................................................................................11
Setting the Time, Date, Sound Volume and Memory..................................................................................13
Using EM44 Blood Glucose Test Strips ...............................................................................16
Chapter 2: Control Solution Testing..............................................................................................................17
Why Run a Control Solution Test ...............................................................................................................17
About The Control Solutions ......................................................................................................................18
Running a Control Solution Test ................................................................................................................19
Understanding Control Solution Test Results ............................................................................................21
Chapter 3: Testing Your Blood Glucose .......................................................................................................23
Using the Lancing Device .........................................................................................................................23
Inserting a Lancet into the Lancing Device ................................................................................................24
Running a Blood Glucose Test with Blood from Your Fingertip .................................................................26
Alternate Site Testing (AST)……...……………………………………………………………………………….29
Running a Blood Glucose Test with Blood from Your Palm or Forearm ……..........................................31
Discarding Used Lancets …......................................................................................................................33
Expected Values………………….…...........................................................................................................34
Unusual Test Results…..............................................................................................................................34
Comparing Your Meter Result to Lab Results …........................................................................................35
Chapter 4: Meter Memory, Setup …...............................................................................................................36
Memory, Storing Test Results …................................................................................................................36
Viewing Test Results ….................................................................................................................37

Deleting a single Test Result …..................................................................................................................39
Chapter 5: Maintenance and Troubleshooting ….........................................................................................40
Installing Batteries …..................................................................................................................................40
Cleaning and Disinfecting Your Meter and Lancing Device...……...........................................................41
Cleaning and Disinfection Frequency.........................................................................................................47
Maintenance and Testing ...........................................................................................................................48
Screen Messages and Troubleshooting ….................................................................................................49
Chapter 6: Technical Information …..............................................................................................................52
Specifications ….........................................................................................................................................52
Limitations…...............................................................................................................................................53
Device Information ….................................................................................................................................55
Warranty ...................................................................................................................................................57

11
Chapter 1: Understanding Your Meter
The EM44 Blood Glucose Meter
The
Overview
of
the
Display Meaning
1
month and date Shows the month and date
2
Meal Before meal, after meal or marked meal.
3 Test result Shows the test result
4 Insert test strip Insert the test strip to start testing blood
glucose
5
Sound volume Beep function can be turned on/off
6 Application of blood or
control solution
Test your level of blood glucose
7
Time Shows the time
8 Thermometer The thermometer icon appears when the
temperature is too high or too low
9 Memory The meter will automatically record all
test results
10
Battery status When the battery symbol appears,
prepare other batteries for installation
11
Glucose unit The testing unit of blood glucose
The Overview of the Test Strip
A. Blood collection area.
B. Reaction area.
C. Holding area.
D. Strip insert’s direction
E. Electrode

12
Up Button-
Press to enter memory,
adjust setting, and scroll
through results.
Down Button- Press to
enter memory, adjust
setting, and scroll
through results.
Display-
Shows results,
messages, and results
stored in memory.
Test Strip Slot-
Insert test strip
here.
ON/OFF
Button- Press to
turn on and off the meter;
confirm the setting.
Apple
Button- Press to
set before meals, after
meals or marked meals.

13
Setting the Time, Date, Sound Volume and Memory
Setting the current time and date in your meter is important if you use the meter memory.
3.
Repeat step 2 to set the date and time.
The flashing field is the one you are
currently setting.
(Hour setting: 24hr)
1. Press up and ON/OFF button for 5 seconds or
insert batteries, the meter beeps and turns on.
2. The last 2-digits of the year flash at the top of the
display. Press up button to increase year or press
down button to decrease year and press ON/OFF
button to confirm the setting.

14
5. Press up or down button to turn on or turn
off the volume and press ON/OFF button to
confirm the setting. (Defaulted setting: ON)
.
4. Press up or down button to set the backlight
and press ON/OFF button to confirm the
setting. (Defaulted setting: ON)
.

15
5. Press up or down button to decide
whether to delete all memories.
6. If you decide to delete all memories,
press ON/OFF button to confirm the
setting. The meter will beep and you
can start to insert a test strip.

16
Using EM44 Blood Glucose Test Strips
 Use only with EM44 Blood Glucose Meters.
 Run a control solution test every time you open a new box of test strips (See Chapter 2 "Control Solution
Testing.")
 Keep the test strips in their original bottle.
 After you take a test strip out of the bottle, tightly close the bottle immediately. This keeps the test strips
dry.
 Use the test strip within three minutes after taking it out of the bottle.
 The strip is for single use only. Do not reuse it.
 Record the date you open the test strip bottle. Be sure to check the expiration date on the test strip bottle.
The test strip is good for three months from the date the bottle is opened or until the expiration date on
the bottle, whichever comes first.
 Store the test strip bottle and your meter in a cool dry place.
 Store the test strips between 35.6°F - 86°F (2°C ~30°C). Do not freeze.
 Do not apply blood or control solution to the test strip before you insert it into the meter.
 Do not touch the test strip with wet hands. Do not bend, cut, or twist the test strips.
 EM44 Self-Monitoring Blood Glucose Test System is a “no code”system and does not require any test
strip calibration.

17
Chapter 2: Control Solution Testing
Why Run a Control Solution Test
We recommend that you run the EM44 control test because it lets you know that your meter and test strips are
working properly to give reliable results. You should run the control solution tests when:
 You use the EM44 Blood Glucose Meter for the first time.
 You open a new bottle of test strips.
 You think the meter or test strips may be working incorrectly.
 You drop the meter.
 You have repeated a test and the test results are still lower or higher than expected.
 You are practicing the test procedure.

18
About The Control Solutions
 Use with EM44 test strips.
 Write the date you opened the control solution bottle on the bottle label. The control solutions are good
for three months from the date the bottle is opened or until the expiration date on the bottle, whichever
comes first.
 Do not use a control solution that is past the expiration date.
 Control solutions can stain clothing. If you spill the solution, wash your clothes with soap and water.
 Close the bottle tightly after every use.
 Left over control solution should not be added back into the control bottle.
 Store control solution at room temperature, between 35.6°F - 86°F (2°C~30°C). Do not freeze.
 If you would like to purchase EM44 level 2 and level 3 Control Solutions, please contact your local
dealer.

19
Running a Control Solution Test
You need the meter, a test strip, and control solution.
1. Press ON/OFF button or put a
test strip into the meter in the
direction of the arrow. The
meter will turn on automatically.
2. Press up or down button, the
display shows “CtL” and the
meter is ready to run a control
solution test.
3. Place the meter on a flat
surface, like a table.
4. Remove the control solution
bottle cap and wipe the tip of
the bottle with a tissue.
5. Squeeze the bottle until a tiny
drop forms at the tip of the
bottle.
6.
Touch the drop to the Blood
collection area at the end of the
test strip.
Do not put control solution on
top of the test strip.
When you hear the meter beep,
you have enough control solution
on the test strip.
The meter starts to count down
from 5 seconds and will show the
results.

20
7. A result appears on the display. Don’t remove
the test strip yet.
Check if the reading falls within the range
printed on the test strip bottle.
8. Remove the test strip and throw it away
after you have compared the reading to the
range printed on the test strip bottle.