EPS Bio Technology EMV3.1 User manual

EMV3.1
Self-Monitoring Blood Glucose System
User’s Manual
Dear EMV3.1 SMBG System Owner,
Please read this User’s Manual thoroughly
before using your blood glucose meter.

Thank you for using the EMV3.1 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 EMV3.1 Self-Monitoring Blood
Glucose System. To start testing quickly, you can also refer to the Quick Reference Guide.
Thanks again for choosing the EMV3.1 SMBG.
Intended Use
The EMV3.1 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 includes the speaking function but is not intended to be operated by visually impaired users. 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 EMV3.1 Blood Glucose meter and accessories are working together to measure the amount of glucose
in your blood. The system includes:
Optional Accessories
• EMV3.1 Blood Glucose Meter
• Alkaline Battery (2 ct)
• EMV3.1 Blood Glucose Test Strips
(10 pcs)
• Test Strip Instructions
• Lancets (10 pcs)
• Lancing device
• AST Lancing Device Cap
• User’s Manual
• Quick Reference Guide
• Self-Test Log Book
• EMV3.1 Level 2 Control Solution
• Control Solution Instructions
• Carrying Case
• EMV3.1 Level 3 Control Solution
Note:
1. EMV3.1 Level 2 Control Solution is included with the system.
2. EMV3.1 Level 3 Control Solution are available. For purchase, please call the Customer Care
Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM).

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 Standard Time, Mon-Fri 8:00AM~6:00PM). During non-service hours, please contact your healthcare
professional.
Note:
Although the EMV3.1 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
 EMV3.1 blood glucose meter is designed and approved for testing in fresh capillary whole blood samples
from your fingertip, palm or forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the
body). It should not be used to diagnose or screen for diabetes.
 EMV3.1 blood glucose meter can only be used with EMV3.1 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. The store condition
should be at 36-86°F (2-30°C) and 40-85% RH.
 Keep the meter, test strips and lancing device away from children and pets.
 This meter should not be used on the critically ill.
 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 fingertip, palm or 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.
 It should not be used to diagnose or screen for diabetes.

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 healthcare professional 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
Standard Time, Mon-Fri 8:00AM~6:00PM). During non-service hours, please contact your healthcare
professional.
 Please read your test strip instructions carefully for additional health-related information.

Explanation of Meter Symbols
Date
Before Meal
Time
After Meal
Result Mute
Record/Average
display Volume
Control Solution Insert strip
English Temperature
Espańol Error
AM Memory
PM Apply Blood
24hr Unit
Battery
Note: When shows up in any section of user's manual, the meter will sound and tell you the
instructions
.

Description of Sound
WHEN the meter will speak WHAT the meter will say
Meter has been turned on. Power on and greeting music.
Setting the meter. Please set the meter. English (En) / Espańol (ES).
Setting Volume. Please set the volume.
Setting Year. Please set the year.
Setting Date. Please set the date.
Setting Time. Please set the time.
Meter is ready to insert test strips. Please insert a test strip.
When the meter is ready to apply blood. Please apply blood into the strip.
Blood Glucose test is complete and the
result is shown on screen. Blood glucose is (number) milligram per deciliter.
Humidified / Used strips. Humidified or used strips. Please replace with a new strip.
Low Power. Low power. Please replace with new batteries.
System error. System error.

WHEN the meter will speak WHAT the meter will say
Blood Glucose test result is ABOVE the
measurement range of 600 mg/dL.
Unable to measure. Test result is higher than 600 milligram per
deciliter. Please test again and if you get the same result, please
contact your healthcare professional immediately.
Blood Glucose test result is BELOW the
measurement range of 20 mg/dL.
Unable to measure. Test result is lower than 20 milligram per
deciliter. Please test again and if you get the same result, please
contact your healthcare professional immediately.
Press C button to delete a memory. Please confirm the deletion.
Memory was deleted. Memory deleted.
Memory mode. (7/14/30/60/90) day average is (number) milligram per deciliter.
If the blood is not enough. Insufficient blood. Please try with a new strip.
Temperature is too high and it may
affect the test results. Temperature is too high.
Temperature is too low and it may affect
the test results. Temperature is too low.
Turn off the meter. Goodbye and power-off music.
N
ote:
There is no speaking function for
“Viewing
& Deleting
Test Results”
in the Chapter 4.

Table of Contents
Chapter 1: Understanding Your Meter ….......................................................................................................14
The EMV3.1 Blood Glucose Meter ….........................................................................................................14
Understand Your Meter - the “M”, “C”, “Power” Buttons…...................................................................15
The EMV3.1 Accessories ...........................................................................................................................16
Inserting Batteries.......................................................................................................................................17
Setting The Language And Volume............................................................................................................18
Setting The Time And Date …………………..............................................................................................19
Using EMV3.1 Blood Glucose Test Strips .................................................................................................20
Chapter 2: Control Solution Testing .............................................................................................................21
Why Run A Control Solution Test ..............................................................................................................21
About Control Solutions .............................................................................................................................22
Running A Control Solution Test ................................................................................................................23
Understanding Control Solution Test Results …........................................................................................25
Chapter 3: Testing Your Blood Glucose .......................................................................................................27
Using the Lancing Device ..........................................................................................................................27
Inserting A Lancet into The Lancing Device ..............................................................................................28
Running A Blood Glucose Test With Blood From Your Fingertip ..............................................................30
Alternative Site Testing (AST) ……………..………………………………………………….………………….32
Running A Blood Glucose Test With Blood From Your Forearm ...............................................................34
Running A Blood Glucose Test With Blood From Your Palm ....................................................................35

Discarding Used Lancets ….......................................................................................................................36
Understanding Your Test Results- Expected Values ….............................................................................37
Unusual Test Results …………………………….......................................…………………………………...37
Comparing Your Meter Result To a Lab Result .…....................................................................................38
Chapter 4: Meter Memory, Setup …...............................................................................................................39
Memory, Storing Test Results …................................................................................................................39
Meter Setup - Using The Set Mode …........................................................................................................39
Viewing & Deleting Test Results …............................................................................................................40
Chapter 5: Maintenance And Troubleshooting ….........................................................................................41
Inserting Batteries …..................................................................................................................................41
Cleaning And Disinfecting Your Meter And Lancing Device…………...………………................................42
Cleaning And Disinfection Frequency…...…...............................................................................................44
Maintenance And Testing ..........................................................................................................................47
Screen Messages And Troubleshooting …................................................................................................48
Chapter 6: Technical Information …..............................................................................................................52
Specifications ….........................................................................................................................................52
Limitations…...............................................................................................................................................53
Device Information ….................................................................................................................................55
Warranty ....................................................................................................................................................55

14
Chapter 1: Understanding Your Meter
The EMV3.1 Blood Glucose Meter
Display-
Shows results,
messages, and results
stored in memory.
M Button-
Press to enter
7/14/30/60/90 memory,
adjust setting, and
scroll through results.
Test Strip Slot-
A light shows you the
direction. Insert test strip
here.
Battery Door-
Flip open the
battery door by
pushing the tab in
the direction of the
arrow and pulling
the door up.
C Button-
Press to enter
memories, adjust
setting, and scroll
through results.
Power Button-
Press to confirm the
setting.

15
Understanding Your Meter - the “M”, “C”, “Power” Buttons
Operation
and Setting
Language setting Volume setting Date and time setting Mode setting
Button M :En
C :Esp
M (Decrease)
C (Increase)
M (Decrease)
C (Increase) M or C
Operation
and Setting
Enter memory
mode
View 7/14/30/60/90
day average
View individual
result
Delete the individual
result
Button M M C (from last to
first order)
C for 3 seconds
Operation
and Setting
Turn on the
meter
Turn off the meter Confirm the setting
and deletion
Speak the test result
repeatedly
Button Power Power for 3 seconds Power Power

16
The EMV3.1 Accessories
Blood Glucose Test Strip
Trigger button
-
Press the trigger
button to activate
the lancing device
Carrier
-
Insert the lancet
into the carrier
Adjustable tip
-
Select the
desired
penetration depth
Hub
-
Unscrew or
Recap the Cap.
Sleeve
-
Hand Hold
Area
AST
Lancing
Device Cap-
Use this
transparency
cap for AST
testing
S
liding barrel
-
Pull on until it clicks
and then release to
enable lancing
device.
Test Strip Bottle
Control Solution Bottle
Lancing Device
Expiration
Date
Strip Insert
Direction
Reaction Area
Hand Hold
Area
Blood
C
ollection
Area
Electrode

17
Inserting Batteries
1.
Open the battery door on the
back of the meter by pushing the
tab in the direction of the arrow
and pulling the door up.
2.
Insert two batteries. You will
hear greeting music.
3.
Put the battery door back in
place and snap it closed.

18
Setting The Language And Volume
1.
Insert Batteries, the meter turns
on. Press M button to select En or
press C button to select ES. (En=
English, ES = Espańol)
2.
And press power button to
confirm the setting.
3
. Repeat step 1 and 2 to set the
volume.
Note: 1. The default
l
anguage
of the
b
lood
g
lucose
meter is set in English.
2. The unit of blood glucose meter is set at mg/dL.
3. Press Power Button to turn on the meter and then press C button to set the language,
volume, time and da
te.

19
Setting The Time and Date
Setting the current time and date in your meter is important if you intend to use the meter memory.
1. Press M button and C
button to set the year.
Press power button to
confirm the setting.
2. Repeat step 1 to set the
date.
3. Repeat step 1 to select P, A or 24 mode and
then set the time. (P=PM, A=AM, 24=24hr
mode.)

20
Using EMV3.1 Blood Glucose Test Strips
 Use only with EMV3.1 Blood Glucose Meter.
 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 test 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 36°F - 86°F (2°C ~30°C) and 40-85% RH. 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.
 EMV3.1 Self-Monitoring Blood Glucose Test System is a “no code”system and does not require any test
strip calibration.