Stat Medical Devices EASYMAX N User manual

EasyMax N
Self-Monitoring Blood Glucose System
User’s Manual
Please read this User’s Manual thoroughly
before using your blood glucose meter.

Dear EasyMax N SMBG System Owner,
Thank you for using the EasyMax N 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 EasyMax N Self-Monitoring Blood
Glucose System.
Thanks again for choosing the EasyMax N SMBG System.
Intended Use
The EasyMax N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement
of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside
the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with
diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes
control.

Standard Accessories
Your new EasyMax N Blood Glucose meter and accessories work together to measure the amount of
glucose in your blood. The system includes:
• Blood Glucose Meter
• Test Strip x 10 ct.
• Normal Control Solution
• Carrying Case
• Control Solution Instructions
• Lancet x 5 ct.
• Lancing device
• AST Lancing Device Cap
• User’s Manual
• Test Strip Instructions

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’ve made this SMBG system as simple as possible to help you to use the meter 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 1-866-203-2761
(Eastern Time, Mon-Fri 9:00AM-9:00PM) or E-mail: [e-mail] . You can also visit www.epsbio.com
for diabetes management tools and product demonstrations.
Note:
Although the EasyMax N SMBG System is easy to use, you may need to consult 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
EasyMax N blood glucose meter is designed and approved for testing fresh capillary blood from fingertip
and forearm. The meter is for outside the body (in vitro) use. It should not be used to diagnose diabetes.
Only use EasyMax N blood glucose meter with EasyMax N Blood Glucose Test Strips. Other test strips
will give inaccurate results.
Testing is not valid for neonatal blood specimen.
Do not disassemble the meter as this may cause damage to the components resulting in incorrect
reading. 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, a bathroom or a 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.
Elevated levels of acetaminophen, uric acid, gentisica acid, levodopa, dopamine, ascorbic acid and
methyldopa may affect results.
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.
Warning for potential biohazard: Healthcare professionals using this system on multiple patients should
be aware that all products or objects that come in contact with human blood, even after cleaning, should
be handled as if capable of transmitting viral disease.
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 very dehydrated, urinating frequently, low blood pressure, shock or hyperosmolar
hyperglycemic nonketotic coma (HHNK), 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, or if you have questions, please talk to your doctor.
Please read your test strip instructions carefully for additional health-related information.
Warning for potential biohazard:
Healthcare professionals using this system on multiple patients should handle all products or
objects in contact with human blood carefully to avoid transmitting viral disease, even after
cleaning.

Table of Contents
Chapter 1: Understanding Your Meter ….......................................................................................................10
The EasyMax N Blood Glucose Meter …...................................................................................................10
Setting The Time And Date ........................................................................................................................12
Using EasyMax N Blood Glucose Test Strips ...........................................................................................14
Chapter 2: Control Solution Test ...................................................................................................................15
Why Run a Control Solution Test ...............................................................................................................15
About The Control Solutions ......................................................................................................................16
Running A Control Solution Test ................................................................................................................17
Understanding Control Solution Test Results …........................................................................................19
Chapter 3: Testing Your Blood Glucose .......................................................................................................21
Using The Lancing Device .........................................................................................................................21
Inserting A Lancet into the Lancing Device ................................................................................................22
Running A Blood Glucose Test With Blood From Your Fingertip ..............................................................25
Alternative Site Testing…………………………………………………………………………………...………. 27
Running A Blood Glucose Test With Blood From Your Forearm ..............................................................29
Discarding Used Lancets ….......................................................................................................................30
Understanding Your Test Results …..........................................................................................................31
Unusual Test Results …………………………….......................................…………………………………...31
Symptoms of High or Low Blood Glucose..................................................................................................32
Comparing Your Meter Result To A Lab Result ….....................................................................................33

Chapter 4: Meter Memory, Setup …...............................................................................................................34
Memory, Storing Test Result …..................................................................................................................34
Viewing & Deleting Test Results …............................................................................................................35
Meter Setup …............................................................................................................................................36
Setting Thermometer …..............................................................................................................................37
Setting The Alarm …...................................................................................................................................38
Setting The Beeper For The Alarm …........................................................................................................40
Setting The Clock …...................................................................................................................................41
Chapter 5: Maintenance And Troubleshooting ….........................................................................................42
Installing Batteries …..................................................................................................................................42
Cleaning Your Meter ……...........................................................................................................................43
Maintenance And Testing ..........................................................................................................................44
Cleaning Your Lancing Device …...............................................................................................................44
Screen Messages And Troubleshooting …................................................................................................45
Chapter 6: Technical Information …..............................................................................................................48
Specifications ….........................................................................................................................................48
Limitation ….........................................................................................................................................49
Device Information ….................................................................................................................................50
Warranty ....................................................................................................................................................52

10
Chapter 1: Understanding Your Meter
The EasyMax N Blood Glucose Meter
Strip Slot
To insert test strip or check strip.
Note:
When you use software with the meter, the symbol of “Type” will show you how to start
operation.
A. Test Records
B. Transfer data to PC
C. Apply blood or control solution
D. Battery status
E. System fault
F. Thermometer
G. Insert test strip

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M Button
To turn on the meter or read records.
S Button
To turn on the meter or go into Setting
Mode.
Test Strip Bottle
A. Blood collection area
B. Reaction area
C. Hand hold area
D. Strip insert direction
E. Electrode
Expiration
date

12
Setting The Time and Date—First Time Use
Setting the current time and date in your meter is important if you intend to use the meter memory or if you
want to download your results to a computer.
1. Press and hold the "S" button
until turning the meter on.
Press "S" button and release
to enter setting mode.
2. The time and date appear on
the display.
The year flashes at the center
of the display.
3. Press "M" button to adjust
the year.
Press and hold "M" button to
scroll faster.

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4. Press and release "S" button
to set the year.
The month will then flash.
5. Repeat step 3 and 4 to set
the date, hour, and minute.
The flashing field is the one
you are setting.
6. Press the "S" button to confirm
the setting. The display will show
"SCL" and the unit of
measurement. Press the "S"
button again, to go to screen
shown in Step 1. Press and hold
"S" for more than 3 seconds, and
the meter will turn off.
Note:
The unit of Blood Glucose Meter is set at mg/dL without any
modification function.

14
Using EasyMax N Blood Glucose Test Strip
Use only with EasyMax N 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.
Close the bottle tightly right away, after you take a test strip out. This keeps the test strip dry.
Use the test strip within three minutes after you take 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 until you insert it into the meter.
Do not touch the test strip with wet hands. Do not bend, cut, or twist the test strips.

15
Chapter 2: Control Solution Testing
Why Run A Control Solution Test
We recommend that you run the EasyMax N Normal control test because it lets you know that your meter and
test strips are working properly to give you reliable results. You should run the control solution test when:
You use the EasyMax N 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.
Note:
Professional users are instructed to follow federal, state, and local guidelines.

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About The Control Solution
Use only with EasyMax N test strips.
Write the date you opened the bottle on the bottle label. The control solution is 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.
The control solution can stain clothing. If you spill it, 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 the bottle of control solution at room temperature, between 35.6°F - 86°F (2°C- 30°C). Do not
freeze.

17
Running A Control Solution Test
You need the meter, a test strip, and control solution.
1. Put a test strip into the meter in
the direction of the arrow. The
meter will automatically turn on.
2. Place the meter on a flat
surface, like a table.
3. Remove the control solution
bottle cap and wipe the tip of
the bottle with a tissue.
4. Squeeze the bottle until a tiny drop
forms at the tip of the bottle.
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 beeper, you have
enough control solution in the test strip.
The meter starts to count down from 5
seconds and will show the results.

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5. 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.
6. Remove the test strip and throw it away
after you have compared the reading to the
range printed on the test strip bottle.

19
Understanding Control Solution Test Results
The label on your test strip bottle shows the acceptable ranges for the Control Solutions. The result you get
should be inside this range. Make sure you compare the result to the correct level of control.
When the control solution result is inside the range on the test strip bottle, your test strips and your meter are
working properly.
If your control solution result is not inside the acceptable range (printed on your test strip bottle), here are
some things you can do to solve the problem:
Note:
Control Solution values will be included in the memory and averages. Refer to the section
“Viewing & Deleting Test Results” to delete the control solution values before averaging your test
results.