EPS BIO D030 Easyplus Mini 2In1 Self-Monitoring Blood Glucose System

Product's Documents

Below are documents related to this product, you can read online or download:
D030 photo

User Manual

This is the main product document for model D030.

The file format is pdf, 53 pages, you can download this manual here .

background
EasyPlus mini 2IN1
Self-Monitoring Blood Glucose System
User’s Manual
background
Dear EasyPlus mini 2IN1 SMBG System Owner,
Thank you for using the EasyPlus mini 2IN1 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 EasyPlus
mini 2IN1 Self-Monitoring Blood Glucose System.
Thanks again for choosing the EasyPlus mini 2IN1 SMBG System.
background
Intended Use
The EasyPlus mini 2IN1 Self Monitoring Blood Glucose Test System is intended for the
quantitative measurement of glucose in fresh capillary whole blood samples drawn from the
fingertips. 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 professional,
as an aid to monitor the effectiveness of diabetes control.
NOTE:
Although the EasyPlus mini 2IN1 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.
background
Standard Accessories
Your new EasyPlus mini 2IN1 Blood Glucose meter and accessories work together to measure the
amount of glucose in your blood. The system includes:
• User’s Manual
Quick Reference Guide
Log Book
Test Strip Instructions
CR2032 Battery x 1
Blood Glucose Meter
Test Strip x 10 ct.
Normal Control Solution
Carrying Case
Control Solution Instructions
Lancet x 10 ct.
background
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
866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM). During non-service hours, please contact
your healthcare provider.
background
Important Information About Your New EasyPlus mini 2IN1
The EasyPlus mini 2IN1 blood glucose meter is designed and approved for testing fresh
capillary blood from fingertip. The meter is for outside the body (in vitro) use. It should not be
used to diagnose diabetes.
Only use EasyPlus mini 2IN1 blood glucose meter with the EasyPlus mini 2IN1 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 and test strips 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.
background
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.
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.
background
Health-Related Information
If you are very dehydrated, urinating frequently, 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 users 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.
NOTE:
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.
background
Explanation of Symbols
mg/dL
Result amount
Blood apply
Hypo
Control Solution
Unit
Date
Time
Memory
Battery
background
Table of Contents
Chapter 1: Understanding Your Meter …......................................................................................13
The EasyPlus mini 2IN1 Blood Glucose Meter …..............................................................13
Installing Batteries ....................................................................................................14
Setting The Time And Date ................................................................................................15
Using EasyPlus mini 2IN1 Blood Glucose Test Strip ...............................................................16
Chapter 2: Control Solution Test ..................................................................................................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
background
Chapter 3: Testing Your Blood Glucose .......................................................................................23
Using the Bulit-in Lancing Device .................................................................................23
Inserting A Lancet into the Lancing Device ...............................................................................24
Running A Blood Glucose Test With Blood From Your Fingertip .............................................27
Discarding Used Lancets ….......................................................................................................29
Understanding Your Test Results …........................................................................................30
Unusual Test Results …........................................................................................31
Symptoms of High or Low Blood Glucose..................................................................................32
Comparing Your Meter Result To A Lab Result …....................................................................34
Chapter 4: Meter Memory, Setup …...............................................................................................35
Memory, Storing Test Result ….................................................................................................35
Viewing & Deleting Test Results …............................................................................................36
background
Chapter 5: Maintenance And Troubleshooting ….......................................................................38
Installing Batteries ….................................................................................................................38
Cleaning Your Meter ……..........................................................................................................39
Maintenance And Testing .........................................................................................................40
Cleaning Your Lancing Device ….............................................................................................41
Screen Messages And Troubleshooting ...............................................................................42
Chapter 6: Technical Information..............................................................................................46
Specifications …........................................................................................................................46
Limitation …...............................................................................................................................47
Device Information ................................................................................................................52
Warranty ....................................................................................................................................52
background
13
Chapter 1: Understanding Your Meter
EasyPlus mini 2IN1 Blood Glucose Meter
Test Strip Slot-
Insert test strip here.
Button-
Press to enter
memory,
adjust setting,
and scroll
through
results.
Button-
Press to turn
the meter
on, confirm
setting, and
scroll through
results.
Depth
Indicator
Cap
Cocking
Button
Battery Door
Display
Release
Button
Carrier-
Insert lancing
here
background
14
Installing Batteries
1. Flip open the battery door by pushing the tab in the direction of
the arrow and pulling the door up.
2. Insert a battery.
3. Put the battery door back in place and snap it closed. The meter
beeps and turns on automatically.
background
15
Setting The Time and DateFirst 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. If your meter does not turn on automatically, press for 3
seconds to turn on the meter.
3. Repeat step 2 to set the date and time. The flashing field is
the one you are currently setting. When finishing the setting,
the meter beeps.
2. The last 2-digits of the year flash at the center of the display.
Press to adjust the year and press to confirm the
setting.
background
16
Using EasyPlus mini 2IN1 Blood Glucose Test Strip
Use only with EasyPlus mini 2IN1 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 dateon 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.
background
17
Chapter 2: Control Solution Testing
Why Run A Control Solution Test
We recommend that you run the EasyPlus mini 2IN1 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 EasyPlus mini 2IN1 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 incorrec tly.
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.
background
18
About The Control Solution
Use only with EasyPlus mini 2IN1 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.
background
19
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.
4. Place the meter on a flat surface, like a table.
5. Remove the control solution bottle cap and wipe the tip of the
bottle with a tissue.
2. The meter beeps and turns on automatically. The icon
shows itself.
3. Press the , the icon shows and the meter is ready to
run a Control Solution Test.
Or press to cancel the Control Solution Test Mode.
background
20
6. Squeeze the bottle until a tiny drop forms at the tip of the
bottle.
7. Touch the drop to the blood collection area at the tip of the test
strip. When you hear beeps, you have enough control solution
in the test strip.
8. The meter starts to count down from 5 seconds, the display
shows Ok, and then shows the test result.
9. Do not remove the test strip yet. Check if the reading falls within
the range printed on the test strip bottle.
10. Remove the test strip and throw it away after you have
compared the reading to the range printed on the test strip bottle.
Please discard the used strip according to the recommendations
of your healthcare professional or into a biohazard container.
background
21
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 NOT included in the memory and averages.
background
22
Troubleshooting Checks Action
Was the test strip exposed to open air for
a long period of time?
Repeat the control test with properly stored strips.
Was the test strip bottle capped tightly?
This will humidify strips inside. Replace the test
strips.
Was the meter functioning well?
You can use control solution to verify the meters
functions. (Chapter 2)
Is the control solution expired or
contaminated?
Replace with new control solution to check the
performance of SMBG system.
Were test strips and control solutions
stored in cool, dry places?
Repeat the control test with properly stored strips
or control solutions.
Did you follow the testing steps properly?
Read Chapter 2 "Control Solution Testing" and test
again. Stop using the meter if you continue to
obtain the inaccurate results. Call Consumer
Services Toll-Free: 866-994-3345 (Eastern Time,
Mon-Fri 9:00AM~5:00PM). During non-service
hours, please contact your healthcare provider.
background
23
Chapter 3: Testing Your Blood Glucose
Using The Built-in Lancing Device
The best depth setting is the lowest number that draws enough blood for a test. Try different
settings to find the one that’s right for you.
Please do not share your lancing device with anyone. And always use a new, sterile lancet.
Lancets are for one time use only.
NOTE:
Used test strips and lancets are considered bio-hazardous waste in accordance with local
regulations and should be handled as if capable of transmitting infection. The users may
discuss methods for disposing of used test strips and lancets with their doctor.
background
24
Inserting A Lancet Into The Built-in Lancing Device
You must first load the lancet into the lancing device to get it ready for use.
1. Unscrew the Cap.
2. Insert a new disposable lancet firmly into the
carrier and then twist off the protective cover.
background
25
3. Recap the front cap.
4. Select the desired penetration
depth.
Select 1-2 for thick or calloused skin. 3 for average. 4-5 for soft or thin skin.
background
26
5. Pull on the cocking button of the
lancing device until it clicks and then
release.
Now the lancing device is ready.
Do not prick your finger until your
meter and strip are prepared.
6. Set the lancing device aside
until later in the test.
background
27
Running A Blood Glucose Test With Blood From Your Fingertip
1. Wash your hands with soap and warm water.
Rinse and dry thoroughly.
2. Put a test strip into the meter in the direction of the arrow.
The meter beeps and turns on automatically.
3. When the blood drop flashes on the display, using the lancing
device.
4. Hold the lancing device firmly against the side of your
finger. Press the release button. Then remove the lancing
device from your finger.
background
28
5. Gently squeeze and/or massage your fingertip until a round
drop of blood on your fingertip.
6. Touch the blood drop at the tip of the transparent window
of the test strip. Do not put blood on top of the strip. When
you hear beeps, you have enough blood in the test strip.
Be sure to get enough blood in the test strip. Otherwise, an
inaccurate reading may result.
7. The meter starts to count down from 5 seconds, the display
shows Ok, and then shows the test result.
8. Remove the test strip and the meter turns off automatically.
background
29
Discarding Used Lancets
2. Discard the used disposable lancet
into an appropriate sharps or
biohazard container.
1. Unscrew and remove the cap. Without
touching the used lancet, stick the
lancet tip into its protective cover. Grip
the lancet carrier firmly and pull the
lancet safely out.
background
30
Understanding Your Test Results
The EasyPlus mini 2IN1 Blood Glucose test strips are plasma referenced and calibrated for easier
comparison to lab results. The normal fasting blood glucose range for an adult without diabetes is
70-130 mg/dL (3.9~7.2 mmol/L)*.
Two hours after meals, the blood glucose range for an adult
without diabetes is less than 180 mg/dL (10 mmol/L).
For people with diabetes: please consult your
doctor for the blood glucose range appropriate for you.
* Reference: American Diabetes Association: Diagnosis and Classification of Diabetes Mellitus (Position
Statement). Diabetes Care 34 (Supp. 1) S66, 2011.
background
31
Unusual Test Results
If your test result doesn’t match the way you feel, please follow these steps:
1. Run a control solution test, Chapter 2 "Control Solution Testing."
2. Repeat a blood glucose test, Chapter 3 "Testing Your Blood glucose."
3. If your test results still don’t reflect the way you feel, call your doctor immediately.
NOTE:
1. Extremely high humidity may affect the test results. A relative humidity greater than
90% may cause inaccurate results.
2. A red blood cell count (Hematocrit) that is either very high (above 50%) or very low
(below 35%) may not provide accurate results.
3. Some studies have shown that electromagnetic fields may affect results. Do not test
near an operating microwave oven.
background
32
Symptoms Of High Or Low Blood Glucose
Being aware of the symptoms of high or low blood glucose can help you understand your test results
and decide what to do if they seem unusual. Here are the most common symptoms:
What It Means:
The test result is higher than reference normal range. (70-130 mg/dL)
Symptoms:
Fatigue, increased appetite or thirst, frequent urination, blurred vision, headache, general
aching, or vomiting.
What to Do:
If you are experiencing any of these symptoms, test your blood glucose.
If the result displayed is greater than 240 mg/dL and you have symptoms of high blood
glucose, contact your healthcare professional immediately.
If the result does not match how you feel, follow the steps under "Unusual Test Results."
Greater than 240 mg/dL
background
33
What It Means:
The test result is lower than reference normal range. (70-130 mg/dL)
Symptoms:
Sweating, trembling, blurred vision, rapid heartbeat, tingling, or numbness around mouth or
fingertips.
What to Do:
If you are experiencing any of these symptoms, test your blood glucose.
If the result displayed is below 60 mg/dL and you have symptoms of low blood glucose,
contact your healthcare professional immediately.
If the result does not match how you feel, follow the steps under "Unusual Test Results."
Below 60 mg/dL
background
34
Comparing Your Meter Result To A Lab Result
A common question is how the blood glucose results on your meter compare to the lab results. Your
blood glucose can change quickly, especially after eating, taking medication, or exercising. If you
test yourself in the morning, then go to the doctor’s office for a blood glucose test. The results will
probably not match, even if you are fasting. This is typically not a problem with your meter, it just
means that time has elapsed and your blood glucose has changed.
If you want to compare your meter result to the lab result, you must be fasting. Bring your meter to
the doctor’s office, and test yourself by fingertip within five minutes of having blood drawn from
your arm by a healthcare professional. Keep in mind that the lab could use different technology
than EasyPlus mini 2IN1 blood glucose meter, and that blood glucose meters for self testing
generally read somewhat lower or higher than the lab result.
For accuracy and precision data and for important information on limitations, see the instructions
that come with your test strips.
background
35
Chapter 4: Meter Memory, Setup
Memory, Storing Test Results
Your meter stores a maximum of 360 test results with the time and date of the test. You can review
them at any time. When the memory is full, the oldest result is dropped as the newest is added, so it
is very important to have the correct time and date set in the meter.
NOTE:
1. Do not change your therapy based on one individual result in memory.
2. The memory is not lost when you replace the battery. You do need to check that the
time and date are still correct. See Section "Setting the time and date" in Chapter 1.
3. Once 360 results are in memory, adding a new result causes the oldest one to be
deleted.
4. Control Solution values will be included in the memory and averages. Refer to the
section Viewing & Deleting Test Resultsto delete the control solution values before
averaging your test results.
background
36
Viewing & Deleting Test Results
3. Continue to press to view the test result from
latest to oldest.
1. Press to turn the meter on.
2. Press to view averages for 7/14/30 days.
background
37
5. Press for 1 second to go back to the total
number of the stored results.
6. Press for 3 seconds to turn off the meter, or the
meter turns off automatically in 120 seconds.
4. To delete a test result, press for 3 seconds. When
display shows "dEL", press to confirm the
deletion.
Or press to cancel the deletion and go back to the
total number of the stored results.
background
38
Chapter 5: Maintenance and Troubleshooting
Installing Battery
The meter uses one CR2032 Battery. Battery will normally last for
more than 1000 tests. Other types of CR2032 batteries are also
acceptable, but the capacity of test times may differ. Install the
battery when you first use the meter or replace with new battery
when the "LP" (low power) message and the low battery symbol
appear on the display. The meter will not turn on the first time the
battery is installed. Please press and hold button or insert the test strip to turn your meter on.
The meter will turn off automatically. Or you can press and hold button to turn your meter off.
NOTE:
1. The meter won’t delete earlier records after you replace the battery.
2. You should reset the time and date again after you replace the battery.
3. CR2032 x 1 battery are available at most stores. You may take the old battery with you
for replacement.
4. Remove the battery when you will not be using the meter for one month or more.
background
39
Cleaning Your Meter
Caring for your EasyPlus mini 2IN1 SMBG system does not require special cleaning. Please keep
the meter free of dirt, dust, bloodstain, and water stains. Follow these guidelines carefully to help
you get the best performance possible:
Do Not:
Get any moisture in the test strip slot.
Spray any cleaning solution directly onto
the meter.
Put the meter under water or liquid.
Pour liquid into the meter.
Do:
Make sure the meter is turned off.
Gently wipe the meters surface with a soft
cloth slightly dampened.
background
40
Maintenance And Testing
Your meter needs little or no maintenance with normal use. It
automatically tests its own systems every time you turn it on
and lets you know if something is wrong. (See "Screen
Messages" and what to do about them.)
To make sure the display is working properly, turn off the meter.
Press and hold to see the complete display. All the
indicators should be clear and look exactly like the picture to the
left. If not, please call the Customer Service Center toll-free: 866-994-3345 (Eastern Time, Mon-Fri
9:00AM~5:00PM). During non-service hours, please contact your healthcare provider.
background
41
Cleaning Your Lancing Device
To clean the lancing device, wipe with a soft cloth dampened with water and mild detergent.
DO NOT place the entire device under water.
To disinfect the cap after cleaning by placing it in 70%-75% rubbing alcohol for 10 minutes at
least once a week. Allow the cap to air-dry after disinfecting.
background
42
Screen Messages And Troubleshooting
Never make treatment decisions based on an error message. If you have any concerns, please
contact your healthcare professional.
What it means ?
System err.
Humidified or used strip.
What to do ?
Please replace the batteries
first. If Err appears again,
please call the Customer
Service Center toll-free:
866-994-3345 (Eastern Time,
Mon-Fri 9:00AM~5:00PM).
Please replace with a new
strip.
background
43
What it means ?
Memory err.
Low power.
What to do ?
Please replace the batteries
first. If Err appears again,
please call the Customer
Service Center toll-free:
866-994-3345 (Eastern Time,
Mon-Fri 9:00AM~5:00PM).
Please replace with a new
battery.
background
44
What it means ?
You may have a very high
blood glucose level
(severe hypoglycemia),
over 600 mg/dL.
You may have a very low
blood glucose level
(severe hypoglycemia),
lower than 20 mg/dL.
What to do ?
Please test again and if you
get the same result, please
contact your healthcare
professional immediately.
Please test again and if you
get the same result, please
contact your healthcare
professional immediately.
background
45
What it means ?
Temperature is too high,
outside the required range of
50°F - 104°F (10°C - 40°C).
This alerts users that an
incorrect result may occur if
the test continues.
Temperature is too low,
outside the required range of
50°F - 104°F (10°C - 40°C).
This alerts users that an
incorrect result may occur if
the test continues.
What to do ?
Relocate the meter to a
location with temperature
between 50°F - 104°F
(10°C - 40°C).
Relocate the meter to a
location with temperature
between 50°F - 104°F
(10°C - 40°C).
background
46
Chapter 6: Technical Information
Memory capacity 360 results
Test specimen Capillary whole blood
Sample volume 0.6μL
Testing time 5 seconds
HCT range 30~55%
Measuring range 20~600 mg/dL
Operating range
50°F - 104°F (10°C - 40°C), R.H. 90%
Dimension (L x W x D) 3.7” x 1.3” x 0.6”
Weight 1.13 oz (without battery)
Battery life Over 1,000 times
Power supply CR2032 Lithium battery x 1
Auto shut-off 2 minutes
Data transferring NFC
background
47
Limitation
The test strips are used for fresh capillary whole blood samples.
1. DO NOT use neonate blood sample.
2. Extreme humidity may affect the results. A relative humidity greater than 90% may cause
incorrect results.
3. The system should be used at a temperature between 50°F - 104°F (10°C - 40°C). Outside this
range, the system may get incorrect results.
4. DO NOT reuse the test strips. The test strips are for single use only.
5. Hematocrit: The hematocrits between 30% and 55% will not significantly affect the results.
Hematocrit below 30% may cause higher results. Hematocrit above 55% may cause lower
results. If you do not know your hematocrit level, please consult with your healthcare
professional.
6. Altitude up to 10,000 feet above sea level has no effect on readings.
Healthcare ProfessionalsPlease note these additional Limitations
7. Patients undergoing oxygen therapy may have inaccurate results.
8. If the patient has the following conditions, the result may fail:
Severe dehydration Severe hypotension (low blood pressure)
background
48
Shock A state of hypoglycemic-hyperosmolar state (with or without ketosis)
9. Lipemic samples: Cholesterol level up to 500 mg/dL and triglycerides up to 3,000 mg/dL do not
affect the results. Grossly lipemic patient samples have not been tested and are not
recommended for testing with EasyPlus mini 2IN1 Blood Glucose Meter.
10. Critically ill patients should not be tested with home-use blood glucose meters.
11. Interfering Substances depend on the concentration. The below substances up to the test
concentration will not affect the test results.
Interfering ,
Substance
Test
Concentration
mg/dL
Bias at 50±5
mg/dL
% Bias at 250±5
mg/dL
% Bias at 500±5
mg/dL
Acetaminophen
8
10.2
6.5
3.8
Ascorbic Acid
2.5
11.8
-6.8
5.3
Dopamine
2
4.3
12.9
6.3
Gentisic Acid
6
7.8
2.8
-4.3
L-Dopa
2
3.8
-1.2
-1.8
Methyldopa
2
5.2
-2.3
4.1
Uric Acid
13
7.6
3.9
3.8
background
49
Near-field communication (NFC) Technology
This blood glucose meter utilizes Near Field Communication (NFC) wireless technology for data
sharing. NFC operates at 13.56 MHz with a data rate of up to 53 Kbit/s, allowing communication
when the meter and smartphone are within 1 cm proximity. Only one device can connect at a time,
minimizing data transmission interference.
NFC communication involves two components: an initiator that generates an RF field, and a target
that utilizes this field. For the meter to function with a device, the device must support NFC technology
and have compatible software to read the meter’s data.
The device complies with United States Federal Communication Commission (FCC) regulations,
specifically FCC Part 15, ensuring:
1. The device may not cause harmful interference.
2. must accept any interference received, including interference that may cause
undesired operation.
Adhering to these rules ensures proper functionality without disrupting other devices. If interference
occurs, relocating the meter or other devices, such as turning them off, can resolve issues. Common
sources of interference include environmental factors and cross-interference.
background
50
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
Adjusting or relocating the receiving antenna.
Increasing distance between the equipment and receiver.
Using separate electrical circuits for the equipment and receiver.
Seeking assistance from a dealer or radio/TV technician.
Modifications not approved by EPS Bio Technology Corp. may void the user's authority to operate
the device. The equipment complies with FCC and IC radiation exposure limits for uncontrolled
environments, designed for direct contact with the user's body under normal operation. It should not
be co-located or operated with other antennas or transmitters.
Additionally, ensure a minimum distance of 20 cm between the radiator and your body during
installation and operation.
background
51
Electromagnetic Compatibility
This meter complies with the electromagnetic immunity requirements specified by EN ISO 15197.
Electrostatic discharge immunity testing was based on the standard IEC 61000-4-2. Additionally, the
meter meets electromagnetic emission requirements according to EN 60601-1-2, ensuring low
electromagnetic emissions. It is not expected to interfere with other electrically-driven equipment.
Performance Analysis
Please refer to the test strip instructions.
background
52
Device Information
EasyPlus mini 2IN1 SMBG System,
EasyPlus mini 2IN1 Blood Glucose Test Strips,
EasyPlus mini 2IN1 Blood Glucose Meter,
EasyPlus mini 2IN1 Normal Control Solution,
EasyPlus mini 2IN1 High Control Solution.
Manufacturer:
EPS Bio Technology Corp.
No.8, R&D RD III, Hsinchu Science Park, Hsinchu County, Taiwan 30076
Tel: +886-3-6686868 Fax: +886-3-6686866
E-mail: info@epsbio.com.tw
Website: http://www.epsbio.com
Warranty
EPS warrants the original purchaser for a period of 5 years from the date of purchase. This means
during the warranty period if your Self-Monitoring Blood Glucose System does not work for any
reason (other than obvious abuse), EPS will replace it with a new system or an equivalent product
free of charge.
background
53
Lancet
Meets the requirements of MDD 93/42/EEC
Manufacturer:
SAE HAN MEDICAL CORP.
# 700-113 PUB GOT-DONG, IL SAN-GU, GOYANG-CITY, KYUNGGI-DO, KOREA
TEL82-31-923-4330 FAX82-31-923-4331
E-mailsaehan@saehanmed.com
P/N. 718039600_0376_2026-07-28_02

Specifications

Indexed Terms: Glucometer, 2-in-1

EPS BIO D030 Questions and Answers

Questions and Answers

Related Products