I-D-I0304_(718032300)_v1_MS R13N User`s Manual E

I-D-I0304_(718032300)_v1_MS R13N User`s Manual E
EasyPlus mini R13N
Self-Monitoring Blood Glucose System
User’s Manual
Dear EasyPlus mini R13N SMBG System Owner,
Thank you for using the EasyPlus mini R13N Self-Monitoring Blood Glucose (SMBG)
System. We design this system for medical care on diabetes. The test results can help
you determine the effects of food, exercise and diabetes medications. We design 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 will help you
get the most from your EasyPlus mini R13N SMBG System. It provides you and your
diabetes care team with important information and step-by-step direction to use the
EasyPlus mini R13N Self-Monitoring Blood Glucose System. To start testing quickly, you
can also refer to the Quick Reference Guide.
If you have questions, please contact your healthcare professional to get our help. You
can also visit www.epsbio.com for diabetes management tools and product
demonstrations.
Thanks again for choosing the EasyPlus mini R13N blood glucose meter.
Standard Accessories
Your new EasyPlus mini R13N Blood Glucose meter and accessories work together to
measure the amount of glucose in your blood. The system includes:
• EasyPlus mini R13N Blood Glucose Meter
• EasyPlus mini R13N Blood Glucose Test
Strips (10 pcs)
• Lancing device
• AST Cap
• User’s Manual
• Quick Reference Guide
• Wallet
• Check Strip
• CR2032 Lithium Battery (1 pcs)
• Lancets (10 pcs)
• Alcohol Pad (5 pcs)
• Test Strip Instructions
Optional Accessories
• EasyPlus mini R13N Glucose Normal Control Solution
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 and 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, please contact your healthcare professional. You can also visit
www.epsbio.com for diabetes management tools and product demonstrations.
Although the EasyPlus mini R13N 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
„
„
„
„
„
EasyPlus mini R13N blood glucose meter is designed and approved for testing fresh
whole blood from fingertip, palm or forearm. The meter is for outside the body (in
vitro) use. It should not be used to diagnose diabetes.
EasyPlus mini R13N blood glucose meter only use with EasyPlus mini R13N 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 the battery 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 strip with a wet hand.
„ Do not use expired strips (the expiration date is shown on the bottle.)
„ Do not bend, cut or twist the strip.
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 instruction 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.
Explanation of Symbols
SN/
Consult instructions for
use
Caution, consult
accompanying documents
Batch code
Do not re-use
In vitro diagnostic medical
device
CR2032 lithium battery
Use by
Temperature limitation
Manufacturer
Catalog number
Serial number
Control solution
Contains sufficient for <n>
tests
Authorized representative
in the European Community
This product meets the requirements of Directive 98/79/EC in vitro
diagnostic medical devices
Left button
Right button
System fault
AC, before meals
PC, after meals
Morning, from 4:00 am to
10:00 am
Noon, from 10:00 am to
04:00 pm
Evening, from 04:00 pm to
10:00 pm
Night: from 10:00 pm to
04:00 am
Hypoglycemia 20~60
mg/dL
Table of Content
Chapter 1: Understanding Your Meter …....................................................................12
EasyPlus mini R13N Blood Glucose Meter ….........................................................12
Setting The Time And Date ................................................................................13
Checking Your Meter ….......................................................................................14
Using EasyPlus mini R13N Blood Glucose Test Strips ..........................................15
Chapter 2: Control Solution Test .....................................................................16
Why Run A Control Solution Tests ........................................................................16
About The Control Solutions ............................................................................17
Running A Control Solution Test .......................................................................18
Understanding Control Test Results ….................................................................20
Chapter 3: Testing Your Blood Glucose ..................................................................22
Using The Lancing Device .............................................................................22
Inserting A Lancet into the Lancing Device ............................................................23
Running A Blood Glucose Test With Blood From Your Fingertip .........................25
Alternative Site Testing …........................................................................27
Discard Used Lancets …........................................................................29
Understanding Your Test Results …........................................................................30
Unusual Test Results …………………………………….……………………………...30
Comparing Your Meter Result To A Lab Result ….............................................31
Chapter 4: Meter Memory, Setup …......................................................................32
Memory, Storing Test Result …............................................................................32
Viewing & Deleting Test Results …...................................................................33
Meter Memory ….................................................................................................34
Chapter 5: Maintenance And Troubleshooting …....................................................35
Installing A Battery …...................................................................................35
Cleaning Your Meter ……..............................................................................36
Maintenance And Testing ..............................................................................37
Cleaning Your Lancing Device …........................................................................37
Screen Messages And Troubleshooting ….........................................................38
Chapter 6: Technical Information …................................................................40
Specifications …..................................................................................................................40
Device Information …...........................................................................................................41
Warranty ..............................................................................................................................42
Chapter 1: Understanding Your Meter
EasyPlus mini R13N Blood Glucose Meter
The Overview of the
Meaning
Display
Show the moment of month and date.
A month and date
Show the test result.
B Test result
Application of blood Test your level of blood glucose.
C
or control solution
Insert the test strips to start testing
D Insert test strip
blood glucose.
Show the moment of time.
E Time
The meter will memory automatically
F Test records
all of test results.
When the battery symbol appears,
G Battery status
prepare other battery for installation.
12
The Overview of the Test Strip:
A. Blood collection area
B. Reaction area
C. Hand hold area
D. Strip insert direction
E. Electrode
Setting The Time and Date—First Time Use
Setting the current time and date in your meter is important if you use the meter
memory.
2. The last 2-digits of the year flash 3. Repeat step 2 to set the date
1. Put a battery into the
slot and the meter turns at the center of the display. Press
and time. The flashing field
on automatically.
is the one you are currently
to adjust the year and Press
setting.
to confirm the setting.
13
Checking Your Meter
A new check strip is included with your meter.
1. Make sure your check strip
is inserted. The meter will
turn on automatically.
2. The screen displays
"OK".
3. Remove the check strip and the
meter will turn off automatically.
Store the check strip in a safe place.
When the display shows “FAL”, re-insert the check strip. If FAL appears again,
contact your local dealer for repair.
14
Using EasyPlus mini R13N Blood Glucose Test Strip
„ Use only with EasyPlus mini R13N Blood Glucose Meter.
„ 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 before you insert it into the
meter.
„ Do not touch the test strip with a wet hand. Do not bend, cut, or twist the test strips.
15
Chapter 2: Control Solution Testing
Why Run A Control Solution Test
Running a control test lets you know that your meter and test strips are working properly
to give reliable results. You should run a control test when:
„ You use the EasyPlus mini R13N 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.
Professional users are instructed to follow federal, state, and local guidelines
concerning QC practices.
16
About The Control Solution
„ Use only with EasyPlus mini R13N 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 uses 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 and
shows itself.
the icon of
„
„
2. Press
twice to set
“CtL ” and press
to
confirm the setting.
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.
If display stays at
or
and no any setting is made, the test results will be
always in
or
.
If no choose “CtL”, the test results will
18 be included in the memory of blood test.
9. When
you hear the
beeper, you have enough control
6. Squeeze the bottle until a
solution in the test strip.
tiny drop forms at the tip of
The meter starts to count down
the bottle.
from 5 seconds and will show
7. Touch the drop to the Blood
the results.
collection area at the end of 10. A result appears on the display.
the test strip.
Don’t remove the test strip yet.
8. Do not put control solution on Check if the reading falls within
top of the test strip.
the range printed on the test strip
19
bottle.
11. Remove the test strip
and throw it away after
you have compared the
reading to the range
printed on the test strip
bottle.
Understanding Control 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 result is inside the range on the test strip bottle, your test strips and
your meter is working properly.
If your control result is not inside the acceptable range (printed on your test strip bottle),
here are some things you can do to solve the problem:
20
Troubleshooting Checks
Action
Repeat the control test with properly stored
strips.
9 Was the test strip exposing to open air
for a long period of time?
9 Was the test strip bottle capped tightly? This will humidify strips inside. Replace
the test strips.
9 Was the meter functioning well?
You can use the check strip to verify the
meter’s functions.
9 Is the control solution expired or
Replace with new control solution to check
contaminated?
the performance of SMBG system.
9 Were test strips and control solutions
Repeat the control test with properly
stored in cool, dry places?
stored strips or control solutions.
9 Did you follow the testing steps
Read Chapter 2 "Control Solution Testing"
properly?
and test again. If you still have problems,
please contact your local dealer for repair.
21
Chapter 3: Testing Your Blood Glucose
Using The 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.
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.
22
Inserting A Lancet Into The Lancing Device
You must first load the lancet into the lancing device to get it ready for use.
1. Unscrew the cap.
2. Insert the lancet into the
lancing device firmly then
twist off the protective
cover.
23
3. Recap the front cap.
4. Select the desired
penetration depth.
5. Pull on the sliding barrel of
the lancing device until it
clicks and then release.
6. Now the lancing device is ready.
Do not prick your finger until
your meter and strip are
prepared. Set the lancing device
aside until later in the test.
Note:
Select 1-2 for soft or thin skin, 3 for average, and 4-5 for thick or calloused skin.
24
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
and the icon of
shows itself.
3. Press
to set
or
and
to confirm
press
the setting
25
5. When the blood drop
flashes on the display,
obtain a drop of blood
from your fingertip.
6. Gently squeeze your
finger to assist the flow
of blood.
7. The meter will beep when 8. Without touching the used
lancet, stick the lancet tip into its
enough blood has entered
protective cover. Grip the lancet
the strip’s reaction zone.
The result will appear on the carrier firmly and pull the lancet
safely out.
display after 5 seconds.
26
9. Discard the used
disposable lancet into
an appropriate sharps
or biohazard container.
Alternative Site Testing
1. This graphic
shows where
the meter
cleared for
alternative
site testing.
2. Massage the
puncture area of
forearm or palm for a
few seconds.
3. Press and hold the
device with one clear
adjustable tip against
the forearm.
„ Check with your healthcare professional before test other sites that not fingertip.
„ Please do NOT use the first drop of blood sample.
27
4. If you choose the
palm, repeat step
1-3 to obtain a drop
of blood sample.
5. Press the trigger
button to activate the
lancing device.
28
6. Hold the device against
forearm or palm and
increase pressure until the
blood sample size is
sufficient
Discarding Used Lancets
1. Unscrew and remove the adjustable 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.
2. Discard the used disposable
lancet into an appropriate sharps
or biohazard container.
29
Understanding Your Test Results
The EasyPlus mini R13N 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 70~120 mg/dL (3.9~6.7 mmol/L). Two hours after meals,
the blood glucose range for an adult without diabetes is less than 140 mg/dL (7.8
mmol/L). For people with diabetes: please consult your doctor for the blood glucose
range appropriate for you.
Unusual Test Results
If your test result doesn’t match the way you feel, please follow these steps:
1. Run a control 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.
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 55%) or very low
(below 30%) may not provide accurate results.
3. Some studies have shown that electromagnetic fields may affect results. Do not test
near an operating microwave oven.
30
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 R13N 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.
31
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.
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 480 results are in memory, adding a new result causes the oldest one to
be deleted.
4. Average function:
From the latest test result (001) to the earliest one, the meter executes average
function of all test results in 7-, 14-, 30-, 60-, and 90-day and all test results of
AC and PC in 30-day.
32
Viewing & Deleting Test Results
You can review them at any time without inserting a test strip.
1. Press
to review
test results of 30 days
in
or
.
to review
2. Press
all results in order
from records of 001 to
360.
33
3. To delete a test result, press
for 3 seconds and
display shows “dEL”.
4. press
to keep to review
the following results.
5. The meter will turn off in 1
minute automatically.
Meter Memory
You can review them at any time without inserting a test strip.
1. Press
to review test
results of 30 days in
,
,
, or
.
2. Press
to review
results of 7, 14, 30,
60 or 90 days.
34
3. Press
to go back
the display of
.
4. Meter will turn off in 1
minute automatically.
Chapter 5: Maintenance and Troubleshooting
Installing A Battery
The meter uses one CR2032 lithium battery. One battery will normally
last for over 1000 tests. Other types of CR2032 lithium batteries are
also acceptable, yet the capacity of test times may differ. Install the
battery when you first use the meter or replace with a new battery
when the "LP" message and the low battery symbol appear on the
display.
Low battery symbol
1. The meter won’t delete earlier records after you replace batteries.
2. You should reset the time and date again after you replace a battery.
3. CR2032 lithium batteries are available in shops. You may take the old batteries
with you for replacement.
4. Remove batteries when you will not be using the meter for one month or more.
35
Cleaning Your Meter
Caring for your EasyPlus mini R13N 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:
Do:
„ Get any moisture in the test strip
slot.
„ Make sure the meter is turned off.
„ Gently wipe the meter’s surface
with a soft cloth slightly dampened.
„ Spray any cleaning solution directly
onto the meter.
„ Put the meter under water or liquid.
„ Pour liquid into the meter.
36
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.
to see the complete display. All the indicators
Press and hold
should be clear and look exactly like the picture to the left. If not,
please contact your local dealer.
Cleaning Your Lancing Device
„ To clean the lancing device, wipe them 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.
37
Screen Messages And Troubleshooting
Never make treatment decisions based on an error message. If you have any concerns,
please contact your local dealers.
Humidified/Used
strips
Action: Replace
with a new strip.
Low power
Action: Replace
with one new
battery.
System fault
Action: Replace the
batteries first. If 001
ERROR appears again,
contact your local dealer
for repair.
38
Test result is higher
than 630 mg/dL.
Action: Test again. If the
result is still the same,
please contact your
healthcare professional.
The test result
is among 20~60
mg/dL.
Action: Please
contact your
healthcare
professional.
The test result is
lower than 20
mg/dL.
Action: Test again.
If the result is still
the same, please
contact your
healthcare
professional.
The "Ht" icon appears.
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.
Action: Relocate the meter
to a location with
temperature between 50°F
~104°F
(10°C ~40°C).
39
The "Lt" icon appears.
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.
Action: Relocate the meter
to a location with
temperature between 50°F
~104°F (10°C ~40°C).
Chapter 6: Technical Information
Specifications
Brand name
Range
Response time
Memory sets
Operating condition
Storage and
transportation
condition
Temp.
Relative Humidity
Temp.
EasyPlus mini R13N Blood Glucose Meter
20~630 mg/dL
5 seconds
480 test results
50°F ~104°F (10°C ~40°C)
R.H. ≦ 90%
39°F ~104°F (4°C ~40°C)
Relative Humidity
R.H. ≦ 90%
Blood sample
Hematocrit (Hct)
Power
Battery life
Display dimension
Device dimension H × W × D (mm)
Weight
Principles
0.6 μL
Fresh blood from fingertip, palm or arm
30~55%
CR2032 Lithium Battery
Over 1000 tests
42.0 × 32.0 (mm)
75.0 × 44.0 × 10.0 (mm)
30.0 grams w/o battery
Electrochemical biosensor technology
40
Device Information
EasyPlus mini R13N SMBG System,
EasyPlus mini R13N Blood Glucose Test Strips,
EasyPlus mini R13N Blood Glucose Meter.
EMC
This monitor conforms to European Standard EN 61326 and is subject to particular
precautions with regard to electromagnetic compatibility (EMC). Please note that
portable and mobile HF communication systems may interfere with this instrument. For
more details, please contact customer service at the address indicated.
Disposal:
When disposing of monitor components, strictly observe the generally applicable
precautions for
working with working with blood and follow the national requirement to dispose unit.
41
Manufacturer:
EPS BIO TECHNOLOGY CORP.
2F, No.49-2, Lane 2, Guang-Fu Rd., Sec. 2, Hsinchu City, Taiwan 300
TEL:+886-3-5752522
FAX:+886-3-5752552
Website:http://www.epsbio.com
E-mail:[email protected]
Obelis s.a.
34, Av. de Tervuren, bte 44, B-1040 Brussels, Belgium
TEL:(32) 2.732.59 54 FAX:(32) 2.732.60 03
E-mail: [email protected]
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.
42
Lancing Device
Meets the requirements of MDD 93/42/EEC
Manufacturer:
Global Medical Market Corp.(GMMC)
Rm # 1112, Ace Tower 9th Bldg., 345-30, Kasan-Dong
Kumchon-Ku, Seoul, Korea (Zip:153-782)
E-mail : [email protected]
Lancet
Manufacturer:
SAE HAN MEDICAL CORP.
# 700-113 PUB GOT-DONG, IL SAN-GU, GOYANG-CITY, KYUNGGI-DO, KOREA
TEL:82-31-923-4330
FAX:82-31-923-4331
E-mail:[email protected]
43
Alcohol Pad
Manufacturer:
China Surgical Dressings Center Co., Ltd.
No.21, Lane 424, Sec. 6, Changnan Rd., Fu-Tien Li, Changhwa City, Taiwan 500
TEL:886-4-7321239
E-mail:[email protected]
P/N. 718032300 Rev.A01
44
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