EPS Bio Technology EasyPlus mini R13N User`s manual


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EPS Bio Technology EasyPlus mini R13N User`s manual | Manualzz

EasyPlus mini R13N

Self-Monitoring Blood Glucose System

User’s Manual

Please read this User’s Manual thoroughly before using your blood glucose meter.

Dear EasyPlus mini R13N SMBG System user,

Thank you for choosing the EasyPlus mini R13N Self-Monitoring Blood Glucose (SMBG) System.

We designed this system to be reliable, use-friendly and efficient 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 R13N Self-Monitoring Blood Glucose System. To start testing quickly, you can also refer to the Quick Reference Guide.

Once again, thank you for choosing the

EasyPlus mini R13N

SMBG System.

Intended Use

The EasyPlus mini R13N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertips, palm and forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for self-testing

(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 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 • Wallet

• EasyPlus mini R13N Blood Glucose Test

Strips (10 pcs)

• Lancing device

• CR2032 Lithium Battery (1 pcs)

• Lancets (10 pcs)

• Alcohol Pad (5 pcs)

• AST Cap

• User’s Manual

• Test Strip Instructions

• Quick Reference Guide

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 to help you to 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 contact your healthcare provider. 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 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

„

„

„

„

„

EasyPlus mini R13N blood glucose meter is designed and approved for testing fresh capillary whole blood samples from your fingertips, palm and forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the body). It should not be used to diagnose diabetes.

EasyPlus mini R13N blood glucose meter can only be used 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 or a bathroom, or refrigerator.

Keep the meter, test strips and lancing device away from children and pets.

You should not test critically ill patients with home-use blood glucose meters.

„ 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.

Please dispose device according to the local rule of the disposition of electronic device / accessory waste.

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 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 3,048 meters above sea level has no effect on readings.

Health-Related Information

„ If you are very dehydrated, urinating frequently, have low blood pressure, in shock or hyperosmolar hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than what your blood glucose really is. If you think you are dehydrated, call your doctor right away.

„

„

If you have followed the steps in the user’s manual, but still have symptoms that don’t seem to match your test results, or if you have questions, please contact your healthcare provider.

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.

Explanation of Symbols

Consult instructions for use Caution

Batch code

In vitro diagnostic medical device

Do not re-use

3V (CR2032) x 1 battery only

Use by Temperature limitation

Manufacturer

SN/ Serial number

<n>

Catalogue number

Control

Sufficient for

Authorized representative in the

European Community

This product meets the requirements of Directive 98/79/EC in vitro diagnostic medical devices

Table of Content

Chapter 1: Understanding Your Meter … ...........................................

.........

...........................

....11

EasyPlus mini R13N Blood Glucose Meter …........................................................................

11

The EasyPlus mini R13N Blood Glucose Test Strip and Accessories....................................12

Setting The Time And Date .............................................................

...

.......................

.............13

Using EasyPlus mini R13N Blood Glucose Test Strips ........

..............

...

...

..............................14

Chapter 2: Control Solution Test ........

...............................................................

...

.....................

15

Why Run A Control Solution Test ....

....................................................................

...

.............

..15

About The Control Solution ........................................

.............................................

...

............

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 ........

.........................

...

..

.....24

Alternate Site Testing (Optional) …........................................................................................26

Running a Blood Glucose Test with Blood From Your Forearm (Optional) ...........................28

Running a Blood Glucose Test with Blood From Your Palm (Optional) .................................29

Discard 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 Results …...........................

.......

....

..................................

...

...

..............34

Viewing & Deleting Test Results …..............

.......................................................

...................35

Meter Memory …............................

..............................

...

.....................................

..................36

Chapter 5: Maintenance And Troubleshooting

….............

............................................

...

........

.37

Inserting Battery ….......

..............................................

.....

......

.....

..................................

...

......

.37

Cleaning Your Meter …….......................................................

.

..

....................................

...

......

38

Cleaning Your Lancing Device …................

....................................................................

...

....

38

Maintenance And Testing ....................................

..................................

...........................

...

..39

Screen Messages And Troubleshooting …...........

...........................................................

...

..

.40

Chapter 6: Technical Information

…...........

...............................................

...

..

.43

Specifications …...........................................

.......................

........

....................................

...

...

.43

Device Information …......................

...............

.

..............

.

...................................................

...

...

44

Warranty .....

.............

............

............................................

.

.................................................

...

..

44

Chapter 1: Understanding Your Meter

EasyPlus mini R13N

Blood Glucose Meter

A. Month and date

B.

Test result

C. Application of blood

D. Insert test strip or Application of control solution

E.

Time

F. Test records

G. Battery status

Explanation of Meter Symbols

System fault

Before meals

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

Left button

Right button

11

The EasyPlus mini R13N Blood Glucose Test Strip and Accessories

Blood Glucose Test Strip

Electrode

Test Strip Bottle

Control Solution Bottle

Lancing Device

Sliding barrel

Sleeve

Strip Insert

Direction

Trigger button

AST

Lancing

Device Cap

Hub

Hand Hold

Area

Carrier

Reaction Area

Blood Collection

Area

Expiration Date

Adjustable tip

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.

1.

Put a battery into the slot and the meter turns on automatically.

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.

3.

Repeat step 2 to set the date and time. The flashing field is the one you are currently setting.

The unit of Blood Glucose Meter is set at mg/dL without any modification function.

13

Using EasyPlus mini R13N Blood Glucose Test Strips

„

„

„

„

Use only with EasyPlus mini R13N Blood Glucose Meter.

Keep the test strips in their original bottle.

After you take a test strip out of the bottle, close the bottle immediately.

Use the test strip within 3 minutes after you taking it out of the bottle.

„

„

„

„

The test strip is for single use only. Do not reuse it.

Write down the date on strip bottle when the strip bottle is first time opened. Be sure to check the expiration date on the test strip bottle. The test strip will be expired either in three months after the date of the bottle is opened or till the expiration date printed on the bottle.

Store the test strip bottle and your meter in a shady and arid place.

Store the test strips between 2°C - 30°C (36°F- 86°F). 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.

14

Chapter 2: Control Solution Testing

Why Run a Control Solution Test

We recommend that you run the EasyPlus mini R13N Normal control solution 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 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.

Professional users are instructed to follow federal, state, and local guidelines.

15

About The Control Solution

„

„

„

Use only with EasyPlus mini R13N test strips.

Write the date you opened the control solution bottle on the bottle label. The control solutions are good for three months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first.

Do not use a control solution that is past the expiration date.

„

„

„

„

Control 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 control solution at room temperature, between 2°C - 30°C (36°F - 86°F). Do not freeze.

16

Running A Control Solution Test

You need the meter, a test strip, and control solution

3.

Place the meter on a flat surface, like a table.

1.

Put a test strip into the meter in the direction of the arrow and the icon of shows itself.

2. Press twice to set

“CtL ” and press to confirm the setting.

4.

Remove the control solution bottle cap and wipe the tip of the bottle with a tissue.

1. If display stays at

or and no any setting is made, the test results will always in or .

2. If you do not choose “CtL”, the test results will be included in the memory of blood test.

17

5. Squeeze the bottle until a tiny drop forms at the tip of the control solution cap.

6.

Touch the drop to the

Blood Collection Area at the end of the test strip.

7.

Do not put control solution on top of the test strip.

8.

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.

9.

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.

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

18

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 the acceptable range for the appropriate control solution level.

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:

Control Solution values will not be included in the memory and averages.

19

Troubleshooting Checks Action

9 Was the test strip exposed to open air for a long period of time?

9 Does test strip cap close tightly? Or was test strip cap left open?

9 Is the meter functioning well?

9 Is the control solution expired or contaminated?

9 Were test strips and control solutions stored in cool, dry places?

9 Did you follow the testing steps properly?

If yes, repeat the control test with properly stored strips.

If the cap was not tight, or the bottle was left uncapped, open a new bottle of test strips.

Do not reuse the strips from the affected bottle.

You can use control solution to verify the meter’s functions. (Chapter 2)

If yes, replace with new control solution to check the performance of SMBG system.

If no, repeat the control test with properly stored strips or control solutions.

Read Chapter 2 "Control Solution Testing" and test again. Stop using the meter if you continue to obtain the inaccurate results. If you have questions or need assistance, please contact your healthcare professional.

20

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. Users may discuss methods for disposing of used test strips and lancets with their doctor.

21

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.

3.

Recap the front cap.

Lancets are for use only and a new, sterile lancet should be used each time you perform a test.

22

4.

Select the desired penetration depth.

5.

Pull on the sliding barrel 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.

1. Select 1-2 for soft or thin skin, 3 for average, and 4-5 for thick or calloused skin.

2. Lancing device and lancets are not to be shared between users. Sharing lancing devices and lancets may transmit blood borne pathogens, such as viral hepatitis.

23

Running A Blood Glucose Test With Blood From Your Fingertips

1.

Wash your hands with soap and warm water.

Rinse and dry thoroughly.

2.

Insert a test strip into the meter in the direction of the arrow and the icon will appear.

3.

Press to set or and press to confirm the setting.

4.

When the blood drop flashes on the display, obtain a drop of blood from your fingertip, using the lancing device.

24

5.

Place the lancing device against the tip or side of your finger; press the trigger button to activate the lancing device.

6.

Gently squeeze your finger to assist the flow of blood. This helps you get a blood drop.

Touch the blood drop to the tip of the transparent window of the test strip.

Do not put blood on top of the strip.

Be sure to get enough blood on the strip’s reaction zone. Otherwise, an inaccurate reading may result.

7.

The meter will beep when enough blood has entered the strip’s reaction zone.

The result will appear on the display after 5 seconds.

8.

Remove the test strip and the meter turns off automatically.

25

Alternate Site Testing (Optional)

Understanding Alternate Site Testing (AST)

What is AST?

Besides the fingertip, you can test the forearm or palm.

What is the advantage of AST?

You have the option of testing other places on your body besides the fingertip.

Consult your health care professional before you begin using the forearm or palm for testing. Blood glucose test results obtained from your forearm or palm may differ significantly from fingertip samples. We strongly recommend that you:

Do AST ONLY in the following intervals:

„ In a pre-meal or fasting state (more than 2 hours since the last meal).

„

„

Two hours or more after taking insulin.

Two hours or more after exercise.

Do NOT use AST if:

„ You think your blood glucose is low.

„

„

„

„

You are unaware of hypoglycemia.

Your AST results do not match the way you feel.

You are testing for hyperglycemia.

Your routine glucose results are often fluctuating.

26

„

„

„

Fingertip test only:

„ sick

„ If blood glucose is low

„ After

„ Two hours or less after eating

When you have just taken insulin

After injecting rapid-acting insulin (two hours or less)

If you often do not notice when your blood glucose is low, do a fingertip test.

AST Results:

„ If the blood glucose test result from the alternate site test does not match how you feel, do a fingertip test to confirm the result again.

„ Do NOT change your treatment just because of an alternate site result, do a fingertip test to confirm the result.

„

„

„

„

Talk with your healthcare professional before you test with your palm or forearm.

Do NOT ignore symptoms of high or low blood glucose.

Fingertip samples are able to show the rapid change of glucose faster than forearm samples.

Do NOT change your treatment just because of a result.

27

Running a Blood Glucose Test with Blood From Your Forearm (Optional)

Please use the clear cap with the lancing device for AST testing.

1.

Massage the puncture area of forearm for a few seconds.

2.

Press and hold the device with clear adjustable tip against the forearm.

3. Press the trigger button to activate the lancing device.

4. Hold the device against forearm and increase pressure until the blood sample size is sufficient.

28

Running a Blood Glucose Test with Blood From Your Palm (Optional)

1.

Massage the puncture area of palm for a few seconds.

2. Press and hold the device with one clear adjustable tip against the palm.

3. Press the trigger button to activate the lancing device.

4.

Hold the device against palm and increase pressure until the blood sample size is sufficient.

Check with your healthcare professional before testing other sites than fingertip.

29

Discarding Used Lancets

1.

Unscrew and remove the cap.

2.

Without touching the used lancet, stick the lancet tip int o its protecti ve cover.

3. Pointing the lancing device toward a container for sharp or biohazard material, slide the ejection button down to release the covered lancet into the container.

30

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 with diabetes is 70-130 mg/dL

(3.9~7.2 mmol/L)*.

Two hours after meals, the blood glucose range for an adult with diabetes is less than 180 mg/dL (10.0 mmol/L).

For further queries about diabetes: please consult your doctor for the blood glucose range appropriate for you.

* Reference: American Diabetes Association. Standards of medical care in diabetes-Table 10. Diabetes care. 2011; Vol. 34, Suppl 1, S21.

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 healthcare professional immediately.

1. Extremely high humidity may affect the test results. A relative humidity greater than

90% may cause inaccurate results.

2. Hematocrit below 30% may cause higher results. Hematocrit above 55% may cause lower results.

3. Some studies have shown that electromagnetic fields may affect results. Do not test near an operating microwave oven.

31

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:

Greater than 240 mg/dL (13.33 mmol/L) Below 60 mg/dL (3.33 mmol/L)

What It Means:

The test result is higher than reference normal range. (70-130 mg/dL or 3.89-7.22 mmol/L)

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 (13.33 mmol/L) and you have symptoms of high blood glucose, contact your healthcare professional instantly.

„ If the result does not match how you feel, follow the steps under "Unusual Test Results."

What It Means:

The test result is lower than reference normal range. (70-130 mg/dL or 3.89-7.22 mmol/L)

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 (3.33 mmol/L) and you have symptoms of low blood glucose, contact your healthcare professional instantly.

„ If the result does not match how you feel, follow the steps under "Unusual Test Results."

32

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.

33

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 360 results are in memory, adding a new result causes the oldest one to be deleted.

34

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 .

2.

Press to review all results in order from records of 360 to 001.

3. To delete a test result, press for 3 seconds and display shows “dEL”.

4. Press to keep reviewing test results.

5.

The meter will turn off in 1 minute automatically.

35

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.

3. Press to go back the display of .

4. Meter will turn off in 1 minute automatically.

36

Chapter 5: Maintenance and Troubleshooting

Inserting Battery

The meter uses one CR2032 Lithium Battery. Batteries will normally last for more than 1000 tests. Other types of CR2032 Lithium Battery are also acceptable, but the capacity of test times may differ. Insert the batteries when you first use the meter or replace with new batteries when the "LP"

(Low Power) message and the low battery symbol appear on the display.

Low battery symbol

1. The meter won’t delete earlier records after you replace battery.

2. You should reset the time and date again after you replace the battery.

3. CR2032 Lithium Battery is available at most stores. You may take the old battery with you for replacement.

4. Remove battery when you will not be using the meter for one month or more.

37

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:

„ Make sure the meter is turned off.

„ Gently wipe the meter’s surface with a soft cloth slightly dampened with ethanol

(70~75%).

Cleaning Your Lancing Device

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.

„ To clean the lancing device, wipe it with a soft cloth dampened with water and mild detergent.

DO NOT places the entire device under water.

„ To disinfect the cap after cleaning, place it in 70%-75% rubbing alcohol for 10 minutes at least once a week. Allow the cap to air-dry after disinfecting.

38

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 contact your local dealer.

39

Screen Messages and Troubleshooting

Never make treatment decisions based on an error message. If you have any concerns, please contact your local dealer or healthcare provider.

Message What it means? What to do?

Humidified / Used strips

The meter has detected a problem with the test strip.

Repeat the test with a new strip.

Refer to pages 7-8 for information on sample application.

Low power

The meter batteries do not have enough power to perform a test.

Replace the new batteries.

40

Message What it means?

System error

There may be a problem with the meter.

What to do?

Replace the batteries first.

If Err 001 appears again, please contact your local dealer.

The test result is among 20~60 mg/dL.

Please call your healthcare professional.

The test result is higher than

630 mg/dL.

Re-check your glucose level.

If the result is HI again, obtain and follow instructions from your healthcare professional without delay.

41

Message What it means?

The test result is lower than 20 mg/dL.

The “Ht” and thermometer icon appears. Temperature is too high, outside the required range of 10°C -

40°C (50°F - 104°F). This alerts users that an incorrect result may occur if the test continues.

What to do?

This may require immediate treatment according to your healthcare professional’s recommendations.

Although this message could be due to a test error, it is safer to treat first and then do another test.

Relocate the meter to a location with temperature between 10°C - 40°C

(50°F - 104°F).

The “Lt” and thermometer icon appears. Temperature is too low, outside the required range of 10°C -

40°C (50°F - 104°F). This alerts users that an incorrect result may occur if the test continues.

Relocate the meter to a location with temperature between 10°C - 40°C

(50°F - 104°F).

42

Chapter 6: Technical Information

Specifications

Brand name EasyPlus mini R13N Blood Glucose Meter

Response time

Memory sets

Operating condition

Temp.

Relative Humidity

5 seconds

360 test results

10°C ~40°C (50°F ~104°F)

R.H. ≦ 90%

Storage and transportation condition

Blood sample

Temp.

Relative Humidity

36°F ~86°F (2°C ~30°C)

R.H. ≦ 90%

0.6 μL

Fresh blood from fingertip, palm or forearm

30~55% Hematocrit (Hct)

Power

Battery life

Display dimension

Device dimension H × W × D (mm)

CR2032 Lithium Battery

Over 1000 tests

1.65” x 1.26” (42.0 × 32.0 mm)

2.95” x 1.73” x 0.39” (75.0 × 44.0 × 10.0 mm)

Weight 1.06 oz (30.0 grams) w/o batteries

Principles Electrochemical biosensor technology

43

Device Information

EasyPlus mini R13N SMBG System,

EasyPlus mini R13N Blood Glucose Test Strips,

EasyPlus mini R13N Blood Glucose Meter.

Manufacturer:

EPS Bio Technology Corp.

No. 8, R&D RD III, Hsinchu Science Park, Hsinchu City, Taiwan

Tel: 886-3-6686868 Fax: 886-3-6686866

E-mail: [email protected] Website: http://www.epsbio.com.tw

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.

44

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]

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]

P/N. 718032300_0304_04

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