Suresign Resure User Manual

TM

Blood Glucose

MONITORING SYSTEM

Please read this User Manual
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roughly before using your

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ood glucose meter

User Manual

User Manual

Dear Suresign Resure Blood Glucose Monitoring System Owner,

Thank you for using the Suresign Resure Blood Glucose Monitoring 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 Suresign Resure Blood
Glucose Monitoring System. To start testing quickly, you can also refer to the Quick Reference Guide.

Thanks again for choosing Suresign.

Intended Use

The Suresign Resure Blood Glucose Monitoring System is intended for the quantitative measurement of
glucose in venous whole blood or 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.

1. Normal control solution is included with the system.

2. Low control solution and High control solution are available. For purchase, please
contact your healthcare provider.

Standard Accessories

Your new Suresign Resure Blood Glucose meter and accessories work together to measure the amount of
glucose in your blood. The system includes:

Optional Accessories

•

Suresign Resure Blood Glucose Meter

• Alkaline Battery (2 ct.)

• Glucose Test Strips (10 pcs)

• Lancets (10 pcs)

• Lancing device

• AST Lancing Device Cap

• User’s Manual

• Quick Reference Guide

• Test Strip Instructions

• Self-Test Log Book

• Normal Control Solution

• Glucose Control Solution Instructions

• Carrying Case

• Low Control Solution

• High 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 have made this blood glucose monitoring system as simple as possible to help you use it regularly. Your
meter is easy to use, and you can adjust the lancing device for your comfort.

Do you need help?

If you have questions or need assistance, please contact your healthcare provider.

Although the Suresign Resure Blood Glucose Monitoring 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

 Suresign Resure 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.

 Suresign Resure blood glucose meter can only be used with Suresign Resure Blood Glucose Test

Strips. Other test strips will give inaccurate results.

 Testing is not valid for neonatal blood specimens.
 Do not disassemble the meter as this may cause damage to the components resulting in incorrect

readings. Disassembling the meter will also void the warranty.

 Always keep the meter clean and store it in a safe place. Protect the meter from direct sunlight to ensure

a longer lifespan.

 You should not store the meter and test strips in a car, bathroom, or refrigerator.
 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.
 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 a 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 experiencing dehydration, frequent urination, low blood pressure, shock or hyperosmolar

hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than what your blood
glucose really is. If you think you are dehydrated, call your doctor right away.

 If you have followed the steps in the user’s manual, but still have symptoms that do not 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

Do not reuse

In vitro diagnostic medical
device

1.5V(AAA) x 2 batteries only

Use by

Temperature limitation

Manufacturer

Catalogue number

Serial number

Control

Sufficient for

Authorised representative in the
European Community

Blood glucose test result in
mg/dL

Blood glucose test result in
mmol/L

Green Dot / Duales System Deutschland GmbH (DSD)

Separate collection for WEEE- Waste of electrical and electronic equipment

Discard 6 months (180 days) after opening

Keep away form sunlight

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

Explanation of Meter Symbols

Folder Symbol

Meaning

Date

Show the moment of month and day.

Time

Show the moment of time.

Test result

Show the test result.

Record/Average display

Tracking all the test results or average of 7/14/30/90
days.

Control Solution

Control Solution test and the result is not included

in the memory.

AM

Indicate before noon

PM

Indicate after noon

Batteries status

When the battery symbol appears, prepare new
batteries for installation.

AC = ante cibos

Indicate before meal

PC = post cibos

Indicate after meal

Insert strip

Insert the test strip to test blood glucose.

Thermometer

When the thermometer icon appears, the
temperature is too high or too low.

Error

The meter system is in fault.

Memory

Show the memorized results

Apply blood

Apply blood to the test strip

Glucose unit

The testing unit of blood glucose is mg/dL.

Glucose unit

The testing unit of blood glucose is mmol/L.

Table of Contents

Chapter 1: Understanding Your Meter ….......................................................................................................13

The Suresign Resure Blood Glucose Meter ….........................................................................................13

The Suresign Resure Accessories............................................................................................................14

Inserting Batteries.......................................................................................................................................15

Setting The Time and Date.........................................................................................................................16

Using Suresign Resure Blood Glucose Test Strips ..................................................................................17

Chapter 2: Control Solution Testing..............................................................................................................18

Why Run a Control Solution Test ...............................................................................................................18

About The Control Solutions ......................................................................................................................19

Running a Control Solution Test ................................................................................................................20

Understanding Control Solution Test Results ............................................................................................22

Chapter 3: Testing Your Blood Glucose .......................................................................................................24

Using the Lancing Device .........................................................................................................................24

Inserting a Lancet into the Lancing Device ................................................................................................25

Running a Blood Glucose Test with Blood from Your Fingertips................................................................27

Alternative Site Testing (AST)……...…………………………………………………………………………….30

Running a Blood Glucose Test with Blood from Your Forearm ……..........................................................32

Running a Blood Glucose Test with Blood from Your Palm ……...............................................................33

Discarding Used Lancets …......................................................................................................................34

Understanding Your Test Results……………………………......................................................................35

Unusual Test Results…..............................................................................................................................35

Symptoms of High or Low Blood Glucose.................................................................................................36

Comparing Your Meter Result to a Lab Results ….....................................................................................37

Chapter 4: Meter Memory, Setup …...............................................................................................................38

Memory, Storing Test Results …................................................................................................................38

Viewing Test Results …..............................................................................................................................39

Chapter 5: Maintenance and Troubleshooting ….........................................................................................40

Inserting Batteries …..................................................................................................................................40

Cleaning Your Meter...…………………………………………..…….............................................................41

Cleaning Your Lancing Device...………………………………………...........................................................41

Maintenance and Testing ...........................................................................................................................42

Screen Messages and Troubleshooting ….................................................................................................43

Chapter 6: Technical Information …..............................................................................................................46

Specifications ….........................................................................................................................................46

Limitations…...............................................................................................................................................47

Device Information ….................................................................................................................................49

Warranty ...................................................................................................................................................50

13

Chapter 1: Understanding Your Meter

The Suresign Resure Blood Glucose Meter

Test Strip Slot-

Insert test strip
here.

Strip Ejector-
Push the Strip
Ejector to
remove the strip.

Display-

Shows results,
messages, and
results stored in
memory.

Left ()
Buttons-

Press to enter
memory, adjust
setting, and
scroll through
results.

Battery Door-

Flip open the battery door by
pushing the tab in the direction of
the arrow and pulling the door up.

Right () Buttons- Press to
turn the meter on, confirm
setting, and scroll through
results.

14

The Suresign Accessories

Blood Glucose Test Strip

Test Strip Bottle
Control Solution Bottle

Lancing Device

Trigger button-

Press the trigger
button to activate
the lancing device

Carrier-

Insert the lancet
into the carrier

Adjustable tip-

Select the
desired
penetration depth

Hub-

Unscrew or
Recap the Cap.

Sleeve-

Hand Hold
Area

AST
Lancing
Device Cap-

Use this
transparency
cap for AST
testing

Sliding barrel -

Pull on until it clicks
and then release to
enable lancing
device.

Strip Insert
Direction

Reaction area

Hand Hold
Area

Blood collection
area

Electrode

Expiration

Date

15

Inserting Batteries

1. Open the battery door on the

back of the meter by pushing
the tab in the direction of the
arrow and pulling the door up.

3. Put the battery door back in

place and snap it closed.
The meter turns on
automatically.

2. Insert two batteries and the

meter beeps.

16

Setting the Time and Date

Setting the current time and date in your meter is important if you use the meter memory.

3. Repeat step 2 to set the date and

time. The flashing field is the one
you are currently setting. (A=AM,
P=PM)

1. Press  (right button) to

turn the meter on.

2. The display shows the last

2-digit of the year that flashes at
the top of display as well. Press
 (left button) to adjust the year
and press  (right button) to
confirm the setting.

17

Using Suresign Resure Blood Glucose Test Strips

 Use only with Suresign Resure Blood Glucose Meters.
 Run a control solution test every time you open a new bottle of test strips (See Chapter 2 "Control

Solution Testing.")

 Keep the test strips in their original bottle.
 After you take a test strip out of the bottle, tightly close the bottle immediately. This keeps the test strips

dry.

 Use the test strip within three minutes after taking it out of the bottle.
 The 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 6 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 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.

18

Chapter 2: Control Solution Testing

Why Run a Control Solution Test

We recommend that you run the Suresign Resure control test because it lets you know that your meter and
test strips are working properly to give reliable results. You should run the control solution tests when:

 You use the Suresign Resure 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.

19

About The Control Solutions

 Use only with Suresign Resure 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 solutions 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.
 If you would like to purchase Suresign Resure Control Solutions, please contact your healthcare provider.

20

Running a Control Solution Test

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

1. Put a test strip into the

meter according to the
direction of the arrow on
the test strip. The meter
turns on automatically.

3. The icons and

are displayed.

2. Press  (left button) to set (AC), (PC)
or CS Mode, then press  (right button) to
confirm the setting.

21

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.

6. Squeeze the bottle until a tiny

drop forms at the tip of the
bottle.

Be aware that there are Normal and High ranges listed on
your test strip bottle. The Normal and High refer to the three
different control solutions that are available. Please be sure
that you are looking at the correct range.

7. Touch the control solution drop

to the tip of the transparent
window of the test strip.

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

8. The meter starts to count down

from 5 seconds 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. Push the Strip Ejector to remove

the test strip.

11. Throw the test strip away after

you have compared the reading
to the range printed on the test
strip bottle.

22

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:

1. If “ ” is not set, then the control test values will be counted into 7/14/30/60/90 days

average mode.

2. If “ ” is set, the control solution values will not be counted into averages, but only in

the memory for review.

23

Troubleshooting Check Action

 Was the test strip exposed to open air for a long

period of time?

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

 Does test strip cap close tightly? Or was test

strip cap left open?

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.

 Is the meter functioning well?

You can use the control solutions to verify the
meter’s functions.

 Is the control solution expired or contaminated?

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

 Were test strips and control solutions stored in

cool, dry places?

If no, 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.

24

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 used test strips and lancets with their doctor.

25

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.

26

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

6. Set the lancing device aside

until later in the test.

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.

4. Select the desired penetration
depth.

27

Running A Blood Glucose Test With Blood From Your Fingertips

You can also turn on the meter by inserting a test strip.

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 turns on automatically.

3. Press  (left button) to set

(AC) or (PC)
Mode, then press  (right
button) to confirm the setting.

28

Please make sure to apply blood when the blood drop appears on the display.

5. Hold the lancing device firmly

against the side of your finger.
Press the trigger button. Then
remove the lancing device
from your finger.

6. Gently squeeze and/or massage
your fingertip until a round drop
of blood on your fingertip.

7. Wipe away the first drop with a
tissue and use the second drop.

4. The icons and
show themselves.

When the blood drop flashes

on the display, obtain a drop
of blood from your finger.

29

8. Touch the 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 in
the strip’s confirmation window.
Otherwise, an inaccurate
reading may yield.

9. The meter starts to count
down from 5 seconds and
then shows the test result.

10. Push the Strip Ejector to remove

the test strip.

11. Throw it away after you have

compared the reading to the range
printed on the test strip bottle.

30

Alternative Site Testing (AST)

Understanding Alternative Site Testing

Consult your health care professional before you begin using the palm or forearm for testing. Blood glucose
test results obtained from your palm or forearm may differ significantly from fingertips 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.

What is AST?

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

What is the advantage of AST?

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

31

Fingertip test only:

 If sick
 If blood glucose is low
 After exercising
 Two hours or less after eating
 When you have just taken insulin
 After injecting rapid-acting insulin (two hours or less)

AST Results:

 If the blood glucose test result from the alternative 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 alternative site result, do a fingertip test to

confirm the result.

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

Caution:

 Talk with your healthcare professional before you test with your palm or forearm.
 Do NOT ignore symptoms of high or low blood glucose.
 Fingertips samples are able to show the rapid change of glucose faster than forearm samples.
 Do NOT change your treatment just because of a result.

32

4. Press the trigger button to

activate the lancing device.

5. Hold the device against

forearm and increase pressure
until the blood sample size is
sufficient.

2. Massage the puncture area of
forearm for a few seconds.

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

1. This graphic shows where the
meter cleared for alternate
site testing.

Running a Blood Glucose Test with Blood from Your Forearm

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

33

2. Press and hold the device
with a 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.

1. Massage the puncture area of
palm for a few seconds.

Running a Blood Glucose Test with Blood from Your Palm

1. Check with your healthcare professional before testing sites other that the fingertip.

2. Please do NOT use the first drop of blood sample.

34

Discarding Used Lancets

1. Unscrew and remove the

cap.

2. Without touching the used
lancet, stick the lancet tip
into its protective cover.

3. Pointing the lancing device

toward a container for sharp or
biohazard material, slide the
eject button up to release the
covered lancet into the
container.

35

Understanding Your Test Results

The Suresign Resure 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 eating, 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 healthcare provider 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 does not 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 do not 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. Hematocrit below 20% may cause higher results. Hematocrit above 60% may cause
lower results.

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

36

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 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."

Greater than 240 mg/dL (13.33 mmol/L)

Below 60 mg/dL (3.33 mmol/L)

37

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 fingertips 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 Suresign Resure
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.

38

Chapter 4: Meter Memory, Setup

Memory, Storing Test Results

Your meter stores a maximum of 480 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 latest 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 for future readings. 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.

39

Viewing Test Results

The meter provides average readings over 7, 14, 30 and 90 days, allowing you to easily track your blood
glucose levels.

1. Press  until turning the meter on.

2. Press  to view the latest test result.

3. All results are shown in turn from

records of M480 to M001.

4. Press to view averages of

30day-AC/PC and 7/14/30/90 days.

40

Chapter 5: Maintenance and Troubleshooting

Inserting Batteries

The meter uses two alkaline 1.5V (AAA) batteries. Batteries will normally last
for more than 2000 tests. Other types of 1.5V (AAA) batteries 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.

The meter will not turn on the first time batteries are inserted.
Please press and hold the right button or insert the test strip to turn your
meter on.
The meter will turn off automatically, or you can press and hold the right
button to turn your meter off.

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 the batteries.

3. 1.5V (AAA) x 2 batteries are available at most stores. 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.

41

Cleaning Your Meter

Caring for your Suresign Resure Blood Glucose Monitoring System does not require special cleaning.
Please keep the meter free of dirt, dust, bloodstains, and water stains. Follow these guidelines carefully to
help you get the best performance possible:

Cleaning Your Lancing Device

 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.

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 meter’s surface with a soft

cloth slightly dampened with ethanol
(70~75%).

42

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 the right button 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 healthcare provider.

43

Screen Messages and Troubleshooting

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

Low power

Action: Replace with new
batteries.

System fault

Action: Replace the batteries first. If

ERROR 001 appears again, please
contact your local dealer.

Humidified/Used strips

Action: Replace with a
new strip.

44

Test result is higher than 630
mg/dL (35.0 mmol/L).

Action: Test again. If the result is

still the same, try a control solution
test and if the control solution test
falls within the correct range, please
call your healthcare provider.

System fault

Action: Replace the

batteries first. If Err
appears again, please
contact your local dealer.

The test result is lower than 20
mg/dL (1.1 mmol/L).

Action: Test again. If the result is still

the same, try a control solution test
and if the control solution test falls
within the correct range, please call
your healthcare provider.

45

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.

Action: 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.

Action: Relocate the meter to a
location with temperature
between 10°C - 40°C (50°F ­104°F).

Err message. Not enough
sample was drawn into the
test strip for measurement.

Action: Discard the test strip
and repeat the test..

46

Chapter 6: Technical Information

Specifications

Brand name

Suresign Resure Blood Glucose Meter

Range

20~630 mg/dL (1.1~35.0 mmol/L)

Response time

5 seconds

Memory sets

480 test results

Operating condition

Temp.

10°C-40°C (50°F -104°F)

Relative Humidity

R.H. ≦ 90%

Storage and
transportation condition

Temp.

2°C -30°C (36°F -86°F)

Relative Humidity

40-85 % RH

Blood sample

0.6 μL

Fresh blood from fingertips, palm, or forearm

Hematocrit (Hct)

20~60%

Power

2 Alkaline 1.5V (AAA)

Battery life

Over 2000 tests

Display dimension

1.4 x 1.7 inches (35.0 x 43.0 mm)

Device dimension H × W × D

98 x 57 x 22 mm (3.9 x 2.2 x 0.9 inches)

Weight

43.2 grams (1.52 oz.) w/o batteries

Principles

Electrochemical biosensor technology

47

Limitations

The test strips are used for fresh capillary whole blood samples.

1. DO NOT use serum or plasma sample.

2. DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation.

3. DO NOT use neonate blood sample.

4. Extreme humidity may affect the results. A relative humidity greater than 90 % may cause incorrect results.

5. The system should be used at temperatures between 50°F and 104°F (10°C and 40°C). Outside this range,
the system may get incorrect results.

6. DO NOT reuse the test strips. The test strips are for single use only.

7. Hematocrit: The hematocrit between 20% and 60% will not affect the results. Hematocrit below 20% may
cause higher results. Hematocrit above 60% may cause lower results.

8. Altitude up to 3,048 meters above sea level has no effect on readings.

Healthcare Professionals – Please note these additional Limitations

1. If the patient has the following conditions, the result may fails:

 Severe dehydration
 Severe hypotension (low blood pressure)
 Shock
 A state of hyperglycemic-hyperosmolar state (with or without ketosis)

2. Lipemic samples: Cholesterol level up to 500 mg/dL (12.92 mmol/L) and triglycerides up to 3,000 mg/dL
(33.6mmol/L) do not affect the results. Grossly lipemic patient samples have not been tested and are not
recommended for testing with Suresign Resure Blood Glucose Meter.

48

3. Critically ill patients should not be tested with Suresign Resure glucose meters.

4. DO NOT use during xylose absorption testing. Xylose in the blood will interfere with the Blood Glucose
Monitoring System.

5. Interfering Substances depend on the concentration. The below substances up to the test concentration
will not affect the test results.

80 mg/dL

(4.4 mmol/L)

250 mg/dL

(13.9 mmol/L)

500 mg/dL

(27.8 mmol/L)

Ascorbic Acid, 4 mg/dL (0.26mmol/L)

10.89%

-1.76%

4.55%

Ibuprofen, 50 mg/dL (2.43mmol/L)

3.10%

2.88%

4.62%

L-Dopa, 1.8 mg/dL (0.09mmol/L)

10.59%

7.91%

4.90%

Sodium Salicylate, 50 mg/dL (3.12mmol/L)

-2.59%

9.42%

-0.84%

Tetracycline, 1.5 mg/dL (0.03mmol/L)

-5.32%

3.81%

3.20%

Tolbutamide, 100 mg/dL (3.7mmol/L)

-2.60%

12.30%

0.89%

Bilirubin-unconjugated, 2.4 mg/dL (0.04mmol/L)

-2.52%

4.05%

-0.23%

Uric acid, 8 mg/dL (0.48mmol/L)

2.71%

9.55%

-1.75%

Xylose, 4 mg/dL (0.27mmol/L)

-5.12%

-1.64%

-4.44%

Glucose
Level

Bias

Concentrations
of the interference tested

49

Device Information

Suresign Resure Blood Glucose Monitoring System,
Suresign Resure Blood Glucose Test Strips,
Suresign Resure Blood Glucose Meter,
Suresign Resure Normal Control Solution,
Suresign Resure High Control Solution,
Suresign Resure Low Control Solution

Obelis s.a.

Boulevard Général Wahis 53, B-1030 Brussels, Belgium
TEL：[phone] FAX：[phone]

E-mail: [email protected]

Manufacturer:

EPS BIO TECHNOLOGY CORP.

No.8, R&D RD. III, Hsinchu Science Park, Hsinchu, Taiwan 30077
TEL：[phone] FAX：[phone]

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

Distributor:
CICA Healthcare Ltd.

Kilcran House, Kildowney Road, Ballymena, UK BT44 9EY
E-mail: [email protected] Website: www.suresign.com

50

Warranty

EPS warrants the original purchaser for a period of 3 years from the date of purchase. This means during the
warranty period if the 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.

Lancing Device & Lancet

Meets the requirements of MDD 93/42/EEC

Manufacturer:

STERILANCE MEDICAL (SUZHOU) INC.

68# LiTangHe RD, XiangCheng, Suzhou, China 215131
Tel: [phone] Fax: [phone]

IFU RSBGM107-UM-RESURE

REV 07-13