EME Self-Monitoring Blood Glucose System User`s manual

EME
Self-Monitoring Blood Glucose System
User’s Manual
Please read this User’s Manual thoroughly
Before using your blood glucose meter
Dear EME SMBG System Owner,
Thank you for using the EME Self-Monitoring Blood Glucose (SMBG) System. We designed this system to be
dependable, easy-to-use, compact, lightweight and portable to help you monitor your blood glucose on a
regular basis.
Please read this manual thoroughly before you begin testing. This manual provides you and your diabetes
care team with important information and step-by-step direction to use the EME Self-Monitoring Blood
Glucose System.
Thanks again for choosing the EME SMBG.
Intended Use
The EME Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of
glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done
outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single
patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The
system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative
site testing can be only used during steady-state blood glucose conditions.
2
Important Safety Instructions
Lancets and meters are for single use only. A new, sterile lancet should be used each time you perform a
test. The lancing device, lancets and meter are NOT to be shared between users or other family members.
Do NOT use on multiple individuals. Sharing a lancing device and lancets may transmit blood borne
pathogens, such as viral hepatitis.
All parts of the kit are considered biohazardous and may transmit infection, even if you have performed
cleaning and disinfection. Wash hands thoroughly with soap and water before and after handling the meter
or lancing device.
For further information, please see: "FDA Public Health Notification: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication" (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.
"CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Blood borne Pathogens" (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
3
Standard Accessories
The EME Blood Glucose meter and accessories are working together to measure the amount of glucose in
your blood. The system includes:
• User’s Manual
• Quick Reference Guide
• Log Book
• Level 2 Control Solution
• Control Solution Instructions
• Test Strip Instructions
• Blood Glucose Meter
• 10 Test Strips
• Carrying Case
• 2 Alkaline Batteries
• 10 Lancets
• Lancing Device
• AST Lancing Device Cap
Optional Accessories
• Level 3 Control Solution
Note:
1. EME Level 2 Control Solution is included with the system.
2. EME Level 3 Control Solution is available. For purchase, please call the Customer Care Service
toll-free at 866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM).
4
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 SMBG 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 call the Customer Care Service toll-free at 866-994-3345
(Eastern Time, Mon-Fri 9:00AM~5:00PM). During non-service hours, please contact your healthcare provider.
Please complete your warranty card and mail it, so you receive the best customer service possible and news
about product update.
Note:
Although the EME 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.
5
Important Information about Your New Meter
„ EME blood glucose meter is designed and approved for testing fresh capillary whole blood samples from
your fingertip palm, and forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the
body). It should not be used to diagnose or screen for diabetes.
„ EME blood glucose meter can only be used with EME 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.
6
Note:
„ Consult with your healthcare professional before testing on your palm and 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.
„ Up to the altitude of 10,000 feet has effect on readings.
7
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 don’t seem to match
your test results, contact your Healthcare Professional or physician immediately. If you have questions
regarding the use of the meter, please call the Customer Care Service toll-free at 866-994-3345 (Eastern
Time, Mon-Fri 9:00AM~5:00PM). During non-service hours, please contact your healthcare provider.
„
Please read your test strip instructions carefully for additional health-related information.
8
Table of Contents
Chapter 1: Understanding Your Meter ….......................................................................................................11
The EME Blood Glucose Meter …..............................................................................................................11
The EME Accessories …..........................................................................................................................13
Installing Batteries …..................................................................................................................................14
Setting The Time and Date - First Time Use .............................................................................................15
Using EME Blood Glucose Test Strips ......................................................................................................16
Chapter 2: Control Solution Testing..............................................................................................................17
Why Run a Control Solution Test ...............................................................................................................17
About The Control Solutions ......................................................................................................................18
Running a Control Solution Test ................................................................................................................19
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 Fingertip .................................................................27
Alternate Site Testing (AST)……...……………………………………………………………………………….30
Running a Blood Glucose Test with Blood from Your Palm or Forearm …….............................................32
Discarding Used Lancets …......................................................................................................................33
Expected Values………………….…...........................................................................................................34
Unusual Test Results…..............................................................................................................................34
9
Symptoms of High or Low Blood Glucose …..............................................................................................35
Comparing Your Meter Result to Lab Results …........................................................................................36
Chapter 4: Meter Memory, Setup …...............................................................................................................37
Memory, Storing Test Results …................................................................................................................37
Viewing Test Results …..............................................................................................................................38
Chapter 5: Maintenance and Troubleshooting ….........................................................................................39
Installing Batteries ….................................................................................................................................39
Cleaning and Disinfecting Your Meter and Lancing Device...……..............................................................40
Cleaning and Disinfection Frequency.........................................................................................................44
Maintenance and Testing ..........................................................................................................................45
Screen Messages and Troubleshooting ….................................................................................................46
Chapter 6: Technical Information …..............................................................................................................49
Specifications ….........................................................................................................................................49
Limitations…...............................................................................................................................................50
Device Information …................................................................................................................................52
Warranty ....................................................................................................................................................54
10
Chapter 1: Understanding Your Meter
The EME Blood Glucose Meter
Test Strip SlotInsert test strip
here.
Strip EnjectorPush the Strip
Ejector to
remove the strip.
DisplayShows results,
messages, and
results stored in
memory.
Left (ƒ)
ButtonsPress to enter
memory, adjust
setting, and
scroll through
results.
Right („) Buttons- Press to
turn the meter on, confirm
setting, and scroll through
results.
Battery DoorFlip open the battery door by
pushing the tab in the direction of
the arrow and pulling the door up.
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Folder Symbol
Date
Meaning
Show the moment of month and day.
Time
Show the moment of time.
Test result
Show the test result.
AM
Tracking all the test results or average of
/14/30/90 days.
Control Solution test and the result is not
included in the memory.
Indicate before noon
PM
Indicate after noon
Record/Average display
Control Solution
AC = ante cibos
When the battery symbol appears, prepare
new batteries for installation.
Indicate before meal
PC = post cibos
Indicate after meal
Insert strip
Insert the test strip to test blood glucose.
Batteries status
Thermometer
Error
When the thermometer icon appears, the
temperature is too high or too low.
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.
12
The EME Accessories
Test Strip Bottle
Test Strip
Sliding barrel Pull on until it clicks
and then release to
enable lancing
device.
Electrode
Strip Insert
Direction
SleeveHand Hold
Area
Trigger buttonPress the trigger
button to activate
the lancing device
Hand Hold
Area
HubUnscrew or
Recap the Cap.
CarrierAST
Lancing
Device Cap-
Confirmation
Window
Edge to Apply
Sample
Lancing Devicing
Expiration
Date
13
Use this
transparency
cap for AST
testing
Insert the lancet
into the carrier
Adjustable tipSelect the
desired
penetration depth
Installing 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.
2. Insert two batteries and the
meter beeps.
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3. Put the battery door back in
place and snap it closed.
The meter turns on
automatically.
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.
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
ƒ (left button) to adjust the year
and press „ (right button) to
confirm the setting.
15
3. Repeat step 2 to set the date and
time. The flashing field is the one
you are currently setting. (A=AM,
P=PM)
Using EME Blood Glucose Test Strips
„ Use only with EME Blood Glucose Meters.
„ Run a control solution test every time you open a new box of test strips (See Chapter 2 "Control Solution
Testing.")
„ Keep the test strips in their original bottle.
„ 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 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 wet hands. Do not bend, cut, or twist the test strips.
„ EME Self-Monitoring Blood Glucose Test System is a “no code”system and does not require any test
strip calibration.
16
Chapter 2: Control Solution Testing
Why Run a Control Solution Test
We recommend that you run the EME level 2 and level 3 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 EME 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.
17
About The Control Solutions
„ Use with EME 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 the solution, 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 35.6°F - 86°F (2°C~30°C). Do not freeze.
„ If you would like to purchase EME level 2 and level 3 Control Solutions, please contact your local dealer.
18
Running a Control Solution Test
You need the meter, a test strip, and control solution.
1. Put a test trip into the
meter as the direction
of the arrow on the test
strip. The meter turns
on automatically.
2. Press ƒ (left button) to set
(AC),
(PC)
or CS Mode, then press „ (right button) to
confirm the setting.
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3. The icons
and
show themselves.
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.
7. Touch the drop at the tip of the
test strip.
8. The meter starts to count down
from 5 seconds and then
shows the test result.
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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.
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Understanding Control Solution Test Results
The label on your test strip bottle shows the acceptable ranges for the Control Solutions. The result you get
should be inside this range. Make sure you compare the result to the correct level of control.
When the control solution result is inside the range on the test strip bottle, your test strips and your meter are
working properly.
If your control solution result is not inside the acceptable range (printed on your test strip bottle), here are
some things you can do to solve the problem:
Note:
” is not set, then the control test values will be counted into 7/14/30/60/90 days
1. If “
average mode.
” is set, the control solution values will not be counted into averages, but only in
2. If “
the memory for review.
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Troubleshooting Checks
Action
9 Was the test strip exposed to open air for a long
period of time?
Repeat the control test with properly stored strips.
9 Does the cap on the bottle keep tightly prevent
moisture or humidity from affecting 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.
9 Is the control solution expired or contaminated?
Replace with new control solution to check the
performance of SMBG system.
9 Were test strips and control solutions stored in
cool, dry places?
Repeat the control test with properly stored strips
or control solutions.
9 Did you follow the testing steps properly?
If you have followed the steps properly, contact
physician. If you continue to have problems please
contact Customer Support at 1-866-994-3345.
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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.
„ If the meter and lancing device are being operated by a second person who is providing testing
assistance to the user, the meter and lancing device should be disinfected prior to use by the second
person. For the disinfection instruction, please refer to Chapter 5: Maintenance And Troubleshooting
“Cleaning and disinfect your meter”.
Note:
Used test strips and lancets are considered bio-hazardous waste in accordance with local
regulations and should be handled as if capable of transmitting infection. Users may discuss
methods for disposing used test strips and lancets with their doctor.
24
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.
Note:
Lancets are for single use only and a new, sterile lancet should be used each time you perform a
test.
25
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.
Note: 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.
26
Running a Blood Glucose Test with Blood from Your Fingertip
1. Wash your hands with soap
and warm water.
Rinse and dry thoroughly.
2. Put a test strip into the meter in
the direction of the arrow. The
meter turns on automatically.
27
3. Press ƒ (left button) to set
(AC) or
(PC)
Mode, then press „ (right
button) to confirm the setting.
4. The icons
and
show themselves.
When the blood drop flashes
on the display, obtain a drop
of blood from your finger.
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.
Note: please make sure to apply blood when the blood drop appears on the display.
28
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.
29
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.
Alternative Site Testing (AST)
Understanding Alternative Site Testing
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.
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 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.
„
If you are pregnant.
30
Fingertip test only:
„
„
„
„
„
If sick
If blood glucose is low
After exercising
Two hours or less after eating
After injecting rapid-acting insulin (two hours or less)
What NOT to do:
„ 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 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.
Measurements from alternative site testing should never be used to calibrate a continuous glucose
monitor (CGM) or entered into insulin dose calculators for insulin dosing recommendations.
31
Running a Blood Glucose Test with Blood from Your Palm or Forearm
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.
„ Note: 1. Check with your healthcare professional before
testing sites other that the fingertip.
2. Please do NOT use the first drop of blood sample.
32
3. Press the trigger button to activate
the lancing device. Hold the device
against forearm and increase
pressure until the blood sample
size is sufficient.
4. Wipe away the first drop with a
tissue and use the second drop.
Discarding Used Lancets
1. Unscrew and remove the
adjustable cap.
2. Pull on the sliding barrel of
the lancing device and slide
the ejection control at the
same time. The used lancet
will be pushed out.
33
3. Discard used disposable
lancets into an appropriate
sharps or biohazard container.
Expected Values*
The EME Blood Glucose test strips are whole-blood referenced and calibrated for easier comparison to lab
results. The American Diabetes Association recommends the following values to normal people without
diabetes*:
A post-meal glucose level of less than 180 mg/dL
A pre-meal glucose of 70–130 mg/dL
For people with diabetes: please consult with your doctor for the appropriate blood glucose range.
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.
Note:
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.
34
Comparing Your Meter Result to a Lab Result
A common question is how the blood glucose results on your meter compare to the lab results. Your blood
glucose can change quickly, especially after eating, taking medication, or exercising. If you test yourself in the
morning, then go to the doctor’s office for a blood glucose test. The results will probably not match, even if you
are fasting. This is typically not a problem with your meter, it just means that time has elapsed and your blood
glucose has changed.
If you want to compare your meter result to the lab result, you must be fasting. Bring your meter to the
doctor’s office, and test yourself by fingertip within five minutes of having blood drawn from your arm by a
healthcare professional. Keep in mind that the lab could use different technology than your EME 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.
35
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 newest is added, so it is very important
to have the correct time and date set in the meter.
Note:
1. Do not change your therapy based on one individual result in memory.
2. The memory is not lost when you replace the battery. You do need to check that the time and
date are still correct 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.
36
Viewing Test Results
The meter provides 7, 14, 30 and 90 days averaging to help track your blood glucose result soundlessly.
4. Press „to view averages of
30day-AC/PC and 7/14/30/90 days.
1. Press „ until turning the meter on.
2. Press ƒ to view the latest test result.
3. All results are shown in turn from
records of M480 to M001.
37
Chapter 5: Maintenance and Troubleshooting
Installing 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.
Install 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 installed.
Please press and hold “„” button or insert the test strip to turn your
meter on.
The meter will turn off automatically. Or you can press and hold “„”
button to turn your meter off.
Low battery symbol
Note:
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.
38
Cleaning and Disinfecting Your Meter and Lancing Device
Choosing the disinfectant
The recommended EPA-registered disinfected product is as follow:
PDI® Super SANI-CLOTH® Germicidal disposable wipe (EPA Reg. No.:9480-4)
Super Sani-Cloth germicidal wipe contains active ingredients: n-Alkyl (60% C14, 30%C16, 5%C12, 5%C18)
dimethyl benzyl ammonium chlorides and n-Alkyl (68%C12, 32%C14) dimethyl ethylbenzyl ammonium
chlorides and they have been shown to be safe for use with the EME meter, but any other disinfectant product
with the EPA registration number may be used on this device.
Please find the Super Sani-Cloth germicidal wipe in any pharmaceutical store or purchase on the PDI website:
http://www.pdipdi.com/healthcare/surface_disinfect.aspx
Cleaning and Disinfection Instruction
Please keep the meter and lancing device free of dirt, dust, bloodstain, and water stains. EME blood glucose
meter and lancing device should be used only on one patient and not shared. Follow these guidelines carefully
to clean your meter
After every use (for up to 9 times a day), follow the cleaning instruction to prevent the growth of any
microorganism and also to help improving the effectiveness of disinfection. Then follow disinfection
instruction once per week which could effectively kill blood borne pathogens, such as viral hepatitis and
prevent cross-contamination. Therefore, if the meter and lancing device are being operated by a second
person who is providing testing assistance to the user, the meter and lancing device should be disinfected
prior to use by the second person.
39
Cleaning Instruction: All blood and other body fluids must be thoroughly cleaned from surfaces and
objects before disinfection by the germicidal wipe. Open, unfold and use first germicidal wipe to remove heavy
soil after every use.
Disinfection Instruction: Unfold a clean wipe and thoroughly wet all the surface of the meter, including the
strip port and other connection port. Unfold a clean wipe and thoroughly wet all the surface of the lancing
device, including cap or AST cap if used. Treated area must remain visibly wet for a full 2 minutes. Let the
devices air dry for 0.5 minute. Do disinfection once per week.
Do:
„ Make sure the meter is turned off during cleaning and
disinfection.
„ Keep the test strip vials tightly closed when performing the
cleaning and disinfection procedures because the fumes
from the disinfectant may affect the performance of the strip
„ After cleaning or disinfection, please perform the physical
appearance and performance check of devices. Please
follow the instruction on the page 41 to 43.
40
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.
Physical Appearance check of the meter after each cleaning or disinfection
Check item
Accept Result
Is it clear to see through the transparency part, like display?
Yes
Is the strip slot and other components free from erosion?
Yes
Is the labeling on the meter legible?
Yes
Action: If any of the results is “No” the user should call the Customer Care Service toll-free at
866-994-3345(Eastern Time, Mon-Fri 9:00AM~5:00PM) for assistance.
Performance check of the meter
Steps
Check item
Accept
Result
After each cleaning
1. Press and hold left
button for 3 sec.
2. Press and release right
button.
Is the meter powered on?
Did the meter beep?
Is the testing result correctly stored in the memory?
Can the result be clearly read?
41
Yes
Yes
Yes
Yes
After each disinfection
1. Insert test strip
2. Apply Level 2 control
solution
Is the meter powered on?
Yes
Any reading?
Yes
Is the reading within control range?
Yes
3. Remove test strip
Is the meter powered off?
Yes
4. Press and hold left
Is the meter powered on?
Yes
button for 3 sec.
Did the meter beep?
Yes
5. Press and release right
Is the testing result correctly stored in the memory?
Yes
button.
Can the result be clearly read?
Yes
Action: If any of the results is “No”, stop using the device. Please call the Customer Care Service toll-free
at 866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM) for replacement with a new meter.
Physical Appearance check of the lancing device after each cleaning or disinfection
Check item
Accept Result
Are all components free from erosion?
Yes
Action: If any of the results is “No” the user should call the Customer Care Service toll-free at
866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM) for assistance.
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Performance check of the Lancing device
Step
Check item
Accept
Result
After each cleaning
1.Cap the normal cap to the lancing device.
2. Pull on the sliding barrel and then
release.
3. Press trigger button.
Can the cap be screwed on the lancing device?
Can the lancing device click?
Yes
Yes
Can the lancet be fired?
Yes
After each disinfection
1. Install the lancet on the lancet holder.
2. Cap the AST cap to the lancing device.
3. Remove the AST cap. Recap the normal
cap to the lancing device.
Can the lancet be fixed on the lancet holder?
Can the AST cap be screwed on the lancing
device?
Can the cap be screwed on the lancing device?
Can the penetration depth ring be adjusted?
Can the lancing device click?
Yes
Yes
Yes
Yes
Yes
4. Pull on the sliding barrel and then
release.
5. Press trigger button.
Can the lancet be fired?
Yes
Action: If any of the results is “No”, please call the Customer Care Service toll-free at
866-994-3345(Eastern Time, Mon-Fri 9:00AM~5:00PM) for replacement with a new device.
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Cleaning and Disinfection Frequency
At least 9 cycles of cleaning per day and 1 cycle of disinfection per week with allow the user to use the device
for 4 years. The meter can sustain at least 20,000 cycles of cleaning and disinfection and the lancing device
can sustain at least 14,600 cycles of cleaning and disinfection.
Cleaning Frequency: 9 cycles/day X 365 days/year X 4 year product life = 13,140 cycles of cleaning
Disinfection Frequency: 1 cycle/week X 52 weeks/year X 4 year product life = 208 cycles of disinfections
< 20,000 validated cycles of cleaning and disinfection for the meter
<14,600 validated cycles of cleaning and disinfection for the lancing device
4 year product life is for properly cleaning and disinfection. After 4 years, the meter must be replaced
with a new meter.
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Maintenance and Testing
Your meter needs little or no maintenance with normal use. It
automatically tests its own systems every time you turn it on and lets you
know if something is wrong. (See "Screen Messages" and what to do
about them.)
To make sure the display is working properly, turn off the meter. Press and
hold “„” to see the complete display. All the indicators should be clear and
look exactly like the picture to the left. If not, please call the Customer Care
Service toll-free at 866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM).
During non-service hours, please contact your local dealer.
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Screen Messages and Troubleshooting
Never make treatment decisions based on an error message. If you have any concerns, please call the
Customer Care Service toll-free at 866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM).
Humidified/Used strips
Action: Replace with a
new strip.
Low power
Action: Replace with new
batteries.
46
System fault
Action: Replace the batteries first. If
ERROR 001 appears again, please
call the Customer Care Service
toll-free at 866-994-3345 (Eastern
Time, Mon-Fri 9:00AM~5:00PM).
During non-service hours, please
contact your local dealer.
System fault
Action: Replace the
batteries first. If Err
appears again, please call
the Customer Care
Service toll-free at
866-994-3345 (Eastern
Time, Mon-Fri
9:00AM~5:00PM). During
non-service hours, please
contact your local dealer.
Test result is higher than 600
mg/dL.
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 health care provider.
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The test result is lower than 20
mg/dL.
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 health care provider.
Err message. Not enough
sample was drawn into the
test strip for measurement.
Action: Discard the test strip
and repeat the test..
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).
48
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).
Chapter 6: Technical Information
Specifications
Brand name
Range
Response time
Memory sets
Operating condition
Storage and
transportation condition
Temp.
Relative Humidity
Temp.
Relative Humidity
Blood sample
Hematocrit (Hct)
Power
Battery life
Display dimension
Device dimension H × W × D (mm)
Weight
Principles
EME Blood Glucose Meter
20~600 mg/dL
5 seconds
480 test results
50°F -104°F (10°C-40°C)
R.H. ≦ 90%
35.6°F -86°F (2°C -30°C)
40-85 % RH
0.6 μL
Fresh capillary blood from fingertip, palm, or forearm
20~60%
2 Alkaline 1.5V (AAA)
Over 2000 tests
35.0 × 43.0 mm
98 x 57 x 22 mm
43.2 grams w/o battery
Electrochemical biosensor technology
49
Limitations
The test strips are used for fresh capillary whole blood samples.
1. DO NOT use neonate blood sample.
2. Not to be used for diagnosis or screening of diabetes.
3. Alternative site testing with this system can be used only during steady-state blood glucose conditions.
4. Measurements from alternative site testing should never be used to calibrate a continuous glucose monitor
(CGM) or entered into insulin dose calculators for insulin dosing recommendations.
5. Extreme humidity may affect the results. A relative humidity greater than 90﹪may cause incorrect results.
6. The system should be used at a temperatures between 50°F and 104°F(10°C and 40°C). Outside this
range, the system may get incorrect results.
7. DO NOT reuse the test strips. The test strips are for single use only.
8. Hematocrit: The hematocrits between 20% and 60% will not significantly affect the results. Hematocrit
below 20% may cause higher results. Hematocrit above 60% may cause lower results. If you do not know
your hematocrit level, please consult with your healthcare professional.
9. Altitude up to10,000 feet above sea level has no effect on readings.
10. The below substances up to the test concentration will not affect the test results.
Interfering substance
Concentration tested up to (mg/dL)
Gentisic Acid
6
Ascorbic Acid
4
Ibuprophen
50
Methyldopa
2
Sodium Salicylate
50
Tetracycline
1.5
Tolbutamide
100
50
Galactose
Maltose
Manose
Sucrose
Xylitol
Glipizide
Bilirubin
Cholesterol
Creatinine
Triglycerides
Fructose
20
20
10
50
200
8
25
500
30
1000
30
11. Interference was observed with the substances below at the concentrations listed.
Interfering substance
Interference observed at (mg/dL)
Acetaminophen
8
Dopamine
5.2
L-Dopa
4
Xylose
8
Uric Acid
15.9
51
Device Information
EME SMBG System,
EME Blood Glucose Test Strips,
EME Blood Glucose Meter,
EME Level 2 Control Solution,
EME Level 3 Control Solution
Reference:
* American Diabetes Association. Standards of medical care in diabetes-Table 10 Diabetes care. 2011; Vol.
34, Suppl. 1, S21.
Manufacturer:
EPS BIO TECHNOLOGY CORP.
No.8, R&D RD. III, Hsinchu Science Park, Hsinchu, Taiwan 30077
TEL:+886-3-6686868
FAX:+886-3-6686866
E-mail:info@epsbio.com.tw
Website:http://www.epsbio.com.tw
52
Lancing Device
Meets the requirements of MDD 93/42/EEC
Manufacturer:
STERILANCE MEDICAL (SUZHOU) INC.
No. 32 Xinlian RD. Pingjiang Suzhou P.R. China 215031
TEL:0086 (512) 67217661
FAX:0086 (512) 67217663
E-mail:guopings@xinda-medical.com
Lancet
Meets the requirements of MDD 93/42/EEC
Manufacturer:
SAE HAN MEDICAL CORP.
# 700-113 PUB GOT-DONG, IL SAN-GU, GOYANG-CITY, KYUNGGI-DO, KOREA
TEL:82-31-923-4330
FAX:82-31-923-4331
E-mail:saehan@saehanmed.com
53
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.
Please read EME User’s Manual before operation. If you have any questions and/or need assistance, please
contact us as follows:
Within the USA, call toll-free: 866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM). During non-service
hours, please contact your healthcare provider.
Outside the USA, call your authorized representative or write to:
Customer Service E-mail: info@epsbio.com.tw
Distributor:
GEMCO MEDICAL
5640 Hudson Industrial Parkway P.O. Box 429, Hudson, OH 44236
Customer Line: 800-733-7976 Fax:330-342-9444
Website:http:// www.gemcomedical.com
P/N: 71800270A Rev.X01
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