Long Term Care (LTC) Self-Monitoring Blood Glucose System
User’s Manual
Please read this User’s Manual thoroughly
before using this blood glucose meter.
Introduction
Welcome to the EasyMax LTC Self-Monitoring Blood Glucose (SMBG) System. This system is dependable and
easy-to-use, utilizing a compact, lightweight and portable meter that will aide you in monitoring your patients’
blood glucose levels.
Please read this manual thoroughly before you begin testing. It provides you and your diabetes care team
important information and step-by-step directions for use of the EasyMax LTC Self-Monitoring Blood Glucose
System.
Intended Use
The EasyMax LTC 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). The EasyMax LTC Blood Glucose System can be
used by a single patient or for multiple-patient use in professional healthcare settings, as an aid to monitor the
effectiveness of diabetes control. When used in Long Term Care Settings, this system must be used with safety
lancets. The system is not to be used on neonates, nor for the diagnosis of, or screening for, diabetes mellitus.
Important Safety Instructions
In Long Term Care settings, use only single-use safety lancets, and a new safety lancet should be used for
each test.
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 after handling the meter. Follow
Standard Precautions when using the meter and obtaining a sample. A new pair of gloves should be worn by
the user before testing each patient.
The meter should be disinfected after each use. The EasyMax LTC Self Monitoring Blood Glucose Test
System may be used for testing multiple patients when Standard Precautions and the disinfection procedures
included in this manual are followed.
EasyMax LTC Blood Glucose Meter Accessories:
• EasyMax 15 Blood Glucose Test Strips
• EasyMax 15 Level 1 (Low) Control Solution
• EasyMax 15 Level 2 (Normal) Control Solution
• User’s Manual
• 2 AAA batteries
For further information, please see:
"Biosafety in Microbiological and Biomedical Laboatories (BMBL)"
http://www.cdc.gov/biosafety/publications/bmbl5/
"Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline--Third Edition
" Clinical and Laboratory Standards Institute (CLSI) M29-A3.
“Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007”,
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
“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.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
Why is it so important to test blood glucose regularly?
Testing blood glucose regularly can make a big difference in how you or your patient manages their day to day
diabetic care. We’ve made EasyMax LTC Self-Monitoring Blood Glucose System as simple as possible to help
you use it regularly.
Do you need help?
If you have questions or need assistance, please call the Customer Care Service toll-free at 866-994-3345
(Eastern Standard Time, Mon-Fri 8:00AM-6:00PM).
Important Information about your new EasyMax LTC Meter
The EasyMax LTC Blood Glucose Meter is designed and approved for testing fresh capillary whole blood
samples from the fingertip, palm and forearm. The meter is for in vitro use ONLY (for testing outside the
body). It should not be used to diagnose diabetes.
Remove batteries if the meter will not be used for one month or more.
The EasyMax LTC Blood Glucose Meter can only be used with EasyMax 15 Blood Glucose Test Strips.
Other test strips will give inaccurate results. EasyMax 15 Blood Glucose Test Strips feature a unique and
accurate glucose dehydrogenase chemistry system.
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, a bathroom or a refrigerator.
Keep the meter, test strips and safety lancets away from children and pets.
You should not test critically ill patients with home-use blood glucose meters.
Critically ill patients should not be tested with blood glucose meters. See page 9 for more information.
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.
Note:
Do not touch the strips with wet hands.
Do not use expired strips (the expiration date is shown on the vial.)
Do not bend, cut or twist the strips.
Altitude up to 10,000 feet above sea level has no effect on readings.
Health-Related Information
If the patient is experiencing dehydration, frequent urination, low blood pressure, shock or hyperosmolar
hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than the actual blood
glucose level. We recommend confirming the result on such patients via a clinical laboratory.
If you have followed the steps in the user’s manual, but your patient still has symptoms that don’t seem to
match their test results, or if you have questions, please call the Customer Care Service toll-free at
866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM-6:00PM).
Healthcare personnel should wash hands and change gloves between patients, even if patient-dedicated
testing devices and single-use lancing devices are used.
Note: Warning for potential biohazard:
Healthcare professionals using this system on multiple patients should handle all products or
objects in contact with human blood carefully to avoid transmitting viral disease, even after
cleaning.
Explanation of Meter Symbols
Date
(on the left side)
Medical Record No.
(patient number)
Time
(on the right side)
Apply Control Solution
Apply blood
Unit
Result / Message
Battery
Insert a strip
Temperature
Table of Contents
Chapter 1: Understanding Your Meter …........................................................................................................12
EasyMax LTC Blood Glucose Meter …......................................................................................................12
The EasyMax LTC
Accessories..................................................................................................................13
Inserting Batteries........................................................................................................................................14
Setting the Time, Date and Medical record..................................................................................................15
Using EasyMax 15 Blood Glucose Test Strips …...…………………...........................................................17
Chapter 2: Control Solution Test ....................................................................................................................18
When to Run a Control Solution Test ..........................................................................................................18
About Control Solution ................................................................................................................................19
Running a Control Solution Test .................................................................................................................20
Understanding Control Solution Test Results ….........................................................................................22
Chapter 3: Testing Blood Glucose ........................................................................................................24
Instructions for Using Safety Lancets…………………………………………………......................................24
Running a Blood Glucose Test with Blood from Fingertip ..................................................................26
Understanding Test Results …...........................................................................................................29
Unusual Test Results …..............................................................................................................................29
Chapter 4: Meter Memory, Setup …................................................................................................................30
Memory, Storing Test Result …...................................................................................................................30
Viewing and Deleting Test Results…...........................................................................................................31
Using With Your Computer…......................................................................................................................32
Chapter 5: Maintenance and Troubleshooting …..........................................................................................33
Battery Information......................................................................................................................................33
Cleaning and Disinfecting the EasyMax LTC Meter in LTC Settings...........................................................34
Cleaning And Disinfection Frequency..........................................................................................................38
Maintenance and Testing ...........................................................................................................................39
Screen Messages and Troubleshooting …..................................................................................................40
Chapter 6: Technical Information …...............................................................................................................44
Specifications …..........................................................................................................................................44
Limitations.................................................................................................................................................45
Device Information …..................................................................................................................................48
Warranty......................................................................................................................................................48
12
Chapter 1: Understanding Your Meter
EasyMax LTC Blood Glucose Meter
Display-
Shows results,
patient numbers,
and messages.
Left () Button-
Press to enter memory,
adjust setting, and
scroll through results.
Test Strip Slot-
Insert a test strip here.
Battery Door-
Flip open the battery
door by pushing the
tab in the direction of
the arrow and pulling
the door up.
Right () Button-
Press to enter
memories, adjust setting,
and scroll through
results.
Power Button-
Press to turn on/off
the meter, and to
confirm the setting.
Strip Ejector-
Push the strip ejector
up to remove the
strip.
13
The EasyMax LTC Accessories
EasyMax 15 Blood Glucose Test Strip
Test Strip Bottle &
Control Solution Bottle
Expiration Date
Strip Insert
Direction
Reaction area
Hand Hold
Area
Blood collection
area
Electrode
14
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.
2. Insert two AAA batteries. The meter will beep to confirm the batteries are inserted correctly.
3. Put the battery door back in place and snap it closed.
15
Setting the Time, Date and Medical record — First Time Use
Setting the current time and date on your meter is important if you use the meter memory.
2. Press (Right button) for 2
seconds to get into the setting
mode.
3. The screen display flashes the
last 2-digits of the year. Press
(Left button) or (Right button)
to adjust the year and press
Power Button to confirm the
setting.
1. Press (Power Button)
and hold the button until
the meter turns on.
16
4. Repeat step 3 to set the date and time.
The flashing field is the one you are
currently setting.
5. Press (Left button) or (Right button) to turn on/off the
function of medical record number and press (Power
Button) to confirm the setting.
Note:
1. When the function of
is on, it allows you to keep testing records of multiple users separate
by marking them from 001-999.
2. The meter defaults to the medical record function being “
”. Press (Right button) to reset
this function.
17
Using EasyMax 15 Blood Glucose Test Strips
Use only with EasyMax LTC or EasyMax NG Blood Glucose Meters.
EasyMax LTC Self-Monitoring Blood Glucose System is a no code system and does not require test strip
calibration.
EasyMax LTC Self-Monitoring Blood Glucose System utilizes glucose dehydrogenase chemistry to avoid
incorrect readings on patients receiving Oxygen therapy.
Run a control solution test every time you open a new box of strips (See Chapter 2 “Control Solution
Testing.”)
After you take a test strip out of the vial, tightly close the vial immediately to keep the test strips dry.
Use the test strip within three minutes after taking it out of the vial.
The strip is for single use only. Do not reuse it.
When you open a new test strip vial, check the expiration date. The test strips are good for six months
from the initial date the vial is opened or until the expiration date, whichever comes first. Record the date
you first open the test strip vial in the designated spot on the vial.
Store the test strip vial and your meter in a cool, dry place, between 36°F - 86°F (2°C- 30°C). Do not
freeze.
Insert the test strip into the meter before applying blood or control solution.
Do not touch the test strip with wet hands. Do not bend, cut, or twist the test strips.
18
Chapter 2: Control Solution Testing
When to Run a Control Solution Test
Running the EasyMax 15 Control Solution Test will let you know that your meter and test strips are working
properly. You should run control solution tests:
If you are using a new EasyMax LTC Blood Glucose Meter.
When you open a new vial of EasyMax 15 test strips.
If you think the meter or test strips may be working incorrectly.
If the meter has been dropped.
If the results are lower or higher than expected, and you have repeated the test with similar results.
When you practice the test procedure.
When your facility mandates control solution tests.
19
About Control Solution
Use only with EasyMax 15 test strips and EasyMax LTC or EasyMax NG meters.
Write the date you first open the Control Solution bottle on the label. The control solution is good for three
months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first.
Do not use a control solution that is past the expiration date.
The control solution can stain clothing. If you spill it, wash your clothes with soap and water.
Close the bottle tightly after every use.
Left over control solution should not be returned to the control solution bottle.
Store the bottle of control solution at room temperature, between 36°F - 86°F (2°C- 30°C). Do not freeze.
20
Running a Control Solution Test
You need the meter, a test strip, and control solution.
1. Put a test strip into the meter in
the direction of the arrow. If the
medical record function is on, it
does not matter which number
you select because once it is
flagged as control solution, it will
not be attached to that number.
3. Place the meter on a flat
surface, like a table.
4. Remove the control solution
bottle cap and wipe the tip
of the bottle with a tissue.
5. Squeeze the bottle until a
tiny drop forms at the tip of
the bottle and place solution
on top of bottle cap.
2. Press (Left button) to select
the mode of Control Solution,
and the icon of flashes.
Note: If the Patient Medical Record is on, it does not matter which record number you select if you
flag the result as a control solution test. The result will be displayed in the meter’s memory as
a control solution test.
21
6. Touch the drop to the blood
collection area at the tip of the
test strip. Do not put control
solution on the top of test
strip. The meter starts to count
down from 5 seconds and will
show the results.
7. Do not remove the test strip until you
confirm that the reading falls within
the range printed on the test strip vial.
Be sure to match the correct control
solution range to your test result.
8. Push the Strip Ejector to
eject the test strip into a
proper trash receptacle.
22
Understanding Control Solution Results
The label on your test strip vial shows the acceptable ranges for the different control solution levels. 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 result is inside the range on the test strip vial, your test strips and your meter are working
properly.
If your control solution result is not within the acceptable range printed on your test strip vial, look at the
troubleshooting checks on next page.
23
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 Was the test strip vial capped tightly?
If it wasn’t, the strips could be humidified. Replace
the test strips.
9 Is the meter functioning well?
You can use control solution to verify the meter’s
functions. (Chapter 2)
9 Is the control solution expired or contaminated?
Replace with new EasyMax 15 control solution to
check the performance of your EasyMax LTC meter.
9 Were test strips and control solutions stored in
cool, dry places?
Repeat the control test with properly stored strips
and/or control solutions.
9 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
inaccurate results. Please contact the EasyMax
Customer Care Service line at 866-994-3345 for
further troubleshooting.
24
Chapter 3: Testing Blood Glucose
Instructions for Using Single-Use Pressure Activated Safety Lancets
Clean test site prior to use.
1. Your patient should wash their hands with
soap and warm water. Rinse and dry
thoroughly.
Note: Used test strips and lancets are considered bio-hazardous waste in accordance with U.S. &
local regulations and should be handled as if capable of transmitting infection. Follow your
healthcare facility’s policies for the proper handling of bio-hazardous materials and sharps
disposal.
2. Remove the protective cap from the
safety lancet.
25
3. Place the raised platform end of
safety lancet on the test site.
4. Gently push the safety lancet
down against test site to
activate the lancet mechanism.
5. Without touching the used
lancet, stick the lancet tip into
its protective cover.
6. Please discard used disposable
lancets according to your facility’s
guidelines. Or discard the used
disposable lancet into an appropriate
sharps or biohazard container.
26
Running a Blood Glucose Test with Blood from Fingertip
1. Wash your hands with soap and
warm water. Rinse and dry
thoroughly. You can also use an
alcohol prep pad to clean the
site. When testing others, a new
pair of clean gloves should be
worn before testing each patient.
4. Please wait at least 5 seconds
until the intended area is dry
and clean before using the
safety lancet.
5. Remove the protective lancet
cap.
6. Position the lancet and press
it firmly against the puncture
site.
Note: If the function of is on, and you do not choose a medical record number before
applying blood, the test result will be recorded under
.
2. Put a test strip into the meter in
the direction of the arrow. The
meter turns on and the icon
shows automatically.
3. Press (Left button) or
(Right button) to set a Patient
number and press to
confirm the setting (only if
function is on).
27
7. Gently squeeze and/or massage
the fingertip until a round drop of
blood forms on the fingertip.
8. Touch the blood drop at 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 error code will appear.
n Apply blood to the edge
of the test strip.
o Do not apply blood on
top of the test strip.
p Be sure to get enough
blood on strip to make it
to the confirmation
window.
n
p
28
9. The meter starts to count down from 5
seconds and then displays the test
result.
10. Push the Strip Ejector to eject the test strip.
Properly dispose of both strip and lancet.
11. After discarding, wash hands thoroughly with
soap and water. Rinse and dry thoroughly.
12. Clean and disinfect the meter following the
instruction in Chapter 5.
13. Change gloves between patients.
29
Understanding Test Results
Expected Values*
The EasyMax 15 Blood Glucose test strips are plasma referenced and calibrated for easier comparison to lab
results. The American Diabetes Association recommends a post-meal glucose level of less than 140 mg/dL and
a pre-meal glucose of less than 100 mg/dL*.
*American Diabetes Association: Diagnosis and Classification of Diabetes Mellitus (Position Statement). Diabetes Care 34
(Supp. 1) S66, 2011.
Unusual Test Results
If the results are inconsistent with your patient’s symptoms, please follow these steps:
1. Run a control solution test, Chapter 2 "Control Solution Testing."
2. Repeat a blood glucose test, Chapter 3 "Testing Blood Glucose."
3. After running the quality control and retesting the patient, if there are still concerns about the performance of
the meter, inform the Nursing Supervisor and follow your facility’s procedure for cross-checking results with
the Laboratory or another glucose test method (not another meter).
4. For accuracy and precision data and for important information on limitations, see the instructions that come
with your test strips.
Note: 1. Extremely high humidity may affect the test results. A relative humidity above 90% may
cause inaccurate results.
2. Hematocrit below 20% may cause higher results. Hematocrit above 60% may cause lower
results.
30
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.
The memory function is necessary in order to transmit data to a central location (separate software &
instructions are available), and should not be used as a substitute for proper charting of patient data.
Note:
1. Do not change therapy based on one individual result in memory.
2. The memory is not lost when you replace the battery. You do need to check that the time and
date are still correct. See Section "Setting the time and date" in Chapter 1.
3. Once 480 results are in memory, adding a new result causes the oldest one to be deleted.
31
Viewing and Deleting Test Results
1. Press (Left button) or (Right
button) to view the test results of
each patient’s number.
2. The test results of control
solution will show without
Patient’s numbers and will
have the control solution icon
located in the left corner.
3. To delete a test result, press
(Left button) for more than
2 seconds and display shows
“dEL”, press to confirm
deletion.
4. Press (Left button) or
(Right button) to keep
reviewing the results.
32
Using With Your Computer
To Transfer data, the meter can be turned on or turned off. The USB mini port can be found on the bottom of
your meter below the power, left and right buttons.
1. Use the USB cable to connect
your meter and computer. The
display shows ”PC”.
2. The meter starts to transfer
data to the GlucoManager
TM
software.
3. When all data is uploaded from
the meter to the PC, the meter
shows “OK” and beeps. In the
software, select Multiple
Mana
g
ement.
33
Chapter 5: Maintenance and Troubleshooting
Battery Information
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.
Note:
1. The meter won’t delete earlier records after you replace the battery.
2. You should reset the time and date again after you replace the battery.
3. 1.5V (AAA) x 2 batteries are available at most stores. You may take the old battery with you for
replacement.
4. Remove the battery when you will not be using the meter for one month or more.
34
Cleaning and Disinfecting the EasyMax LTC Meter in LTC Settings
Choosing a disinfectant
According to Guideline for Disinfection and Sterilization in Healthcare Facilities in 2008, you should clean your
glucose meter after every use to prevent any possibility of cross infection. Wipes used should be
EPA-registered as a disinfectant. Many EPA-registered disinfectant wipes have "2-minute" claims. If your wipes
have higher or lower kill times, you should adjust your technique accordingly.
Cleaning and Disinfection Instructions
Please keep the meter free of dirt, dust, bloodstain, and water stains. After every use, follow both the cleaning
and disinfection instructions below, using the EPA-registered wipes.
Meter cleaning area
Code Name
Possibility of
contact with blood
A
Strip Slot High
B
Front Case Medium
C
Side Case High
D
Front Buttons High
E
Back Case Low
F
Battery Cover Medium
A
B
C
D
E
F
35
Step 1: Cleaning Instruction: Clean first to remove any heavy soil left on the surface of the meter. All blood
and bodily fluids must be thoroughly cleaned from surfaces and objects before disinfection with a germicidal
wipe. Open, unfold and use the first germicidal wipe to remove heavy soil.
Step 2: Disinfection Instruction: After cleaning, & before using the meter again, unfold a new wipe and
thoroughly wet all meter surfaces, including the strip port and the connection port. Treated area must remain
visibly wet for a full 2 minutes. Use additional wipe(s) if needed to ensure a continuous 2 minute wet contact
time. Let the device air dry for 30 seconds.
Note:
After disinfection, users’ gloves should be removed and hands should be thoroughly washed with
soap and water before proceeding to the next patient.
Do Not:
Get any moisture into the test strip slot.
Spray any cleaning solution directly onto
the meter.
Put the meter under water or liquid.
Pour liquid onto the meter.
Do:
Make sure the meter is turned off during cleaning and
disinfection.
Keep test strip vial(s) tightly closed when performing
cleaning and disinfection procedures; the fumes from
the disinfectant may affect the performance of the
strips.
After cleaning and disinfection, please perform a
physical appearance and performance check of
devices.
Always wear gloves when cleaning and testing.
36
Performance check of the meter
Steps Check item
Accept
Result
After each cleaning
Does the meter turn on? Yes 1. Press and hold power
button for 3 sec.
Does the meter beep? Yes
Does the meter have stored results? Yes 2. Press and release left or
right button.
Is the display clear? Can you read the result? Yes
After each disinfection
1. Insert test strip Does the meter turn on? Yes
Any reading? Yes 2. Run control solution test
Is the reading within control range? Yes
3. Eject test strip Does the meter turn off? Yes
Does the meter turn on? Yes 4. Press and hold power
button for 3 sec.
Does the meter beep? Yes
Does the meter have stored results? Yes 5. Press and release left or
right button.
Is the display clear? Can you read the result? Yes
Action: If any of the results are “No” the user should call the Customer Care Service toll-free at 866-994-3345
(Eastern Standard Time, Mon-Fri 8:00AM-6:00PM) for assistance.
37
Physical Appearance check of the meter after each cleaning or disinfection
Check item Accept Result
Is the display clear to read? Is the screen clear? Yes
Is the strip slot and other parts free of corrosion? Yes
Action: If any of the results are “No” the user should call the Customer Care Service toll-free at
866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM-6:00PM) for assistance.
Meter Life when Cleaned and Disinfected
The meter has been tested through 20,000 validated cycles (10,000 cycles of cleaning and 10,000 cycles of
disinfection). If the meter is used for 9 cycles of cleaning and 9 cycles of disinfection per day, it will last in
professional use for 3 years.
38
Cleaning And Disinfection Frequency
At least 9 cycles of cleaning per day and 1 cycle of disinfection per week will allow the user to use the device for
4 years. The meter can sustain 20,000 cycles of cleaning and disinfection and the lancing device can sustain
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.
39
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
power 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 Customer Service at
866-994-3345.
40
Screen Messages And Troubleshooting
Never make treatment decisions based on an error message. If you have any concerns, call the Customer
Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM-6:00PM).
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 and
puncture site.
Refer to pages 26-28 for information on
sample application.
Low power
The meter batteries do not have enough
power to perform a test.
Replace with new batteries.
41
Message
What it means? What to do?
System error
There may be a problem with the meter.
Replace the batteries first.
Refer to pages 14 and 33. If this error
message appears again, please contact
Customer Service.
Memory Error
Replace the batteries first. If ERROR
005 appears again, please contact
Customer Service.
No result in memory.
The test proceeds incompletely. The
meter was unable to recall this result.
You can still perform a blood glucose
test and get an accurate test result.
42
Message
What it means? What to do?
Insufficient Volume error
The volume of blood or
control solution is NOT
enough.
Repeat the test with a new strip,
puncture site, and enough
blood/control solution.
Refer to pages 26-28 for information on
sample application.
Test result is higher than
600 mg/dL.
Re-check your glucose level.
If the glucose result is HI again, follow
your facility’s procedures without delay.
The test result is lower
than 20 mg/dL.
This may require immediate treatment
according to your facility’s guidelines.
Although this message could be due to
a test error, it is safer to treat first and
then do another test.
43
Message
What it means? What to do?
The “HF” and thermometer icon
appears. Temperature is too high,
outside the required range of 50°F 104°F (10°C - 40°C). This alerts
users that an incorrect result may
occur if the test continues.
Relocate the meter to a location with
temperature between 50°F - 104°F
(10°C - 40°C).
The “LF” and thermometer icon
appears. Temperature is too low,
outside the required range of 50°F 104°F (10°C - 40°C). This alerts
users that an incorrect result may
occur if the test continues.
Relocate the meter to a location with
temperature between 50°F - 104°F
(10°C - 40°C).
44
Chapter 6: Technical Information
Specifications
Brand name EasyMax LTC Blood Glucose Meter
Range 20-600 mg/dL
Response time 5 seconds
Memory sets 480 test results
Temp. 50°F - 104°F (10°C - 40°C)
Operating condition
Relative Humidity R.H. ≦ 90%
Temp. -4F - 122°F (-20°C - 50°C)
Storage and transportation
condition
Relative Humidity R.H. ≦ 90%
0.6 μL
Blood sample
Fresh blood from fingertip
Hematocrit (Hct) 20~60%
Power Alkaline Battery (2 ct.)
Battery life Over 2000 tests
Display dimension 1.4 x 1.7 inches (35.0 x 43.0 mm)
Device dimension H × W × D 3.7 x 2.0 x 0.8 inches (94 x 50 x 19.5 mm)
Weight
1.68 oz. without batteries (47.7±1 gram)
Principles Electrochemical biosensor technology
Software via USB GlucoManagerTM
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Limitations
The test strips are used for fresh capillary whole blood samples.
1. DO NOT use neonate blood sample.
2. Extreme humidity may affect the results. A relative humidity greater than 90% may cause incorrect results.
3. The system should be used at temperatures between 50°F and 104°F (10°C and 40°C). Outside this range,
the system may get incorrect results.
4. DO NOT reuse test strips. The test strips are for single use only.
5. 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.
6. Altitude up to 10,000 feet 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 fail:
♦ 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 and triglycerides up to 3,000 mg/dL do not affect the
results. Grossly lipemic patient samples have not been tested and are not recommended for testing with
the EasyMax LTC Blood Glucose Meter.
3. Critically ill patients should not be tested with home-use blood glucose meters.
4. DO NOT use during xylose absorption testing. Xylose in the blood will interfere with the Self-Monitoring
Blood Glucose System.
5. Interfering Substances depend on the concentration. EPS (EasyMax LTC mfg) has tested above the
therapeutic levels and at or above the suggested testing levels of the EPA for many common substances.
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Based on this chart, many of these substances do not have an effect on EasyMax LTC blood glucose results.
Blood Concentration, mg/dL
Exogenous Interferent Therapeutic Conc.
Suggestion tested
conc. by EPA
Result
(+/-)
EPS
tested conc.
Acetaminophen 1~2 0.5-3 - 7
Ascorbic Acid 0.8~1.2 4 - 4
Dopamine NA 0.09 - 2.6
Gentisic Acid 1.8 1.8 - 6
Glipizide 0.2 0.2 - 8
Ibuprofen 0.5~4.2 50 - 50
L-Dopa 0.5~8.0 ---- - 2
Methyldopa 0.1~0.5 0.5 - 2
Sodium Salicylate 15~30 - - 50
Tetracycline 0.4 1.5 - 1.5
Tolbutamide 5.3~10 64 - 100
Bilirubin-unconjugated 1.2 1-4 - 25
Cholesterol 300 ---- - 500
Creatinine 1.5 1.5-5.0 - 30
Triglycerides 190 150-250 - 1000
Uric Acid 7~14 3-9 - 11.9
Fructose - - - 30
Galactose 10 10 - 20
Sucrose - - - 50
Maltose 5 5 - 20
Mannose - - - 10
Xylose 10 10 - 6
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Device Information
EasyMax LTC SMBG System
EasyMax LTC Blood Glucose Meter
EasyMax 15 Blood Glucose Test Strip
Manufacturer:
EPS BIO TECHNOLOGY CORP.
No.8, R&D RD. III, Hsinchu Science Park, Hsinchu, Taiwan 30077
Oak Tree Health warranty
During the warranty period, if your EasyMax LTC Self-Monitoring Blood Glucose System does not work for
any reason (other than obvious abuse), Oak Tree Health will replace it with a new system or an equivalent
product free of charge. Please call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard
Time, Mon-Fri 8:00AM-6:00PM).
P/N: 718063760 Rev.A01
EasyMax 15 Level 1 (Low) Control Solution
EasyMax 15 Level 2 (Normal) Control Solution
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