EPS Bio Technology EasyMax N User manual

Long Term Care
Manual
EasyMax N Blood Glucose Monitoring System
This Manual is intended for facilities where point-of-care testing is
conducted by a healthcare professional. Please thoroughly read
the EasyMax N Owner’s Guide and all product instructions before
making use of this Manual.
EasyMax N Blood Glucose Monitoring System
Manufactured by:
EPS Bio Technology Corp.
No.8, R&D Road III, Hsinchu Science Park
Hsinchu, Taiwan 30077
Customer Service: 1-866-994-3345 (Toll Free)
(Mon-Fri 9:00 AM - 9:00 PM)

Introduction
This manual has been created for Healthcare professionals for the purposes of performing point-of-
care testing.
Caution: Please carefully read the User’s Manual and all product instructions before using this Long
Term Care Manual and administering blood glucose tests.
Summary of Contents:
 • AnoutlineoftheEasyMaxNBloodGlucoseMonitoringSystem.
 • QualityControlMethod,includinghowtotroubleshootpotentialissuesthatmayarisewhile
performing EasyMax N blood glucose tests.
 • Traininginformationforhealthcareprofessionals
Intended Use:
The EasyMax N Glucose Monitoring System is intended for the quantitative measurement of
glucoseinfreshcapillarywholebloodsamplesdrawnfromthengertipsorforearm.Testingisdone
outside the body (In Vitro diagnostic use). It is indicated for use at home (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.
Questions?
If you have questions or need assistance, please call Customer Service toll-free at 1-866-994-3345
(Eastern Time, Mon-Fri 9:00 AM-9:00 PM). You can also visit www.oaktree-int.com for diabetes
management tools and product demonstrations.
Important Information About the EasyMax N System:
 • EasyMaxNbloodglucosemeterisdesignedandapprovedfortestingfreshcapillarybloodfrom
  ngertipandforearm.Themeterisforoutsidethebody(invitro)use.Itshouldnotbeusedto
diagnose diabetes.
 • OnlyuseEasyMaxNbloodglucosemeterwithEasyMaxNBloodGlucoseTestStrips.Using
other test strips will give inaccurate results.
 • Testingisnotvalidforneonatalbloodspecimen.
 • Donotdisassemblethemeterasthismaycausedamagetothecomponentsresultingin
incorrect reading. Disassembling the meter will also void the warranty.
 • Alwayskeepthemetercleanandstoreitinasafeplace.Protectthemeterfromdirectsunlight
to ensure a longer lifespan.
 • Thesystemshouldbeusedatatemperaturebetween50°F-104°F(10°C-40°C).Outsidethis
range, the system may get incorrect results.
 • Youshouldnotstorethemeterandteststripsinacar,bathroom,orrefrigerator.
 • Elevatedlevelsofacetaminophen,uricacid,gentisicaacid,levodopa,dopamine,ascorbicacid
and methyldopa may affect results.
 • Removebatteriesifthemeterwillnotbeusedforonemonthormore.
 • Donottouchthestripswithwethands.
 • Donotuseexpiredstrips(theexpirationdateisshownonthebottle,andonceopenedthe
strips have a 90 day shelf life).
 • Donotbend,cutortwistthestrips.
 • Altitudeupto10,000feetabovesealevelhasnoeffectonreadings.
 • DONOTreusetheteststrips.Theteststripsareforsingleuseonly.
 • 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.
Page 1
 • Youshouldnottestcriticallyillpatientswithhome-usebloodglucosemeters.
 • Patientsundergoingoxygentherapymayhaveinaccurateresults.
 • Ifthepatienthasthefollowingconditions,theresultmayfail:
 • Severedehydration
 • Severehypotension(lowbloodpressure)
 • Shock
 • Astateofhypoglycemic-hyperosmolarstate(withorwithoutketosis)
 • 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 EasyMax N Glucose Meter.
Interfering Substances depend on the concentration. The below substances up to the test
concentration will not affect the test results.
Interfering
Substance
Test Concentration
mg/dl
Bias at 50±5
mg/dl
% Bias at 250±5
mg/dl
% Bias at 500±5
mg/dl
Acetaminophen 8 10.2 6.5 3.8
Ascorbic Acid 2.5 11.8 -6.8 5.3
Dopamine 2 4.3 12.9 6.3
Gentisic Acid 6 7.8 2.8 -4.3
L-Dopa 2 3.8 -1.2 -1.8
Methyldopa 2 5.2 -2.3 4.1
Uric Acid 13 7.6 3.9 3.8
Alternate Site Testing (AST)
EasyMaxNgivespatientstheoptiontotestontheirngertiportheirforearm.Bloodglucosetest
resultsobtainedfromtheforearmmaydiffersignicantlyfromngertipsamples.
It is preferred that you Do NOT perform Alternate Site Testing (AST) if:
 • Yourpatienthasfrequentlowbloodglucose.
 • Yourpatientisunawareofhypoglycemia.
 • TheASTresultsdonotmatchthewaythepatientfeels.
 • Youaretestingforhyperglycemia.
 • Thepatient’sroutineglucoseresultsareoftenuctuating.
 • Ifthepatientispregnant.
Quality Control
If you are using the EasyMax N and the result seems lower or higher than expected, it is
recommended that you repeat the test with a new strip. If you get the same result, please conduct a
control solution test to ensure your meter and test strips are working properly.
If you are evaluating the EasyMax N results and are comparing it to lab results, please note that the
patientshouldbefastingandthengertiptestshouldoccurwithinveminutesofhavingblooddrawn.
It is also important to know that the lab technology may be different than the EasyMax N technology;
therefore results may not always be a complete match.
Page 2

Troubleshooting Screen Messages :
Please do not make treatment decisions based on an error message. If you have any concerns, please
contact Customer Service Toll-Free: 1-866-203-2761(Eastern Time, Mon-Fri 9:00 AM - 9:00 PM)
Humidied/Used strips
Action: Replace with a
new strip.
Low Power
Action: Replace with
new batteries.
System Fault
Action: Replace the
batteriesrst.If001
ERROR appears again,
please call Customer
Service toll-free
1-866-203-2761.
System Fault
Action: Replace the
batteriesrst.IfErr
appears again, please
call Customer Service
toll-free 1-866-203-2761.
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, then
please take immediate
medical action.
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, then
please take immediate
medical action.
Page 3
The "Ht" and thermometer icon appears.
Temperature is too high, outside the required
range of 50°F - 104°F (10°C - 40°C). This alerts
user that an incorrect result may occur if the
test continues.
Action: Relocate the meter to a location with
temperaturebetween50°F-104°F(10°C-40°C).
The "Lt" 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.
Action: Relocate the meter to a location with
temperaturebetween50°F~104°F(10°C-40°C).
Page 4
Caring for your Blood Glucose Meter in a LTC Setting
1. Make sure
the meter is
off.
2. Put on a pair of
protective gloves
before you start the
cleaning procedure
3. Sanitizetheglucose
meter with any EPA
approved disinfectant
product that meets the
1:10 bleach solution.
4. Wipethesurfaceofthe
glucose meter including the
test strip port and USB port
after each use. Be careful to
make sure no liquid goes into
 eitherport.Wipethemeter
thoroughly; the treated surface
must remain visibly wet for a
full 2 minutes to attain
complete disinfection.
5. Ifyoundanyblood
stains on the device,
make sure you clean it
with caution.
6. Air dry the meter to
 sanitizecompletely
before next use.
In order to prevent the growth of microorganism, make sure you cover al the steps below.

EasyMax Test Strip
Setting the Time and Date - First Time Use
A. Blood Collection Area
B. Reaction Area
C. Hand Hold Area
D. Strip Insert Direction
E. Electrode
Strip Slot
To insert test strip or check strip.
1. Press and hold the “S”
button until turning the
meter on. Press “S”
button and release to
enter setting mode.
2. The time and date appear
on the display. The year
 ashesatthecenterofthe
display.
3. Press “M” button to adjust
the year. Press and hold
“M” button to scroll faster.
Page 5
Chapter 1: Understanding Your Meter
The EasyMax N Blood Glucose Meter
S Button
To turn on the meter or go into Setting Mode.
M Button
To turn on the meter or read records.
Memory, Storing Test Results
This 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. The memory is not lost when you replace the battery. The time and date will remain correct.
2. Once 480 results are in memory, adding a new result causes the oldest one to be deleted.
3. Control Solution values will be included in the memory and averages. Refer to the section
“Viewing & Deleting Test Results” to delete the control solution values before averaging test
results.
Viewing & Deleting Results
1. Press and hold the “S”
button until turning the
meter on.
2. Press the “M” button to
view the last test result.
3. Press “S” to view the
previous results in order
from the most recent to
the oldest.
4. To delete a test result,
Press and hold “M” for
more than 3 seconds. The
display will show “dEL”.
5. Continue pressing “M”
without releasing, the
currently viewed result
will be erased.
6. Press “M” and release to
review the average results
for the last seven days.
7. Press “S” to view averages
for 14 or 28 days.
8. Press “M” to close the
memory mode.
Page 6
4. Press and release “S”
button to set the year.
The month will then
 ash.
6. Pressthe“S”buttontoconrm
the setting. The display will
show “SCL” and the unit of
measurement. Press the “S”
button again, to go to the screen
shown in Step 1. Press and hold
“S” for more than 3 seconds, and
the meter will turn off.
Note: The unit of Blood Glucose Meter is set at mg/dL
without any modication function.
5. Repeat step 3 and 4 to
set the date, hour and
 minute.Theashingeld
is the one you are setting.

Understanding Control Solution Test Results
Important: Please follow your institution’s control solution testing regulations and procedures.
The label on your test strip bottle shows the acceptable ranges for the
Control Solution. 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(See1A)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, here are
some things you can do to solve the problem:
Troubleshooting Checks Action
Wastheteststripexposedtoopenairfora
long period of time? Repeat the control test with properly stored strips.
Wastheteststripbottlecappedtightly? This will humidify strips inside. Replace the test
strips.
Is the control solution expired or
contaminated?
Replace with new control solution to check the
performance of the system.
Wereteststripsandcontrolsolutionsstoredin
cool, dry places?
Repeat the control test with properly stored strips
and/orcontrolsolutions.
Did you follow the testing steps properly?
Read Chapter 2 in the manual “Control Solution
Testing” and test again. Stop using the meter if you
continue to obtain the inaccurate results. Call
Customer Service Toll-Free: 1-866-994-3345
(Eastern Time, Mon-Fri 9:00 am - 9:00 pm)
Page 8
Setting the Thermometer
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. The meter will
automatically turn on.
2. Placethemeteronaat
surface, like a table.
3. Remove the control solution
bottle cap and wipe the tip
of the bottle with a tissue.
4. Squeezethebottleuntilatinydrop
forms at the tip of the bottle. Touch
the drop to the Blood collection
area at the end of the test strip.
Do not put control solution on top
 oftheteststrip.Whenyouhear
the beep, you have enough
control solution on the test strip.
The meter starts to count down
from 5 seconds and will show the
results.
1. Press the “S” to turn the meter on.
2. Press the “M” and “S” button at the
same time and hold for more than
3 seconds. The meter will go into
Centigrade Thermometer Mode.
3. Press the “S” and the meter will change the
temperature reading to Fahrenheit.
4. Press the “S” again and the meter will
change to the Alarm Setting Mode.
Expiration date.
This date applies to
unopened bottles only.
Once opened, the control
solution has a shelf life
of 90 days.
Page 7
1A

Performing a Blood Glucose Test
Please adhere to your institution’s medical device handling and site preparation procedures.
1. Washyourpatient’shands
with soap and warm water.
Rinse and dry thoroughly. Your
institution may require that
you use an alcohol prep pad.
Please ensure that the test
site is completely dry before
proceeding.
2. Put a test strip into the meter
in the direction of the arrow.
The meter will automatically
turn on.
3. Please wait at least 5
seconds until the intended
area is dry and clean before
sampling the blood.
4. Whentheblooddropashes
on the display, obtain a drop
 ofbloodfromngertip,using
the safety lancet. (See
image above)
5. Touch the blood drop to the
tip of the transparent window
of the test strip. Do not put
blood on top of the strip. Be
sure to get enough blood on
 thestrip’sreactionzone.
Otherwise, an inaccurate
reading may result.
6. The meter will beep when
enough blood has entered
 thestrip’sreactionzone.The
result will appear on the
display after 5 seconds.
7. Discard the used safety lancet
and test strip into an
appropriate sharps or
 biohazardcontainer.
Page 9
EasyMax N System
Specications
Brand Name EasyMax N Blood Glucose Meter
Range 20~600mg/dL
Test Time 5 Seconds
Memory Sets 480 Test Results
Operating Condition
Temp. 500F~1040F (100C~400C)
Relative Humidity R.H. <90%
Blood Sample
0.6 µL
Fresh Blood from Fingertip or Forearm
Hematocrit (Hct) 30~55%
Power 2 Alkaline 1.5V (AAA)
Battery Life Over 2,000 Tests
Display Dimension 1.60” x 1.30” (40.6 x 33.0 mm)
DeviceDimensionHxWxD(mm) 3.2” x 2” x 0.7” (81.3 x 50.89 x 17.8 mm)
Weight 1.6oz(45.5Grams)w/oBatteries
Principles Electrochemical Biosensor Technology
Page 10
In a Long Term Care facility setting, we recommend that a safety lancet be used for each
individual blood glucose test. For demonstration purposes, we are using SteriLance™’s
Pressure Activated Safety Lancets.
1. Carefully pull off the protective cap.
2. Pushthelancetrmlyontothechosensitetore.
3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume.
EasyMax N system requires a small 0.6 microliter blood sample.

EasyMax N Blood Glucose Monitoring System
Training Information
for
Healthcare Professionals
Page 11
EasyMax N System Trainer Checklist
You may use the following checklist to assess the trainee’s ability to perform the following tasks.
1. IdentiestheequipmentusedwiththeEasyMaxNSystem.
EasyMax N Blood Glucose Monitor
EasyMax N Blood Glucose Test Strips
EasyMax N Control Solutions: Low, High, Normal
Safety Lancet
2. Blood Glucose Meter
Locates the serial number
Identiesthestripslot
Locatestheon/offbutton
Locates the setting button
3. Blood Glucose Test Strip
Locates the expiration date (opened & unopened)
Checks the lot number
Identiesthebloodcollectionarea
Understands the correct strip insert direction
Locates the electrode end of test strip
Identiesthedesignated“handhold”area
4. Demonstrates proper test strip use.
Only uses EasyMax N blood glucose meter with EasyMax N blood glucose test strips
Runs a control solution test every time a new vial of test strips is opened
Keeps test strips in their original vial
Closes vial immediately after taking a test strip out, to eliminate the contamination of the
other test strips
Knows test strips are single use only. Do not re-use.
Records the date the test strip bottle is opened. Checks the “Expiration Date” on the test
strip bottle. The test strips are good for three months from the date the bottle is opened or
  untiltheexpirationdateonthebottle,whichevercomesrst.
Stores the test strips between 35.6OF - 86OF.Donotfreeze.
Follows proper disposal of used test strips according to your institution’s policy.
Page 12

EasyMax N Quiz
Thisquizismultiplechoice,llintheblank,andtrue/false.
1. The EasyMax N system does not require calibration.
True False
2. EasyMax N control solution, once opened and assuming the expiration on the vial has not
 expiredrst,hasanexpirationdateof:
A. 60 days
B. 6 months
C. 3 months
D. 45 days
3. You should perform a control solution test when:
A. You think the meter or test strips may be working incorrectly.
B. You drop the meter.
C. You have repeated a test and the test results are still lower or higher than expected.
D. All of the Above
4. Whenperformingabloodglucosetest,whereshouldyouapplytheblood?
A. On top of the test strip
B. On the side of the test strip
C. The tip of the test strip
D. The middle of the test strip
5. Whenconductingaqualitycontroltest,whichofthefollowingstepswillbetaken?
A. Turn the meter off and on again.
B. Push the setting button twice.
C. Change the battery
D. Perform a control solution test
6.Ifyouareperformingabloodglucosetest,andyougetthiserror,whatshouldyoudorst?
A. Re-test
B. Replace the battery
C. Turn the meter off and on again
D. Replace with a new strip
7. The memory will store ______ results.
A. 300
B. 250
C. 480
D.1000
Page 14
5. Demonstration of blood glucose testing.
Demonstrates proper safety lancet technique when collecting blood sample
Understands the different sites that may be used with the meter
Demonstrates appropriate disposal of safety lancet in accordance with institution’s policy
Demonstrates the correct way to insert the test strip into meter
Understands symbols that appear on the meter screen and what, if any, corresponding
action
Demonstrates correct placement of blood on test strip
Recordsresultsasspeciedperyourinstitution
Understands the protocool for inaccurate results (re-tests, control solution test,
troubleshoot)
Knows the actions to be taken when results are abnormally high or low
6. QualityControl
Performs a control solution test, and can explain why it should be done
Understands the dates listed on the control solution and how they apply to opened vs
unopened vials
Recognizeswhatitmeanswhenacontrolsolutiontestresultfallsintherangelistedon
the vial, and when the test result falls out of the range on the vial
7. Troubleshooting Guidelines
Understands the steps to follow when troubleshooting
Knows the warranty of meter
Knows how to handle defective meter, strips, etc. (next steps, manufacture customer
service\service phone number)
8. Proper Care
Understands how to maintain the meter
Locates proper storage
Demonstrates proper cleaning
Demonstrates proper battery installation
9. Documentation
Understands what information must be documented by law and what is required by your
institution.
Page 13

8. Name two substances that have the potential to interfere with an accurate blood glucose result.
9. Describe how test strips should be inserted into the meter.
10. Ifyougetthismessage,thebloodglucoseresultislowerthan_________mg/dL.
11. WhattypeofbatterydoestheEasyMaxNrequire?
A. 3 Volt Lithium
B. Alkaline 1.5 Volt (AAA)
C. Alkaline 1.5 Volt, (AAAA)
D. None of the above
12. Describe the proper way to dispose of a safety lancet.
13. The appropriate way to clean the meter is:
A. Soak the meter in water for 5 minutes
B. Pour Bleach on the meter, then rinse
C. Spray the cleaning solution on the meter, then rinse
 D.Wipethemeter’ssurfacewithaslightlydamptowel
Answers available upon request.
Page 15
EasyMax N Blood Glucose Quality Control Results Log
Facility Name: Monitor #
Month/Year: Results Reviewed by:
Date Time Staff
Performing
Test Strip
Lot#
Low Control Normal Control High Control Action Taken
Lot Range Result Lot Range Result Lot Range Result
Page 16