EPS Bio Technology EasyMax L User manual

Long Term Care
Manual
EasyMax L Self-Monitoring Blood Glucose System
This Manual is intended for facilities where point-of-care testing is
conducted by a healthcare professional. Please thoroughly read
the EasyMax L Owner’s Guide and all product instructions before
making use of this Manual.

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)
EasyMax L Self-Monitoring Blood Glucose System

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LSelf-MonitoringBloodGlucoseTestSystem.
 • QualityControlMethod,includinghowtotroubleshootpotentialissuesthatmayarisewhile
performing EasyMax blood glucose tests.
 • Traininginformationforhealthcareprofessionals
Intended Use:
The EasyMax L Self-Monitoring Blood Glucose Test 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 L System:
 • EasyMaxLbloodglucosemeterisdesignedandapprovedfortestingfreshcapillarywhole
  bloodsamplesfromyourngertipandforearm.Themeterisforoutsidethebody(invitro)use.
It should not be used to diagnose diabetes.
 • EasyMaxLbloodglucosemetercanonlybeusedwithEasyMax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 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.
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 • 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 L 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Lgivespatientstheoptiontotestontheirngertipor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 L 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 L 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 L technology;
therefore results may not always be a complete match.
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Page 3
EasyMax L System
Specications
Brand Name EasyMax L 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 CR2032 Lithium Cell (3V (2 ct)
Battery Life Over 2,000 Tests
Display Dimension 1.70” x 1.38” (43 x 35 mm)
DeviceDimensionHxWxD(mm) 3.39” x 1.85” x 0.54” (86 x 47 x 13.8 mm)
Weight 1.517oz(43Grams)w/oBatteries
Principles Electrochemical Biosensor Technology

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.
In order to prevent the growth of microorganism, make sure you cover all the steps below.
6. Airdrythemetertosanitize
completely before next use.

EasyMax Test Strip
A. Blood Collection Area
B. Reaction Area
C. Hand Hold Area
D. Strip Insert Direction
E. Electrode
Page 5
The EasyMax L Blood Glucose Meter
The Overview of the Display Meaning
A month and date Shows the month and date
B Memory The meter will automatically record all
test results
C Error The meter system is in fault
D Test result Shows the test result
E Thermometer The themometer icon appears when
the temperature is too high or too low
FApplication of blood or control
solution Test your level of blood glucose
G Time Shows the time
H PC Connect to the PC
I Sound volume Beepfunctioncanbeturnedon/off
J Insert test strips Insert the test strip to start testing
blood glucose
K Glucose unit The testing unit of blood glucose
L Battery status Whenthebatterysymbolappears
prepare other batteries for installation

Page 6
1. Insert batteries, the
meter turns on
automatically.
2. The last 2-digits of the
 yearashatthetopof
the display. Press “ “ or
“ “ to adjust the year
 andpresstoconrm
setting.
4. Press “ “ or “ “ to turn on or
turn off the volume and press
 toconrmthesetting.
Note: The unit of Blood Glucose Meter is set at mg/dL without any modication function.
3. Repeat step 2 to set the
 dateandtime.Theashing
 eldistheoneyouare
currently setting.
(A=AM, P=PM)
Setting the Time, Date and Sound Volume-First Time Use
Setting the current time and date in your meter is important if you use the meter memory.
You can also set the time, date and sound volume without replacing the batteries.
1. Keep pressing “ “ until you see the
“SEL”. After 2 seconds the meter
enters the setting mode automatically.
2. Repeat step 2 to 4 above to set the
year, date, time and sound volume.
 Theashingeldistheoneyouare
currently setting.

Setting the Time, Date and Sound Volume-First Time Use
Setting the current time and date in your meter is important if you use the meter memory.
You can also set the time, date and sound volume without replacing the batteries.
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.
4. Squeezeout1-2drops
of solution and discard.
5. Nowsqueezeoutanotherdropofsolutionontothecontrolsolutioncap.Takethe
cap and touch the drop to the blood collection area at the end of the test strip. The strip will sip in the
control solution.
Page 7
2. Placethemeteronaat
surface.Take the control
solution between your
 ngertipsandrollthe
solution back and forth to
mix up the solution.
3. Twist off control solution
bottle cap and wipe the tip
of the bottle with a tissue.
Do not put control solution on top
of the test strip. This may cause
an incorrect reading.
Do not apply the control solution directly
from the solution bottle to the test strip.
This can cause cross contamination and
the entire control solution will no longer be
accurate for future tests.

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
Expiration date.
This date applies to
unopened bottles only.
Once opened, the control
solution has a shelf life
of 90 days.
6. Whenthemeterbeeps,
there is enough control
solution on the strip. The
meter counts down from
5 seconds and will
display the results. Do
not remove the strip yet.
Check if the reading falls
within the range printed
on the test strip bottle.
7. Remove the test strip
and throw it away after
you have compared the
reading to the range
printed on the test strip
bottle.
8. Close the control
 solutionvialtightly.Wipe
the tip of the control cap
with a tissue to remove
any excess solution.

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
a safety lancet. (See image
above)
5. Touch the drop of blood 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.
Page 9
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 L system requires a small 0.6 microliter blood sample.
7. Discard the used safety
lancet and test strip into an
appropriate sharps or
 biohazardcontainer.

Page 10
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: 1-866-994-3345 (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
1-866-994-3345.
The “HF” and
thermometer icon
appears. Temperature
is too high, outside
the required range
of 500F-1040F (100C-
400C). This alerts
users that an
incorrect result may
occur if the test
continues.
Action: Relocate the
meter to a location with
temperature between
500F-1040F (100C-
400C).
The “LF” and
thermometer icon
appears. Temperature
is too high, outside
the required range
of 500F-1040F (100C-
400C). This alerts
users that an
incorrect result may
occur if the test
continues.
Action: Relocate the
meter to a location with
temperature between
500F-1040F (100C-
400C).
Test result is higher
than 600 mg/dL.
Action: Test again. If the
result is still the same,
please call Customer
Service toll-free
1-866-994-3345.
Test result is lower
than 20 mg/dL.
Action: Test again. If the
result is still the same,
please call Customer
Service toll-free
1-866-994-3345.

EasyMax L Self-Monitoring Blood Glucose System
Training Information
for
Healthcare Professionals
Page 11

EasyMax L 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LSystem.
EasyMax L Blood Glucose Monitor
EasyMax Blood Glucose Test Strips
EasyMax 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 blood glucose meters with EasyMax blood glucose test strips
Runs a control solution test every time a new vial of test strips are 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

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

EasyMax L Quiz
Thisquizismultiplechoice,llintheblank,andtrue/false.
1. The EasyMax L system does not require calibration.
True False
2. EasyMax 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
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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L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:
_____________________________________________________________________________
_____________________________________________________________________________
Answers available upon request.
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EasyMax L 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
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