EPS Bio Technology EasyMax LTC User manual

Long Term Care
Manual
EasyMax LTC 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 LTC 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 8:00 AM - 6:00 PM)
EasyMax LTC 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LTC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 LTC Self-Monitoring Blood Glucose Test System is intended for the quantitative
measurementofglucoseinfreshcapillarywholebloodsamplesdrawnfromthengertips,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.
Questions?
If you have questions or need assistance, please call Customer Service toll-free at 1-866-994-3345
(Eastern Time, Mon-Fri 8:00 am-6:00 pm). You can also visit www.oaktree-int.com for diabetes
management tools and product demonstrations.
Important Information about the EasyMax LTC System:
 • TheEasyMaxLTCBloodGlucoseMeterisdesignedandapprovedfortestingfreshcapillary
  wholebloodsamplesfromyourngertip,palmandforearm.Themeterisforoutsidethebody
(in vitro) use. It should not be used to diagnose diabetes.
 • Removebatteriesifthemeterwillnotbeusedforonemonthormore.
 • 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.
 • Keepthemeter,teststripsandsafetylancetsawayfromchildrenandpets.
 • Criticallyillpatientsshouldnotbetestedwithbloodglucosemeters.
 • 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.
 • Donottouchthestripswithwethands.
 • Donotuseexpiredstrips(theexpirationdateisshownonthevialandonceopenedthestrips
have a six month shelf life.)
 • Donotbend,cutortwistthestrips.
 • Altitudeupto10,000feetabovesealevelhasnoeffectonreadings.
Page 1

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
Page 2

Page 3
EasyMax LTC System
Specications
Brand Name EasyMax LTC 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
Hematocrit (Hct) 20~60%
Power Alkaline Battery AAA (2 ct.)
Battery Life Over 2,000 Tests
Display Dimension 1.4” x 1.7” (35 x 43 mm)
DeviceDimensionHxWxD 3.7” x 2.0” x 0.8” (94 x 50 x 19.5 mm)
Weight 1.68oz(47.7+Grams)w/oBatteries
Principles Electrochemical Biosensor Technology
Software Via USB GlucoManager™
Unusual Test Results
If the results are inconsistent with your patient’s symptoms, please follow these steps:
1. Run a control solution test (page 7).
2. Repeat a blood glucose test (page 9).
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.
=
-

Page 4
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
Step 1: Cleaning Instruction: Cleanrsttoremoveanyheavysoilleftonthesurfaceofthemeter.
Allbloodandbodilyuidsmustbethoroughlycleanedfromsurfacesandobjectsbeforedisinfection
withagermicidalwipe.Open,unfoldandusetherstgermicidalwipetoremoveheavysoil.
Step 2: Disinfection Instruction: After cleaning, and 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.
Do: Do Not:
• 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,performa
 physicalappearanceandperformancecheckof
 devices.
• Alwaysweargloveswhencleaningandtesting.
• 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.
Note:
After disinfection, users’ gloves should be removed and hands should be thoroughly washed
with soap and water before proceeding to the next patient.

EasyMax 15 Test Strip
Page 5
The EasyMax LTC Blood Glucose Meter
AB
F
D
GI
J
CE
H
Overview of Display Meaning
A Date Shows the date
BTime Shows the time
CApply Blood Test your level of blood glucose
D Test Result/Error
Message
Shows the test result or error
message
EInsert a Test Strip Insert a test strip to start testing
blood glucose
FMedical Record No. Shows the patient number
GApply Control Solution Control solution test marker
HGlucose Unit The testing unit of blood glucose
I
Battery Status
Shows remaining battery power.
Whenthebatterysymbolappears,
replace batteries
J
Temperature
Temperature icon appears with an
“HF” or “LF” when the temperature
is too high or too low

Page 6
1. Press (Power Button)
and hold the button until
the meter turns on.
3. Thescreendisplayashesthe
last 2-digits of the year. Press
(Left Button) or (Right Button)
to adjust the year and press
 (PowerButton)toconrmthe
setting.
2. Press (Right Button) for
2 seconds to get into the
setting mode.
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.
4. Repeat step 3 to set the date and
 time.Theashingeldistheoneyou
are currently setting.
5. Press (Left Button) or (Right Button) to turn
on/off the medical record function and press
 (PowerButton)toconrm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.

Running a Control Solution Test with EasyMax 15 Control Solution
You need the meter, a test strip, and control solution
1. Put a test strip into the meter
in the direction of the arrow.
3. Placethemeteronaat
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 the bottle
cap.
Note: If the Patient Medical Record is on, it does not matter which record number you select if you
  agtheresultasacontrolsolutiontest.Theresultwillbedisplayedinthemeter’smemory
as a control solution test.
Page 7
2. Press (Left Button) to
select the mode of
Control Solution, and the
 iconofashes.
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.
8. Push the Strip Ejector to
eject the test strip into a
proper trash receptacle.
7. Do not remove the test
 stripuntilyouconrm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.

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 different
control solution levels. 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 within 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? Ifitwasn’t,thestripscouldbehumidied.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 Page 7 in this manual “Running a Control
Solution Test” 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 8:00 am - 6:00 pm)
Page 8
Expiration date.
This date applies to
unopened bottles only.
Once opened, the control
solution has a shelf life
of 90 days.
9. Close the control
 solutionvialtightly.Wipe
the tip of the control cap
with a tissue to remove
any excess solution.
1A

Performing a Blood Glucose Test with EasyMax 15 Test Strips
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 turns on and the icon
shows automatically.
3. Press (Left Button) or
(Right Button) to set a
Patient Number and press
 toconrmthesetting(onlyif
function if on).
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rmlyagainstthepuncture
site.
7.Gentlysqueezeand/or
 massagethengertipuntil
a round drop of blood forms
 onthengertip.
Page 9
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 . .
9. The meter starts to count
down from 5 seconds and
then displays the test result.

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.
10. Push the Strip Ejector to eject the test strip. Properly dispose of both the
strip and the lancet.
11. After discarding, wash hands thoroughly with soap and water. Rinse and dry
thoroughly.
12. Clean and disinfect the meter following the instructions on page 4.
13. Change gloves between patients.
In a Long Term Care facility setting, we recommend that a safety lancet be used for each individual glucose
test.

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 8:00 am - 6:00 pm).
Humidied/Usedstrips
Action: Replace with a
new strip.
Low Power
Action: Replace with
new batteries.
Problem with the
System
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 low, 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 LTC Self-Monitoring Blood Glucose System
Training Information
for
Healthcare Professionals
Page 11

EasyMax LTC 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LTCSystem.
EasyMax LTC Blood Glucose Monitor
EasyMax 15 Blood Glucose Test Strips
EasyMax 15 Control Solutions: Level 1, Level 2
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 LTC blood glucose meters with EasyMax 15 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 six 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
Demonstrates appropriate disposal of safety lancets 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 protocol 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 strip 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,manufacturercustomer
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 LTC Quiz
Thisquizismultiplechoice,llintheblank,andtrue/false.
1. The EasyMax LTC system does not require calibration.
True False
2. EasyMax 15 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. Describe the proper way to clean and disinfect the EasyMax LTC meter.
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LTC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. Describe the medical record function.
_____________________________________________________________________________
_____________________________________________________________________________
Answers available upon request.
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EasyMax LTC Blood Glucose Quality Control Results Log
Facility Name: Monitor #
Month/Year: Results Reviewed by:
Date Time Staff
Performing
TestStrip
Lot#
Level1Control Level2Control ActionTaken
Lot Range Result Lot Range Result
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