EPS Bio Technology EasyMax - Page 2

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