Freestyle OPTIUM NEO - Getting to Know Your Meter; Testing Your Meter, Blood Glucose and Control Solution; Setting Up Your Meter; Setting Date and Time

AbbottDiabetesCareLtd.
RangeRoad
Witney,Oxon
OX290YL,UK
Acontrolsolutiontestshouldbeperformedwhenyouarenotsureof
your results and want to conrm that your meter and test strips are
working properly.
IMPORTANT:
•UseonlyMediSenseglucoseandketonecontrolsolutionswiththemeter.
•Controlsolutionresultsshouldfallwithinthecontrolsolutionrangeprintedon
the test strip instructions for use.
•CheckthattheLOTnumberprintedontheteststripfoilpacketandinstructions
for use match.
•Donotusecontrolsolutionpastitsexpirydate.Discardcontrolsolution
3monthsafteropeningorontheexpirydateprintedonthebottle,whichever
comesrst.(Example:openApril15,discardJuly15;writethediscarddateon
the side of the bottle.)
•Thecontrolsolutionrangeisatargetrangeforcontrolsolutiononly,notfor
blood glucose levels.
•Replacethecapsecurelyonthebottleimmediatelyafteruse.
11
Glucose and Ketone Control Solutions
Performing a Control Solution Test
1. Open the foil test strip packet at the notch and
tear down to remove the test strip.
2. Insert the test strip until the meter turns on.
Notes:
•Besuretocheckthatyourmeterscreenisworking
properly each time you turn your meter on. If you see
any white segments in the black o screen, or any
black segments in the white test screen, there may be
a problem with the meter. (See Section 5, Getting to
Know Your Meter, for more details.)
•Themeterturnsoafter3minutesofinactivity.
Remove and reinsert the unused test strip to restart
the meter.
IMPORTANT: (continued)
•Donotaddwaterorotherliquidtocontrolsolution.
•Controlsolutionresultsdonotreectyourbloodglucose.
•ContactCustomerCareforinformationonhowtoobtaincontrolsolution.
Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.
Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.
4˚C
The blinks, indicating the meter is ready for you to
apply a sample to the test strip.
Note: KETwill appear on the screen if you have inserted a
purple blood ketone strip.
3. Pressandholdthedownarrowfor3secondsto
mark the test as a control solution test. The
appears. The meter is now ready for you to apply
control solution to the test strip.
IMPORTANT: The test result will be saved to memory as a blood result if
not marked as a control solution test. This may aect your blood glucose
averages.
4. Apply control solution to the test strip.
Shake the control solution bottle to mix the solution.
Applyadropofcontrolsolutiontothewhiteareaat
the end of the test strip in the area shown. The control
solution is drawn into the test strip.
5. Hold the control solution to the test strip until:
•Yousee3shortlinesonthemeterscreen.This
means you have applied enough control solution
and the meter is reading the control solution.
Notes:
• Ifyouaretestingwithabloodglucosestrip,you
will see a 5-second countdown. If you are testing
with a blood ketone strip, you will see a 10-second
countdown.
• Donot remove the test strip from the meter during
the countdown.
• Ifthecountdowndoesnotstart,removeand
discard the used test strip, turn o the meter and
try again with a new strip.
➧
Examples:
6. View the result.
The test is complete (examples shown) when the
result appears on the meter screen. The result is
stored in memory as a control solution result.
Compare the control solution result to the range
printed on the blood glucose or blood ketone test
strip instructions for use. The result should fall within
the range.
Note: KETappearswith the result if performing a
ketone control solution test.
Out of Range Control Solution Results:
•Repeatthetestifcontrolsolutionresultsareoutside
the range printed on the test strip instructions for
use.
•Stopusingthemeterifcontrolsolutionresultsare
consistently outside the range printed on the test
strip instructions for use. Contact Customer Care.
12
Transferring Meter Data to a Computer
Transferring meter data to a computer requires a compatible data management system. You
willalsoneedamicroUSBcabletoconnectyourmeter’sUSBporttoyourcomputer.
For more information, please contact Customer Care.
WARNING: To avoid the possibility of electric shock, never perform a blood glucose test
while the meter is connected to the computer.
13
Error Messages
15
Troubleshooting
What It Means What To Do
1. Test strip
is inserted
in the
strip
port and
nothing
happens.
Test strip is not inserted properly or fully into the meter 1.Withthecontactbars(3blacklines)facingup,inserttheteststripintothemeteruntilitstops.
This turns on the meter.
2. If the meter still does not turn on, contact Customer Care.
No batteries are installed; Batteries installed incorrectly RefertoSection14,TakingCareofYourMeter, on how to properly install batteries.
Dead batteries Changebatteries.Resetdateandtime,ifneeded.
Meter may be plugged into a computer (PC appears on meter screen) Unplug the meter from the computer.
Problem with the test strip Try a new test strip.
Problem with the meter Contact Customer Care.
2. The test
does not
start after
applying
the blood
sample.
Blood sample is too small 1. See test strip instructions for use for re-application instructions.
2.Repeatthetestusinganewteststrip.
3. If the test still does not start, contact Customer Care.
Sample applied after meter turns o 1.Reviewthetestinginstructions.
2.Repeatthetestusinganewteststrip.
3. If the test still does not start, contact Customer Care.
Problem with meter or test strip 1.Repeatthetestusinganewteststrip.
2. If the test still does not start, contact Customer Care.
17
Meter Specications
14
Taking Care of Your Meter
Message What It Means What To Do
The temperature is too hot
or too cold for the meter to
work properly
1.Movethemeterandteststripsto
a location where the temperature
is within the test strip operating
range. (See test strip instructions
for use for the appropriate range.)
2.Waitforthemeterandteststripsto
adjust to the new temperature.
3.Repeatthetestusinganewtest
strip.
4.Iftheerrorreappears,contact
Customer Care.
Meter error 1.Turnothemeter.
2.Repeatthetestusinganewtest
strip.
3.Iftheerrorreappears,contact
Customer Care.
Message What It Means What To Do
Blood drop is too small
or
Incorrect test procedure
or
There may be a problem with
the test strip
1.Reviewthetestinginstructions.
2.Repeatthetestusinganewteststrip.
3.Iftheerrorreappears,contact
Customer Care.
The blood glucose level may
be too high to be read by the
system
or
There may be a problem with
the test strip
1.Repeatthetestusinganewteststrip.
2.Iftheerrorreappears,contact
Customer Care.
Blood was applied to the test
strip too soon
1.Reviewthetestinginstructions.
2.Repeatthetestusinganewteststrip.
3.Iftheerrorreappears,contact
Customer Care.
Message What It Means What To Do
Meter error 1.Checkthatyouareusingthecorrect
strip for this meter. (See test strip
instructions for use to verify your strip
is compatible with this meter.)
2.Repeatthetestusingateststripfor
use with your meter.
3.Iftheerrorreappears,contact
Customer Care.
No coding required
or
Test strip may be damaged,
used, or the meter does not
recognise it
1.Checkthatyouareusingthecorrect
test strip for this meter. (See test strip
instructions for use to verify your strip
is compatible with this meter.)
2.Repeatthetestusingateststripfor
use with your meter.
3.Iftheerrorreappears,contact
Customer Care.
Meter error 1.Turnothemeter.
2.Repeatthetestusinganewteststrip.
3.Iftheerrorreappears,contact
Customer Care.
Changing Batteries
You will see this screen when your batteries are low.
Note: Your meter settings and logbook information will be saved
when you change the batteries.
Step Action
1. Turn meter over and slide open the battery door on
the side as shown.
IMPORTANT: Afteryourstseethiswarning,youcanperform
approximately28testsbeforeyouneedtochangethebatteries.
WARNING: Batteries should be kept away from small children. If swallowed, contact a
healthcare professional immediately.
Step Action
2. Removetheoldbatteries.
3. Install new batteries with (+) facing up.
Note: Themeter uses 2 replaceable CR 2032 coin cell
batteries.
4. Slide the door back into place until it clicks.
Note: Thenexttime you turn your meter on, it may
prompt you to reset the time and date. (Refer to Section
6, Setting Up the Meter).
Note: When you no longer need the meter, remove the batteries and dispose of the batteries and
meter in accordance with your local government regulations.
The European Battery Directive requires separate collection of spent batteries,
aiming to facilitate recycling and to protect the environment. The batteries
in this product should be removed and disposed in accordance with local
regulations for separate collection of spent batteries.
Cleaning Your Meter
Step Action
1
Clean the outside of the meter using a damp cloth and:
•Milddetergent/soapandwater,or
•70%isopropylalcohol,or
•Amixtureof1parthouseholdbleach,9partswater
2
Allowthemetertodry.
IMPORTANT: Do notplacethemeterinwaterorotherliquids.Avoidgetting
dust, dirt, blood, control solution, water, or any other substance in the
meter’steststripportandUSBport.
16
Insulin Dose Logging
Introduction
This feature allows you to log insulin doses so they are recorded in the logbook. You can enable
this feature at any time.
Set Up for Insulin Dose Logging
1. WhileontheHomescreen,pressandhold for
3secondsuntilthe appears. Insulin Dose
Logging is now enabled.
Note: Toturn o this feature, repeat this step.
How to Use Insulin Dose Logging
Forlong-actinginsulinand/orinsulinforbreakfast,lunch,ordinner.
1. WhileontheHomescreen,press .
2. Choose type of insulin dose.
Using the chart below, press the button for the dose
you want to log.
3. Press
or to enter the actual dose
amount.
2. Press or to enter the actual dose
amount.
3. Press
to log dose.
means you took dose
Assay method Amperometry
Automatic shuto Atleasttwominutesofinactivity
Battery life Upto3000tests
Measurement range
Forbloodglucosetesting1.1-27.8mmol/L
Forbloodketonetesting0.0-8.0mmol/L
Memory
Upto1000events,includingbloodglucose,bloodketone,
and control solution results, insulin doses, and other meter
information
Minimum computer
requirements
SystemmustonlybeusedwithEN60950-1ratedcomputers.Use
a USB certied cable
Operating relative
humidity
10%to90%(non-condensing)
Operating
temperature
Meter:10°Cto50°C(50°Fto122°F)
System: See test strip instructions for use
Power source TwoCR2032lithium(coincell)batteries
Size
5.97cm(w)x8.68cm(l)x0.87cm(d)
2.35in(w)x3.42in(l)x0.34in(d)
Storage temperature -20°Cto60°C(-4°Fto140°F)
System altitude See test strip instructions for use
Weight 33to37g(1.2to1.3oz.)includingbatteries
Note: For test strip specications, see test strip instructions for use.
Electromagnetic Compatibility (EMC): FreeStyle Optium Neo meter has been tested for both electrostatic discharge and radio
frequency interference. Emissions are low and unlikely to interfere with other nearby electronic equipment. To limit radio
frequency interference do not use the FreeStyle Optium Neo meter near cellular or cordless telephones, radio transmitters or
other electrical or electronic equipment that are sources of electromagnetic radiation, as these may interfere with the proper
operationofthemeter.Avoiduseofthedeviceinverydryenvironments,aselectrostaticdischargesfromsyntheticmaterials
(e.g., carpets) could cause damage.
18
Other Symbols
Symbol
What It Means Symbol What It Means
Consult instructions for use Caution
Temperature limit Use-by date
Manufacturer In vitro diagnostic medical device
Batch code Catalogue number
Do not re-use
Recycle
Date of manufacture
Serial number
Do not drink
Sterilised using irradiation
(lancets only)
CE Mark
The European Battery Directive requires separate collection of spent batteries, aiming
to facilitate recycling and to protect the environment. The batteries in this product
should be removed and disposed in accordance with local regulations for separate
collection of spent batteries.
19
References
1. SchadeDS,EatonRP.Metabolicandclinicalsignicanceofketosis.SpecialTopicsinEndocrinologyandMetabolism1982;
4:1–27.
2. WiggamMI,O’KaneMJ,HarperR,AtkinsonAB,HaddenDR,TrimbleER,BellPM.Treatmentofdiabeticketoacidosisusing
normalizationofblood3-hydroxybutyrateconcentrationastheendpointofemergencymanagement.DiabetesCare1997;
20:1347–1352.
3. HaranoY,KosugiK,HyosuT,SuzukiM,HidakaH,KashiwagiA,UnoS,ShigetaY.KetonebodiesasmarkersforType1
(insulin-dependent)diabetesandtheirvalueinthemonitoringofdiabetescontrol.Diabetologia1984;26:343-348.
4. Ubukata E. Diurnal variation of blood ketone bodies in insulin-dependent diabetes mellitus and non-insulin-dependent
diabetesmellituspatients:TherelationshiptoserumC-peptideimmunoreactivityandfreeinsulin.AnnNutrMetab1990;
34:333–342.
5. LuziL,BarrettEJ,GroopLC,FerranniniE,DeFronzoRA.Metaboliceectsoflow-doseinsulintherapyonglucose
metabolismindiabeticketoacidosis.Diabetes1988;37:1470–1477.
6. HalePJ,CraseJ,NattrassM.Metaboliceectsofbicarbonateinthetreatmentofdiabeticketoacidosis.BrMedJ1984;289;
1035–1038.
FreeStyleandrelatedbrandmarksaretrademarksofAbbottDiabetesCareInc.invarious
jurisdictions.
Thisproduct(s)and/oritsmanufactureand/oruseareprotectedbyoneormoreofthe
followingpatents:US5,509,410;US5,628,890;US5,727,548;US6,129,823;US6,736,957;
US6,764,581;US6,939,450;US6,377,894;US6,600,997;US6,773,671;US5,682,884;
US6,591,125;US7,058,437;US7,504,019;US7,740,581;US7,905,999;US7,922,883;
US7,998,337;US8,118,993;US8,182,671;US8,211,280;US8,221,612;US8,241,485;
US8,241,486;US8,372,261;EP1,009,850B1;EP1,119,637B8;EP1,023,455B1;
EP1135679B1;EP1801229B1;CA2302448C;CA2346415C;CA2351796C;CA2353670C;
CA2305800C.Additionalpatentsmaybeissuedand/orpending.
©2013Abbott ART29756-002Rev.B10/13
4. Press to log dose.
means you took dose
How to Log Additional Rapid-Acting Insulin Doses
(e.g. snacks, bedtime correction, etc.)
1. WhileontheHomescreen,pressandhold for
3secondsuntilthescreenchanges.
breakfast Meal insulin
lunch Meal insulin
dinner Meal insulin
evening Long-acting insulin
morning Long-acting insulin
Distributed by:
AbbottLaboratoriesIreland,Ltd.
AbbottDiabetesCare
4051KingswoodDrive
Citywest Business Campus
Dublin24
Ireland
1800776633
AbbottLaboratoriesLtd.
AbbottDiabetesCare
AbbottHouse
Vanwall Business Park
VanwallRoad
Maidenhead
Berkshire
SL64UD
UK
0500467466
ART29756-002_rev-B.indd 2 10/8/13 1:01 PM