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 confirm 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 first. (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 off 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 off 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 reflect your blood glucose.
• Contact Customer Care for information on how to obtain control solution.
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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 affect 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 off 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 off
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 Specifications
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 off 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 off 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 first 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 off 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 shutoff
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 certified 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 specifications, 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 significance 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 effects of low-dose insulin therapy on glucose
metabolism in diabetic ketoacidosis. Diabetes 1988; 37:1470–1477.
6. Hale PJ, Crase J, Nattrass M. Metabolic effects 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