Medtronic OneTouch Ultalink User Manual
TM
Owner’s Booklet
Blood
Glucose
Monitoring
System
Wirelessly sends accurate glucose results to
MiniMed Paradigm®and Guardian®Devices
†
†
Applies to compatible Medtronic MiniMed Paradigm
®
insulin pumps and Guardian®REAL-Time Systems
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Welcome to the OneTouch®family!
OneTouch®is committed to creating a world without limits for people with
diabetes.
The OneTouch®UltraLink™Meter, developed by LifeScan and Medtronic
Diabetes, makes it simple to get a blood glucose test result and review past
results. We designed this product to make testing easy and to help you
manage your diabetes.
A special wireless communication feature lets the meter automatically transmit
glucose test results to compatible*Medtronic Diabetes devices.
This owner’s booklet will help you learn how to use your meter properly. Please
read it carefully.
If you need assistance, please contact Customer Service at 1 866 621-4846 toll
free. Customer Service is available 24 hours a day, 7 days a week. If you cannot
reach Customer Service, contact your health care professional for advice.
If you have specific questions about any partner device**from Medtronic
Diabetes, you may contact the manufacturer’s 24-hour line at
1 800 646-4633 (calls within the United States) or 1 818 576-5555 (calls
outside the United States), or visit their website at www.medtronicdiabetes.com.
i
* For information on compatible Medtronic Diabetes devices, contact Medtronic directly.
** Throughout the owner’s booklet, references to Medtronic Diabetes devices will be referred to as simply
“partner devices.”
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Setting up pg. 2
your system
Table of contents
• Getting to know your
OneTouch
®
UltraLink™Blood
Glucose Meter and Test Strips
• Turning your meter on and off
• Setting up your meter
• Turning the PUMP COMM
(partner device communication)
feature on and off.
Your meter comes pre-set to
automatically transmit glucose
test results to your partner
device. You will also need to
program your meter ID into
your partner device for results
to be transmitted. See page 13
for instructions on where to
find your meter ID and how to
program it into your partner
device.
Starting the test process pg. 14
NOTE: Before testing, read
this owner’s booklet carefully.
Insert a test strip
Check the code on the test strip
vial before inserting the test
strip. Make sure the three
contact bars are facing you.
Push the test strip in as far as
it will go. Do Not bend the test
strip.
The meter will turn on, show a
black start-up screen and then a
code number. The first time you
use the meter, the CAL CODE
screen will display “––” instead
of a number.
Match the code displayed on
the meter with the code on the
test strip vial
If the code on the meter does
not match the code on the vial,
press or to change the
code. If the display changes to
the
APPLY BLOOD screen before
you are ready, remove the
test strip and re-start the test
process.
Press when the numbers
match.
The meter is ready for testing
when the
APPLY BLOOD screen
appears.
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Getting a blood sample pg. 18
Prepare the OneTouch®Lancing Device
Remove the blue (or black) cap
and put a new lancet in the
lancing device. Twist off the
protective disk. Replace the cap
and cock the lancing device.
Get a drop of blood
Hold the OneTouch
®
Lancing
Device firmly against your finger.
Press the release button.
Gently squeeze and/or massage
your fingertip until a round
drop of blood ( sample size)
forms.
Applying blood pg. 30
and reading results
Touch and hold the drop of blood to the narrow
channel in the top edge of the test strip
Blood will be drawn into the test
strip. Keep holding the drop of
blood to the top edge of the test
strip until the confirmation
window is full. The meter will
begin to count down from 5 to 1.
Then, your blood glucose level
appears on the display along
with the unit of measure, and
the date and time of the test.
Your glucose test result will flash on the display
to indicate that it is being transmitted to your
partner device. The result will stop flashing after
it has been received. After about 60 seconds, if
the result has not been received by the partner
device, the transmit feature will turn off and the
result will stop flashing.
If the test results are lower than, higher than,
or not what you expect, see pages 36–38.
iii
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Add a meal flag to track
different types of averages
While viewing your test result,
(or after it stops flashing if the
PUMP COMM feature is turned
on), press to get to the
MEAL
FLAG
screen.
Press or to highlight
BEFORE MEAL or AFTER MEAL.
To confirm your selection,
press .
The meal flag you chose will
appear above the result.
If you do not wish to add a
meal flag, select NO FLAG and
press . This will return you
to the glucose result screen.
Add a comment
While viewing your test result,
(or after it stops flashing if the
PUMP COMM feature is turned
on), press to get to the
COMMENT screen.
Press or to highlight
an appropriate comment.
To confirm your selection,
press .
The comment you chose
appears below the result.
Caring for your pg. 56
system
Control solution pg. 50
testing
Troubleshooting pg. 62
Detailed information pg. 70
about your system
Index pg. 79
• Last result
• All results
• Result averages
• Downloading results
Meal flag
Comment
Reviewing past pg. 44
results and averages
Attaching flags or comments to your results pg. 40
iv
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v
Before you begin
Before using this product to test your blood glucose, carefully read this booklet and
the inserts that come with the OneTouch®Ultra®Test Strips and OneTouch®Ultra
®
Control Solution. Take note of warnings and cautions throughout this booklet, which
are identified with . Many people find it helpful to practice the test with control
solution before testing with blood for the first time. See page 50 in the Control
solution testing section.
Intended use
• The OneTouch
®
UltraLink™Blood Glucose Monitoring System is intended to be
used for self-testing outside the body (in vitro diagnostic use) for the quantitative
measurement of glucose in fresh capillary whole blood obtained from the finger,
forearm or palm.
• The OneTouch
®
UltraLink™System is intended for use by people with diabetes in
a home setting and by health care professionals in a clinical setting as an aid to
monitor the effectiveness of diabetes control.
• Not for the diagnosis of diabetes
• Not for use with neonates
WARNING: Failure to carefully follow the directions in this owner’s booklet can
lead to inaccurate test results.
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vi
• Test strips for single use only
• Test strips are specific to D-glucose and do not react to other sugars that may be
present in the blood
• Not for use with serum or plasma
The OneTouch
®
UltraLink™Blood Glucose Monitoring System may also be used with
designated partner devices. OneTouch®UltraLink™is set up to automatically transmit
each glucose result to the partner device.
See your partner device manual for instructions for setting up, using, and
troubleshooting problems with your partner device.
Test principle
Glucose in the blood sample mixes with special chemicals in the test strip and a small
electric current is produced. The strength of this current changes with the amount of
glucose in the blood sample. Your meter measures the current, calculates your blood
glucose level, displays the result, and stores it in its memory.
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vii
About RF
Radio frequency (RF) is a type of wireless communication. Cell phones use RF technology,
as do many other devices. RF is how your OneTouch
®
UltraLink™Blood Glucose Meter
transmits glucose test results to your partner device.
Your OneTouch
®
UltraLink™Meter comes from the factory pre-set to automatically transmit
glucose test results to the partner device. You must also program the partner device to
recognize the unique meter ID stored in your meter for test results to be received. This will
help ensure that only results from your OneTouch
®
UltraLink™Meter will be received by your
partner device.
Your meter is subject to and complies with U.S. federal guidelines, Part 15 of the FCC rules
for devices with RF capability. These rules state two conditions specific to the operation of
the device. They are:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may cause
undesirable operation.
These guidelines help ensure that your meter will not affect the operation of other nearby
devices. Additionally, other devices should not affect the use of your meter.
Other wireless devices that are in use nearby, such as a cell or mobile phone, or a wireless
network, may prevent or delay the transmission of data from your meter to your partner
device. Moving away from or turning off these devices may allow communication.
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viii
The meter has been tested and found to be appropriate for use at home. In most cases,
it should not interfere with other home electronic devices if used as instructed. However,
this meter gives off RF energy when the RF feature is turned on and in use; so, if not used
correctly, your meter may interfere with your TV, radio, or other electronic devices that
receive or transmit RF signals. If you experience meter interference problems, you should
try moving your meter away from the source of the interference, or relocate the electronic
device or its antenna to another location to resolve the problem.
If you continue to experience interference problems, contact Customer Service at
1 866 621-4846, or contact support service for the manufacturer of the device causing
the interference.
In locations where cell phone use is not permitted, such as hospitals, some health care
professional offices, and airplanes, you should turn the meter RF feature off.
If you plan to travel to another country, be familiar with local regulations regarding the use
of RF devices. You may contact 1 866 621-4846 for more information about local
regulations.
WARNING: If you plan to use the RF feature on your meter to automatically
transmit test results to your partner device, Do Not let anyone else use your meter
to test their blood glucose. This will prevent other people’s results from being
transmitted to your partner device or being included in your past results and
averages. If you must lend your meter to anyone else, be sure to turn the RF
(PUMP COMM) feature off.
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a
b
e
f
d
g
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1
The OneTouch®UltraLink™Blood Glucose Monitoring System
To test with the OneTouch®UltraLink™System you will need the following:
a OneTouch®UltraLink™Meter (batteries included)
b OneTouch®Ultra®Control Solution
c Lancing Device
If another type of lancing device was included, see the separate instructions
that came with that lancing device.
d OneTouch®Clear Cap
e Sterile Lancets
f Carrying Case
g OneTouch®Ultra®Test Strips
Documents in your kit include this owner’s booklet, a quick reference guide,
a control solution insert, a test strip insert and a warranty registration card. If any
items are missing from your kit, call Customer Service.
WARNING: Keep the meter and testing supplies away from young children.
Small items such as the battery door, batteries, test strips, lancets, protective
disks on the lancets, and control solution vial cap are choking hazards.
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2
Display
Test port
Insert test strip here to
turn meter on for testing
mg/dL is the
pre-set unit of
measure
OK button
Turns the meter on/off
Confirms menu selections
Setting up your system
Getting to know your OneTouch®UltraLink™Blood Glucose Meter and test strips
Front
Back
Test strip
Battery compartment cover
Meter ID
Meter ID
Confirmation
window
Contact bars
Insert into
test port
Edge to
apply sample
Data port
Serial
number
Indicates
selection available
using up or down
button
Up and down buttons
Select or change information
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3
Turning your meter on
There are two ways to turn your meter on:
To perform a test, insert a test strip as far as it will go. The meter will briefly
perform system checks, then the display will turn on.
or,
With the meter turned off, press and hold for two seconds to access MAIN
MENU.
Check that the screen shows solid black for two seconds. If it does, the display
is working properly. If the meter does not power on, try changing the meter
batteries. See pages 58–61.
CAUTION: If you see any light areas within the black start-up screen, there
may be a problem with the meter. Call Customer Service.
Setting up your system
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Turning your meter off
There are several ways to turn your meter off:
• Press and hold for five seconds.
• Your meter will turn off by itself if left alone for two minutes.
• Go to MAIN MENU and press or to highlight METER OFF, then press .
• Before or after completing a test, remove the test strip. If you advance from
the test result screen to the MAIN MENU by pressing , removing the test
strip will not turn the meter off. Use one of the three methods above.
Setting the meter language, date and time
You can change many of the settings that came pre-set with your meter. Before
using your meter for the first time or if you change the meter batteries, you
should check and update these settings. Make sure you complete steps 1
through 8 below to ensure your desired settings are saved.
1. Turn the meter on, see page 3
2. Get to the LANGUAGE screen
When using the meter for the first time, or after changing the meter batteries,
you will automatically start in the LANGUAGE screen.
Setting up your system
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5
Setting up your system
In other cases, from the
MAIN MENU, press or
to select SET UP. To confirm
your selection, press . Then,
press or to select METER
SETTINGS.
To confirm your
selection, press .
The display now shows the LANGUAGE screen.
3. Choose a language
Now press or to highlight the language of your
choice. To confirm your selection, press .
The display now shows the DATE FORMAT screen.
NOTE: If you select the wrong language, press and
hold for five seconds to turn the meter off. Then, turn
the meter back on and re-start from step 1.
4. Set the date format
Press or to highlight the date format—choose
month first (MM-DD-YYYY) or day first (DD-MM-YYYY).
To confirm your selection, press .
The display now shows the DATE SET UP screen.
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6
5. Set the date
In the DATE SET UP screen, press or to change the
first value. To confirm your selection, press .
Press or to change the second value.
To confirm your selection, press .
Press or to change the year. To confirm your
selection, press .
The display now shows the TIME FORMAT screen.
6. Set the time format
Press or to select the time format you
prefer—AM/PM or 24 HR. To confirm your selection,
press .
The display now shows the TIME SET UP screen.
Setting up your system
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7
Setting up your system
7. Set the time
Press or to set the hour.
To confirm your selection,
press .
Press or to set the minutes.
To confirm your
selection, press .
If you have selected the AM/PM time format, AM or PM
will be displayed next to the minutes.
Press or to set AM or PM.
To confirm your selection,
press .
The display now shows the SETTINGS screen.
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8
If you want to cancel your settings and start the settings process over again,
press or to highlight NO and press . You will be returned to the
LANGUAGE screen. Note that none of the settings you entered will be saved.
Setting up your system
8. Confirm your settings
The choice YES will be highlighted at the bottom of the
screen. If your settings are correct, press to confirm
and save the settings and return to the MAIN MENU.
WARNING: The unit of measure mg/dL must be displayed here.
If your display shows mmol/L rather than mg/dL, contact Customer
Service. You cannot change the unit of measure. Use of the wrong unit
of measure may cause you to misinterpret your blood glucose level,
and may lead to incorrect treatment.
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9
Setting up your system
Turning the flags/comments feature off or on
Your OneTouch®UltraLink™Meter allows you to attach optional notes to any blood
glucose test result. See pages 40–43 for the types of meal flags and comments
you can attach to a result, and the reasons for using this feature.
We suggest you talk to your health care professional to see how meal flags
and comments may help you manage your diabetes.
If you do not wish to track separate result averages for before and after meals, nor
attach comments to any test result, you may turn this feature off. See page 10.
If you turn off the flags/comments feature, you will not see on the test result
screen after you complete a blood glucose test. You will be able to review the ALL
RESULTS AVG
screen, but not before- or after-meal averages. See page 46 for
more information about result averages.
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10
Setting up your system
To turn the flags/comments feature off or on:
1. From MAIN MENU, press or to select SET UP
To confirm your selection, press .
2. From the SET UP screen, select FLAGS/COMMENTS
To confirm your selection, press .
3. Press or to highlight your response
Select YES if you wish to change the setting, or NO if
you wish to leave it as it is.
Press to confirm your selection and return to MAIN
MENU
.
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Automatic transmission of blood glucose test results to your partner device
Blood glucose test results will be transmitted automatically to your partner
device when:
• the PUMP COMM feature is turned on, and
• your meter and partner device are paired (“linked”).
Turning the PUMP COMM (partner device communication) feature on and off
The PUMP COMM feature allows your meter to automatically transmit glucose
test results to your partner device using a wireless (RF) link.
The meter comes pre-set with the PUMP COMM feature turned on. If you turn the
PUMP COMM feature off, your test results will not be transmitted automatically,
and you will need to manually enter test results into your partner device.
Setting up your system
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Setting up your system
To turn the PUMP COMM feature off or on:
1. From MAIN MENU, press or to select PUMP
COMM
To confirm your selection, press .
2. Press or to highlight your response
Your unique meter ID will be displayed on the top
line of the screen. The current PUMP COMM setting
will be displayed underneath.
Select YES if you wish to change the setting,
or NO if you wish to leave it as it is.
Press to confirm your selection and return to MAIN MENU.
To confirm the PUMP COMM feature is set the way you want, select PUMP COMM
from the MAIN MENU and press .
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Pairing (linking) your meter and partner device
Programming your meter ID links your partner device to the meter. If you do not
“link” the meter to your partner device, you will enter your blood glucose test
results manually. Each meter has its own unique ID. This helps ensure only
partner devices with your unique meter ID can automatically receive blood
glucose test results from your meter. Partner devices without your unique meter
ID cannot receive your blood glucose test results.
Your unique meter ID is stored in the meter memory.
To display the ID on your meter, you must complete
step 1 in the previous section. The ID also appears
on both labels on the back side of the meter.
IMPORTANT: See your partner device manual for instructions for programming
your meter ID into your partner device.
Meter ID
Setting up your system
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Starting the test process
Have these things ready when you test your blood
glucose level:
• OneTouch®UltraLink™Meter
• OneTouch®Ultra®Test Strips
• Lancing device
• Sterile lancets with protective disks
• OneTouch®Ultra®Control Solution
NOTE:
• Use only OneTouch®Ultra®Test Strips with your
OneTouch®UltraLink™Meter.
• Make sure your meter and test strips are about
the same temperature before you test.
• Testing must be done within the operating
temperature range (43–111°F). For the most
accurate results, try to test as close to room
temperature (68–77°F ) as you can.
• OneTouch®Ultra®Test Strips are for single use only.
Never re-use a test strip that had either blood or
control solution applied to it.
CAUTION: The test
strip vial contains drying
agents that are harmful if
inhaled or swallowed and
may cause skin or eye
irritation.
CAUTION: If you
cannot test due to a
problem with your testing
supplies, contact your
health care professional
or Customer Service.
Failure to test could delay
treatment decisions and
lead to a serious medical
condition.
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1. Check the code on the test strip vial before inserting the test strip
Code numbers are used to calibrate your meter with the
test strips you are using.
2. Insert a test strip to turn on the meter
Start with the meter off. If you have turned the meter
on to change settings or review past results,turn it off.
Remove a test strip from its vial and immediately replace
the vial cap and close it tightly. With clean, dry hands,
you may touch the test strip anywhere on its surface.
Do Not bend, cut or modify the test strips in any way.
Use each test strip immediately after removing it from
the vial.
Insert the test strip into the test port as shown. Make sure the three contact bars
are facing you. Push the test strip in as far as it will go. Do Not bend the test
strip.
Starting the test process
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16
After the black start-up screen appears, the meter will
display the code from your last test. If a flashing “––”
appears instead of a code number, such as when you
are first using the meter, follow the instructions in
step 3 to change to a numerical code.
3. Match the code on the meter with the code on the test strip vial
If the code on the meter does not match the code on the
test strip vial, press or to match the code number
on the test strip vial. The new code number will flash on
the display for three seconds, then briefly stop flashing,
after which the display will advance to the APPLY BLOOD
screen.
Starting the test process
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CAUTION: Matching the code on the meter and the code on the test strip
vial is essential to obtaining accurate results. Each time you test, check to
make sure the code numbers match.
NOTE:
• If the APPLY BLOOD screen appears before you are sure the codes match,
remove the test strip, and re-start from step 1, see page 15.
• If you change APPLY BLOOD to APPLY CONTROL by mistake, press to change
it back to APPLY BLOOD.
Starting the test process
If the codes already match, press to go to the APPLY
BLOOD
screen. When you do not make a change after
five seconds, the display will advance to the APPLY
BLOOD
screen.
The meter is now ready to perform a blood glucose test.
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Overview of the OneTouch®Lancing Device
CAUTION: To reduce the chance of infection:
• Make sure to wash the puncture site with soap and water before sampling.
• Never share a lancet or a lancing device with anyone.
• Always use a new, sterile lancet—lancets are for single use only.
• Keep your meter and lancing device clean. See pages 57–58.
NOTE: If you do not have a OneTouch
®
Lancing Device, please refer to the
instructions that came with your lancing device.
Getting a blood sample
OneTouch®UltraSoft®Sterile Lancet
Blue (or black) cap* (for fingertip sampling)
Depth indicator
*The blue (or black) cap and OneTouch
®
Clear Cap are also used for depth adjustment.
Cocking control
Release button
OneTouch
®
Clear Cap*
(for alternate site sampling)
Lancet point
Protective disk
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Choosing the right sampling site at the right time
The OneTouch®UltraLink™Meter allows you to sample blood from your fingertip,
forearm or palm. At times, results obtained at the forearm or palm may be
different from a fingertip measurement. Talk to your health care professional
before you begin using your forearm or palm for sampling.
Use blood
If you are testing: sample from your:
Routinely before meals
Prior to or more than two hours after:
• a meal
• a rapid-acting insulin injection or insulin pump bolus
• exercise
When your blood glucose is changing rapidly, such as:
• within two hours after a meal
• within two hours after a rapid-acting insulin injection
or insulin pump bolus, or
• during or within two hours after exercise
When you are concerned about the possibility of
hypoglycemia (low blood sugar)
When the AST site results do not agree with the way
you feel, during illness or during times of stress
Fingertip
Fingertip, forearm,
or palm
Getting a blood sample
Fingertip, forearm,
or palm
Fingertip
Fingertip
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