LifeScan B OneTouch UltraLink Blood Glucose Meter User Manual Manual

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UltraLink®
Blood Glucose Monitoring System
User Handbook
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Table of Contents
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 User Handbook 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.
Setting up your system
Starting the test process
13
Getting a blood sample
16
Applying blood and reading results
25
Attaching flags or comments to your results
34
Reviewing past results and averages
37
Control solution testing
42
Caring for your system
47
Troubleshooting
52
Detailed Information about your system
60
Index
70
* For information on compatible Medtronic Diabetes devices, contact Medtronic directly.
** M
 edtronic partner devices include MiniMed Paradigm® Insulin Pumps and Guardian® REAL-Time Continuous
Glucose Monitoring Systems.
Throughout this handbook, references to Medtronic Diabetes devices will be referred to as simply “partner devices”.
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m WARNING: Failure to carefully follow the directions in this User Handbook
can lead to inaccurate test results.
Before you begin
Before using this product to test your blood glucose, carefully read this User Handbook
and the inserts that come with the OneTouch® Ultra® Test Strips and OneTouch® Ultra®
Control Solutions. Take note of warnings and cautions throughout this booklet, which
are identified with m. Many people find it helpful to practice the test with control
solution before testing with blood for the first time. See page 42 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
• 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® can be set up to automatically
transmit glucose results to the partner device. See your partner device manual for
instructions for setting up, using, and troubleshooting problems with your partner
device.
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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.
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
automatically transmits glucose test results to your 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 electronic devices. Additionally, other electronic devices should not affect the use
of your meter.
Other electronic 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 electronic devices may allow
communication.
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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 BG link 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 electronic 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 set the meter BG link mode to 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.
The OneTouch® UltraLink® Blood Glucose Monitoring System
To test with the OneTouch® UltraLink® System you will need the following:
a. O neTouch® UltraLink® Meter (batteries included)
b. Lancing Device
If another type of lancing device was included,
see the separate instructions that came
with that lancing device.
c. OneTouch® Clear Cap
d. Sterile Lancets
e. Carrying Case
Available separately:
f. OneTouch® Ultra® Control Solution
m WARNING: If you plan to use the BG link 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 set the BG link mode to off.
g. OneTouch® Ultra® High Control Solution
h. OneTouch® Ultra® Test Strips
Additionally, your kit includes this User Handbook. For availability of test strips and
control solutions, contact LifeScan Customer Service or ask your pharmacist or health care
professional. If any items are missing from your kit, call Customer Service.
m 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 caps are choking hazards.
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Turning your meter on
There are two ways to turn your meter on:
Setting
system
Setting upup
youryour
system
The OneTouch® UltraLink® Blood Glucose Meter
and test strips
Front
Display
• 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,
Back
• With the meter turned off, press and hold
Test port
Insert test strip here
to turn meter on for
testing
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 48-51.
Meter ID
Serial
number
mg/dL is the
pre-set unit of
measure
Indicates
selection available
using up or down
button
OK button
Turns the meter on/off
Turns backlight on/off
Confirms menu selections
Data port
Battery compartment
cover
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NOTE: The backlight also lights the test port, and the
Confirmation
window
Contact bars
Insert into test port
and
buttons.
Turning your meter off
There are several ways to turn your meter off:
•
•
•
•
Test strip
m CAUTION: If you see any light areas within the black start-up screen, there may be a
problem with the meter. Call Customer Service.
Using the meter backlight
When the meter is on, press and hold for two seconds to turn the backlight on or off.
Up and down buttons
Select or change information
Edge to
apply sample
for two seconds to access MAIN MENU.
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 methods above.
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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.
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.
Then, press or to select METER SETTINGS. To
confirm your selection, press .
The display now shows the LANGUAGE screen.
Now press or to highlight the language of your
choice. To confirm your selection, press .
The display now shows the DATE FORMAT screen.
LANGUAGE
ENGLISH
ESPAÑOL
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.
1. Turn the meter on, see page 3
In other cases, from the MAIN MENU, press or
select SET UP. To confirm your selection, press .
3. Choose a language
to
MAIN MENU
PUMP LINK
LAST RESULT
ALL RESULTS
RESULT AVG
SET UP
METER OFF
SET UP
METER SETTINGS
FLAGS/COMMENTS
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.
DATE FORMAT
MM-DD-YYYY
DD-MM-YYYY
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 .
DATE SET UP
SET DATE:
06 - 08 - 2010
MM DD YYYY
The display now shows the TIME FORMAT screen.
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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.
TIME FORMAT
AM/PM
24HR
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.
SETTINGS
ENGLISH
06/08/10
11:15 AM
mg/dL
SETTINGS OK?
YES
7. Set the time
Press
press
or
to set the hour. To confirm your selection,
Press or to set the minutes. To confirm your
selection, press .
TIME SET UP
SET TIME:
11 : 15 AM
Press or to set AM or PM. To confirm your
selection, press .
m 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.
TIME SET UP
SET TIME:
11 : 15 AM
If you have selected the AM/PM time format, AM or PM
will be displayed next to the minutes.
NO
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.
TIME SET UP
SET TIME:
11 : 15 AM
The display now shows the SETTINGS screen.
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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 34-36 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 below.
on the test result screen
If you turn off the flags/comments feature, you will not see
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 39 for more information about
result averages.
To turn the flags/comments feature off or on:
1. From MAIN MENU, press
or
To confirm your selection, press
to select SET UP
3. Press
or
to highlight your response
FLAGS/COMMENTS
Select YES if you wish to change the setting, or NO if you
wish to leave it as it is.
NOW SET TO: ON
Press to confirm your selection and return to
MAIN MENU.
CHANGE TO OFF?
YES
NO
Transmission of blood glucose test results to your
partner device
Blood glucose test results will automatically be transmitted to your partner device when:
• BG link mode is set to allow results to be transmitted, and
• your meter and partner device are paired (“linked”), and
• your meter option is turned on in your partner device.
Setting the BG link mode on your meter
The BG link mode lets you choose if and how your glucose results should be transmitted from
the meter to your partner device after taking a test.
2. From the SET UP screen, select FLAGS/COMMENTS
To confirm your selection, press
SET UP
METER SETTINGS
FLAGS/COMMENTS
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1. From MAIN MENU, press
PUMP LINK
or
To confirm your selection, press
to highlight
MAIN MENU
PUMP LINK
LAST RESULT
ALL RESULTS
RESULT AVG
SET UP
METER OFF
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The display now shows the PUMP LINK screen:
PUMP LINK
ULTRALINK METER ID:
123456
2. With BG LINK MODE highlighted, press
The display now shows the BG LINK MODE screen.
BG LINK MODE
ASK AFTER BG TEST
Indicates that the BG link mode is ASK AFTER
BG TEST. This means you would like to decide
whether or not to transmit glucose results to your
partner device after each test.
MENU
3. On the BG LINK MODE screen press
To make your selection, press
or
to highlight your choice
There are three options for setting the BG link mode:
BG LINK OFF
Indicates that the BG link mode is OFF. This means
glucose results will not be transmitted to your
partner device after each test.
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BG LINK MODE
BG LINK ON
BG LINK OFF
ASK AFTER BG TEST
BG LINK ON
BG LINK OFF
ASK AFTER BG TEST
BG LINK MODE
With CONFIRM highlighted, press to confirm your
selection and return to the PUMP LINK screen.
If you want to change to a different BG link mode,
press or to highlight CHANGE and press
to return to the BG LINK MODE screen.
• BG Link on
• BG Link off
• Ask after BG test
BG LINK ON
Indicates that the BG link mode is ON. This means
glucose results will be automatically transmitted to
your partner device after each test.
4. Confirm your selection
BG LINK MODE
ASK AFTER BG TEST
CONFIRM
CHANGE
NOTE: The BG link mode icon/symbol that corresponds to the selection you made will also
appear on the APPLY BLOOD screen when taking a test. The meter allows you to change the
BG link mode before you apply your blood sample. See page 15.
BG LINK MODE
BG LINK ON
BG LINK OFF
ASK AFTER BG TEST
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Pairing (linking) your meter and partner device
Programming your meter ID into your partner device links that partner device to the meter.
If you do not “link” the meter to your partner device, you will need to 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 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 the label on the back
side of the meter.
Meter ID
IMPORTANT: See your partner device manual for instructions for programming your meter
ID into your partner device.
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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:
• U se only OneTouch® Ultra® Test Strips with your OneTouch® UltraLink® Meter.
•M
 ake 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.
m CAUTION:
• I f 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.
• The test strip vial contains drying agents that are harmful if inhaled or swallowed and
may cause skin or eye irritation.
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1. Check the code on the test strip vial before
inserting the test strip
3. Match the code on the meter with the code on the
test strip vial
Code numbers are used to calibrate your meter with the
test strips you are using.
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.
2. Insert a test strip to turn on the meter
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.
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.
APPLY BLOOD
The meter is now ready to perform a blood glucose test.
(Example with BG LINK ON)
m 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.
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.
NOTE:
• I f the APPLY BLOOD screen appears before you are sure the codes match, remove the test
strip, and re-start from step 1, see page 14.
After the black start-up screen appears, the meter will
display the code from your last test.
CAL CODE
25
CHECK CODE
14
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• I f you change APPLY BLOOD to APPLY CONTROL by mistake, press
APPLY BLOOD.
to change it back to
4. Confirm the BG link mode
When the APPLY BLOOD screen appears, an icon also appears in the lower left corner of the
display to indicate the current BG link mode setting. If you would like to change the BG link
mode (for this and future test results) press until the desired icon
appears.
See pages 9-11 for more information.
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Getting a blood sample
Overview of the OneTouch® Lancing Device
Cocking control
OneTouch Clear Cap*
(for alternate site sampling)
®
Release button
Depth indicator
Protective disk
Black cap* (for fingertip sampling)
OneTouch UltraSoft Sterile Lancet Lancet point
®
®
*The black cap and OneTouch® Clear Cap are also used for depth adjustment.
m 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 47-48.
NOTE: If you do not have a OneTouch® Lancing Device, please refer to the instructions that
came with your lancing device.
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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.
If you are testing:
Use blood sample from your:
Routinely before meals
Fingertip, forearm, or palm
Prior to or more than two hours after:
• a meal
• a rapid-acting insulin injection or insulin
partner device bolus
• e xercise
Fingertip, forearm, or palm
When your blood glucose is changing rapidly,
such as:
•w
 ithin two hours after a meal
• within two hours after a rapid-acting insulin
injection or insulin partner device bolus, or
• d uring or within two hours after exercise
Fingertip
When you are concerned about the possibility of
hypoglycemia (low blood sugar)
Fingertip
When the AST site results do not agree with the
way you feel, during illness or during times of
stress
Fingertip
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2/23/10 12:02:31 PM
IMPORTANT: Be sure to read your partner device manual carefully and consult with your
health care professional before using alternate site blood glucose results obtained from
your meter with the partner device. For example, calibrating continuous glucose monitoring
systems.
m CAUTION: Do Not test on your forearm or palm when:
• You think your blood glucose is rapidly falling, such as within two hours of exercise or
a rapid-acting insulin injection or insulin partner device bolus. Testing with a fingertip
sample may identify hypoglycemia or an insulin reaction sooner than testing with a
forearm or palm sample.
• It has been less than two hours after a meal, a rapid-acting insulin injection or insulin
partner device bolus, physical exercise, or you think your glucose level is changing
rapidly.
• You are concerned about the possibility of hypoglycemia or an insulin reaction, such
as when driving a car. This is especially important if you suffer from hypoglycemia
unawareness (lack of symptoms to indicate an insulin reaction).
Remember: Consult with your health care professional before using your forearm or palm for
testing.
Choose a different puncture site each time you test. Repeated punctures in the same spot
may cause soreness and calluses.
Preparing your sample site
Before you test your blood glucose, wash your hands and
forearm (if applicable) thoroughly with warm, soapy
water. Rinse and dry.
Lancing and sampling from your fingertip
1. Remove the black cap by snapping it off
2. Insert a sterile lancet into the OneTouch® Lancing Device
Insert the lancet into the holder and push in firmly. Twist the protective disk until it separates
from the lancet and save the disk for later use. Do Not twist the lancet.
If bruising occurs at an alternate site or you have difficulty getting a sample, consider
sampling from a fingertip instead. You may want to review the choice of sites with your
health care professional.
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2/23/10 12:02:33 PM
3. Replace the black cap by snapping it back on
7. Get a round drop of blood
4. Adjust the depth setting
Gently squeeze and/or massage your fingertip until a
round drop of blood ( sample size) forms.
The OneTouch® Lancing Device has nine puncture depth
settings, numbered 1 through 9. The smaller numbers are
for a shallower puncture, and the larger numbers are for
a deeper puncture. Shallower punctures work for children
and most adults. Deeper punctures work well for people
with thick or callused skin. Twist the black cap until the
correct setting appears.
NOTE: A shallower puncture may be less painful. Try a shallower setting first and increase
the depth until you find the one deep enough to get a sufficient blood drop ( sample size)
for testing.
If the blood smears or runs, Do Not use that sample. Wipe the area
and gently squeeze another drop of blood or puncture a new site.
5. Cock the OneTouch® Lancing Device
Lancing and sampling from an alternate site
Slide the cocking control back until it clicks. If it does not
click, it may have been cocked when you inserted the
lancet.
Sampling from your palm or forearm allows you to use your fingertips less often. You
may find that obtaining a blood sample from an alternate site is less painful than using
a fingertip. Getting a blood sample from your forearm or palm is different than getting a
sample from your fingertips.
Forearm sampling
6. Puncture your finger
Hold the OneTouch® Lancing Device firmly against the
side of your finger. Press the release button. Remove the
OneTouch® Lancing Device from your finger.
Choose a fleshy area of the forearm away from bone,
visible veins and hair. Sometimes there is less blood flow to
the forearm than to the fingertips. To help you get a large
enough drop of blood, you may gently massage or apply
warmth to the site to increase blood flow.
Forearm
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2. Insert a sterile lancet into the OneTouch®
Lancing Device
Palm sampling
Choose a fleshy area on the palm below your thumb or
pinky finger. Select a spot with no visible veins and away
from deep lines which may cause your blood sample to
smear.
Insert the lancet into the holder and push in firmly. Twist
the protective disk until it separates from the lancet and
save the disk for later use. Do Not twist the lancet.
Palm
IMPORTANT: Be sure to read your partner device manual carefully and consult with your
health care professional before using alternate site blood glucose results obtained from
your meter with the partner device. For example, calibrating continuous glucose monitoring
systems.
The OneTouch® Clear Cap is used
for forearm and palm sampling
only. Replace the black cap with the
OneTouch® Clear Cap.
Black cap for fingertip sampling only
1. Remove the black cap by snapping it off
3. Install the OneTouch® Clear Cap on the
OneTouch® Lancing Device by snapping it on
4. Adjust the depth setting
You may have to adjust the OneTouch® Lancing Device to
a deeper setting to get a large enough drop of blood from
your forearm or palm. Twist the OneTouch® Clear Cap
toward the larger numbers to increase the depth.
5. Cock the OneTouch® Lancing Device
Slide the cocking control back until it clicks. If it does not
click, it may have been cocked when you inserted the
lancet.
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2/23/10 12:02:45 PM
6. Puncture your forearm or palm
Firmly press and hold the lancing device against your
forearm or palm for a few seconds. Wait until the skin
surface under the OneTouch® Clear Cap changes
color (as blood collects beneath the skin). This tells
you there is enough blood flow for a good sample.
Then press the release button while continuing to apply
pressure. Keep holding the lancing device against your
skin until a round drop of blood forms under the cap.
Applying blood and reading results
Once you have a blood sample and your meter shows the APPLY BLOOD screen, you are
ready to obtain a blood glucose result. If your meter does not show the APPLY BLOOD screen,
remove the unused test strip and re-start the test process. See page 13.
Forearm
7. Remove the OneTouch® Lancing Device
Keeping your finger extended and steady, move the meter
and test strip toward the blood drop.
Do Not apply blood on the top of
the test strip.
Carefully lift the lancing device away from your skin.
Do Not smear the blood sample.
NOTE:
• Y ou may need to wait a little longer to get a large
enough drop of blood from the forearm or palm.
Do Not squeeze the site excessively.
1. Prepare to apply the sample
Fingertip
Palm
• I f the sample drop of blood runs or spreads due to contact with hair or with a line in your
palm, Do Not use that sample. Try puncturing again in a smoother area.
Do Not hold the meter and test strip underneath the blood drop.
This may cause blood to run into the test port and damage the
meter.
• R emember: You may have to adjust the lancing device to a deeper setting to get a large
enough drop of blood.
IMPORTANT: Be sure to read your partner device manual carefully and consult with your
health care professional before using alternate site blood glucose results obtained from
your meter with the partner device. For example, calibrating continuous glucose monitoring
systems.
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2/23/10 12:02:48 PM
When applying a drop of blood from your forearm or palm, keep your palm or forearm steady
and bring the top edge of the test strip to the drop of blood with your other hand.
IMPORTANT: Be sure to read your partner device manual carefully and consult with your
health care professional before using alternate site blood glucose results obtained from
your meter with the partner device. For example, calibrating continuous glucose monitoring
systems.
Be careful not to push the test strip against your fingertip or the
test strip may not fill completely.
NOTE:
• D o Not smear or scrape the drop of blood with the test strip.
• D o Not apply more blood to the test strip after you have moved
the drop of blood away.
• D o Not move the test strip in the meter during a test.
m CAUTION: You may get an ERROR 5 message or an inaccurate result if the blood
sample does not fill the confirmation window completely. See page 57. Discard the test
strip and re-start the test process.
2. Apply the sample
Line up the test strip with the blood drop so that the narrow channel on the edge of the test
strip is almost touching the edge of the blood drop.
3. Wait for the confirmation window to fill
completely
The blood drop will be drawn into the narrow channel and
the confirmation window should fill completely.
Confirmation window full
Narrow Channel
Gently touch the channel to the edge of the blood drop.
When the confirmation window is full, this means
you have applied enough blood. Now you can move
the test strip away from the blood drop and wait for
the meter to count down from 5 to 1.
Full
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Not full
27
2/23/10 12:02:52 PM
4. Read your result on the meter
•	If the BG link mode is ASK AFTER BG TEST
you must confirm that you want the result
transmitted. To transmit this result, press with YES highlighted. Your result will then
flash on the display, to indicate it is being transmitted.
Your blood glucose level appears on the display, along with
the unit of measure, and the date and time of the test.
Blood glucose results are automatically stored in the meter’s
memory.
104
mg/dL
SEND BG VALUE?
YES
NO
(Example)
5. Check that the result has been transmitted to your partner device
NOTE: Results are transmitted only if your meter and partner device are paired and the meter
or ASK AFTER BG TEST .
BG link mode is set to either BG LINK ON
• If the BG link mode is BG LINK ON
the blood glucose
test result will begin to flash as soon as it appears on
the display, to indicate it is being transmitted.
➧
104
06-17-10
If you do not want to transmit this result, press or
to highlight NO and press . You will return to
the result screen.
mg/dL
3:37 PM
104
mg/dL
06-17-10 3:37 PM
104
06-17-10
mg/dL
3:37 PM
When the transmission is successful, the result stops
flashing and a “transmitted” icon
will appear to the
right of your result.
104
mg/dL
06-17-10 3:37 PM
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After about 60 seconds, if the result has not been
successfully transmitted, the meter will stop transmitting.
The meter display will provide the option to retry or
cancel the transmission.
METER SEND
CONNECTION PROBLEM
CHECK CONNECTED
PUMP
To cancel the transmission, press
highlight CANCEL and press .
with RETRY
or
If you are having difficulty transmitting your result see
page 52 in the Troubleshooting section.
• A ttach notes to this result if the flags/comments feature is on, see page 34, or
to go to MAIN MENU, see page 37, or
• T urn the meter off by removing the test strip.
CANCEL
NOTE:
to
If you select CANCEL, you will return to the result screen.
The “delivery cancelled” icon
will appear to the right
of your result.
Once you have read your result and transmission is complete or cancelled, you may:
• R eview your meter memory by pressing
RETRY
To retry the transmission, press
highlighted.
After getting a result
• Y our result may only flash for a few seconds before it is received by your partner device.
104
• S ee your partner device manual for instructions on how to manually enter your glucose
result into the partner device if it was not transmitted.
mg/dL
06-17-10 3:37 PM
6. Confirm that a test result is received by the partner device
When the partner device is idle, it will beep or vibrate when it receives a glucose result from
your meter. The result will also appear on the partner device display. See your partner device
manual for more information.
•W
 hile the result is flashing, your meter will only respond to pressing the button for five
seconds. This will cancel the transmission of your result to your partner device but only if
the result has not already been transmitted.
• I f you remove the test strip while the result is flashing, the meter will stay on until the
result is received by the partner device. Then the meter will turn off. Leave the test strip in
the meter if you plan to add meal flags or comments to your result.
• I f the result does not flash, check to be sure the BG link mode is set to allow results to be
transmitted to the partner device. If the result is not received by the partner device, refer to
page 52 in the Troubleshooting section for instructions.
•W
 ARNINGS/ERRORS, LOW GLUCOSE and HIGH GLUCOSE test results, and control solution
test results are Not transmitted to your partner device.
m WARNING: If mg/dL does not appear with the test result, call Customer
Service. 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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2/23/10 12:02:55 PM
m CAUTION: If you test at the low end of the operating range (43°F) and your glucose
is high (over 180 mg/dL), the reading on your meter may be lower than your actual
glucose. In this situation, repeat the test in a warmer environment with a new test strip
as soon as possible.
Error messages
If you get an ERROR message on your screen rather than a result, see pages 52-59.
Unexpected test results
Refer to these cautions m whenever your test results are lower than, higher than, or not
what you expect.
m CAUTION: Dehydration and low glucose results
• You may get false low glucose results if you are severely dehydrated. If you think you
are severely dehydrated, contact your health care professional immediately.
m CAUTION: Low glucose results
• If your test result is lower than 70 mg/dL or is shown as LOW GLUCOSE, it may mean
hypoglycemia (low blood glucose). This may require immediate treatment according
to your health care professional’s recommendations. Although this result could be due
to a test error, it is safer to treat first, then do another test.
m CAUTION: High glucose results
• If your test result is higher than 180 mg/dL, it may mean hyperglycemia (high blood
glucose). If you are uncertain about this test result, consider re-testing. Your health
care professional can work with you to decide what actions, if any, you should take if
your results are higher than 180 mg/dL.
m CAUTION: High glucose results
• If your meter displays HIGH GLUCOSE, you may have a very high blood glucose level
(severe hyperglycemia) exceeding 600 mg/dL. Re-check your glucose level. If the
result is HIGH GLUCOSE again, this indicates a severe problem with your blood glucose
control and it is important you obtain and follow instructions from your health care
professional without delay.
m CAUTION: Repeated unexpected glucose results
• If you continue to get unexpected results, check your system with control solution.
See Control solution testing, pages 42-46.
• I f you are experiencing symptoms that are not consistent with your blood glucose
results and you have followed all instructions in this User Handbook, call your health
care professional. Never ignore symptoms or make significant changes to your
diabetes control program without speaking to your health care professional.
m CAUTION: Unusual red blood cell count
• A hematocrit (percentage of your blood that is red blood cells) that is either very high
(above 55%) or very low (below 30%) can cause false results.
Removing the used lancet
Remove the lancing device cap by snapping it off. Cover the
exposed lancet tip before removing the lancet. Place
the lancet protective disk on a hard surface. Push the lancet
tip into the disk. Remove the lancet and place it in a container
for sharp objects. Replace the cap.
Disposing of the used lancet and test strip
Used test strips and lancets may be considered biohazardous waste in your area. Be sure to
follow your health care professional’s recommendations or your local regulations for proper
disposal.
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Attaching flags or comments to your test results
Add or change a meal flag
Your meter allows you to attach optional notes to your blood glucose result. There are two
kinds of notes and different reasons to apply them.
If the flags/comments feature is turned on, the up arrow at the bottom right corner of the
result screen will flash when a result is first displayed. If the result was transmitted to the
partner device, the up arrow will flash after the result has been transmitted. The flashing
arrow is to remind you to enter a meal flag.
Note type
Recommendation
Benefit
Meal Flag
Add a meal flag to every blood
glucose test result.
Allows you to link the effects of
food to your blood glucose results.
To add or change a meal flag:
Provides you with separate
averages for before-meal and
after-meal tests.
If you have transmitted your test result to the partner device, wait for the test result to stop
flashing.
Comment
Select an appropriate comment
whenever you test under
conditions that you or your
health care professional feel are
worth noting.
Helps track possible reasons for
test results.
You can attach notes just after a blood glucose test, or after the result has been transmitted
to the partner device if the BG link mode is set to allow results to be transmitted to the
partner device. In both cases you must attach the notes before you remove your used test
strip from your meter. You can also add or remove notes when reviewing a past result.
You will not be able to add a meal flag or comment to a result marked as a control solution
test.
You can choose not to attach a meal flag or comment after a blood glucose test. If you do
not want to use this feature at all, you can turn it off so the meter will not prompt you to add
notes or to select a type of result average to review. See pages 8-9 for instructions.
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AW05946101/A_OT UltraLink_UH_Insides_R8.indd 34-35
1. While viewing a result, press
2. Press or
AFTER MEAL
to display the MEAL FLAG screen
to highlight BEFORE MEAL or
If you decide not to assign a flag to this result, select
NO FLAG.
MEAL FLAG
BEFORE MEAL
AFTER MEAL
NO FLAG
3. To confirm your selection, press
The meal flag you chose will appear above the result on
the result screen.
AFTER MEAL
138
mg/dL
06-17-10 1:45 PM
NOTE: Testing after a meal can show how the food you ate affects your blood glucose. These
results can be flagged as AFTER MEAL and are usually obtained two hours after the start of
the meal. Your health care professional may suggest another time period or other use for this
feature.
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2/23/10 12:02:56 PM
Add or change a comment
The down arrow at the bottom right corner of the result screen will flash after you enter a
meal flag for a new result to remind you to consider entering a comment.
To add or change a comment:
1. While viewing a result, press
2. Press
or
to display the COMMENT screen
NO COMMENT
NOT ENOUGH FOOD
TOO MUCH FOOD
MILD EXERCISE
HARD EXERCISE
MEDICATION
STRESS
ILLNESS
FEEL HYPO
MENSES (period)
VACATION
OTHER
If you have just completed a test, press to get to the
MAIN MENU screen. If your meter is off, press and
hold to turn it on. From the MAIN MENU screen you
can choose:
• L AST RESULT to view your most recent result,
• A LL RESULTS to review up to 1000 of your most recent
results, or
to highlight an appropriate comment
The available choices are:
Reviewing
Setting
up yourpast
systemresults and averages
MAIN MENU
PUMP LINK
LAST RESULT
ALL RESULT
RESULTS AVG
SET UP
METER OFF
• R ESULT AVG to select one of three types of result averages.
COMMENT
NO COMMENT
NOT ENOUGH FOOD
TOO MUCH FOOD
MILD EXERCISE
1 OF 3
Highlight NO COMMENT if you decide not to add a comment, or if you want to erase a
previously entered comment from the result.
Press or to highlight LAST RESULT, ALL RESULTS, or RESULT AVG.
To confirm your selection, press .
Last result
The meter will display your most recent result. This result will include the unit of measure
and the date and time of the test. If the result was marked as CONTROL SOLUTION or with
either a meal flag or comment, these notes will be shown as well. Press to return to
MAIN MENU. If you wish to add or change a meal flag or comment for this result, see pages
35-36.
Use OTHER when the available choices do not apply. You may want to write down what
OTHER means to you so you can discuss it with your health care professional.
3. To confirm your selection, press
The comment you chose will appear below the result.
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AFTER MEAL
138
mg/dL
TOO MUCH FOOD
06-17-10 1:45 PM
37
2/23/10 12:02:57 PM
All results
Result averages
The meter will display four results at a time, in the order the tests were done, starting with
the most recent. For each test result, the meter will display the date and time of the test.
Results may also contain the following symbols:
If the flags/comments feature is on, the meter will display the three types of averages you
can access:
• the average of before-meal results, and
HI if the result was above 600 mg/dL.
LO if the result was below 20 mg/dL.
if a comment has been chosen for the result.
C if the result is from a control solution test.
– if the result is flagged BEFORE MEAL.
+ if the result is flagged AFTER MEAL.
ALL RESULTS
mg/dL
09-19 2:25 PM 104
09-18 8:15 AM 90
09-17 10:23 AM 112
09-16 11:44 AM LO C
1 of 4
MENU
The meter stores a maximum of 1000 blood glucose or control solution test results. When the
memory is full, the oldest result is dropped as the newest is added.
• the average of after-meal results.
MENU
To select the type of result average you want to see, press
then press .
The meter will display each of your 7-, 14-, and 30-day
averages. The top of the display shows which type of
average you are looking at.
To view more recent results, continue to press after the top result on the display is
highlighted. If you press when the most recent result is highlighted, you will see the
oldest stored results.
For each of the 7-, 14-, and 30-day periods leading up to
the current date, the meter will display the number of
results obtained (NUM) and the average of those results
(AVG).
To view older results, press after MENU is highlighted. Pressing and holding
allows you to move more quickly through the results.
or
or
to highlight your choice,
If you have turned the flags/comments feature off, selecting RESULT AVG from the MAIN
MENU will lead directly to the ALL RESULTS AVG screen.
To view details of an individual result, press or to highlight the result you want,
then press . If you wish to add or change a meal flag or comment for this result, see pages
35-36. To return to the list of all results from an individual result, press .
To return to the main menu, highlight MENU, then press
RESULT AVG
ALL RESULTS AVG
BEFORE MEAL AVG
AFTER MEAL AVG
• the average of all test results,
BEFORE MEAL AVG
mg/dL
DAYS
14
30
NUM
14
34
43
AVG
148
140
137
In result averages, a HIGH GLUCOSE result is counted as 600 mg/dL, and a LOW GLUCOSE
result as 20 mg/dL. Control solution results are not part of your averages.
to go back to the previous screen. To return
From any screen showing averages, press
to the main menu from the RESULT AVG screen, press until MENU is highlighted, then
press
to confirm your selection.
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2/23/10 12:02:57 PM
NOTE:
• Result averages provide information from past results. Do Not use result averages to make
immediate treatment decisions.
• I f you change your date setting, your averages may change too. The meter calculates
averages based on the 7-, 14-, and 30-day periods ending on the current date setting.
• I f you do not have results in the past 7-, 14-, and 30-day
periods, the NUM and AVG columns will show 0. Also,
if you do not use the meal flag feature, then the NUM
and AVG columns will show 0 on the BEFORE MEAL and
AFTER MEAL average screens.
ALL RESULTS AVG
mg/dL
DAYS
14
30
NUM
AVG
To see averages for different parts of the day or over a
different number of days, you can use OneTouch®
Diabetes Management Software and your home computer.
See the next section, on page 40.
Downloading results to a computer
You can use your meter with OneTouch® Diabetes Management Software (DMS) for storing
your records and to help you spot patterns for planning meals, exercise, and medication.
OneTouch® DMS puts information downloaded from the meter into charts and graphs.
Use only the mini USB interface cable provided by LifeScan, Inc. Connect only to a computer
certified to UL 60950-1.
1. Obtain the required software
m WARNING:
• The use of electronic devices may result in the build up of electrostatic
discharge (ESD) which can impact their use.
• To avoid a possible shock, Do Not insert a test strip or change the batteries
when the meter is connected to a computer with the interface cable.
NOTE: For downloading instructions to Medtronic CareLink® Personal Software, refer to
www.carelink.medtronicdiabetes.com.
3. Get ready to transfer readings
Connect the mini USB interface cable provided by LifeScan
to the USB port on your computer. Make sure the meter is
turned off. If you insert the cable while the meter is already
on, the meter will not respond to computer commands.
Then connect the other end of the interface cable to the
meter data port.
4. Transfer data
Mini USB interface cable
Follow the instructions provided with the OneTouch® DMS to download the results from the
meter. Once the command to start the download is sent from the computer to the meter, the
meter display will show “PC” indicating that the meter is in communication mode. You will
not be able to perform a test when the meter is in communication mode.
For order information and to learn more about OneTouch® Diabetes Management Software,
visit www.OneTouchDiabetesSoftware.com.
2. Install the software on a computer
Follow the installation instructions provided with the Software. Install the USB format
software driver.
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2/23/10 12:02:59 PM
Control
solution
Setting
up yourtesting
system
OneTouch® Ultra® Control Solutions are used to check that the meter and the test strips are
working together properly and that you are performing the test correctly.
Do a control solution test:
•
•
•
•
Whenever you open a new vial of test strips.
If you suspect that the meter or test strips are not working properly.
If you have had repeated unexpected blood glucose results.
If you drop or damage the meter.
NOTE: Results marked as control solution tests are not transmitted to your partner device.
m CAUTION:
• D o Not swallow control solution; it is Not for human consumption.
• D o Not apply control solution to the skin or eyes as it may cause irritation.
Performing a control solution test
Start with the meter off. If you have turned the meter on to change settings or review past
results, turn it off.
1. Check the code on the test strip vial before
inserting the test strip
2. Insert a test strip to turn on the meter
Remove a test strip from its vial and immediately replace
the vial cap and close it tightly. 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.
NOTE:
• Use only OneTouch® Ultra® Control Solutions with your OneTouch® UltraLink® Meter.
• OneTouch® Ultra® High Control Solution (vial with the red cap) can be used in addition
to OneTouch® Ultra® Control Solution (vial with the blue cap). If you test with OneTouch®
Ultra® High Control Solution, you should always test with OneTouch® Ultra® Control
Solution first. Refer to instructions in the OneTouch® Ultra® High Control Solution inserts for
details.
• F or information on second level of control solution, contact Customer Service at
1 866 621-4846. If you cannot reach Customer Service, contact your health care
professional for advice.
• C ontrol solution tests must be done at room temperature (68–77°F). Make sure your
meter, test strips, and control solution are at room temperature before testing.
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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.
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.
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2/23/10 12:03:01 PM
4. Mark the test as a control solution test
APPLY CONTROL
Press to change APPLY BLOOD to APPLY CONTROL.
You must mark the test before you apply control solution.
Once you have completed the test, you cannot change the
marking.
The meter is now ready to perform a control solution test.
m WARNING: Be sure to correctly mark every control solution test or the
result will be mistakenly transmitted to your partner device if the meter is set
to allow results to be transmitted.
6. Read your result
When the confirmation window is full, the meter will count down from 5 to 1.
Your control solution result will then appear on the display, along with the date, time,
unit of measure, and the words CONTROL SOLUTION.
The control solution results can be viewed in the list of past results, but are not counted in
your result averages.
CONFIRMATION
WINDOW
5. Prepare and apply control solution
Shake the control solution vial before each test. Remove the cap and squeeze the vial to
discard the first drop. Then wipe the tip with a clean tissue or cloth. Hold the vial upside
down and gently squeeze a hanging drop.
Touch and hold the hanging drop of control solution where the narrow channel meets the
TOP EDGE of the test strip. Make sure the confirmation window fills completely. Control
solution should not be applied to the flat face of the test strip.
NARROW
CHANNEL
TOP EDGE
112
mg/dL
CONTROL SOLUTION
06-17-10 10:23 AM
7. Check if the result is in range
• I f you are using OneTouch® Ultra® Control Solution
(vial with blue cap), compare to the range on the test
strip vial.
OneTouch® Ultra®
102-136 mg/dL
(Example range)
• I f you are using OneTouch® Ultra® High Control Solution (vial with red cap), compare to the
range on the OneTouch® Ultra® High Control Solution vial or the OneTouch® Ultra® High
Control Solution insert.
Apply drop here
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2/23/10 12:03:02 PM
NOTE:
• I t is important to compare your control solution result with the correct control range or your
result may appear to be out of range.
• I f your control solution result falls outside the expected range, repeat the test with a new
test strip.
Setting
up your
Caring
forsystem
your system
Your OneTouch® UltraLink® Blood Glucose Monitoring System does not need any special
maintenance.
Storing your system
Out-of-range results may be due to:
• not comparing your control solution result with the correct control range on the test strip
vial or control solution vial,
• not following the instructions detailed on pages 43-45,
• use of control solution that is contaminated, expired, or past its discard date,
• use of a test strip that is contaminated, damaged, expired, or past its discard date,
• a problem with the meter, or
• control solution test was performed outside the correct temperature range (68-77°F).
m CAUTION:
• The control solution range printed on the test strip vial and control solution vial are
for OneTouch® Ultra® Control Solution only. It is not a recommended range for your
blood glucose level.
• If you continue to get control solution test results that fall outside the range printed
on the test strip vial or control solution vial, Do Not use the meter, the test strips, or
the control solution. Call Customer Service.
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Store your meter, test strips, control solution and other items in your carrying case after each
use. Store each item in a cool, dry place below 86°F, but Do Not refrigerate. Keep all items
away from direct sunlight and heat.
Tightly close the cap on the test strip vial and/or control solution vial immediately after use
to avoid contamination or damage. Store test strips only in their original vial.
Checking for expiration or damage to test strips and control solution
Test strips and control solution have expiration dates printed on their vials. When you first
open a test strip or control solution vial, you must record the discard date (date opened plus
six months for test strips and date opened plus three months for control solution) in the
space provided on the label.
m CAUTION:
• D o Not use the test strips or control solution after the expiration date printed on the
vial or the discard date, whichever comes first, or your results may be inaccurate.
• D o Not use your test strips if your vial is damaged or left open to air. This could lead
to error messages or tests that read higher than the actual value. Call Customer
Service immediately if the test strip vial is damaged.
47
2/23/10 12:03:03 PM
Cleaning your meter
To clean your meter, wipe the outside with a soft cloth dampened with water and mild
detergent. Do Not use alcohol or another solvent to clean your meter.
Do Not get any liquids, dirt, dust, blood, or control solution inside the meter through the test
port or the data port. Never spray cleaning solution on the meter or immerse it in any liquid.
Cleaning your OneTouch® Lancing Device and OneTouch® Clear Cap
To clean these items, wipe them with a soft cloth dampened with water and mild detergent.
Do Not immerse the OneTouch® Lancing Device in any liquid.
To disinfect these items, prepare a solution of one part household bleach to ten parts water.
Wipe the OneTouch® Lancing Device with a soft cloth dampened with this solution. Immerse
the caps only in this solution for 30 minutes. After disinfecting, rinse briefly with water and
allow both to air dry.
m WARNING: Certain batteries may cause leaking which can damage the
meter or cause the batteries to lose power sooner than normal. Replace
leaking batteries immediately.
Low meter batteries
The meter shows a battery icon
in the upper right corner of the display or a low battery
message to indicate the condition of the batteries.
The LOW BATTERY message first appears when you turn
the meter on and there is enough power for a minimum
of 100 more tests. Press to continue, but replace the
battery as soon as possible.
WARNING
LOW BATTERY
REPLACE BATTERY
SOON!
SEE USER HANDBOOK
Batteries
Your OneTouch® UltraLink® Meter uses two AAA alkaline
batteries. Replacement batteries can be found in most
stores where batteries are sold. Your meter comes with
two batteries already installed. Batteries should last a
minimum of two months at an average of four tests per
day when the BG Link mode is set to ON.
When your meter displays the DEAD BATTERY message,
there is not enough battery power remaining to perform
a test. You must install new batteries before using your
meter.
WARNING
DEAD BATTERY
REPLACE BATTERY
NOW!
SEE USER HANDBOOK
IMPORTANT: Use only AAA alkaline batteries with your meter.
• Do Not use rechargeable batteries.
• Do Not connect your meter to any mini USB charging device.
Use of an incorrect battery type may result in your meter providing fewer tests than normal
from when the battery icon or the LOW BATTERY screen first appears.
48
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49
2/23/10 12:03:04 PM
Replacing batteries
1. Remove the old batteries
Start with the meter off. Remove the battery cover by squeezing the tab on the side of the
cover. Pull up on the battery ribbon to lift both batteries out of the compartment.
4. Replace the cover
Insert the two battery cover tabs into the matching
holes, and push down until you hear the cover click into
place.
5. Dispose of batteries
Dispose of batteries according to your local environmental regulations.
m WARNING: To avoid a possible shock, Do Not change either battery while
the meter is connected to a computer with the interface cable.
NOTE: The meter will use more battery power when the BG link mode is set to ON or when
using the backlight.
2. Insert the new batteries
Insert two AAA alkaline batteries on top of the black
ribbon. Plus (+) and minus (–) signs inside the battery
compartment will guide you in placing the batteries.
If the meter does not power on after you have replaced
the meter batteries, check that the batteries are correctly
installed. If the meter still does not power on, call
Customer Service.
3. Check your meter settings
Removing the meter batteries will not affect your stored results. However, you may need to
re-set your meter settings. See pages 4-7.
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2/23/10 12:03:06 PM
Troubleshooting
Setting up your system
m WARNING: Failure to carefully follow the directions in this User Handbook
can lead to inaccurate test results.
RF communications problems
If a glucose test result on your meter was not received by your partner device, be sure to
check the following:
Understanding error and other messages
The OneTouch® UltraLink® Meter displays messages when there are problems with the test
strip, with the meter, or when your blood glucose levels are higher than 600 mg/dL or lower
than 20 mg/dL. Improper use may cause an inaccurate result without producing an error
message.
NOTE: WARNINGS/ERRORS, LOW GLUCOSE and HIGH GLUCOSE test results, and control
solution test results, are Not transmitted to your partner device.
• The BG link mode is set to ON.
• T he BG link mode is set to ASK AFTER BG TEST and that you confirmed you wanted to
transmit your test result to your partner device.
• The meter option feature on your partner device is turned on.
• Your meter ID is entered correctly into your partner device.
WARNING
LOW GLUCOSE
BELOW 20 mg/dL
• Your meter and partner device are within RF range. If not, try moving the devices closer
together.
What to do
This may require immediate treatment
according to your health care professional’s
recommendations.
Although this message could be due to a test error, it is
safer to treat first and then do another test.
• If there are other electronic devices nearby that might be affecting the BG link. If so, try
turning off those devices or move to another location.
m CAUTION: Changes or modifications not expressly approved by LifeScan could void
the user’s authority to operate the equipment.
IMPORTANT: If your glucose result was not transmitted to your partner device, you can
manually enter your glucose result into the partner device. See your partner device manual
for:
• manually entering your glucose results,
• troubleshooting RF communication,
• other problems with your partner device.
52
AW05946101/A_OT UltraLink_UH_Insides_R8.indd 52-53
What it means
You may have a very low blood glucose level (severe
hypoglycemia), lower than 20 mg/dL.
WARNING
HIGH GLUCOSE
What it means
You may have a very high blood glucose level (severe
hyperglycemia), over 600 mg/dL.
ABOVE 600 mg/dL
What to do
Re-check your glucose level. If the result is
HIGH GLUCOSE again, obtain and follow instructions
from your health care professional without delay.
53
2/23/10 12:03:07 PM
WARNING
TEMPERATURE
ERROR
OUT OF OPERATING
RANGE
SEE USER HANDBOOK
WARNING
ERROR 1
METER PROBLEM
CALL CUSTOMER
SERVICE
WARNING
ERROR 2
METER OR STRIP
PROBLEM
RETEST WITH A
NEW STRIP
What it means
Meter is too hot (above 111°F) or too cold (below 43°F)
to work correctly.
What to do
Wait a few minutes and insert a new test strip. If you
do not get another TEMPERATURE ERROR message, the
meter is now within the operating range.
What it means
There is a problem with the meter.
What to do
Do Not use the meter. Contact Customer Service.
WARNING
ERROR 3
METER WAS NOT
READY
RETEST WITH A
NEW STRIP
WARNING
ERROR 4
STRIP PROBLEM
SEE USER HANDBOOK
What it means
The sample was applied before the meter was ready.
What to do
Repeat the test with a new test strip. Apply a blood
or control solution sample only after APPLY BLOOD or
APPLY CONTROL appears on the display. If this message
continues to appear, contact Customer Service.
One of the following may apply:
What it means
You may have high glucose and have tested in
an environment near the low end of the system’s
operating temperature range (43–111°F).
What it means
Error message could be caused either by a used test
strip or a problem with the meter.
What to do
If you tested in a cool environment, repeat the test in a
warmer environment with a new test strip; see pages
25-28. If the error message appears again, contact
Customer Service.
What to do
Repeat the test with a new test strip; see pages 25-28.
If this message continues to appear, contact Customer
Service.
ERROR 4 information continues on next page.
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2/23/10 12:03:08 PM
WARNING
ERROR 4
STRIP PROBLEM
SEE USER HANDBOOK
or,
What it means
There may be a problem with the test strip. For
example, it may have been damaged or moved during
testing.
What to do
If you tested in a normal or warm environment, repeat
the test with a new test strip; see pages 25-28. If the
error message appears again, contact Customer Service.
or,
What it means
The sample was improperly applied.
What to do
If you applied the sample incorrectly, review pages on
blood application (see pages 25-28) or control solution
testing (see pages 42-46) and repeat the test with
a new test strip. If the error message appears again,
contact Customer Service.
WARNING
ERROR 5
STRIP PROBLEM OR
SAMPLE TOO SMALL
RETEST WITH A
NEW STRIP
104
mg/dL
06-17-10 11:15 AM
WARNING
or,
What it means
There may be a problem with the meter.
What to do
If the error message appears again, contact Customer
Service.
56
ERROR 4 information begins on previous page.
AW05946101/A_OT UltraLink_UH_Insides_R8.indd 56-57
LOW BATTERY
REPLACE BATTERY
SOON!
SEE USER HANDBOOK
What it means
The meter has detected a problem with the test
strip. Possible causes are test strip damage or an
incompletely filled confirmation window.
What to do
Repeat the test with a new test strip. Refer to
information on blood application (see pages 25-28) or
control solution testing (see pages 42-46).
What it means
Meter batteries are low but still have enough power to
perform a test.
What to do
When the battery icon first appears, there is enough
power for about 100 more tests if using alkaline
batteries. Test results will still be accurate, but replace
the batteries as soon as possible.
What it means
Meter batteries are low but still have enough power to
perform a test.
What to do
When the LOW BATTERY message first appears, there is
enough power for about 100 more tests if using alkaline
batteries. Test results will still be accurate, but replace
the batteries as soon as possible.
57
2/23/10 12:03:10 PM
WARNING
DEAD BATTERY
REPLACE BATTERY
NOW!
SEE USER HANDBOOK
What it means
Meter batteries do not have enough power to perform
a test.
What to do
Replace meter batteries.
METER SEND
CONNECTION PROBLEM
CHECK CONNECTED
PUMP
What it means
Your test result was not successfully transmitted to your
partner device.
RETRY
What to do
You may either retry to transmit the result or cancel
transmission. If you are having difficulty transmitting
your result see page 52 in the Troubleshooting section.
CANCEL
–––
58
ALL RESULTS
mg/dL
09-19 2:25 PM 104
--09-17 10:23 AM 112
09-16 11:44 AM LO C
1 of 4
MENU
What it means
Your meter was unable to recall this result. This result
will not be included in the result averages.
What to do
You can still perform a blood glucose test and get an
accurate result, but contact Customer Service to report
this occurrence.
What it means
No result in memory, such as the first time use of the
meter or after a download of all data to a computer.
or,
Your meter was unable to recall this result. This result
will not be included in the result averages.
What to do
You can still perform a blood glucose test and get an
accurate result. Contact Customer Service to report this
occurrence if this is not:
1. Your first time use of the meter, or
2. After you just downloaded results from your meter.
AW05946101/A_OT UltraLink_UH_Insides_R8.indd 58-59
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2/23/10 12:03:11 PM
Detailed Information about your system
Comparing meter and laboratory results
Test results with the OneTouch® UltraLink® Meter are plasma-calibrated. This helps you and
your health care professional to compare your meter results with laboratory tests. If you have
been using another type of meter—one that provides whole blood-calibrated results—you
may notice that your test results with the OneTouch® UltraLink® Meter are approximately
12% higher.
OneTouch® UltraLink® Meter test results and laboratory test results both are expressed in
plasma-equivalent units. However, your meter result may differ from your laboratory result
due to normal variation. Meter results can be affected by factors and conditions that do not
affect laboratory results in the same way.
Your OneTouch® UltraLink® Meter glucose value is considered accurate when it is
within ±20% of the laboratory measurement. There are some specific situations that could
cause a difference of more than ±20%:
• Y ou have eaten recently. After meals, the blood glucose level from a fingertip can be up to
70 mg/dL higher than blood drawn from a vein (venous sample) used for a lab test.1
For accuracy and precision data and for important information on limitations, see the insert
that comes with your test strips.
To maximize your chances of an accurate comparison between meter and laboratory results,
follow a few basic guidelines:
Before going to the lab
• Perform a control solution test to make sure the meter is working properly.
• Do Not eat for at least eight hours before you test your blood.
• Take your meter with you to the lab.
While at the lab
• Conduct your meter test within 15 minutes of the lab test.
• Use only fresh, capillary blood obtained from the fingertip.
• F ollow all instructions in this User Handbook for performing a blood glucose test with your
meter.
• Y our hematocrit (percentage of your blood that is red blood cells) is high (above 55%) or
low (below 30%).
• You are severely dehydrated.
• Y ou tested at a temperature near the low end of the operating range (43°F) and you get
a high glucose result (i.e., greater than 180 mg/dL). In this situation, repeat the test in a
warmer environment with a new test strip as soon as possible.
Sacks, D.B.: “Carbohydrates.” Burtis, C.A., and Ashwood, E.R. (ed.), Tietz Textbook of Clinical Chemistry.
Philadelphia: W.B. Saunders Company (1994), 959.
60
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Additional Health Care Professional Information for use in a Clinical Setting
Health care professionals should follow World Health Organization (WHO) recommendations
for Standard Precautions1, Centers for Disease Control and Prevention (CDC) recommended
practices as they pertain to diabetes care 2, 3, 4, and/or institutional infection control guidelines
designed to minimize the risk of transmission of blood borne pathogens when performing
blood glucose testing with multiple patients. These guidelines include hand hygiene and the
use of personal protective equipment such as disposable gloves when performing glucose
testing on patients.
Lancing Devices
• A single–use, retractable–needle, lancing device, such as the LifeScan OneTouch®
SureSoft® disposable lancing device, should be used for each patient skin puncture.
Dispose of single-use lancing devices in an appropriate container immediately after use.
m CAUTION: Do not use the durable multi-use lancing devices and disposable lancets
originally supplied with OneTouch® Brand Meters for the testing of multiple patients.
Durable multi-use lancing devices are not designed, and are not safe, to obtain samples
from more than one patient.
Meter
• O neTouch® UltraLink® can be used by health care professionals in a clinical setting. For
infection control purposes, it is not recommended that a OneTouch® UltraLink® Meter be
used by more than one patient in a multi-patient setting. Have each individual patient
bring in and use their own meters. Do Not share meters among users.
Test Strips
• OneTouch® Brand test strips are intended for single use only. They should be disposed of in
an appropriate container immediately after use.
Meter Disinfection
• Please visit www.OneTouchDiabetes.com for additional instructions on using OneTouch®
Meters in a clinical setting (e.g., long term care facilities, physician offices).
62
AW05946101/A_OT UltraLink_UH_Insides_R8.indd 62-63
H ealth-care facility recommendations for standard precautions (2007). World Health Organization, Geneva,
Switzerland. http://www.who.int/csr/resources/publications/EPR_AM2_E7.pdf
C DC. Transmission of Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring in
Long-Term--Care Facilities --- Mississippi, North Carolina, and Los Angeles County, California, 2003-2004.
Morbidity and Mortality Weekly Report (MMWR Weekly) March 11, 2005 / 54(09);220-223
Centers for Disease Control. Recommended Infection–Control and Safe Injection Practices to Prevent
Patient–to–Patient Transmission of Bloodborne Pathogens.
http://www.cdc.gov/hepatitis/Populations/PDFs/diabetes_handout.pdf accessed March 2009.
R utala WA, Weber DJ, et al. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Centers for
Disease Control and Prevention. www.cdc.org – accessed July 13, 2009.
63
2/23/10 12:03:11 PM
Technical specifications
Reported result range
Calibration
20–600 mg/dL
Plasma-equivalent
Sample
Fresh capillary whole blood
Test time
5 seconds
Radio Frequency (RF)
916.5MHz
Assay method
Glucose oxidase biosensor
Meter power source	Two replaceable AAA alkaline batteries. Expected battery life is
a minimum of 2 months at an average of 4 tests per day with
the BG link mode set to ON.
Unit of measure
mg/dL
Memory
1000 blood glucose or control solution test results
Automatic shutoff
2 minutes after last action
Size
3.6 x 2.2 x 0.8 inches
Separation distance
Minimum 12 inches**
from other wireless	**The use of a cell phone within 12 inches of your meter
(RF) devices	or partner device may interfere with the transmission of
blood glucose test results to the partner device. Other types
of electronic wireless devices that are in use nearby may also
prevent or delay the transmission of test results. Moving
away from or turning off these interfering devices may allow
communication.
Expected delay
Minimum 3 seconds
(latency range) in
Maximum 60 seconds
wireless (RF)
communication
Weight
Approximately 3 ounces, with batteries
Operating ranges	Temperature: 43–111°F
Relative humidity: 10–90%
Altitude: up to 10,000 feet
Hematocrit: 30–55%
Battery ratings
2 x 1.5 V d.c., 40 mA • (2 x AAA alkaline batteries)
direct current
Maximum 4 feet*
Wireless (RF)
operating range	*Your partner device must be within 4 feet of your meter to
receive a blood glucose test result.
64
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System accuracy
Analytical Performance Characteristics
The accuracy of the OneTouch® UltraLink® Blood Glucose Monitoring System was assessed by
comparing blood glucose test results on TBD subjects, with those obtained using a YSI Model
2300 Glucose Analyzer. TBD results were obtained for each subject (each tested in duplicate
with test strips from TBD separate lots). The following results were obtained:
System Accuracy Results for Glucose Concentrations <75 mg/dL
Within ±5 mg/dL
Within ±10 mg/dL
Within ±15 mg/dL†
# of
Subjects
# of
Tests
TBD
TBD
Slope Intercept
(mg/dL) (mg/dL)
TBD
TBD
95% CI
Slope
95% CI Std. Error
Intercept
(Sy.x)
TBD
TBD
TBD
R2
TBD
Precision
System Accuracy Results for Glucose Concentrations ≥75 mg/dL
Within ±5%
Within ±10%
Within ±15%
Within ±20%†
System Accuracy Results across the entire Glucose Range
Within ±15 mg/dL or ±20%
These results indicate that the OneTouch® UltraLink® Blood Glucose Monitoring System
meets the ISO 15197 requirements for accuracy.
†
Regression Statistics
Samples were tested in duplicate on each of TBD test strip lots. Results indicate that the
OneTouch® UltraLink® Meter compares well with a laboratory method.
Within Run Precision (TBD venous blood tests)
Target
Glucose
(mg/dL)
Mean
Glucose
(mg/dL)
Standard
deviation
(mg/dL)
Coefficient
of
variation (%)
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
TBD
ISO 15197 Minimum Acceptable Accuracy Requirements:
• T BD% of individual glucose results must fall within ±15 mg/dL of the YSI reference at
glucose concentrations <75 mg/dL
• T BD% of individual glucose results must fall within ±20% of the YSI reference at glucose
concentrations ≥75 mg/dL
66
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2/23/10 12:03:12 PM
Total Precision (TBD control solution tests)
Glucose
Levels
(mg/dL)
Mean
Glucose
(mg/dL)
Standard
deviation
(mg/dL)
Coefficient
of
variation(%)
Low
TBD
TBD
TBD
Normal
TBD
TBD
TBD
High
TBD
TBD
TBD
Results show that the greatest variability observed (of TBD lots tested) is TBD% or less.
Electrical and safety standards
This meter complies with CISPR 11: 2003, Class B (Radiated Only). Emissions of the energy
used are low and not likely to cause interference in nearby electronic equipment.
The meter has been tested for immunity to Level 3 electrostatic discharge as specified in
IEC 61000-4-2.
This meter has been tested for immunity to radio frequency interference over the frequency
range 80MHz to 2.5GHz at 3V/m as specified in IEC 61000-4-3.
Complies with IEC 61010-1 and IEC 61010-2-101.
If meter is used in a manner not specified in these instructions, the safety protection provided
by the meter may be impaired.
Rationale ISO: 61010-1
OUR COMMITMENT TO YOU:
Our goal is to provide you with quality health care products and dedicated customer service.
If you are not fully satisfied with this product or need assistance, contact your authorized
LifeScan representative 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.
Guarantee
LifeScan guarantees that the OneTouch® UltraLink® Meter will be free of defects in material
and workmanship for three years, valid from the date of purchase. The guarantee extends
only to the original purchaser and is not transferable.
68
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Index
AFTER MEAL AVG
AFTER MEAL flag
ALL RESULTS AVG
Alternate site testing procedure
Backlight
Batteries
Battery, icon on display
BEFORE MEAL AVG
BEFORE MEAL flag
BG link mode
Black start-up screen
Buttons on meter
Cable, interface
Cleaning your meter and lancing device
Code
Comment, adding or changing
Comment, reason for adding
Comments feature, turning off or on
Communication, RF
Confirmation window
Connecting to a computer
Control solution
Control solution, result range
Control solution, storing
Control solution, testing
Data port
Date format
Date setting
DEAD BATTERY message
70
AW05946101/A_OT UltraLink_UH_Insides_R8.indd 70-71
39
35
39
21
48
49, 57, 58
39
35
3, 14
40, 41
48
14, 43
36
34
v, vi, 52
2, 27, 45
40, 41
1, 42
45
47
42
2, 41
49, 58
Dehydration
Discard date, control solution
Discard date, test strips
Display check
Downloading results to a computer
Drop of blood
Error messages
Expiration date, control solution
Expiration date, test strips
Fingertip testing procedure
Flags feature, turning off or on
Forearm
Forearm or palm sampling, important information
Guarantee
Health care professional, additional information
HIGH GLUCOSE message
Hyperglycemia
Hypoglycemia
Infection, reduce the chance
Intended use
Interface cable
Kit components
Lab results, comparing with meter results
Lancet, disposal
Lancet, insert in lancing device
Lancet, protective disk
Lancing
Lancing device and cap
Lancing device, OneTouch® Clear Cap
Lancing device, depth setting
Language, choosing in set up
32
47
47
3, 14
40
20, 21
32, 53
47
47
19
17, 31, 24, 26
17
68
62
32, 33, 38, 53
32, 33
17, 18, 32
16
iv
40, 41
60
33
19, 23
16, 19, 23
20, 24
16, 19, 48
16, 23, 48
16, 20, 23
71
2/23/10 12:03:12 PM
LOW BATTERY message
LOW GLUCOSE message
MAIN MENU screen
Meal flag, adding or changing
Meal flag, reason for adding
Meter ID
mg/dL
mmol/L
PC communication mode
Plasma calibration
Partner device LINK feature
Radio Frequency (RF) communication
Repeated unexpected glucose results
Result averages, before or after meal
Result averages, 7-, 14-, and 30-day
Result screen
Result, last
Results, all
Results, reviewing past
RF (Radio Frequency) communication
Set up
Software, OneTouch® Diabetes Management
Start-up screen
Storing your control solution
Storing your meter
Storing your test strips
Symbols
System accuracy and precision
Technical specifications
Temperature
TEMPERATURE ERROR message
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49, 57
32, 38, 53
3, 37
35
34
2, 12
2, 7, 31, 64
41
60, 61
12
v, vi, 52
33
39
39
28
37
38
37
v, vi, 52
40
3, 14
47
47
47
inside back cover
66
64
13, 42, 47, 54, 60, 64
54
Testing procedure
Test strip, applying drop of blood
Test strip, confirmation window
Test strip, contact bars
Test strip, disposal
Time format
Time setting
Troubleshooting
Turning meter off
Turning meter on for reviewing results
Turning meter on for testing
Unexpected test results
Unit of measure
13
25
2, 27, 45
2, 14, 43
33
52
3, 37
3, 14
32
2, 7, 31, 64
73
2/23/10 12:03:12 PM
Leg1
Reminders
Time of day
Your target ranges
from your health care professional
Before breakfast
Before lunch or dinner
1 hour after meals
2 hours after meals
Between 2 a.m. and 4 a.m.
Patent information
The system described herein is covered by one or more of the following U.S. patents:
5,708,247, 5,951,836, 6,241,862, 6,284,125, 7,112,265, and 7,462,265. Use of the
monitoring device included herein is protected under one or more of the following U.S.
patents: 6,413,410, 6,733,655, 7,250,105, 7,468,125. Purchase of this device does not act
to grant a use license under these patents. Such a license is granted only when the device
is used with OneTouch® Ultra® Test Strips. No test strip supplier other than LifeScan is
authorized to grant such a license. The accuracy of results generated with LifeScan meters
using test strips manufactured by anyone other than LifeScan has not been evaluated by
LifeScan.
AW05946101/A_OT UltraLink_UH_Insides_R8.indd 74-75
2/23/10 12:03:12 PM

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Create Date                     : 2010:02:23 12:02:17-08:00
Modify Date                     : 2010:03:11 14:42:41-08:00
Metadata Date                   : 2010:03:11 14:42:41-08:00
Creator Tool                    : Adobe InDesign CS3 (5.0.4)
Thumbnail Format                : JPEG
Thumbnail Width                 : 256
Thumbnail Height                : 256
Thumbnail Image                 : (Binary data 5991 bytes, use -b option to extract)
Format                          : application/pdf
Producer                        : Adobe PDF Library 8.0
Trapped                         : False
Has XFA                         : No
Page Count                      : 41
Creator                         : Adobe InDesign CS3 (5.0.4)

EXIF Metadata provided by EXIF.tools