Lifescan UltraSmart User manual

Blood Glucose Monitoring System
Meter and Electronic Logbook In One
Owner’s Booklet
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Owner’s Booklet
UltraSmart
®
™
Blood Glucose Monitoring System
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Serial Number
Lot Number
In Vitro Diagnostic Medical Device
Expiration Date Symbol
Sterilized by irradiation Symbol
SN
LOT
IVD
Symbols
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Dear OneTouch®UltraSmart™System Owner:
You have chosen one of the best blood glucose monitoring
systems available. This booklet has important information you
must know about the OneTouch®UltraSmart™Blood Glucose
Monitoring System. Read it carefully.
Blood glucose monitoring plays an important role in diabetes
control. A long-term study showed that keeping blood glucose
levels close to normal can reduce the risk of diabetes
complications by up to 60%*. The results you get with the
OneTouch®UltraSmart™System can help you and your healthcare
professional monitor and adjust your treatment plan to gain
better control of your diabetes.
Your OneTouch®UltraSmart™System requires a small drop of
blood (at least 1microlitre) and five seconds to provide you with
an accurate plasma-calibrated test result.
The OneTouch®UltraSmart™Meter also has a memory that allows
it to function as an “electronic logbook.” Now you can store such
vital everyday information as insulin and oral medication doses,
food intake, amount of exercise, illnesses, and other pertinent
data. You can use your OneTouch®UltraSmart™System simply to
test or to serve as a complete storehouse of information
regarding your diabetes treatment plan.
The makers guarantee that the OneTouch®UltraSmart™Meter
shall be free of defects in material and workmanship for a period
of three years. This guarantee is valid from the date of purchase.
The guarantee extends only to the original purchaser and is not
transferable.
*American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993).
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INTENDED USE: The OneTouch®UltraSmart™Blood Glucose
Monitoring System is intended to be used for the quantitative
measurement of glucose in fresh capillary whole blood. The
OneTouch®UltraSmart™System is intended for self-test use
outside the body (for in vitro diagnostic use) by people with
diabetes at home and health care professionals in a clinical
setting as an aid to monitor the effectiveness of diabetes control.
The OneTouch®UltraSmart™System should not be used for the
diagnosis of diabetes or testing of newborns.
The OneTouch®UltraSmart™Blood Glucose Monitoring System
provides the user with electronic logbook functions which serve
to store such data as insulin and oral medication doses, food
intake, amount of exercise, health information such as illnesses,
and other pertinent data. The meter includes a data port that
enables the user to download logbook data to a personal
computer.
CAUTION: Before using any product to test your blood glucose,
read all instructions and practice the test. Do all quality control
checks as directed and consult with a diabetes healthcare
professional. These recommendations apply to all blood glucose
monitoring systems and are supported by the American
Association of Diabetes Educators, the U.S. Food and Drug
Administration, and the Advanced Medical Technology Association.
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Important Information
• Severe dehydration and excessive water loss may cause false
low results. If you believe you are suffering from dehydration,
consult a healthcare professional immediately.
• Test results below 3.9 mmol/L mean low blood glucose
(hypoglycaemia). Test results greater than 13.3 mmol/L mean
high blood glucose (hyperglycaemia). If you get results below
3.9 mmol/L or above 13.3 mmol/L and do not have symptoms,
first repeat the test. If you have symptoms or continue to get
results that fall below 3.9 mmol/L or above 13.3 mmol/L, follow
the treatment advice of your healthcare professional.
• If you are experiencing symptoms that are not consistent with
your blood glucose test results and you have followed all
instructions described in the OneTouch®UltraSmart™Owner’s
Booklet, call your healthcare professional.
• A red blood cell count (haematocrit) that is very high (above
55%) or very low (below 30%) can cause false results.
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THE OneTouch®UltraSmart™SYSTEM . . . . . . . . . . . . . 1
OneTouch®UltraSmart™Meter . . . . . . . . . . . . . . . . 2
Navigation Buttons . . . . . . . . . . . . . . . . . . . . . . . . . 3
SmartButtons™. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
OneTouch®Ultra™Test Strips . . . . . . . . . . . . . . . . . 7
BEFORE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Checking the Display . . . . . . . . . . . . . . . . . . . . . . . . 9
Setting the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Coding the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Checking the System . . . . . . . . . . . . . . . . . . . . . . . 12
TESTING YOUR BLOOD . . . . . . . . . . . . . . . . . . . . . . . . 19
Preparing the OneTouch®UltraSoft™Sampler . . . 20
Fingertip Blood Sampling . . . . . . . . . . . . . . . . . . . 23
Arm Blood Sampling (“Alternate Site”) . . . . . . . . 24
Step-by-Step Test Procedure . . . . . . . . . . . . . . . . 28
Used Lancet Disposal . . . . . . . . . . . . . . . . . . . . . . 33
Special Messages . . . . . . . . . . . . . . . . . . . . . . . . . 34
COMPARING METER AND LABORATORY RESULTS . . 36
CARING FOR YOUR SYSTEM . . . . . . . . . . . . . . . . . . . . 38
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
OneTouch®UltraSoft™Sampler . . . . . . . . . . . . . . . 38
Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
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Table of Contents
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DISPLAY MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . 42
WARNINGS AND ERROR MESSAGES . . . . . . . . . . . . . 47
METER SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Entering Basic Set-up Mode . . . . . . . . . . . . . . . . . 54
Selecting Display Language . . . . . . . . . . . . . . . . . 55
Setting Date and Time . . . . . . . . . . . . . . . . . . . . . 56
CUSTOM METER SET-UP SEQUENCE . . . . . . . . . . . . . 58
Set-up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
YOUR METER LOGBOOK . . . . . . . . . . . . . . . . . . . . . . . 73
Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Rules for Adding Comments . . . . . . . . . . . . . . . . . 74
How to Add a Comment . . . . . . . . . . . . . . . . . . . . 74
Logbook Entries . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Using the SmartButtons™. . . . . . . . . . . . . . . . . . . 78
Rules for Logbook Entries . . . . . . . . . . . . . . . . . . . 80
Entering the Date and Time . . . . . . . . . . . . . . . . . 81
Adding, Changing, or Deleting
Logbook Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
OneTouch®UltraSmart™FastFacts™FEATURE . . . . .104
FastFacts™Menu . . . . . . . . . . . . . . . . . . . . . . . . . 105
Data Downloading . . . . . . . . . . . . . . . . . . . . . . . 118
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
GUARANTEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
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THE OneTouch®UltraSmart™SYSTEM
The OneTouch®UltraSmart™System uses the latest blood glucose
monitoring technology. It measures the glucose content of a blood
sample by means of an electrical current produced in the test strip
and sent to the meter for measurement. Test results are “plasma-
calibrated.” This makes it easier for you and your diabetes-care team
to compare your meter results with laboratory tests. If you have been
using another type of meter–one that provides whole-blood
results–you may notice that your test results with the OneTouch®
UltraSmart™System are about 12% higher.
The OneTouch®UltraSmart™Blood Glucose Monitoring System
consists of three main products: the OneTouch®UltraSmart™Meter,
OneTouch®Ultra™Test Strips, and OneTouch®Ultra™Control Solution.
These products have been designed, tested, and proven to work
together as a system to produce accurate blood glucose test results.
Use no other test strips or control solution with your meter.
Your system includes:
• OneTouch® UltraSmart™
Meter
• 10 OneTouch®Ultra™
Test Strips
• OneTouch®Ultra™
Control Solution
• OneTouch®UltraSoft™
Adjustable Blood Sampler
• OneTouch®UltraClear™Cap
• 10 OneTouch®UltraSoft™
Sterile Lancets
• Owner’s Booklet
• Carrying Case
• Quick Reference Guide
• Warranty Registration Card
• Two AAA Alkaline Batteries
(Installed)
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OneTouch®UltraSmart™Meter
2
TEST PORT
The meter turns on when
you insert test strip here.
DATA PORT
Used to download logbook
memory to a computer.
DISPLAY WITH
BACKLIGHT
Test results, messages,
symbols, and other data
appear here.
SmartButtons™
(See pages 4–5 for
description and use.)
OneTouch®Ultra™TEST STRIP
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Navigation Buttons
BACK BUTTON
(OFF BUTTON)
Goes back to previous display on certain
screens. Press and hold for two seconds to
turn off the meter.
ARROW BUTTON
Scroll through menus, code numbers,
and logbook.
OK BUTTON
(BACKLIGHT BUTTON)
Accept entries and move to next display.
Press and hold for two seconds to turn
on backlight.
Note: Press and release buttons. Do not
hold buttons down for an extended period
of time.
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The SmartButtons™are your keys to getting the most
out of your OneTouch®UltraSmart™Meter. They allow
you to enter information about your diabetes
management plan into the large logbook memory.
There are SmartButtons™for exercise, health,
medication, and food. The FastFacts™SmartButtons™
is used to view the records in the logbook memory.
You may press any SmartButtons™to turn on the
meter and move directly to the category.
SmartButtons™
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HEALTH SmartButton™
Enter information
on health.
EXERCISE SmartButton™
Enter exercise amount
and level.
MEDICATION
SmartButton™
Enter insulin and
diabetes pill information.
FOOD SmartButton™
Enter meal and snack
information.
FastFacts™SmartButton™
Review test results and
logbook memory.
Note: For complete information on using the
Exercise, Health, Medication, and Food
SmartButtons,™please see pages 78–103. See
pages 104–117 for more information on the
FastFacts™feature and the FastFacts™
SmartButton.
™
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Display Contrast
You can change the contrast of the meter display. To
make it darker, press and hold the Back button
and the “up” Arrow button . To make it
lighter, press and hold the Back button and
“down” Arrow button .
Scroll (move) up only.
Scroll down only.
Scroll up or down.
Scroll up or down.
No entry.
Shows where you are on the
display. Press OK to accept
highlighted area.
OK
SYMBOL MEANING
Display Symbols
These symbols guide you while using your meter:
– – –
▲
▼
HIGHLIGHT
▲
▼
▲▼
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OneTouch®Ultra™Test Strips
The OneTouch®UltraSmart™System measures the
amount of glucose in whole blood. Blood is applied to
the TOP EDGE of the OneTouch®Ultra™Test Strip and is
automatically drawn into the reaction cell where the
reaction takes place.
See pages 19–35, Testing Your Blood, for
complete instructions.
Contact Bars
Insert this end of the test strip,
contact bars facing up, into the
meter. Push it all the way in until it
will go no further.
Top Edge
Apply a drop of blood to the
narrow channel here in the top
edge of the test strip.
Confirmation Window
Check here to confirm if enough
blood has been applied.
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Important Test Strip Information
• Store test strip vials in a cool, dry place below 30°C. Keep away
from direct sunlight and heat. Do not refrigerate.
• Store test strips in their original vial only. To avoid damage or
contamination, do not transfer test strips to any other place.
• Do not use test strips beyond the expiration date printed on
the package since they may provide inaccurate results.
• After removing a test strip from the vial, replace the vial cap
immediately and close it tightly.
• With clean, dry hands, you may touch the test strip anywhere
on its surface.
• Use each test strip immediately after removing it from the vial.
• Count three months from the date you first open a new vial of
test strips and write this date on the vial label. Throw test
strips and vial away after this discard date.
• Apply only OneTouch®Ultra™Control Solution or a blood
sample to the test strip.
• Do not bend, cut, or modify test strips in any way.
• OneTouch®Ultra™Test Strips are for single use only. Never
reuse a test strip that has had either blood or control solution
applied to it.
• Refer to additional information in the OneTouch®Ultra™Test
Strip package.
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BEFORE TESTING
Checking the Display
Each time you turn the meter on, the display
background will quickly change from dark to
light and form the words “OneTouch
UltraSmart.” This tells you that the system is
performing several self-checks to confirm
that the meter is working properly. If, at any
time during the life of the meter, these
graphics appear to be different, call your
local LifeScan Customer Service office. See
back cover for contact information.
Setting the Meter
The OneTouch®UltraSmart™Meter is set at the
factory to display results in the English language
using millimole per litre (mmol/L) as the unit of
measure. The time and date are also factory-set. If
you are using the meter for the first time and simply
wish to test, insert a test strip into the test port and
begin by coding the meter. If you wish to change the
date, time, or language, see Meter Set-up, pages
54–57. To customize your meter, see Custom Meter
Set-up, pages 58–72.
UltraSmart
Note: It is important that the time of day is correct and that
your medication set up and mealtimes are set according to
your personal daily schedule. Otherwise, some FastFacts™
information will not be correct.
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Coding the Meter
Code numbers are used to calibrate the OneTouch®
UltraSmart™Meter with the OneTouch®Ultra™Test
Strips for accurate results. You must code the meter
before using it for the first time and then every time
you change to another vial of test strips. Each time
you test, check to be sure that the code number on
the meter display matches the code number on the
test strip vial.
Insert a OneTouch®Ultra™Test Strip to
turn on the meter. Push it all the way in
until it will go no further. “OneTouch
UltraSmart” will appear on the display
briefly.
CAUTION: Failure to code the meter correctly will cause
inaccurate test results.
Enter the Code Mode.
STEP 1
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Compare the code number on the meter
display with the code number on the test
strip vial. If the two code numbers match,
you may begin testing. If they do not
match, follow Step 4. (The first time you
turn the meter on, three dashes [---] will
appear, showing that there is no code
stored in the memory.)
Match the Code Numbers.
STEP 3
See the Code Number.
STEP 2
11
Note: The code number appears on the display
briefly. If you were unable to change the code in
time or entered a code number in error, press
the Back button to return to Step 3.
(Example)
(Example)
The code number will appear on the
display. (After every 25 tests the meter
will display the correct code number and
will prompt “Check Code Press OK.”
Press the OK button if the code
number is still correct.)
OK
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