|  NOTIFICATION
FOR "mmol/L" COUNTRIES
URGENT: MEDICAL DEVICE CORRECTION
-- OneTouch™ Ultra™ and SmartScan™
Meters--
April 2005
If you use a OneTouch™ Ultra™
or SmartScan™ Meter, we want to make you aware of two
possible issues regarding these products.
1. CERTAIN OneTouch Ultra
Systems and all SmartScan Systems are designed to show results in
two different units of measure. When setting the time and date on
these meters, it is possible for you to accidentally change the
unit of measure. You may misunderstand your blood glucose
results if your meter is set to the wrong unit of measure. Your
meter's unit of measure should be set to "mmol/L,"
as shown on the meter display under the test result.
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In countries where "mmol/L" is the standard unit of
measure, LifeScan has chosen to replace--free of charge--all
SmartScan Meters, as well as those OneTouch Ultra Systems
that allow users to change the unit of measure. All
users of these products should contact LifeScan for instructions.
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2. For ALL OneTouch Ultra, and SmartScan
Meters, an event such as dropping the meter while in use can, on
very rare occasions, cause a brief power loss. As a result, the
meter may unexpectedly change the unit of measure and/or the code
number. Each time you test make sure your meter's unit of
measure is set to "mmol/L," and that
the code number on the meter's display matches the code number on
the test strip vial. This very rare power loss may also affect the
meter's 14- and/or 30-day averages. If your averages are not what you
expect, you should not rely on them.
 How
to Check Your Meter's Unit of Measure
Each time you turn on your meter, the unit of measure will appear on the display with the  symbol. The unit of measure will also appear under every test result.
If your
meter is set to the right unit of measure, "mmol/L" will
appear on the display. Your test result will include a decimal
point (Fig. 1, OneTouch Ultra example). Do
Not change this setting-this is the right unit of measure
for your country.
 If
your meter is set to the other unit of measure, "mg/dL" will
appear on the display. The test result will not include a
decimal point (Fig. 2, OneTouch Ultra example). Unless your doctor
has told you to use this unit of measure, do
not test your blood glucose. Contact LifeScan immediately
for assistance.
How to Check the Code Number
 When you insert a strip, your meter will display a code number. Every time you test your blood sugar, compare the code number on the meter display with the code number on the test strip vial (Fig. 3, OneTouch Ultra example). If the two code numbers match, you may begin testing. If they do not match, please refer to your test strip insert or Owner's Booklet for instructions on how to code the meter. If you need assistance, please contact LifeScan.
Always Check The Unit of Measure and Code Number Before Each Test
If you ever notice that:
- your unit of measure or 14- and/or 30-day averages are not what
you expect, or
- your code number has unexpectedly changed, contact LifeScan
for immediate assistance.
How To Contact LifeScan
Free Customer Service Number: 1800 801 497
(Mon-Fri:8.30am-5:00pm)
E-mail: Service@OneTouchAsia.com
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