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btastat.com
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The BTA stat®
Test Instructions for Home Use
[Part 1 of 2]
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Caution:
U.S.A. Federal law restricts this device to sale and distribution by or
on the order of a physician, or to a clinical laboratory, and use is
restricted to, by or on the order of a physician. |
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THE
CONTENTS OF THIS SITE IS FOR INFORMATION ONLY. Not to be used for
performing assay. Please refer to most current package insert
accompanying your test kit.
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INTENDED
USE
The
BTA stat test is to be used only under the guidance of a doctor and
only by patients who have a history of bladder cancer. Your doctor
will use the information from this test along with information from
visual bladder examinations (Cystoscopy) to make decisions about your
medical care.
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WARNINGS
AND PRECAUTIONS
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Please
read the ENTIRE brochure before starting the test.
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Do
not use after the expiration date on the label. The expiration
date is located on the back of the test device pouch next to the
hour glass symbol ( 
). The use of
an expired device could cause a wrong answer.
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Store
the BTA stat test device at room temperature (60 - 85°F).
Do not freeze or refrigerate the device or store above 85°F as
this could cause a wrong answer.
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For
in vitro diagnostic use only (do not eat). Keep out of reach of
children.
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Collect
urine only in the plastic container provided by your doctor.
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Do
not use paper or foam cups or any other container as this could
cause a wrong answer.
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Do
not reuse the test device. Throw away after using once.
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Do
not use a test device if the package is damaged or opened.
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Touch
only the plastic part of the device. Touching any other part of
the device could damage the test device or cause a wrong answer.
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Use
a new dropper (provided with each device) for each test. Reusing a
dropper could cause a wrong answer.
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The
test has been designed to work with 5 drops of urine. The test
will not work correctly unless 5 fully formed drops of urine are
added to the sample well.
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MATERIALS
REQUIRED
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Materials
from home
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Materials
from your doctor
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Stopwatch, clock, or watch
that measures seconds |
Pen or pencil |
Collection cup (Plastic
only) |
BTA
stat test device |
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CONTENTS
OF THE BTA stat TEST PACKAGE |
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Collecting
and Storing Urine
Collect
urine in the clean plastic container provided by your doctor. Do not
use any other container for urine collection. Do not collect your
first morning urine sample. Collect urine anytime of the day after
your first morning urine. Test urine as soon after collection as
possible. If testing can not be performed right after sample
collection, cover the sample container and store urine at room
temperature (60 - 85°F) until tested. Store urine sample covered up
to 2 days if necessary.
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Before
starting the test: Record
the test device lot number and expiration date before removing the
device from the foil package. The lot number is located on the back of
the test device package next to the 
symbol. The expiration date is located on the back of the test device
package next to the hourglass symbol (
). The expiration date is shown in year (Y) - month (M) format, YYYY-MM;
2002-10 indicates that the device may be used until the last day of
October in the year 2002.
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CLICK
HERE FOR PART 2 OF INSTRUCTIONS FOR HOME USE
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