19
SECTION
B
Assure
®
Prism Control Solution
IMPORTANT
Please read the following information and the User’s Manual for the
meter before using the Assure® Prism Control Solutions.
INTENDED USE
The Assure® Prism Control Solutions are red in color. The Assure®
Prism Control Solutions are for use with the Assure® Prism multi
meter and test strips to check that the meter and the test strips
are working together properly and that you are performing the test
correctly.
SUMMARY AND EXPLANATION
The Assure® Prism Control Solutions (Level 1 and 2) each contain a
specific amount of glucose that is used to test the meter and test
strips. The Assure® Prism Control Solutions are for self-testing
outside the body (In Vitro diagnostic use). The control solution may
be used to check the performance of the meter and test strip or your
testing technique. The test results obtained should fall within the
control solution range printed on the vial of test strips that you are
using.
CAUTION
The control solution ranges printed on the test strip vial are for
the Assure® Prism Control Solutions only. These ranges are used
to check the meter and test strip performance.
These are not recommended ranges for blood glucose level.
Use Assure® Prism Control Solution when:
• You want to practice the test procedure, without using blood
• You use the Assure® Prism multi meter for the first time
• You begin using a new vial of test strips
• You suspect that the meter or the test strips are not working
properly
• You think your test results are inaccurate or they do not reflect
how the patient feels
• You drop the meter
STORAGE AND HANDLING
Store the Assure® Prism Control Solution at temperatures between
46˚F-86˚F/8˚C-30˚C, tightly capped in the vial. It must be kept at
room temperature (68˚F-77˚F/20˚C-25˚C) at least 30 minutes before
testing to obtain correct results. Do not refrigerate or freeze the
control solution.
WARNING AND PRECAUTIONS
• The Assure® Prism Control Solution is for In Vitro diagnostic
use only.
• Use the Assure® Prism Control Solution only with the Assure®
Prism multi meter and test strips.
• Do not swallow or inject the control solution.
• Check the expiration date shown on the vial label. Do not use if
expired.
• Do not use beyond 3 months (90 days) after opening the vial.
Record the discard date (3 months from the day the vial was
opened) on the vial label.
• If the control test results are outside the range printed on the test
strip vial, do not use the system to test blood until you have
resolved the problem.
• Control Solution, meter and test strips must be stored at room
temperature (68˚F-77˚F/20˚C-25˚C) at least 30 minutes before
testing.
• The control solution contains a dye that may stain clothes.
TEST PROCEDURE
Step 1
Insert the test strip into the meter’s port. The applied blood
symbol will appear on the display after 3 seconds.
Step 2
Shake the control solution vial well before using.
Step 3
Discard one or two drops of control solution. Apply one drop of
control solution to the top of the control solution cap.
Step 4
Touch the narrow edge of the test strip to the control solution
until the meter beeps.
Step 5
Test results appear after the meter counts down to 1. Compare the
control solution result with the appropriate control solution range
printed on the test strip vial. If the result falls within the specified
range, you are ready to use the meter and test strips to test blood.
Step 6
Remove the used test strip from the meter’s test strip port. The
meter will turn off automatically. Please read the User’s Manual for
further information before using the Assure® Prism Control Solution.
INTERPRETATION OF OUT-OF-RANGE RESULTS
If the control solution test results do not fall within the expected
range printed on the test strip vial, repeat the test. Out-of-range
results may be due to one or more of the following factors:
• An error in the way you perform the test
• Expired or contaminated control solution
• Damaged or outdated test strips
• A problem with the meter
• Control solution is too warm or too cold
• Failure to shake the control solution vial vigorously or to
wipe the top of cap clean
IMPORTANT
If the control solution test results continue to fall outside the
range printed on the test strip vial, the system may not be
working properly. Do not use the system. If you are unable to
resolve the problem, contact customer service at 800.818.8877,
24 hours a day, 7 days a week, USA and Canada.
CHEMICAL COMPOSITION
Each 4 mL vial of Assure® Prism Control Solution contains:
• D-Glucose
• Preservative
• FD&C red dye
For questions / comments, contact Customer Service at 800.818.8877,
24 hours a day, 7 days a week, USA and Canada. In case of emergency,
consult the patient's healthcare provider or emergency medical
response.
Manufactured for
Minneapolis, MN 55439 USA
www.arkrayusa.com
© A R K R A Y U S A , I n c .
P/N 5122-03
PGK7E0006 REV3 04/2015
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