29
INTENDED USE
The purpose of the control solution test
is to validate the performance of the
EVENCARE G3 Blood Glucose Monitoring
System using a testing solution with a
known range of glucose. A control test that
falls within the acceptable range indicates
the user’s technique is appropriate and
the meter and test strip are functioning
properly.
SUMMARY
The EVENCARE G3 Glucose Control
Solutions contain a measured amount of
glucose. These solutions are used with the
EVENCARE G3 Blood Glucose Test Strips
to confirm the meter and test strips are
working correctly.
CONTROL SOLUTIONS
SHOULD BE USED WHEN:
•
Using the meter for the first time.
• Using a new bottle or box of EVENCARE
G3 Blood Glucose Test Strips.
• At least once per week to verify that
the meter and test strips are working
properly together.
• The test strip bottle is left open
(for vial test strips).
• The meter is dropped.
• You suspect the meter and
test strips are not working
properly together.
• A patient’s test results do not agree
with how they feel.
• A patient’s readings appear to
be abnormally high or low.
• Test strips have been exposed to
a condition outside the specified
storage conditions.
• Practicing your testing technique.
CHEMICAL COMPOSITION
The EVENCARE G3 Glucose Control
Solution is an aqueous solution.
It contains D-glucose in concentrations of:
• Level 1 Control
38 mg/dL
• Level 3 Control
130 mg/dL
The non-reactive ingredients included in
the solution are buffers, stabilizer and
preservative.
WARNINGS AND
PRECAUTIONS
Control solutions are for in vitro diagnostic
use only and are not intended for human
consumption or injection.
• Shake the EVENCARE G3 Glucose
Control Solutions well before using.
• DO NOT apply a second drop of control
solution to the yellow sampling end of
the test strip.
• DO NOT smear the solution with the tip
of the bottle.
• Replace the cap of the control solution
immediately after use.
• Use only EVENCARE G3 Glucose Control
Solutions.
• Always check the expiration date.
• DO NOT use expired control solutions.
STORAGE AND HANDLING
• Control solutions should be stored
between 59°F – 86°F. DO NOT FREEZE
OR REFRIGERATE.
• DO NOT use past the expiration date.
• Discard any unused control solution
90 days after first opening or after
expiration date, whichever comes first.
CONTROL SOLUTION TEST
PROCEDURE
Materials needed to perform
control solution tests include:
• EVENCARE G3 Glucose Control
Solutions (Level 1 and Level 3).
• EVENCARE G3 Meter and
User’s Guide.
• EVENCARE G3 Blood Glucose
Test Strips.
Conduct test as follows:
1. Newly opened bottles of control
solutions must be marked with the
date opened on the space provided on
the control solution labels. Check the
expiration date of the control solutions
to make sure they have not expired.
Discard any unused control solutions 90
days after opening or after expiration
date, whichever comes first.
2. Refer to the User’s Guide for
instructions on how to run a control
solution test.
EXPECTED VALUES
The EVENCARE G3 Glucose Control
Solution testing should provide results
within the expected range indicated on
the test strip bottle (for vial test strips)
or the box (for foil-wrapped test strips).
If results are not within the acceptable
ranges, carefully review each step before
performing another test. Any error in
technique or meter use could cause results
to be outside the acceptable range. If the
control solution test results continue to
be outside the acceptable range and the
testing technique is correct, use a new
test strip from a previously unopened
bottle (for vial test strips) or the box
(for foil-wrapped test strips) of test
strips and repeat the test. If readings
are still not within the acceptable range,
please call Medline Technical Support at
1-866-274-2131.
CAUTION
If control solution results continue to
be out of range after all instructions
have been followed, the system is not
working properly. DO NOT use the system
to test blood glucose until you get a
control solution reading that is within the
acceptable range.
www.medline.com
©2016 Medline Industries, Inc.
Medline and EVENCARE are registered
trademarks of Medline Industries, Inc.
Manufactured in Taiwan for Medline
Industries, Inc., Mundelein, IL 60060 USA
Technical Support: 1-866-274-2131
(8:00 am– 5:00 pm CT / Monday – Friday)
To Reorder: 1-800-MEDLINE
RH16APB U.S. Patent # 7,655,128.
MPH3560
GLUCOSE CONTROL SOLUTIONS
EVENCARE
®
G
3
