INTENDED USE
cose monitoring system is an over the counter (OTC)
The C
®
N
LINK 2.4 wireless blood glucose monitoring system is an over the counter (OTC)
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e settings for the measurement of glucose in whole
device utilized by persons with diabetes in home settings for the measurement of glucose in whole
uld not be shared. The C
blood, and is for single-patient use only and should not be shared. The C
N
LINK 2.4 wireless
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r use with fresh capillary whole blood samples drawn
blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn
nsists of a C
from the fingertip and palm only. The system consists of a C
N
LINK 2.4 wireless blood
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N
glucose meter, C
control solutions.
N
test strips and C
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esting by persons with diabetes for the quantitative
C
N
test strips are intended for self-testing by persons with diabetes for the quantitative
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s from 20 to 600 mg/dL.
measurement of glucose in whole blood samples from 20 to 600 mg/dL.
us glucose solutions intended for use in self-testing by
The C
N
control solutions are aqueous glucose solutions intended for use in self-testing by
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people with diabetes as a quality control check.
cose monitoring system is intended to be used
The C
N
LINK 2.4 wireless blood glucose monitoring system is intended to be used
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MiniMed
®
670G pumps and facilitate transfer of
to transmit glucose values to MiniMed
of radio frequency communication.
information to CareLink
Software through use of radio frequency communication.
®
cose monitoring system is not intended for the diagnosis
The C
N
LINK 2.4 wireless blood glucose monitoring system is not intended for the diagnosis
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ntended for use on neonates.
of or screening for diabetes mellitus and is not intended for use on neonates.
N
IMPORTANT SAFETY INFORMATION
WARNINGS
Serious Illness
ood glucose testing may not be clinically appropriate
• Capillary (fingerstick or Alternative Site) blood glucose testing may not be clinically appropriate
, severe hypotension, hyperosmolar hyperglycemia,
when peripheral flow is decreased. Shock, severe hypotension, hyperosmolar hyperglycemia,
severe dehydration are examples of clinical conditions
diabetic ketoacidosis, and occurrence of severe dehydration are examples of clinical conditions
nt of glucose in peripheral blood.
that may adversely affect the measurement of glucose in peripheral blood.
1-3
tains small parts which could cause suffocation if
• Keep out of reach of children. This kit contains small parts which could cause suffocation if
accidentally swallowed.
nal
Talk to Your Health Care Professional
r Low Alerts on your meter.
• Before setting any Target ranges or High or Low Alerts on your meter.
n test results.
• Before changing your medication based on test results.
g/dL, follow medical advice immediately.
• If your blood sugar reading is under 50 mg/dL, follow medical advice immediately.
g/dL, wash and dry your hands well and repeat the test
• If your blood sugar reading is over 250 mg/dL, wash and dry your hands well and repeat the test
call your health care professional as soon as possible.
with a new strip. If you get a similar result, call your health care professional as soon as possible.
T) is appropriate for you.
• About whether Alternative Site Testing (AST) is appropriate for you.
Potential Biohazard
h soap and water and dry them well before and after
• Always wash and dry your hands well with soap and water and dry them well before and after
or test strips.
testing, handling the meter, lancing device or test strips.
for single person use. Do not share them with anyone
• The meter, lancing device and lancets are for single person use. Do not share them with anyone
se on multiple persons.
including other family members. Do not use on multiple persons.
4,5
rdous and can potentially transmit infectious diseases,
• All parts of this kit are considered biohazardous and can potentially transmit infectious diseases,
nd disinfection. For Cleaning and Disinfection
even after you have performed cleaning and disinfection. For Cleaning and Disinfection
instructions, please see page 63.
s intended for self-testing by a single patient. It must
• The lancing device provided with your kit is intended for self-testing by a single patient. It must
to the risk of infection.
not be used on more than one person due to the risk of infection.
®
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N
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LINK 2.4 wireless blood
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control solutions.
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®
630G or MiniMed
®
670G pumps and facilitate transfer of
WARNINGS
1-3
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•
•
• Always dispose of test strips and lancets as medical waste or as advised by your health care
• Always dispose of test strips and lancets as medical waste or as advised by your health care
professional. All products that come in contact with human blood should be handled as if
professional. All products that come in contact with human blood should be handled as if
LINK 2.4 wireless
capable of transmitting infectious diseases.
capable of transmitting infectious diseases.
PRECAUTIONS
PRECAUTIONS
•
•
Read your C
Read your C
Medtronic device user guide and all instructional materials provided in your meter kit before testing.
Medtronic device user guide and all instructional materials provided in your meter kit before testing.
Please follow all instructions for use and care exactly as described to help avoid inaccurate results.
Please follow all instructions for use and care exactly as described to help avoid inaccurate results.
• Examine product for missing, damaged, or broken parts. If the test strip bottle is open inside a new
• Examine product for missing, damaged, or broken parts. If the test strip bottle is open inside a new
box of strips, do not use those strips. For replacement parts, contact Customer Service. Please see
box of strips, do not use those strips. For replacement parts, contact Customer Service. Please see
back cover for contact information.
back cover for contact information.
• The C
• The C
control solutions.
control solutions.
• Always keep the C
• Always keep the C
after removing a test strip. The bottle is designed to keep the test strips dry. Avoid exposing meter and
after removing a test strip. The bottle is designed to keep the test strips dry. Avoid exposing meter and
test strips to excessive humidity, heat, cold, dust, and dirt. Exposure to room humidity from leaving the
test strips to excessive humidity, heat, cold, dust, and dirt. Exposure to room humidity from leaving the
bottle open or not storing the strips in their original bottle can damage your test strips. This could lead
bottle open or not storing the strips in their original bottle can damage your test strips. This could lead
to inaccurate results. Do not use a test strip that appears damaged or has been used.
to inaccurate results. Do not use a test strip that appears damaged or has been used.
• Check the expiration dates on your test strips and control solution. Do not use the test strips or control
• Check the expiration dates on your test strips and control solution. Do not use the test strips or control
solution if the expiration date printed on the bottle label and carton has passed. This can cause
solution if the expiration date printed on the bottle label and carton has passed. This can cause
inaccurate results. For the control solution, do not use if it has been 6 months since you first opened
inaccurate results. For the control solution, do not use if it has been 6 months since you first opened
the bottle. After first opening the bottle, write the 6-month discard date on the control solution label.
the bottle. After first opening the bottle, write the 6-month discard date on the control solution label.
• If your control solution test result is out of range, contact Customer Service. Please see back cover for
• If your control solution test result is out of range, contact Customer Service. Please see back cover for
contact information. Do not use the meter for blood glucose testing until you resolve this issue.
contact information. Do not use the meter for blood glucose testing until you resolve this issue.
• The meter has been designed to give accurate results at temperatures between 41° to 113°F. If you
• The meter has been designed to give accurate results at temperatures between 41° to 113°F. If you
are outside this range, you should not test. Whenever the meter is moved from one location to another,
are outside this range, you should not test. Whenever the meter is moved from one location to another,
allow approximately 20 minutes for the meter to adjust to the temperature of the new location before
allow approximately 20 minutes for the meter to adjust to the temperature of the new location before
performing a blood glucose test.
performing a blood glucose test.
• Do not perform a blood glucose test when the C
• Do not perform a blood glucose test when the C
computer.
computer.
• Use only approved cables or wall charger from the manufacturer or a 5V charger approved by a
• Use only approved cables or wall charger from the manufacturer or a 5V charger approved by a
certified body such as UL or TUV.
certified body such as UL or TUV.
• The C
• The C
of glucose per deciliter of blood).
of glucose per deciliter of blood).
Results in mg/dL will never have a decimal point;
Results in mg/dL will never have a decimal point;
O
O
Results in mmol/L will always have a decimal point.
Results in mmol/L will always have a decimal point.
O
O
Example:
Example:
Check your display screen to be sure the results are shown the right way. If not, please
Check your display screen to be sure the results are shown the right way. If not, please
O
O
see Customer Service contact information on the back cover of this user guide.
see Customer Service contact information on the back cover of this user guide.
• The C
• The C
20 mg/dL to 600 mg/dL.
20 mg/dL to 600 mg/dL.
For results under 20 mg/dL or over 600 mg/dL;
For results under 20 mg/dL or over 600 mg/dL;
O
O
о
о
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Use a new lancet each time you test because it is no longer sterile after use.
Use a new lancet each time you test because it is no longer sterile after use.
N
N
LINK 2.4 user guide, the lancing device package insert, your
LINK 2.4 user guide, the lancing device package insert, your
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®
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N
N
LINK 2.4 meter only works with C
LINK 2.4 meter only works with C
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EXT
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N
test strips in their original bottle. Tightly close the bottle immediately
test strips in their original bottle. Tightly close the bottle immediately
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EXT
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N
LINK 2.4 meter has been preset and locked to display results in mg/dL (milligrams
LINK 2.4 meter has been preset and locked to display results in mg/dL (milligrams
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93
93
.
.
or
or
N
N
LINK 2.4 wireless blood glucose monitoring system has a measuring range of
LINK 2.4 wireless blood glucose monitoring system has a measuring range of
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If your blood sugar reading is under 20 mg/dL, the "Follow Medical Advice Immediately" screen
If your blood sugar reading is under 20 mg/dL, the "Follow Medical Advice Immediately" screen
will display and the meter will beep twice. Contact your health care professional.
will display and the meter will beep twice. Contact your health care professional.
®
®
N
N
test strips and C
test strips and C
®
®
N
N
EXT
EXT
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N
N
LINK 2.4 meter is connected to a
LINK 2.4 meter is connected to a
EXT
EXT
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