User guide

WARNING:
The meter and lancing device are for single patient
use. Do not share them with anyone including other
family members! Do not use on multiple patients!
1, 2
All parts of the kit are considered biohazardous and
can potentially transmit infectious diseases, even
after you have performed cleaning and disinfection.
For complete instructions on cleaning and disinfecting
your meter and lancing device, please see page 16.
IMPORTANT: 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. Contact Bayer
Diabetes Care Customer Service at 1-800-348-8100
(available 24 hours a day, 7 days a week) for replacement
parts.
Important
www.bayerdiabetes.com/us
I
Important
Need Help ? Bayer Diabetes Care: 1-800-348-8100
(available 24 hours a day, 7 days a week)
II
Indications for Use:
The CONTOUR
®
LINK Wireless Blood Glucose Monitoring
System is an over the counter (OTC) device utilized by
persons with diabetes in home settings for the
measurement of glucose in whole blood, and is for
single-patient use only and should not be shared. The
CONTOUR LINK Wireless Blood Glucose Monitoring
System is indicated for use with fresh capillary whole
blood samples drawn from the fi ngertip only.
CONTOUR test strips are intended for self-testing by
persons with diabetes for the quantitative measurement
of glucose in whole blood samples from 20 to 600 mg/dL.
The CONTOUR
®
LINK Wireless Blood Glucose Monitoring
Syste m is intend ed to b e u sed to tran smit glucose values
to Medtronic MiniMed Paradigm
®
Insulin Pumps or
Medtronic MiniMed Paradigm
®
REAL-Time Revel™ Insulin
Pumps through use of radio frequency communication.
The CONTOUR LINK
Wireless Blood Glucose Monitoring
System
is not intended for the diagnosis of or screening
for diabetes mellitus and is not intended for use on
neonates.
Important Safety Instructions
The MICROLET
®
2 lancing device included in this kit is not
intended for use on multiple patients by health care
professionals.
Neither the C
ONTOUR
®
LINK meter nor the MICROLET
®
2
lancing device or lancets should be used with more than
one person due to the risk of infection. The meter and
lancing device are for single patient use. Do not share
them with anyone including other family members. Do
not use on multiple patients.
After fi rst use, all parts of the C
ONTOUR
®
LINK kit are
considered contaminated with body fl uids (blood) and
could potentially transmit infectious diseases, even after
you have performed the recommended cleaning and
disinfection process.
Used test strips and lancets are possible biohazards and
must be disposed of properly.
Read your CONTOUR
®
LINK user guide, the MICROLET
®
2
lancing
device insert 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.
Always wash your hands well with soap and water before
and after handling the meter, lancing device, or test strips.
For more information see:
“FDA Public Health Notifi cation: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne
Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
Important Safety Instructions
Important Safety Instructions
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