User guide

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®
INTENDED USE
The CONTOUR
®
NEXT LINK wireless blood glucose monitoring system
from Bayer (meter, test strips and control solution) is intended for
self-testing by persons with diabetes to monitor glucose concentrations
for the quantitative measurement of glucose in fresh capillary whole
blood drawn from the fingertip or palm. It is intended for in vitro
diagnostic use only . The clinical utility of this device is that it may
be used as an aid to monitor the effectiveness of a diabetes control
program.
The C
ONTOUR NEXT LINK wireless blood glucose monitoring system is
intended to be used to transmit glucose values to compatible Medtronic
devices and facilitate transfer of information to Medtronic CareLink
®
Software through use of radio frequency communication.
The CONTOUR NEXT LINK wireless blood glucose monitoring system
from Bayer is not intended for the diagnosis of or screening for diabetes
mellitus and it is not intended for use on neonates.
IMPORTANT SAFETY INFORMATION
WARNINGS
Serious Illness
• Capillary (fingerstick or Alternative Site) blood glucose
testing may not be clinically appropriate when peripheral
flow is decreased. Shock, severe hypotension, hyperosmolar
hyperglycaemia, diabetic ketoacidosis, and occurrence of
severe dehydration are examples of clinical conditions that
may adversely affect the measurement of glucose in peripheral
blood.
1-3
• Keep out of reach of children. This kit contains small parts which
could cause suffocation if accidentally swallowed.
Talk to Your Health Care Professional
• Before setting any Target ranges or High or Low Alerts on
your meter.
• Before changing your medication based on test results.
• If your blood sugar reading is under 2.8 mmol/L, follow medical
advice immediately.
• If your blood sugar reading is over 13.9 mmol/L, wash and dry
your hands well and repeat the test with a new strip. If you get
a similar result, call your health care professional as soon as
possible.
• About whether Alternative Site Testing (AST) is appropriate
for you.
Potential Biohazard
• Always wash and dry your hands well with soap and water before
and after testing, handling the meter, lancing device or test strips.
• The lancing device and lancets are for single person use. Do not
share them with anyone including other family members. Do not
use on multiple persons.
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• All parts of this kit are considered biohazardous and can
potentially transmit infectious diseases, even after you have
performed cleaning and disinfection. For instructions, please see
Cleaning and Disinfection, page 66.
• The MICROLET
®
2 lancing device is intended for self-testing by a
single patient. It must not be used on more than one person due
to the risk of infection.
•
Use a new MICROLET
®
lancet each time you test because it is
no longer sterile after use.
• 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 capable of
transmitting infectious diseases.
84766780_CntrNextLINK_UG_ENca_FpBp_v0.indd ii-iii84766780_CntrNextLINK_UG_ENca_FpBp_v0.indd ii-iii 3/27/13 7:58 AM3/27/13 7:58 AM